Voltarol 25mg, 50mg Rapid Tablets

VOLTAROL Rapid Tablets 25 and 50 mg

(diclofenac potassium)

What you need to know about Voltarol Rapid Tablets

Your doctor has decided that you need this medicine to help treat your condition.

Please read this leaflet carefully before you start to take your medicine. It contains important information. Keep the leaflet in a safe place because you may want to read it again.

If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist.

This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet: 1. What Voltarol Rapid Tablets are, and what they are used for 2. Things to consider before you start to take Voltarol Rapid Tablets 3. How to take Voltarol Rapid Tablets 4. Possible side effects 5. How to store Voltarol Rapid Tablets 6. Further information What Voltarol Rapid Tablets are and what they are used for

Diclofenac potassium, the active ingredient in Voltarol Rapid Tablets, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation.

Voltarol Rapid Tablets relieve pain, reduce swelling and ease inflammation in: Rheumatoid arthritis, osteoarthrosis, acute gout, low back pain, ankylosing spondylitis Migraine Conditions affecting the joints and muscles such as sprains and strains, soft tissue sports injuries, frozen shoulder, dislocations, and fractures Conditions affecting the tendons for example, tendonitis, tenosynovitis, bursitis.

They are also used to treat pain and inflammation associated with orthopaedic, dental and other minor surgery.

Things to consider before you start to take Voltarol Rapid Tablets Some people MUST NOT take Voltarol Rapid Tablets. Talk to your doctor if: you think you may be allergic to diclofenac potassium, aspirin, ibuprofen or any other NSAID, or to any of the other ingredients of Voltarol Rapid Tablets. (These are listed at the end of the leaflet.) Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing problems, runny nose, skin rash or any other allergic type reaction you have now, or have ever had, a stomach (gastric) or duodenal (peptic) ulcer, or bleeding in the digestive tract (this can include blood in vomit, bleeding when emptying bowels, fresh blood in faeces or black, tarry faeces) you have had stomach or bowel problems after you have taken other NSAIDs you have severe heart, kidney or liver failure you are more than six months pregnant. You should also ask yourself these questions before taking Voltarol Rapid Tablets: Do you suffer from any stomach or bowel disorders including ulcerative colitis or Crohn's disease? Do you have kidney or liver problems, or are you elderly? Do you have a condition called porphyria? Do you suffer from any blood or bleeding disorder? If you do, your doctor may ask you to go for regular check-ups while you are taking these tablets. Have you ever had asthma? Are you breast-feeding? Do you have heart problems, or have you had a stroke, or do you think you might be at risk of these conditions (for example, if you have high blood pressure, diabetes, or high cholesterol or are a smoker)? Do you have Lupus (SLE) or any similar condition? Do you have an intolerance to some sugars such as sucrose? (Voltarol Rapid Tablets contain sucrose.)

If the answer to any of these questions is YES, discuss your treatment with your doctor or pharmacist because Voltarol Rapid Tablets might not be the right medicine for you.

Are you taking other medicines?

Some medicines can interfere with your treatment. Tell your doctor or pharmacist if you are taking any of the following:

Medicines to treat diabetes Anticoagulants (blood thinning tablets like warfarin) Diuretics (water tablets) Lithium (used to treat some mental problems) Methotrexate (for some inflammatory diseases and some cancers) Ciclosporin or tacrolimus (used to treat some inflammatory diseases and after transplants) Quinolone antibiotics (for infections) Any other NSAID or COX-2 (cyclo-oxgenase-2) inhibitor, for example aspirin or ibuprofen Mifepristone (a medicine used to terminate pregnancy) Cardiac glycosides (for example digoxin), used to treat heart problems Medicines known as SSRIs used to treat depression Oral steroids (an anti-inflammatory drug) Medicines used to treat heart conditions or high blood pressure, for example beta blockers or ACE inhibitors.

Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.

Pregnancy Are you pregnant or planning to become pregnant? Although not common, abnormalities have been reported in babies whose mothers have taken NSAIDs during pregnancy. You should not take Voltarol Rapid Tablets during the last 3 months of pregnancy as it may affect the baby’s circulation. Are you trying for a baby? Taking Voltarol Rapid Tablets may make it more difficult to conceive. You should talk to your doctor if you are planning to become pregnant, or if you have problems getting pregnant. Will there be any problems with driving or using machinery?

Very occasionally people have reported that Voltarol Rapid Tablets have made them feel dizzy, tired or sleepy. Problems with eyesight have also been reported. If you are affected in this way, you should not drive or operate machinery.

Other special warnings You should take the lowest dose of Voltarol for the shortest possible time, particularly if you are underweight or elderly. There is a small increased risk of heart attack or stroke when you are taking any medicine like Voltarol. The risk is higher if you are taking high doses for a long time. Always follow the doctor’s instructions on how much to take and how long to take it for. Whilst you are taking these medicines your doctor may want to give you a check-up from time to time. If you have a history of stomach problems when you are taking NSAIDs, particularly if you are elderly, you must tell your doctor straight away if you notice any unusual symptoms. Because it is an anti-inflammatory medicine, Voltarol may reduce the symptoms of infection, for example, headache and high temperature. If you feel unwell and need to see a doctor, remember to tell him or her that you are taking Voltarol. How to take Voltarol Rapid Tablets

The doctor will tell you how many Voltarol Rapid Tablets to take and when to take them. Always follow his/her instructions carefully. The dose will be on the pharmacist’s label. Check the label carefully. If you are not sure, ask your doctor or pharmacist. Keep taking your tablets for as long as you have been told, unless you have any problems. In that case, check with your doctor.

Take the tablets with or after food.

Voltarol Rapid Tablets are specially formulated to act quickly. Swallow the tablets whole with a drink of water. Do not crush or chew them.

The usual doses are:

Adults

75 mg to 150 mg daily divided into two or three doses. The number of tablets you take will depend on the strength the doctor has given you.

For the relief of migraine in adults:

Take 50 mg at the first signs of an attack. If the migraine has not gone after 2 hours, take another 50 mg. You can take further doses at intervals of 4 to 6 hours if necessary, but you must not take more than 200 mg in a day.

Elderly

Your doctor may advise you to take a dose that is lower than the usual adult dose if you are elderly. Your doctor may also want to check closely that the Voltarol Rapid Tablets are not affecting your stomach.

Children over 14

75 mg to 100 mg daily divided into two or three doses.

Voltarol Rapid Tablets are not recommended for children under 14. They are not recommended for the treatment of migraine in children of any age.

The doctor may also prescribe another drug to protect the stomach to be taken at the same time, particularly if you have had stomach problems before, or if you are elderly, or taking certain other drugs as well.

What if you forget to take a dose?

If you forget to take a dose, take one as soon as you remember. If it is nearly time for your next dose, though, just take the next dose and forget about the one you missed. Do not double up on the next dose to make up for the one missed. Do not take more than 150 mg (three 50 mg tablets or six 25 mg tablets) in 24 hours.

What if you take too many tablets?

If you, or anyone else, accidentally takes too much, tell your doctor or your nearest hospital casualty department. Take your medicine pack with you so that people can see what you have taken.

Possible side effects

Voltarol Rapid Tablets are suitable for most people, but, like all medicines, they can sometimes cause side effects.

Some side effects can be serious

Stop taking Voltarol Rapid Tablets and tell your doctor straight away if you notice:

Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or vomiting (being sick) Any sign of bleeding in the stomach or intestine, for example, when emptying your bowels, blood in vomit or black, tarry faeces Allergic reactions which can include skin rash, itching, bruising, painful red areas, peeling or blistering Wheezing or shortness of breath (bronchospasm) Swollen face, lips, hands or fingers Yellowing of your skin or the whites of your eyes Persistent sore throat or high temperature An unexpected change in the amount of urine produced and/or its appearance.

If you notice that you are bruising more easily than usual or have frequent sore throats or infections, tell your doctor.

The side effects listed below have also been reported.

Up to 1 in 10 people have experienced:

Stomach pain, heartburn, nausea, vomiting, diarrhoea, indigestion, wind, loss of appetite Headache, dizziness, vertigo Skin rash or spots Raised levels of liver enzymes in the blood.

Between 1 in 100,000 and 1 in 100 people have experienced:

Stomach ulcers or bleeding (there have been very rare reported cases resulting in death, particularly in the elderly) Drowsiness, tiredness Hypotension (low blood pressure, symptoms of which may include faintness, giddiness or light headedness) Skin rash and itching Fluid retention, symptoms of which include swollen ankles Liver function disorders, including hepatitis and jaundice. Isolated side-effects, reported in less than 1 in 100,000 people include:

Effects on the nervous system:

Tingling or numbness in the fingers, tremor, blurred or double vision, hearing loss or impairment, tinnitus (ringing in the ears), sleeplessness, nightmares, mood changes, depression, anxiety, mental disorders, confusion, hallucinations, malaise, disorientation and loss of memory, fits, headaches together with a dislike of bright lights, fever and a stiff neck, disturbances in sensation.

Effects on the stomach and digestive system:

Constipation, inflammation of the tongue, mouth ulcers, taste changes, lower gut disorders (including inflammation of the colon).

Effects on the heart, chest or blood:

Palpitations (fast or irregular heart beat), chest pain, hypertension (high blood pressure), inflammation of blood vessels (vasculitis), inflammation of the lung (pneumonitis), congestive heart failure, blood disorders (including anaemia), heart attack, stroke.

Effects on the liver or kidneys:

Kidney or liver disorders, presence of blood or protein in the urine.

Effects on skin or hair:

Serious skin rashes including Stevens-Johnson syndrome and Lyell’s syndrome and other skin rashes which may be made worse by exposure to sunlight.

Hair loss.

Other effects:

Inflammation of the pancreas, impotence.

Medicines such as diclofenac may be associated with a small increased risk of heart attack or stroke.

Do not be alarmed by this list - most people take Voltarol Rapid Tablets without any problems.

If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to give you a different medicine.

How to store Voltarol Rapid Tablets

Store in a dry place, below 30°C. Keep the tablets in their original pack.

Keep out of the reach and sight of children.

Do not take Voltarol Rapid Tablets after the expiry date which is printed on the outside of the pack.

If your doctor tells you to stop taking the tablets, please take any unused tablets back to your pharmacist to be destroyed. Do not throw them away with your normal household water or waste. This will help to protect the environment.

Further information

The sugar-coated tablets come in two strengths containing either 25 mg or 50 mg of the active ingredient, diclofenac potassium.

The tablets also contain the inactive ingredients silica, calcium phosphate, magnesium stearate, maize starch, sodium starch glycollate, povidone, microcrystalline cellulose, red iron oxide (E172), macrogol, sucrose, talc and titanium dioxide (E171).

The tablets come in blister packs containing 2, 3, 28 or 30 tablets. Some of the pack sizes may not be marketed.

The Product licence holder is Novartis Pharmaceuticals UK Limited trading as Geigy Pharmaceuticals Frimley Business Park Frimley Camberley Surrey GU16 7SR England Voltarol Rapid Tablets are released on to the market by Novartis Pharmaceuticals UK Ltd Wimblehurst Road West Sussex RH12 5AB England

This leaflet was revised in March 2009.

If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at Novartis Pharmaceuticals UK Ltd, telephone number 01276 698370.

VOLTAROL is a registered trade mark

Copyright Novartis Pharmaceuticals UK Limited

Read More:

Voltarol Joint Pain 12.5mg Tablets

1. Name Of The Medicinal Product

Voltarol® Joint Pain 12.5mg Tablets

Voltarol Pain-eze® Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 12.5 mg of diclofenac potassium.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

White capsule-shaped film-coated tablet

4. Clinical Particulars 4.1 Therapeutic Indications

Short term relief of headache, dental pain, period pain, rheumatic pain, muscular pain and backache and the symptoms of colds and flu, including fever.

4.2 Posology And Method Of Administration

Adults and children aged 14 years and over:

Initially two tablets, followed by one or two tablets every 4 to 6 hours as needed. No more than 6 tablets (75 mg) should be taken in any 24 hour period.

Voltarol Pain-eze Tablets should not be used for longer than 3 days. If symptoms persist or worsen consult your doctor.

The tablets should be swallowed whole with a drink of water.

Children and Adolescents:

Voltarol Pain-eze Tablets are not to be used in children and adolescents under 14 years of age.

4.3 Contraindications

• Known hypersensitivity to diclofenac or to any of the excipients. Patients in whom attacks of asthma, urticaria, angioedema, or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory drugs such as ibuprofen.

• Gastric or intestinal ulcer, bleeding or perforation.

• Pregnancy or breastfeeding (see section 4.6 Pregnancy and lactation).

• Severe hepatic, renal or cardiac failure (see section 4.4 Special warnings and special precautions for use).

• Concomitant use of anticoagulants and antiplatelets (see section 4.5 Interactions)

• Use with concomitant NSAIDs including cyclo-oxygenase-2 specific inhibitors (see section 4.5 Interactions)

4.4 Special Warnings And Precautions For Use

Warnings

Gastrointestinal bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs and may occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occur in patients receiving diclofenac, the medicinal product should be withdrawn.

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs, including diclofenac (see section 4.8 Undesirable effects). Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Diclofenac should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.

As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can occur in rare cases without earlier exposure to diclofenac.

In common with other NSAIDs, diclofenac may mask the signs and symptoms of infection due to its pharmacodynamic properties.

Precautions

General

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and Cardiovascular risks below).

The concomitant use of diclofenac with systemic NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable effects.

Caution is indicated in the elderly. In particular, it is recommended that the lowest effective dose be used in frail elderly patients or those with a low body weight.

Voltarol Pain-eze Tablets contain lactose and therefore are not recommended for patients with rare hereditary problems of galactose intolerance, of severe lactase deficiency or of glucose-galactose malabsorption.

Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAIDs therapy (see Renal effects below).

Pre-existing asthma

In patients with asthma, seasonal allergic rhinitis, swelling of nasal mucosa (i.e. nasal polypus), chronic obstructive pulmonary disease or chronic infection of the respiratory tract (especially if linked to allergic rhinitis-like symptoms), reactions to NSAIDs such as asthma exacerbations (so-called intolerance to analgesics / analgesics-asthma), angioedema or urticaria are more frequent than in other patients.

Gastrointestinal effects

As with all NSAIDs, close medical surveillance is imperative and caution should be exercised when prescribing diclofenac in patients with symptoms indicative of gastrointestinal (GI) disorders or with a history suggestive of gastric or intestinal ulceration, bleeding or perforation (see section 4.8 Undesirable effects). The risk of GI bleeding is higher with increasing NSAID doses and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation and in the elderly.

Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding). Caution is recommended in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, anti-platelet agents or selective serotonin-reuptake inhibitors (see section 4.5 Interaction with other medicinal products and other forms of interaction).

Close medical surveillance should also be exercised in patients with ulcerative colitis or Crohn's disease, as their condition may be exacerbated (see section 4.8 Undesirable effects).

Cardiovascular and cerebrovascular effects

Clinical trial and epidemiological data suggest that use of diclofenac, particularly at high doses (150 mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Available data do not suggest an increased risk with use of low dose diclofenac (up to 75 mg/day) up to 3 days for relief of pain or fever.

Hepatic effects

Close medical surveillance is required when prescribing diclofenac to patients with impaired hepatic function, as their condition may be exacerbated.

As with other NSAIDs, values of one or more liver enzymes may increase. In the case of diclofenac being prescribed for a prolonged period, regular monitoring of hepatic function is indicated as a precautionary measure. If abnormal liver function tests persist or worsen, if clinical signs or symptoms consistent with liver disease develop, or if other manifestations occur (e.g. eosinophilia, rash), diclofenac should be discontinued. Hepatitis may occur without prodromal symptoms.

Caution is called for when using diclofenac in patients with hepatic porphyria, since it may trigger an attack.

Renal effects

Caution is called for in patiens with impaired renal function, particularly the elderly and patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function and in those patients with substantial extracellular volume depletion.

As fluid retention and oedema have been reported in association with NSAID therapy, particular caution is called for in elderly patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function, and in those patients with substantial extracellular volume depletion from any cause, e.g. before or after major surgery (see section 4.3 Contraindications). Monitoring of renal function is recommended as a precautionary measure when using diclofenac in such cases. Discontinuation of therapy is usually followed by recovery to the pre-treatment state.

Haematological effects

Like other NSAIDs, diclofenac may temporarily inhibit platelet aggregation. Patients with defects of haemostasis should be carefully monitored.

Dermatological effects

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Voltarol Pain-eze Tablets should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

The label will state:

Read the enclosed leaflet before taking this medicine.

Do not take if you:

• have or have ever had a stomach ulcer, perforation or bleeding

• are allergic to diclofenac or any other ingredient of the product, acetylsalicylic acid, ibuprofen or other related painkillers

• are taking other NSAID painkillers, or aspirin

• are pregnant or breastfeeding

Speak to a pharmacist or your doctor before taking this product if you:

• have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, liver, heart, kidney or bowel problems

• are intolerant to some sugars

• are on a controlled potassium diet

• are a smoker

If symptoms persist or worsen, consult your doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Lithium and digoxin: Diclofenac may increase plasma concentrations of lithium and digoxin.

Diuretics and antihypertensive agents: Like other NSAIDs, concomitant use of diclofenac with diuretics or antihypertensive agents (e.g. beta-blockers, angiotensin converting enzyme (ACE) inhibitors) may cause a decrease in their antihypertensive effect. Therefore, the combination should be administered with caution and patients, especially the elderly, should have their blood pressure periodically monitored. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors due to the increased risk of nephrotoxicity. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels, which should therefore be monitored frequently (see section 4.4 Special warnings and special precautions for use).

Other NSAIDs including cyclooxygenase-2 selective inhibitors and corticosteroids:

Co-administration of diclofenac with aspirin or corticosteroids may increase the risk of gastrointestinal bleeding or ulceration. Avoid concomitant use of two or more NSAIDs (see section 4.4 Special warnings and special precautions for use).

Selective serotonin reuptake inhibitors (SSRIs) and anti-platelet agents: Increased risk of gastrointestinal bleeding (see section 4.4 Special warnings and special precautions for use).

Antidiabetics: Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect. However, there have been isolated reports of both hypoglycaemic and hyperglycaemic effects necessitating changes in the dosage of the antidiabetic agents during treatment with diclofenac. Monitoring of the blood glucose level is recommended as a precautionary measure during concomitant therapy.

Methotrexate: Caution is recommended when NSAIDs are administered less than 24 hours before or after treatment with methotrexate, since blood concentrations of methotrexate may rise and the toxicity of this substance be increased.

Ciclosporin and tacrolimus: Diclofenac, like other NSAIDs, may increase the nephrotoxicity of ciclosporin due to the effect on renal prostaglandins. Therefore, it should be given at doses lower than those that would be used in patients not receiving ciclosporin or tacrolimus.

Quinolone antibacterials: There have been isolated reports of convulsions which may have been due to concomitant use of quinolones and NSAIDs.

4.6 Pregnancy And Lactation

Pregnancy

The use of diclofenac in pregnant women has not been studied. Therefore, Voltarol Pain-eze Tablets should not be used during pregnancy except on the advice of a doctor.

Lactation

Like other NSAIDs, diclofenac passes into the breast milk in small amounts. Therefore, Voltarol Pain-eze Tablets should not be administered during breast feeding in order to avoid undesirable effects in the infant.

Fertility

As with other NSAIDs, the use of diclofenac may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of diclofenac should be considered.

4.7 Effects On Ability To Drive And Use Machines

Usually there is no effect at the recommended low-dose and short duration of treatment. However patients experiencing visual disturbances, dizziness, vertigo, somnolence or other central nervous system disturbances while taking diclofenac should refrain from driving or using machines.

4.8 Undesirable Effects

Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: common (

Available data do not suggest an increased risk with use of low dose diclofenac (up to 75 mg/day) for up to 3 days treatment for the relief of pain or fever.

Table 1

Blood and lymphatic system disorders

     

Very rare:

Thrombocytopenia, leukopenia, anaemia (including haemolytic anaemia and aplastic anaemia), agranulocytosis.

Immune system disorders

     

Rare:

Hypersensitivity, anaphylactic and anaphylactoid reaction (including hypotension and shock).

 

Very rare:

Angioneurotic oedema (including face oedema).

Psychiatric disorders

     

Very rare:

Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder.

Nervous system disorders

     

Common:

Headache, dizziness.

 

Rare:

Somnolence.

 

Very rare:

Paraesthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular accident.

Eye disorders

     

Very rare:

Visual disturbance, vision blurred, diplopia.

Ear and labyrinth disorders

     

Common:

Vertigo.

 

Very rare:

Tinnitus, hearing impaired.

Cardiac disorders

     

Very rare:

Palpitations, chest pain, cardiac failure, myocardial infarction.

Vascular disorders

     

Very rare:

Hypertension, vasculitis.

Respiratory, thoracic and mediastinal disorders

     

Rare:

Asthma (including dyspnoea).

 

Very rare:

Pneumonitis.

Gastrointestinal disorders

     

Common:

Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia.

 

Rare:

Gastritis, gastrointestinal haemorrhage, Haematemesis, diarrhoea, hemorrhagic melaena, gastrointestinal ulcer (with or without bleeding or perforation).

 

Very rare:

Colitis, (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis, glossitis, oesophageal disorder, diaphragm-like intestinal strictures, pancreatitis.

Hepatobiliary disorders

     

Common:

Transaminases increased.

 

Rare:

Hepatitis, jaundice, liver disorder.

 

Very rare:

Fulminant hepatitis

Skin and subcutaneous tissue disorders

     

Common:

Rash.

 

Rare:

Urticaria.

 

Very rare:

Bullous eruptions, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), dermatitis exfoliative, loss of hair, photosensitivity reaction, purpura, allergic purpura, pruritus.

Renal and urinary disorders

     

Very rare:

Acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

General disorders and administration site conditions

     

Rare:

Oedema.

Clinical trial and epidemiological data suggest that use of diclofenac (particularly at high doses 150 mg daily and in long-term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) ( see section 4.4 ).

4.9 Overdose

Symptoms

There is no typical clinical picture resulting from diclofenac overdosage. Overdose can cause symptoms such as vomiting, gastrointestinal haemorrhage, diarrhoea, dizziness, tinnitus or convulsions. In the event of significant poisoning, acute renal failure and liver damage are possible.

Therapeutic measures

Management of acute poisoning with NSAIDs essentially consists of supportive measures and symptomatic treatment. These should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression.

Special measures such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating NSAIDs due to the high protein binding and extensive metabolism.

Activated charcoal may be considered in case of a potentially toxic overdose, and gastric decontamination (e.g. vomiting, gastric lavage) in case of a potentially life-threatening overdose.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, acetic acid derivatives and related substances (ATC code M01A B05).

Voltarol Pain-eze Tablets contain diclofenac potassium, a non-steroidal anti-inflammatory drug (NSAID) with pronounced analgesic, anti-inflammatory and antipyretic properties. Inhibition of prostaglandin biosynthesis is considered fundamental to its mechanism of action. Prostaglandins play a major role in causing inflammation, pain and fever.

Diclofenac potassium in vitro does not suppress proteoglycan biosynthesis in cartilage at concentrations equivalent to those reached in humans.

5.2 Pharmacokinetic Properties

Absorption

Diclofenac is rapidly and completely absorbed. Following ingestion of two 12.5 mg coated tablets, mean peak plasma concentrations of 2.15 ?mol/L are attained after approximately 30 minutes (median Tmax).

The amount absorbed is in linear proportion to the size of the dose.

Since about half of diclofenac is metabolised during its first passage through the liver (“first pass” effect), the area under the concentration curve is about half as large following oral administration as it is following a parenteral dose of equal size.

Pharmacokinetic behaviour does not change after repeated administration. No accumulation occurs provided the recommended dosage intervals are observed.

Distribution

99.7% of diclofenac binds to serum proteins, mainly to albumin (99.4%). The apparent volume of distribution is 0.12 to 0.17 L/kg.

Diclofenac enters the synovial fluid, where maximum concentrations are measured 2 to 4 hours after peak plasma values have been reached. The apparent half-life for elimination from the synovial fluid is 3 to 6 hours. Two hours after reaching peak plasma levels, concentrations of the active substance are already higher in the synovial fluid than in the plasma, and they remain higher for up to 12 hours.

Biotransformation

Biotransformation of diclofenac takes place partly by glucuronidation of the intact molecule, but mainly by single and multiple hydroxylation and methoxylation, resulting in several phenolic metabolites, most of which are converted to glucuronide conjugates. Two of these phenolic metabolites are biologically active, but to a much lesser extent than diclofenac.

Elimination

Total systemic clearance of diclofenac from plasma is 263 ± 56 mL/min. The terminal half-life in plasma is 1 to 2 hours. Four of the metabolites, including the two active ones, also have short plasma half-lives of 1 to 3 hours. A fifth metabolite, 3'-hydroxy-4'-methoxy-diclofenac, has a much longer plasma half-life. This metabolite is virtually inactive.

About 60% of the administered dose is excreted in the urine as the glucuronide conjugate of the intact molecule and as metabolites, most of which are also converted to glucuronide conjugates. Less than 1% is excreted as unchanged substance. The rest of the dose is eliminated as metabolites through the bile in the faeces.

Characteristics in patients

No relevant age-dependent differences in the drug's absorption, metabolism, or excretion have been observed.

In patients suffering from renal impairment, no accumulation of the unchanged active substance can be inferred from the single dose kinetics when applying the usual dosage schedule. At a creatinine clearance of less than 10 mL/min, the calculated steady-state plasma levels of the hydroxy metabolites are about 4 times higher than in normal subjects. However, the metabolites are ultimately cleared through the bile.

In patients with chronic hepatitis or non-decompensated cirrhosis, the kinetics and metabolism of diclofenac are the same as in patients without liver disease.

5.3 Preclinical Safety Data

Preclinical data from acute and repeated dose toxicity studies, as well as from genotoxicity, mutagenicity, and carcinogenicity studies with diclofenac revealed no specific hazard for humans at the intended therapeutic doses. There was no evidence that diclofenac had a teratogenic potential in mice, rats or rabbits.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Core: silica, lactose, maize starch, sodium starch glycolate, polyvidone, microcrystalline cellulose, magnesium stearate.

Coating: hypromellose, titanium dioxide (E171), microcrystalline cellulose, stearic acid.

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

PVC/Polychlorotrifluoroethylene/PVC – Alu blister packs.

Polyamide/ALU/PVC – Alu blister packs.

Pack size: 10 or 18 tablets, not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

Novartis Consumer Health

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

8. Marketing Authorisation Number(S)

PL 00030/0073

9. Date Of First Authorisation/Renewal Of The Authorisation

17 June 2008

10. Date Of Revision Of The Text

29 September 2010.

LEGAL CATEGORY

P

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Voltarol Pain-eze® Tablets

1. Name Of The Medicinal Product

Voltarol Pain-eze® Tablets

Voltarol® Joint Pain 12.5mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 12.5 mg of diclofenac potassium.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

White capsule-shaped film-coated tablet

4. Clinical Particulars 4.1 Therapeutic Indications

Short term relief of headache, dental pain, period pain, rheumatic pain, muscular pain and backache and the symptoms of colds and flu, including fever.

4.2 Posology And Method Of Administration

Adults and children aged 14 years and over:

Initially two tablets, followed by one or two tablets every 4 to 6 hours as needed. No more than 6 tablets (75 mg) should be taken in any 24 hour period.

Voltarol Pain-eze Tablets should not be used for longer than 3 days. If symptoms persist or worsen consult your doctor.

The tablets should be swallowed whole with a drink of water.

Children and Adolescents:

Voltarol Pain-eze Tablets are not to be used in children and adolescents under 14 years of age.

4.3 Contraindications

• Known hypersensitivity to diclofenac or to any of the excipients. Patients in whom attacks of asthma, urticaria, angioedema, or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory drugs such as ibuprofen.

• Gastric or intestinal ulcer, bleeding or perforation.

• Pregnancy or breastfeeding (see section 4.6 Pregnancy and lactation).

• Severe hepatic, renal or cardiac failure (see section 4.4 Special warnings and special precautions for use).

• Concomitant use of anticoagulants and antiplatelets (see section 4.5 Interactions)

• Use with concomitant NSAIDs including cyclo-oxygenase-2 specific inhibitors (see section 4.5 Interactions)

4.4 Special Warnings And Precautions For Use

Warnings

Gastrointestinal bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs and may occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occur in patients receiving diclofenac, the medicinal product should be withdrawn.

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs, including diclofenac (see section 4.8 Undesirable effects). Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Diclofenac should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.

As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can occur in rare cases without earlier exposure to diclofenac.

In common with other NSAIDs, diclofenac may mask the signs and symptoms of infection due to its pharmacodynamic properties.

Precautions

General

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and Cardiovascular risks below).

The concomitant use of diclofenac with systemic NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable effects.

Caution is indicated in the elderly. In particular, it is recommended that the lowest effective dose be used in frail elderly patients or those with a low body weight.

Voltarol Pain-eze Tablets contain lactose and therefore are not recommended for patients with rare hereditary problems of galactose intolerance, of severe lactase deficiency or of glucose-galactose malabsorption.

Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAIDs therapy (see Renal effects below).

Pre-existing asthma

In patients with asthma, seasonal allergic rhinitis, swelling of nasal mucosa (i.e. nasal polypus), chronic obstructive pulmonary disease or chronic infection of the respiratory tract (especially if linked to allergic rhinitis-like symptoms), reactions to NSAIDs such as asthma exacerbations (so-called intolerance to analgesics / analgesics-asthma), angioedema or urticaria are more frequent than in other patients.

Gastrointestinal effects

As with all NSAIDs, close medical surveillance is imperative and caution should be exercised when prescribing diclofenac in patients with symptoms indicative of gastrointestinal (GI) disorders or with a history suggestive of gastric or intestinal ulceration, bleeding or perforation (see section 4.8 Undesirable effects). The risk of GI bleeding is higher with increasing NSAID doses and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation and in the elderly.

Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding). Caution is recommended in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, anti-platelet agents or selective serotonin-reuptake inhibitors (see section 4.5 Interaction with other medicinal products and other forms of interaction).

Close medical surveillance should also be exercised in patients with ulcerative colitis or Crohn's disease, as their condition may be exacerbated (see section 4.8 Undesirable effects).

Cardiovascular and cerebrovascular effects

Clinical trial and epidemiological data suggest that use of diclofenac, particularly at high doses (150 mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Available data do not suggest an increased risk with use of low dose diclofenac (up to 75 mg/day) up to 3 days for relief of pain or fever.

Hepatic effects

Close medical surveillance is required when prescribing diclofenac to patients with impaired hepatic function, as their condition may be exacerbated.

As with other NSAIDs, values of one or more liver enzymes may increase. In the case of diclofenac being prescribed for a prolonged period, regular monitoring of hepatic function is indicated as a precautionary measure. If abnormal liver function tests persist or worsen, if clinical signs or symptoms consistent with liver disease develop, or if other manifestations occur (e.g. eosinophilia, rash), diclofenac should be discontinued. Hepatitis may occur without prodromal symptoms.

Caution is called for when using diclofenac in patients with hepatic porphyria, since it may trigger an attack.

Renal effects

Caution is called for in patiens with impaired renal function, particularly the elderly and patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function and in those patients with substantial extracellular volume depletion.

As fluid retention and oedema have been reported in association with NSAID therapy, particular caution is called for in elderly patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function, and in those patients with substantial extracellular volume depletion from any cause, e.g. before or after major surgery (see section 4.3 Contraindications). Monitoring of renal function is recommended as a precautionary measure when using diclofenac in such cases. Discontinuation of therapy is usually followed by recovery to the pre-treatment state.

Haematological effects

Like other NSAIDs, diclofenac may temporarily inhibit platelet aggregation. Patients with defects of haemostasis should be carefully monitored.

Dermatological effects

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Voltarol Pain-eze Tablets should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

The label will state:

Read the enclosed leaflet before taking this medicine.

Do not take if you:

• have or have ever had a stomach ulcer, perforation or bleeding

• are allergic to diclofenac or any other ingredient of the product, acetylsalicylic acid, ibuprofen or other related painkillers

• are taking other NSAID painkillers, or aspirin

• are pregnant or breastfeeding

Speak to a pharmacist or your doctor before taking this product if you:

• have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, liver, heart, kidney or bowel problems

• are intolerant to some sugars

• are on a controlled potassium diet

• are a smoker

If symptoms persist or worsen, consult your doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Lithium and digoxin: Diclofenac may increase plasma concentrations of lithium and digoxin.

Diuretics and antihypertensive agents: Like other NSAIDs, concomitant use of diclofenac with diuretics or antihypertensive agents (e.g. beta-blockers, angiotensin converting enzyme (ACE) inhibitors) may cause a decrease in their antihypertensive effect. Therefore, the combination should be administered with caution and patients, especially the elderly, should have their blood pressure periodically monitored. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors due to the increased risk of nephrotoxicity. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels, which should therefore be monitored frequently (see section 4.4 Special warnings and special precautions for use).

Other NSAIDs including cyclooxygenase-2 selective inhibitors and corticosteroids:

Co-administration of diclofenac with aspirin or corticosteroids may increase the risk of gastrointestinal bleeding or ulceration. Avoid concomitant use of two or more NSAIDs (see section 4.4 Special warnings and special precautions for use).

Selective serotonin reuptake inhibitors (SSRIs) and anti-platelet agents: Increased risk of gastrointestinal bleeding (see section 4.4 Special warnings and special precautions for use).

Antidiabetics: Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect. However, there have been isolated reports of both hypoglycaemic and hyperglycaemic effects necessitating changes in the dosage of the antidiabetic agents during treatment with diclofenac. Monitoring of the blood glucose level is recommended as a precautionary measure during concomitant therapy.

Methotrexate: Caution is recommended when NSAIDs are administered less than 24 hours before or after treatment with methotrexate, since blood concentrations of methotrexate may rise and the toxicity of this substance be increased.

Ciclosporin and tacrolimus: Diclofenac, like other NSAIDs, may increase the nephrotoxicity of ciclosporin due to the effect on renal prostaglandins. Therefore, it should be given at doses lower than those that would be used in patients not receiving ciclosporin or tacrolimus.

Quinolone antibacterials: There have been isolated reports of convulsions which may have been due to concomitant use of quinolones and NSAIDs.

4.6 Pregnancy And Lactation

Pregnancy

The use of diclofenac in pregnant women has not been studied. Therefore, Voltarol Pain-eze Tablets should not be used during pregnancy except on the advice of a doctor.

Lactation

Like other NSAIDs, diclofenac passes into the breast milk in small amounts. Therefore, Voltarol Pain-eze Tablets should not be administered during breast feeding in order to avoid undesirable effects in the infant.

Fertility

As with other NSAIDs, the use of diclofenac may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of diclofenac should be considered.

4.7 Effects On Ability To Drive And Use Machines

Usually there is no effect at the recommended low-dose and short duration of treatment. However patients experiencing visual disturbances, dizziness, vertigo, somnolence or other central nervous system disturbances while taking diclofenac should refrain from driving or using machines.

4.8 Undesirable Effects

Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: common (

Available data do not suggest an increased risk with use of low dose diclofenac (up to 75 mg/day) for up to 3 days treatment for the relief of pain or fever.

Table 1

Blood and lymphatic system disorders

     

Very rare:

Thrombocytopenia, leukopenia, anaemia (including haemolytic anaemia and aplastic anaemia), agranulocytosis.

Immune system disorders

     

Rare:

Hypersensitivity, anaphylactic and anaphylactoid reaction (including hypotension and shock).

 

Very rare:

Angioneurotic oedema (including face oedema).

Psychiatric disorders

     

Very rare:

Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder.

Nervous system disorders

     

Common:

Headache, dizziness.

 

Rare:

Somnolence.

 

Very rare:

Paraesthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular accident.

Eye disorders

     

Very rare:

Visual disturbance, vision blurred, diplopia.

Ear and labyrinth disorders

     

Common:

Vertigo.

 

Very rare:

Tinnitus, hearing impaired.

Cardiac disorders

     

Very rare:

Palpitations, chest pain, cardiac failure, myocardial infarction.

Vascular disorders

     

Very rare:

Hypertension, vasculitis.

Respiratory, thoracic and mediastinal disorders

     

Rare:

Asthma (including dyspnoea).

 

Very rare:

Pneumonitis.

Gastrointestinal disorders

     

Common:

Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia.

 

Rare:

Gastritis, gastrointestinal haemorrhage, Haematemesis, diarrhoea, hemorrhagic melaena, gastrointestinal ulcer (with or without bleeding or perforation).

 

Very rare:

Colitis, (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis, glossitis, oesophageal disorder, diaphragm-like intestinal strictures, pancreatitis.

Hepatobiliary disorders

     

Common:

Transaminases increased.

 

Rare:

Hepatitis, jaundice, liver disorder.

 

Very rare:

Fulminant hepatitis

Skin and subcutaneous tissue disorders

     

Common:

Rash.

 

Rare:

Urticaria.

 

Very rare:

Bullous eruptions, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), dermatitis exfoliative, loss of hair, photosensitivity reaction, purpura, allergic purpura, pruritus.

Renal and urinary disorders

     

Very rare:

Acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

General disorders and administration site conditions

     

Rare:

Oedema.

Clinical trial and epidemiological data suggest that use of diclofenac (particularly at high doses 150 mg daily and in long-term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) ( see section 4.4 ).

4.9 Overdose

Symptoms

There is no typical clinical picture resulting from diclofenac overdosage. Overdose can cause symptoms such as vomiting, gastrointestinal haemorrhage, diarrhoea, dizziness, tinnitus or convulsions. In the event of significant poisoning, acute renal failure and liver damage are possible.

Therapeutic measures

Management of acute poisoning with NSAIDs essentially consists of supportive measures and symptomatic treatment. These should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression.

Special measures such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating NSAIDs due to the high protein binding and extensive metabolism.

Activated charcoal may be considered in case of a potentially toxic overdose, and gastric decontamination (e.g. vomiting, gastric lavage) in case of a potentially life-threatening overdose.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, acetic acid derivatives and related substances (ATC code M01A B05).

Voltarol Pain-eze Tablets contain diclofenac potassium, a non-steroidal anti-inflammatory drug (NSAID) with pronounced analgesic, anti-inflammatory and antipyretic properties. Inhibition of prostaglandin biosynthesis is considered fundamental to its mechanism of action. Prostaglandins play a major role in causing inflammation, pain and fever.

Diclofenac potassium in vitro does not suppress proteoglycan biosynthesis in cartilage at concentrations equivalent to those reached in humans.

5.2 Pharmacokinetic Properties

Absorption

Diclofenac is rapidly and completely absorbed. Following ingestion of two 12.5 mg coated tablets, mean peak plasma concentrations of 2.15 ?mol/L are attained after approximately 30 minutes (median Tmax).

The amount absorbed is in linear proportion to the size of the dose.

Since about half of diclofenac is metabolised during its first passage through the liver (“first pass” effect), the area under the concentration curve is about half as large following oral administration as it is following a parenteral dose of equal size.

Pharmacokinetic behaviour does not change after repeated administration. No accumulation occurs provided the recommended dosage intervals are observed.

Distribution

99.7% of diclofenac binds to serum proteins, mainly to albumin (99.4%). The apparent volume of distribution is 0.12 to 0.17 L/kg.

Diclofenac enters the synovial fluid, where maximum concentrations are measured 2 to 4 hours after peak plasma values have been reached. The apparent half-life for elimination from the synovial fluid is 3 to 6 hours. Two hours after reaching peak plasma levels, concentrations of the active substance are already higher in the synovial fluid than in the plasma, and they remain higher for up to 12 hours.

Biotransformation

Biotransformation of diclofenac takes place partly by glucuronidation of the intact molecule, but mainly by single and multiple hydroxylation and methoxylation, resulting in several phenolic metabolites, most of which are converted to glucuronide conjugates. Two of these phenolic metabolites are biologically active, but to a much lesser extent than diclofenac.

Elimination

Total systemic clearance of diclofenac from plasma is 263 ± 56 mL/min. The terminal half-life in plasma is 1 to 2 hours. Four of the metabolites, including the two active ones, also have short plasma half-lives of 1 to 3 hours. A fifth metabolite, 3'-hydroxy-4'-methoxy-diclofenac, has a much longer plasma half-life. This metabolite is virtually inactive.

About 60% of the administered dose is excreted in the urine as the glucuronide conjugate of the intact molecule and as metabolites, most of which are also converted to glucuronide conjugates. Less than 1% is excreted as unchanged substance. The rest of the dose is eliminated as metabolites through the bile in the faeces.

Characteristics in patients

No relevant age-dependent differences in the drug's absorption, metabolism, or excretion have been observed.

In patients suffering from renal impairment, no accumulation of the unchanged active substance can be inferred from the single dose kinetics when applying the usual dosage schedule. At a creatinine clearance of less than 10 mL/min, the calculated steady-state plasma levels of the hydroxy metabolites are about 4 times higher than in normal subjects. However, the metabolites are ultimately cleared through the bile.

In patients with chronic hepatitis or non-decompensated cirrhosis, the kinetics and metabolism of diclofenac are the same as in patients without liver disease.

5.3 Preclinical Safety Data

Preclinical data from acute and repeated dose toxicity studies, as well as from genotoxicity, mutagenicity, and carcinogenicity studies with diclofenac revealed no specific hazard for humans at the intended therapeutic doses. There was no evidence that diclofenac had a teratogenic potential in mice, rats or rabbits.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Core: silica, lactose, maize starch, sodium starch glycolate, polyvidone, microcrystalline cellulose, magnesium stearate.

Coating: hypromellose, titanium dioxide (E171), microcrystalline cellulose, stearic acid.

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

PVC/Polychlorotrifluoroethylene/PVC – Alu blister packs.

Polyamide/ALU/PVC – Alu blister packs.

Pack size: 10 or 18 tablets, not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

Novartis Consumer Health

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

8. Marketing Authorisation Number(S)

PL 00030/0073

9. Date Of First Authorisation/Renewal Of The Authorisation

17 June 2008

10. Date Of Revision Of The Text

29 September 2010.

LEGAL CATEGORY

P

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Voltarol Pain-eze Extra Strength 25mg Tablets

1. Name Of The Medicinal Product

Voltarol Pain-eze® Extra Strength 25mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains diclofenac potassium 25mg.

Chemical name: potassium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Pale red, round biconvex sugar-coated tablets.

4. Clinical Particulars 4.1 Therapeutic Indications

Short term relief of headache, dental pain, period pain, rheumatic pain, muscular pain and backache and the symptoms of colds and flu, including fever.

4.2 Posology And Method Of Administration

Adults and children aged 14 years and over:

Take one tablet every 4 to 6 hours as needed. No more than 3 tablets (75 mg) should be taken in any 24 hour period.

Voltarol Extra Strength 25mg Tablets should not be used for longer than 3 days. If symptoms persist or worsen consult your doctor.

The tablets should be swallowed whole with a drink of water.

Children and Adolescents:

Voltarol Extra Strength 25mg Tablets are not to be used in children and adolescents under 14 years of age.

4.3 Contraindications

• Known hypersensitivity to diclofenac or to any of the excipients. Patients in whom attacks of asthma, urticaria, angioedema, or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory drugs such as ibuprofen.

• Gastric or intestinal ulcer, bleeding or perforation.

• Pregnancy or breastfeeding (see section 4.6 Pregnancy and lactation).

• Severe hepatic, renal or cardiac failure (see section 4.4 Special warnings and special precautions for use).

• Concomitant use of anticoagulants and antiplatelets (see section 4.5 Interactions)

• Use with concomitant NSAIDs including cyclo-oxygenase-2 specific inhibitors (see section 4.5 Interactions)

4.4 Special Warnings And Precautions For Use

Warnings

Gastrointestinal bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs and may occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occur in patients receiving diclofenac, the medicinal product should be withdrawn.

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs, including diclofenac (see section 4.8 Undesirable effects). Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Diclofenac should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.

As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can occur in rare cases without earlier exposure to diclofenac.

In common with other NSAIDs, diclofenac may mask the signs and symptoms of infection due to its pharmacodynamic properties.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Precautions

General

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and Cardiovascular risks below).

The concomitant use of diclofenac with systemic NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable effects.

Caution is indicated in the elderly. In particular, it is recommended that the lowest effective dose be used in frail elderly patients or those with a low body weight.

Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAIDs therapy (see Renal effects below).

Pre-existing asthma

In patients with asthma, seasonal allergic rhinitis, swelling of nasal mucosa (i.e. nasal polypus), chronic obstructive pulmonary disease or chronic infection of the respiratory tract (especially if linked to allergic rhinitis-like symptoms), reactions to NSAIDs such as asthma exacerbations (so-called intolerance to analgesics / analgesics-asthma), angioedema or urticaria are more frequent than in other patients.

Gastrointestinal effects

As with all NSAIDs, close medical surveillance is imperative and caution should be exercised when prescribing diclofenac in patients with symptoms indicative of gastrointestinal (GI) disorders or with a history suggestive of gastric or intestinal ulceration, bleeding or perforation (see section 4.8 Undesirable effects). The risk of GI bleeding is higher with increasing NSAID doses and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation and in the elderly.

Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding). Caution is recommended in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, anti-platelet agents or selective serotonin-reuptake inhibitors (see section 4.5 Interaction with other medicinal products and other forms of interaction).

Close medical surveillance should also be exercised in patients with ulcerative colitis or Crohn's disease, as their condition may be exacerbated (see section 4.8 Undesirable effects).

Cardiovascular and cerebrovascular effects

Clinical trial and epidemiological data suggest that use of diclofenac, particularly at high doses (150 mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Available data do not suggest an increased risk with use of low dose diclofenac (up to 75 mg/day) up to 3 days for relief of pain or fever.

Hepatic effects

Close medical surveillance is required when prescribing diclofenac to patients with impaired hepatic function, as their condition may be exacerbated.

As with other NSAIDs, values of one or more liver enzymes may increase. In the case of diclofenac being prescribed for a prolonged period, regular monitoring of hepatic function is indicated as a precautionary measure. If abnormal liver function tests persist or worsen, if clinical signs or symptoms consistent with liver disease develop, or if other manifestations occur (e.g. eosinophilia, rash), diclofenac should be discontinued. Hepatitis may occur without prodromal symptoms.

Caution is called for when using diclofenac in patients with hepatic porphyria, since it may trigger an attack.

Renal effects

Caution is called for in patients with impaired renal function, particularly the elderly and patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function and in those patients with substantial extracellular volume depletion.

As fluid retention and oedema have been reported in association with NSAID therapy, particular caution is called for in elderly patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function, and in those patients with substantial extracellular volume depletion from any cause, e.g. before or after major surgery (see section 4.3 Contraindications). Monitoring of renal function is recommended as a precautionary measure when using diclofenac in such cases. Discontinuation of therapy is usually followed by recovery to the pre-treatment state.

Haematological effects

Like other NSAIDs, diclofenac may temporarily inhibit platelet aggregation. Patients with defects of haemostasis should be carefully monitored.

Dermatological effects

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Voltarol Pain-eze Extra Strength 25mg Tablets should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

The label will state:

Read the enclosed leaflet before taking this medicine.

Do not take if you:

• have or have ever had a stomach ulcer, perforation or bleeding

• are allergic to diclofenac or any other ingredient of the product, acetylsalicylic acid, ibuprofen or other related painkillers

• are taking other NSAID painkillers, or aspirin

• are pregnant or breastfeeding

Speak to a pharmacist or your doctor before taking this product if you:

• have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, liver, heart, kidney or bowel problems

• are intolerant to some sugars

• are on a controlled potassium diet

• are a smoker

• If symptoms persist or worsen, consult your doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Lithium and digoxin: Diclofenac may increase plasma concentrations of lithium and digoxin.

Diuretics and antihypertensive agents: Like other NSAIDs, concomitant use of diclofenac with diuretics or antihypertensive agents (e.g. beta-blockers, angiotensin converting enzyme (ACE) inhibitors) may cause a decrease in their antihypertensive effect. Therefore, the combination should be administered with caution and patients, especially the elderly, should have their blood pressure periodically monitored. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors due to the increased risk of nephrotoxicity. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels, which should therefore be monitored frequently (see section 4.4 Special warnings and special precautions for use).

Other NSAIDs including cyclooxygenase-2 selective inhibitors and corticosteroids:

Co-administration of diclofenac with aspirin or corticosteroids may increase the risk of gastrointestinal bleeding or ulceration. Avoid concomitant use of two or more NSAIDs (see section 4.4 Special warnings and special precautions for use).

Selective serotonin reuptake inhibitors (SSRIs) and anti-platelet agents: Increased risk of gastrointestinal bleeding (see section 4.4 Special warnings and special precautions for use).

Antidiabetics: Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect. However, there have been isolated reports of both hypoglycaemic and hyperglycaemic effects necessitating changes in the dosage of the antidiabetic agents during treatment with diclofenac. Monitoring of the blood glucose level is recommended as a precautionary measure during concomitant therapy.

Methotrexate: Caution is recommended when NSAIDs are administered less than 24 hours before or after treatment with methotrexate, since blood concentrations of methotrexate may rise and the toxicity of this substance be increased.

Ciclosporin and tacrolimus: Diclofenac, like other NSAIDs, may increase the nephrotoxicity of ciclosporin due to the effect on renal prostaglandins. Therefore, it should be given at doses lower than those that would be used in patients not receiving ciclosporin or tacrolimus.

Quinolone antibacterials: There have been isolated reports of convulsions which may have been due to concomitant use of quinolones and NSAIDs.

4.6 Pregnancy And Lactation

Pregnancy

The use of diclofenac in pregnant women has not been studied. Therefore, Voltarol Pain-eze Extra Strength 25mg Tablets should not be used during pregnancy except on the advice of a doctor.

Lactation

Like other NSAIDs, diclofenac passes into the breast milk in small amounts. Therefore, Voltarol Pain-eze Extra Strength 25mg Tablets should not be administered during breast feeding in order to avoid undesirable effects in the infant.

Fertility

As with other NSAIDs, the use of diclofenac may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of diclofenac should be considered.

4.7 Effects On Ability To Drive And Use Machines

Usually there is no effect at the recommended low-dose and short duration of treatment. However patients experiencing visual disturbances, dizziness, vertigo, somnolence or other central nervous system disturbances while taking diclofenac should refrain from driving or using machines.

4.8 Undesirable Effects

Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: common (

Available data do not suggest an increased risk with use of low dose diclofenac (up to 75 mg/day) for up to 3 days treatment for the relief of pain or fever

Table 1

Blood and lymphatic system disorders

     

Very rare:

Thrombocytopenia, leukopenia, anaemia (including haemolytic anaemia and aplastic anaemia), agranulocytosis.

Immune system disorders

     

Rare:

Hypersensitivity, anaphylactic and anaphylactoid reaction (including hypotension and shock).

 

Very rare:

Angioneurotic oedema (including face oedema).

Psychiatric disorders

     

Very rare:

Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder.

Nervous system disorders

     

Common:

Headache, dizziness.

 

Rare:

Somnolence.

 

Very rare:

Paraesthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular accident.

Eye disorders

     

Very rare:

Visual disturbance, vision blurred, diplopia.

Ear and labyrinth disorders

     

Common:

Vertigo.

 

Very rare:

Tinnitus, hearing impaired.

Cardiac disorders

     

Very rare:

Palpitations, chest pain, cardiac failure, myocardial infarction.

Vascular disorders

     

Very rare:

Hypertension, vasculitis.

Respiratory, thoracic and mediastinal disorders

     

Rare:

Asthma (including dyspnoea).

 

Very rare:

Pneumonitis.

Gastrointestinal disorders

     

Common:

Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia.

 

Rare:

Gastritis, gastrointestinal haemorrhage, Haematemesis, diarrhoea, hemorrhagic melaena, gastrointestinal ulcer (with or without bleeding or perforation).

 

Very rare:

Colitis, (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis, glossitis, oesophageal disorder, diaphragm-like intestinal strictures, pancreatitis.

Hepatobiliary disorders

     

Common:

Transaminases increased.

 

Rare:

Hepatitis, jaundice, liver disorder.

 

Very rare:

Fulminant hepatitis

Skin and subcutaneous tissue disorders

     

Common:

Rash.

 

Rare:

Urticaria.

 

Very rare:

Bullous eruptions, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), dermatitis exfoliative, loss of hair, photosensitivity reaction, purpura, allergic purpura, pruritus.

Renal and urinary disorders

     

Very rare:

Acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

General disorders and administration site conditions

     

Rare:

Oedema.

Clinical trial and epidemiological data suggest that use of diclofenac (particularly at high doses 150 mg daily and in long-term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

4.9 Overdose

Symptoms

There is no typical clinical picture resulting from diclofenac overdosage. Overdose can cause symptoms such as vomiting, gastrointestinal haemorrhage, diarrhoea, dizziness, tinnitus or convulsions. In the event of significant poisoning, acute renal failure and liver damage are possible.

Therapeutic measures

Management of acute poisoning with NSAIDs essentially consists of supportive measures and symptomatic treatment. These should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression.

Special measures such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating NSAIDs due to the high protein binding and extensive metabolism.

Activated charcoal may be considered in case of a potentially toxic overdose, and gastric decontamination (e.g. vomiting, gastric lavage) in case of a potentially life-threatening overdose.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: NSAID, ATC code: {M01 AB 05}

Voltarol Pain-eze Extra Strength 25mg Tablets contain the potassium salt of diclofenac, a non-steroidal anti-inflammatory drug with pronounced analgesic and anti-pyretic properties.

Voltarol Pain-eze Extra Strength 25mg Tablets have a rapid onset of action and are therefore suitable for the treatment of acute episodes of pain and inflammation.

In migraine attacks Diclofenac potassium has been shown to be effective in relieving the headache and in improving the accompanying symptom of nausea.

Diclofenac is a potent inhibitor of prostaglandin bio-synthesis and modulator of arachidonic acid release and uptake.

Diclofenac possesses clinically demonstrable analgesic, antipyretic and anti-inflammatory effects.

Diclofenac in vitro does not suppress proteoglycan biosynthesis in cartilage at concentrations equivalent to the concentrations reached in human beings.

5.2 Pharmacokinetic Properties

Absorption

Diclofenac is rapidly and completely absorbed from sugar-coated tablets. Food intake does not affect absorption.

Peak plasma concentration after one 50mg sugar-coated tablet was 3.9 mmol/l after 20-60 minutes. The plasma concentrations show a linear relationship to the size of the dose.

Diclofenac undergoes first-pass metabolism and is extensively metabolised.

Distribution

Diclofenac is highly bound to plasma proteins (99.7%), chiefly albumin (99.4%).

Elimination

The total systemic clearance of diclofenac in plasma is 263 + 56 ml/min (mean + SD).

The terminal half life in plasma is 1-2 hours.

Repeated oral administration of Voltarol Pain-eze Extra Strength 25mg Tablets for 8 days in daily doses of 50mg three times a day does not lead to accumulation of diclofenac in the plasma.

Approximately 60% of the dose administered is excreted in the urine in the form of metabolites, and less than 1% as unchanged substance. The remainder of the dose is eliminated as metabolites through the bile in the faeces.

Biotransformation

The biotransformation of diclofenac involves partly glucuronidation of the intact molecule but mainly single and multiple hydroxylation followed by glucuronidation.

In patients suffering from renal impairment, no accumulation of the unchanged active substance can be inferred from the single-dose kinetics when applying the usual dosage schedule. At a creatinine clearance of <10 ml/min the theoretical steady-state plasma levels of metabolites are about four times higher than in normal subjects. However, the metabolites are ultimately cleared through the bile.

Characteristics in patients:

The age of the patient has no influence on the absorption, metabolism, or excretion of diclofenac.

In the presence of impaired hepatic function (chronic hepatitis, non-decompensated cirrhosis) the kinetics and metabolism are the same as for patients without liver disease.

5.3 Preclinical Safety Data

Relevant information on the safety of Voltarol Pain-eze Extra Strength 25mg Tablets is included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Core

Aerosil 200 (silica aerogel)

Calcium phosphate, tribasic

Magnesium stearate

Maize starch

Polyvinylpyrrolidone K30, PH

Sodium carboxymethyl starch

Coating

Avicel PH 101 (cellulose)

Iron oxide, red 17266

Polyethylene glycol 8000

Polyvinylpyrrolidone K30, PH

Sucrose, cryst

Talc PH

Titanium dioxide, PH

6.2 Incompatibilities

None

6.3 Shelf Life

30 months.

6.4 Special Precautions For Storage

Store below 30°C and protect from moisture.

6.5 Nature And Contents Of Container

PVC/PE/PVdC blister strips containing 9 tablets.

6.6 Special Precautions For Disposal And Other Handling

Medicines should be kept out of the reach of children.

7. Marketing Authorisation Holder

Novartis Consumer Health UK Ltd

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

Trading as: Novartis Consumer Health or Zyma Healthcare.

8. Marketing Authorisation Number(S)

PL 00030/0054.

9. Date Of First Authorisation/Renewal Of The Authorisation

03/12/2010

10. Date Of Revision Of The Text

24/05/2011

LEGAL CATEGORY

P

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In the US, Isosorbide (isosorbide mononitrate systemic) is a member of the drug class miscellaneous uncategorized agents.

US matches:

Isosorbide Isosorbide Dinitrate Isosorbide Dinitrate Extended-Release Isosorbide Dinitrate/Hydralazine Isosorbide Mononitrate Isosorbide Mononitrate Sustained-Release Tablets Isosorbide dinitrate Oral, Sublingual Isosorbide Mononitrate Extended Release Isosorbide Dinitrate/Hydralazine Hydrochloride

UK matches:

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Isosorbide (BAN, JAN, USAN) is known as Isosorbide in the US.

Isosorbide Mononitrate

Isosorbide Mononitrate is reported as an ingredient of Isosorbide in the following countries:

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International Drug Name Search

Glossary

BANBritish Approved NameJANJapanese Accepted NameSPC Summary of Product Characteristics (UK)USANUnited States Adopted Name
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A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Beta-lactamase inhibitors block the activity of beta-lactamase enzymes.

Some species of bacteria produce beta-lactamase enzymes, which cleave the beta-lactam group in antibiotics, such as penicillin, that have a beta-lactam ring in their structure. In doing so the beta-lactamase enzyme inactivates the antibiotic and becomes resistant to that antibiotic. To avoid development of resistance, beta-lactamase inhibitors are administered with the beta-lactam antibiotics so the action of beta-lactamase is inhibited. This tends to widen the spectrum of antibacterial activity.

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Medical conditions associated with beta-lactamase inhibitors:

Appendectomy Aspiration Pneumonia Bacteremia Bacterial Infection Bone infection Bronchitis Deep Neck Infection Endometritis Epiglottitis Febrile Neutropenia Intraabdominal Infection Joint Infection Kidney Infections Melioidosis Meningitis Nosocomial Pneumonia Otitis Media Pelvic Inflammatory Disease Peritonitis Pneumonia Pneumonia with Cystic Fibrosis Septicemia Sinusitis Skin and Structure Infection Skin Infection Small Bowel Bacterial Overgrowth Strep Throat Surgical Prophylaxis Upper Respiratory Tract Infection Urinary Tract Infection Drug List: Augmentin-Xr-Extended-Release-Tablets Unasyn Zosyn Augmentin Augmentin-Es-600-Suspension Amoclan-Suspension Timentin

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Furosemide 20mg tablets

Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Index 1 What Furosemide tablets are and what they are used for 2 Before you take 3 How to take 4 Possible side effects 5 How to store 6 Further information What Furosemide tablets are and what they are used for

Furosemide tablets is one of a group of medicines called diuretics (water tablets).

Your doctor has prescribed Furosemide tablets to treat a condition called oedema where there is too much water in your body. This could be due to problems with your heart, kidneys, liver, blood vessels or high blood pressure. Furosemide helps your kidneys to get rid of the extra water that is not needed in your body.

Before you take Do not take Furosemide tablets if you: are allergic (hypersensitive) to furosemide, other sulphonamide related drugs or any of the other ingredients in Furosemide tablets (see section 6) have low blood pressure have severe kidney failure have liver cirrhosis (tiredness, weakness, water retention, feeling or being sick, loss of weight or appetite, yellowing skin or eyes, itch ) have any disorder of body chemicals (this may make you feel weak, apathetic or have muscle spasms) are not producing any urine have digitalis poisoning (feeling or being sick, high levels of potassium in the blood, slow, fast or irregular heart beats). Check with your doctor or pharmacist before taking Furosemide tablets if you have: or have had gout (severe joint pain) prostate trouble or difficulty passing urine low blood volume (hypovolaemia) or may have diabetes. If you are taking insulin, your doctor may need to adjust your insulin dosage.

Your doctor will want to monitor you, and may take blood for testing while you are taking this medicine.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:

drugs to lower blood pressure, such as ACE inhibitors non-steroidal anti-inflammatory drugs (NSAIDs) e.g. ibuprofen or naproxen digoxin for your heart curariform muscle relaxants (eg vercuronium) corticosteroids used to treat allergic reactions laxatives used over a long period of time certain treatments for asthma such as theophylline antibiotics for infections that affect your kidneys or ears (eg cefaclor, colistin, gentamicin, vancomycin) lithium for depression or mania aspirin for pain medicines to control diabetes such as insulin or tablets Pregnancy and breast-feeding

Speak to your doctor before you take Furosemide tablets if you are pregnant, thinking of getting pregnant, or breast-feeding.

Driving and using machines

Do not drive or operate machinery if you feel less alert after taking Furosemide tablets.

Important information about some of the ingredients in Furosemide tablets

Your medicine contains lactose; do not take Furosemide tablets if you have been told by your doctor that you have an intolerance to a sugar called lactose.

How to take

Always take Furosemide tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Swallow the tablets with a glass of water.

Doses: Adults and children over 12 years:
Water retention: the usual starting dose is 40mg in the morning, then 20mg a day or 40mg on alternate days. Up to 80mg a day may be given.
High blood pressure: 20-40mg twice a day. Elderly: may be reduced in this age group. Children under 12 years: 1-3mg per kg of bodyweight. If you take more than you should

If you take more medicine than your doctor has told you to, contact a doctor or your nearest hospital casualty department immediately and take your Furosemide tablets with you. Symptoms of an overdose include dehydration, changes in the levels of certain chemicals in the blood and low blood pressure.

If you forget to take the tablets

If you forget to take a dose, take another as soon as you remember. Then take your next dose at the normal time. Do not take double the amount to make up for a forgotten dose.

If you stop taking Furosemide tablets

Speak to your doctor before you stop taking Furosemide tablets.

Possible side effects

Like all medicines, Furosemide tablets can cause side effects, although not everybody gets them.

If you have any of the following side effects while taking your medicine tell your doctor immediately or go to hospital straight away: severe allergic reaction which may include a skin rash, itching, dermatitis, peeling skin, sensitivity to sunlight or sun lamps or fever inflammation of blood vessels (vasculitis, which may cause rash, fever and joint or muscle pains) or kidney inflammation, this may change the number of times you pass urine or you may see blood in your urine. You may have a fever, feel drowsy, or notice swelling e.g. of the ankles Tell your doctor or pharmacist if you notice any of the following side effects: Altered balance of fluid or chemicals in the body (e.g. sodium, potassium, chlorine and magnesium) causing a dry mouth, weakness, tiredness or drowsiness, restlessness, fits, muscle pain fatigue or cramps, low blood pressure, difficulty passing water, fast heart rate and feeling and being sick Blood: furosemide can occasionally cause changes in your blood; your doctor will perform regular blood tests to ensure no changes have occurred. The symptoms of these changes include anaemia, leading to tiredness and lethargy; unusual bleeding or bruising, blood slow to clot; ulcers in your throat, mouth or on your skin Metabolism: changes in levels of body chemicals (glucose, fats or calcium) Stomach and intestines: stomach irritation or feeling sick Pancreas: inflammation of the pancreas (pancreatitis) which may cause severe pains in your abdomen or back, nausea, vomiting and fever Muscles and joints: muscle tension Urinary and genital: kidney stones in premature babies Senses: hearing problems or ringing in your ears (tinnitus) Other: generally feeling unwell

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store

Keep out of the reach and sight of children.

Store below 25°C in a dry place. Protect from light

Do not use Furosemide after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information What Furosemide tablets contain Each tablet contains 20mg of the active substance furosemide (the ingredient that makes the tablets work). The other ingredients are lactose, magnesium stearate, maize starch, stearic acid. What Furosemide tablets look like and contents of the pack

Furosemide tablets are white, uncoated tablets. Pack size is 28.

Marketing Authorisation Holder and Manufacturer Actavis Barnstaple EX32 8NS UK

This leaflet was last revised in September 2008

Actavis Barnstaple EX32 8NS UK

50130006

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Definition of Borderline Personality Disorder: Borderline personality disorder (BPD) is a serious mental illness characterized by pervasive instability in moods, interpersonal relationships, self-image, and behavior.

Drugs associated with Borderline Personality Disorder

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Drugs associated with Seizure Prevention

The following drugs and medications are in some way related to, or used in the treatment of Seizure Prevention. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

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Gris-PEG Ultramicrosize Tablets

Pronunciation: GRIS-ee-oh-FUL-vin
Generic Name: Griseofulvin
Brand Name: Gris-PEG
Gris-PEG Ultramicrosize Tablets are used for:

Treating certain fungal infections (eg, ringworm) of the hair, skin, and nails. It may also be used for other conditions as determined by your doctor.

Gris-PEG Ultramicrosize Tablets are an antifungal agent. It works by making the skin more resistant to fungal growth.

Do NOT use Gris-PEG Ultramicrosize Tablets if: you are allergic to any ingredient in Gris-PEG Ultramicrosize Tablets you have liver failure or the blood disease porphyria you are pregnant

Contact your doctor or health care provider right away if any of these apply to you.

Before using Gris-PEG Ultramicrosize Tablets:

Some medical conditions may interact with Gris-PEG Ultramicrosize Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to a penicillin antibiotic (eg, amoxicillin) if you have liver disease or lupus

Some MEDICINES MAY INTERACT with Gris-PEG Ultramicrosize Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Barbiturates (eg, phenobarbital) because they may decrease Gris-PEG Ultramicrosize Tablets's effectiveness Anticoagulants (eg, warfarin), cabazitaxel, cyclosporine, oral contraceptives (birth control pills), or ulipristal because their effectiveness may be decreased by Gris-PEG Ultramicrosize Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Gris-PEG Ultramicrosize Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Gris-PEG Ultramicrosize Tablets:

Use Gris-PEG Ultramicrosize Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Gris-PEG Ultramicrosize Tablets by mouth with or without food. Swallow Gris-PEG Ultramicrosize Tablets whole. You may also crush Gris-PEG Ultramicrosize Tablets and sprinkle it onto 1 tablespoonful of applesauce. Mix the medicine with the applesauce and swallow the mixture right away without chewing. To clear up your infection completely, take Gris-PEG Ultramicrosize Tablets for the full course of treatment. Keep taking it even if you feel better in a few days. If you miss a dose of Gris-PEG Ultramicrosize Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Gris-PEG Ultramicrosize Tablets.

Important safety information: Gris-PEG Ultramicrosize Tablets may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Gris-PEG Ultramicrosize Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Be sure to take Gris-PEG Ultramicrosize Tablets for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. Do not drink alcohol while you are taking Gris-PEG Ultramicrosize Tablets. Gris-PEG Ultramicrosize Tablets may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Gris-PEG Ultramicrosize Tablets. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. It is important to practice good hygiene during and after use to prevent reinfection. Hormonal birth control (eg, birth control pills) may not work as well while you are using Gris-PEG Ultramicrosize Tablets. To prevent pregnancy, use an extra form of birth control (eg, condoms). Lab tests, including complete blood cell counts, liver function, and kidney function, may be performed while you use Gris-PEG Ultramicrosize Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Gris-PEG Ultramicrosize Tablets should be used with extreme caution in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: Do not take Gris-PEG Ultramicrosize Tablets if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Gris-PEG Ultramicrosize Tablets are found in breast milk. If you are or will be breast-feeding while you use Gris-PEG Ultramicrosize Tablets, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Gris-PEG Ultramicrosize Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; headache; nausea; stomach upset; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); butterfly-shaped rash on the face; confusion; fever, chills, or sore-throat; flu-like symptoms (eg, headache, joint pain); mental or mood changes; numbness, burning, or tingling of the hands or feet; red, swollen, blistered, or peeling skin; symptoms of liver problems (dark urine, pale stools, severe or persistent stomach pain, yellowing of the skin or eyes); white patches in the mouth.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Gris-PEG side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Gris-PEG Ultramicrosize Tablets:

Store Gris-PEG Ultramicrosize Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Gris-PEG Ultramicrosize Tablets out of the reach of children and away from pets.

General information: If you have any questions about Gris-PEG Ultramicrosize Tablets, please talk with your doctor, pharmacist, or other health care provider. Gris-PEG Ultramicrosize Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Gris-PEG Ultramicrosize Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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Pronunciation: ah-seet-ah-MIN-oh-fen/fen-ill-tole-OX-a-meen
Generic Name: Acetaminophen/Phenyltoloxamine
Brand Name: Examples include Lagesic and Myophen
Lagesic Controlled-Release Tablets are used for:

Treating mild to moderate aches and pains associated with headache, muscle and joint soreness, backache, menstrual cramps, colds and flu, sinusitis, toothache, and minor pain from arthritis, and to reduce fever. It may also be used for other conditions as determined by your doctor.

Lagesic Controlled-Release Tablets are an analgesic, antihistamine, and antipyretic combination. It works by blocking substances in the body that cause fever, pain, and inflammation. It also blocks histamine, which causes sneezing and itchy, watery eyes.

Do NOT use Lagesic Controlled-Release Tablets if: you are allergic to any ingredient in Lagesic Controlled-Release Tablets you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Lagesic Controlled-Release Tablets:

Some medical conditions may interact with Lagesic Controlled-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have bleeding problems, blood vessel problems in the brain, a blockage of the stomach or bowel, a blockage of the bladder, or difficulty urinating if you have lung problems (eg, asthma, emphysema, chronic obstructive pulmonary disease [COPD]), an enlarged prostate, glaucoma, kidney problems, or liver problems

Some MEDICINES MAY INTERACT with Lagesic Controlled-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Isoniazid, monoamine oxidase (MAO) inhibitors (eg, phenelzine), or sodium oxybate (GHB) because the risk of side effects may be increased Anticoagulants (eg, warfarin) because the risk of side effects, including the risk of bruising or bleeding, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lagesic Controlled-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Lagesic Controlled-Release Tablets:

Use Lagesic Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Lagesic Controlled-Release Tablets may be taken with or without food. Swallow Lagesic Controlled-Release Tablets whole. Do not break, crush, or chew before swallowing. If you miss a dose of Lagesic Controlled-Release Tablets and you are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Lagesic Controlled-Release Tablets.

Important safety information: Lagesic Controlled-Release Tablets may cause drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Lagesic Controlled-Release Tablets. Using Lagesic Controlled-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks. Lagesic Controlled-Release Tablets contains acetaminophen. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen. If it does or if you are uncertain, contact your doctor or pharmacist. Avoid taking medicines that cause drowsiness (eg, sedatives, tranquilizers) while taking Lagesic Controlled-Release Tablets. Lagesic Controlled-Release Tablets will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants. Do not exceed the recommended dosage or take Lagesic Controlled-Release Tablets for longer than prescribed without checking with your doctor. If you consume 3 or more alcohol-containing drinks every day, ask your doctor whether you should take Lagesic Controlled-Release Tablets or other pain relievers/fever reducers. Acetaminophen may cause liver damage. Alcohol use combined with Lagesic Controlled-Release Tablets may increase your risk for liver damage. If you are taking Lagesic Controlled-Release Tablets for pain or fever and your symptoms do not improve within 10 days or if they become worse, check with your doctor. Before you have any medical or dental treatments or surgery, tell the doctor or dentist that you are taking Lagesic Controlled-Release Tablets. Caution is advised when using Lagesic Controlled-Release Tablets in CHILDREN because they may be more sensitive to its effects. PREGNANCY and BREAST-FEEDING: It is unknown if Lagesic Controlled-Release Tablets can cause harm to the fetus. If you become pregnant, discuss with your doctor the benefits and risks of using Lagesic Controlled-Release Tablets during pregnancy. Lagesic Controlled-Release Tablets are excreted in breast milk. Do not breast-feed while taking Lagesic Controlled-Release Tablets. Possible side effects of Lagesic Controlled-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Drowsiness; dry mouth, nose, or throat; heartburn; nausea; thickening of mucus in the nose and throat; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; dark urine or pale stools; decreased urination; severe stomach pain; unusual bruising or bleeding; unusual tiredness; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Lagesic side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include abnormal behavior; dark urine; excessive sweating; extreme tiredness; fast or deep breathing; loss of consciousness; ringing in the ears; stomach pain; vomiting.

Proper storage of Lagesic Controlled-Release Tablets:

Store Lagesic Controlled-Release Tablets at room temperature, 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lagesic Controlled-Release Tablets out of the reach of children and away from pets.

General information: If you have any questions about Lagesic Controlled-Release Tablets, please talk with your doctor, pharmacist, or other health care provider. Lagesic Controlled-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Lagesic Controlled-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Lagesic resources Lagesic Side Effects (in more detail) Lagesic Use in Pregnancy & Breastfeeding Lagesic Drug Interactions Lagesic Support Group 1 Review for Lagesic - Add your own review/rating Compare Lagesic with other medications Cold Symptoms Headache Influenza Pain

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