La Prairie Cellular Radiance Emulsion
Generic Name: avobenzone, octinoxate, octisalate Dosage Form: creamCellular Radiance Emulsion

Active Ingredients                        Purpose

Avobenzone 3.0%                        Sunscreen

Octinoxate 7.5%                          Sunscreen

Octisalate  5.0%                        Sunscreen

Leukotriene modifiers

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.

Leukotriene modifiers prevent the action of leukotrienes in the body. Leukotrienes are released from mast cells, basophils and eosinophils. The release of leukotrienes causes airway constriction, increased mucus production, swelling and inflammation in the lungs. This presents as wheezing, shortness of breath in asthma.

Leukotriene modifiers include two types of agents:

Leukotriene-receptor antagonists prevent leukotrienes from binding to its receptors

Leukotriene synthesis inhibitors prevent synthesis of leukotrienes by blocking the enzyme, 5-lipoxygenase, which is necessary for the formation of leukotrienes.

Leukotriene modifiers are used to treat and prevent chronic asthma and allergic rhinitis. Generally they are used in combination with inhaled corticosteroids for best results.

See also

Medical conditions associated with leukotriene modifiers:

AsthmaAsthma, MaintenanceBronchospasm ProphylaxisCOPDHay Fever Drug List:SingulairZyflo

Boots Hayfever Relief Nasal Spray

Boots Hayfever Relief Nasal Spray

(Beclometasone Dipropionate)

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat hayfever. However, you still need to use it carefully to get the best results from it.

Keep this leaflet, you may need to read it again Ask your pharmacist if you need more information or advice You must contact a doctor if your symptoms worsen or do not improve within 10 days What this medicine is for

This medicine contains Beclometasone Dipropionate, which belongs to a group of medicines called corticosteroids, which act to reduce swelling (inflammation) in the nose.

It can be used to treat hayfever.

Before you use this medicine

This medicine can be used by adults aged 18 years and over. However, some people should not use this medicine or should seek the advice of their pharmacist or doctor first.

Do not use: If you are allergic to any of the ingredients If you are pregnant or breastfeeding, unless your doctor tells you to Talk to your pharmacist or doctor: If you think you have a nasal infection as well as hayfever If you have recently had steroid injections or have been taking steroid tablets for a long time If you take other medicines

This medicine is not expected to affect any medicines that you may be taking.

If you are unsure about interactions with any medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

How to use this medicine Directions for using the spray 1. Shake the bottle gently and remove the dust cap and lock-ring (if fitted). 2. A new spray, or one which has not been used for a few days, may not work the first time. You may need to prime the bottle by pumping the spray a few times until a fine mist is produced. To do this put your forefinger and middle finger on the collar either side of the nozzle and your thumb underneath the bottle. Keeping your thumb still, press down with your fingers to pump the spray. Hold the nozzle pointing away from you while you are doing this. If the spray still doesn’t work and you think it may be blocked, clean it as described further on in the leaflet. Never try to unblock it or enlarge the tiny spray hole with a pin or other sharp object because this will destroy the spray mechanism. 3. Blow your nose gently. To use close one nostril and put the nozzle in the other nostril. Tilt your head forward slightly and keep the bottle upright. Hold the bottle as shown. 4. Start to breathe in slowly through your nose. While you are breathing in squirt a spray of fine mist into your nostril by pressing down firmly on the collar with your fingers. Breathe out through your mouth. Repeat this step to take a second spray in the same nostril. Remove the nozzle from this nostril and breath out through your mouth. 5. Repeat step 3 and 4 for the other nostril.

After using the spray, wipe the nozzle carefully with a clean tissue or handkerchief, and replace the dust cap.

To clean the spray 1. Take the dust cap off. 2. Pull upwards on the white collar to remove the nozzle. 3. Soak the nozzle and dust cap in warm water for a few minutes and then rinse under a running tap. 4. Shake off the excess water and allow to dry in a warm, not hot, place. 5. Re-fit the nozzle. 6. ‘Prime’ the bottle if necessary by pumping the spray a few times until a fine mist is produced.

Your nasal spray should be cleaned at least once a week or more often if it gets blocked.

Adults of 18 years and over: Use two sprays in each nostril, twice a day (morning and evening). Don’t use more than 8 sprays in 24 hours. Once your symptoms are controlled try to use one spray in each nostril twice a day. If symptoms return, go back to using two sprays in each nostril.

For use in the nose only.

Do not use on children or adolescents under 18 years.

Do not use more than the amount recommended.

Do not use this medicine continuously for more than 3 months, unless your doctor tells you to.

If symptoms do not improve within 10 days talk to your doctor.

If you use too much or if anyone accidentally swallows some of the medicine: Talk to a doctor or pharmacist.

Possible side effects

Most people will not have problems, but some may get some of these:

Dry irritated nose and throat, nose bleeds Unpleasant taste and smell Rarely, perforation of the middle of the nose, raised pressure in the eye (glaucoma) Skin irritation – possibly caused by benzalkonium chloride in this medicine

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Store below 30°C. Do not refrigerate. Protect from light.

Throw away any medicine left 3 months after you open it.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

Each spray for nasal use contains Beclometasone Dipropionate 50 mcg which is the active ingredient.

As well as the active ingredient, the spray also contains dextrose anhydrous, polysorbate 80, dispersible cellulose, benzalkonium chloride, phenylethanol, purified water.

Who makes this medicine Manufactured for The Boots Company PLC Nottingham NG2 3AA by the Marketing Authorisation holder Generics (UK) Ltd Station Close Potters Bar Herts EN6 1TL

Leaflet prepared March 2008

If you would like any further information about this medicine, please contact

The Boots Company PLC Nottingham NG2 3AA

3439eMC

Cetamide

Generic Name: sulfacetamide ophthalmic (SUL fa SEET a mide off THAL mik) Brand Names: Bleph-10, Ocu-Sul 10, Ocu-Sul 15, Ocu-Sul 30, Sodium Sulamyd, Sulf-10, Sulfac 10%

What is Cetamide (sulfacetamide ophthalmic)?

Sulfacetamide ophthalmic is an antibiotic.

Sulfacetamide ophthalmic is used to treat bacterial infections of the eyes.

Sulfacetamide ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Cetamide (sulfacetamide ophthalmic)? Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear ducts.

Who should not use Cetamide (sulfacetamide ophthalmic)? Do not use sulfacetamide ophthalmic if you have a viral or fungal infection in your eye. It is used to treat infections caused by bacteria only.

Do not use sulfacetamide ophthalmic if you have ever had an allergic reaction to a sulfa-based drug.

It is not known whether sulfacetamide ophthalmic will harm an unborn baby. Do not use sulfacetamide ophthalmic without first talking to your doctor if you are pregnant. It is also not known whether sulfacetamide ophthalmic passes into breast milk. Do not use sulfacetamide ophthalmic without first talking to your doctor if you are breast-feeding a baby. How should I use Cetamide (sulfacetamide ophthalmic)?

Use sulfacetamide ophthalmic eyedrops or ointment exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before using your eyedrops or ointment.

To apply the eye drops:

Shake the drops gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye or drops in both eyes, repeat the process with about 5 minutes between drops.

To apply the ointment:

Hold the tube in your hand for a few minutes to warm it up so that the ointment comes out easily. Tilt your head back slightly and pull down gently on your lower eyelid. Apply a thin film of the ointment into your lower eyelid. Close your eye and roll your eyeball around in all directions for 1 to 2 minutes. If you are applying another eye medication, allow at least 10 minutes before the next application.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye. Do not use any eyedrop that is discolored or has particles in it. Store sulfacetamide ophthalmic at room temperature away from moisture and heat. Keep the bottle or tube properly capped. What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, wash the eye with water and call an emergency room or poison control center near you. If the drops or ointment have been ingested, drink plenty of fluid and call an emergency center for advice.

What should I avoid while using Cetamide (sulfacetamide ophthalmic)? Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye. Use caution when driving, operating machinery, or performing other hazardous activities. Sulfacetamide ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

If you wear contact lenses, ask your doctor if you should wear them during treatment with sulfacetamide ophthalmic. After applying the medication, wait at least 15 minutes before inserting contact lenses, unless otherwise directed by your doctor.

Do not use other eye drops or medications during treatment with sulfacetamide ophthalmic unless otherwise directed by your doctor. Cetamide (sulfacetamide ophthalmic) side effects

Serious side effects are not expected with this medication.

Commonly, some eye burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Cetamide (sulfacetamide ophthalmic)?

Do not use this medication with other eyedrops containing nitrates (e.g., silver nitrate).

Do not use other eye drops or medications during treatment with sulfacetamide ophthalmic unless otherwise directed by your doctor.

Drugs other than those listed here may also interact with sulfacetamide ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Cetamide resources Cetamide Side Effects (in more detail)Cetamide Use in Pregnancy & BreastfeedingCetamide Drug InteractionsCetamide Support Group0 Reviews for Cetamide - Add your own review/rating Bleph-10 Drops MedFacts Consumer Leaflet (Wolters Kluwer) Bleph-10 Prescribing Information (FDA) Isopto Cetamide Prescribing Information (FDA) Compare Cetamide with other medications ConjunctivitisTrachoma Where can I get more information? Your pharmacist has additional information about sulfacetamide ophthalmic written for health professionals that you may read.

See also: Cetamide side effects (in more detail)

Viroptic Drops
Pronunciation: trye-FLURE-i-deenGeneric Name: TrifluridineBrand Name: Viroptic

Ibuspray

Ibuspray may be available in the countries listed below.

UK matches:

Ibuspray (SPC)Ingredient matches for Ibuspray Ibuprofen

Ibuprofen is reported as an ingredient of Ibuspray in the following countries:

United Kingdom

International Drug Name Search

Glossary

SPC Summary of Product Characteristics (UK)Click for further information on drug naming conventions and International Nonproprietary Names.

Itorat

Itorat may be available in the countries listed below.

Ingredient matches for Itorat Itraconazole

Itraconazole is reported as an ingredient of Itorat in the following countries:

Japan

International Drug Name Search

Tobrex Ophthalmic Ointment
Generic Name: tobramycin Dosage Form: ophthalmic ointmentTobrex® (tobramycin ophthalmic ointment) 0.3% DESCRIPTION

TOBREX® (tobramycin ophthalmic ointment) 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections.

Each gram of TOBREX® (tobramycin ophthalmic ointment) 0.3% contains: Active: tobramycin 0.3% (3 mg). Preservative: chlorobutanol 0.5%. Inactives: mineral oil, white petrolatum.

Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens.

The chemical structure of tobramycin is :

Molecular formula:

C18H37N5O9

Molecular weight:

467.52

Chemical name:

0-{3-amino-3-deoxy-?-D-gluco-pyranosyl-(1?4) }-0-{2,6-diamino-2,3,6-trideoxy-?-D-ribohexo-pyranosyl-(1?6) }-2-deoxystreptamine.

CLINICAL PHARMACOLOGY

In Vitro Data : In vitro studies have demonstrated tobramycin is active against susceptible strains of the following microorganisms: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.

Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.

Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species. Bacterial susceptibility studies demonstrate that in some cases, microorganisms resistant to gentamicin retain susceptibility to tobramycin.

INDICATIONS AND USAGE

TOBREX® (tobramycin ophthalmic ointment) 0.3 % is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of TOBREX® (tobramycin ophthalmic ointment) 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.

CONTRAINDICATIONS

TOBREX® (tobramycin ophthalmic ointment) 0.3 % is contraindicated in patients with known hypersensitivity to any of its components.

WARNINGS

NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction to TOBREX® (tobramycin ophthalmic ointment) 0.3% occurs, discontinue use.

PRECAUTIONS

General. As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. Ophthalmic ointments may retard corneal wound healing.

Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy.

Patients should be advised not to wear contact lenses if they have signs and symptoms of ocular infections.

Information For Patients

Do not touch tube tip to any surface, as this may contaminate the ointment.

Do not use the product if the imprinted carton seals have been damaged, or removed.

Pregnancy Category B

Reproduction studies in three types of animals at doses up to thirty-three times the normal human systemic dose have revealed no evidence of impaired fertility or harm to the fetus due to tobramycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Because of the potential for adverse reactions in nursing infants from TOBREX® (tobramycin ophthalmic ointment) 0.3%, a decision should be made whether to discontinue nursing the infant or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 2 months has not been established.

Geriatric Use

No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.

ADVERSE REACTIONS

The most frequent adverse reactions to TOBREX® (tobramycin ophthalmic ointment) 0.3% are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than three of 100 patients treated with TOBREX® (tobramycin ophthalmic ointment) 0.3%. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported from TOBREX® (tobramycin ophthalmic ointment) 0.3% therapy; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration. In clinical trials, TOBREX® (tobramycin ophthalmic ointment) 0.3 % produced significantly fewer adverse reactions (3.7%) than did GARAMYCIN® Ophthalmic Ointment (10.6%).

OVERDOSAGE

Clinically apparent signs and symptoms of an overdose of TOBREX® (tobramycin ophthalmic ointment) 0.3% (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients.

DOSAGE AND ADMINISTRATION

In mild to moderate disease, apply a half-inch ribbon into the affected eye(s) two or three times per day. In severe infections, instill a half-inch ribbon into the affected eye(s) every three to four hours until improvement, following which treatment should be reduced prior to discontinuation.

How to Apply TOBREX® (tobramycin ophthalmic ointment) 0.3%:

1. Tilt your head back.

2. Place a finger on your cheek just under your eye and gently pull down until a ''V'' pocket is formed between your eyeball and your lower lid.

3. Place a small amount (about 1/2 inch) of TOBREX® (tobramycin ophthalmic ointment) 0.3% in the ''V'' pocket. Do not let the tip of the tube touch your eye.

4. Look downward before closing your eye.

HOW SUPPLIED

3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap (NDC 0065-0644-35), containing tobramycin 0.3% (3 mg/g).

Storage: Store at 2°- 25°C (36°- 77°F).

Rx Only

© 2002, 2008 Alcon, Inc.

Revised: July 2008

Manufactured for:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

Manufactured by:

S.A. ALCON-COUVREUR N.V.

Puurs, Belgium

44280-1

PRINCIPAL DISPLAY PANEL

NDC 0065-0644-35  Alcon®

Tobrex®

(tobramycin ophthalmic

ointment) 0.3%

Sterile 3.5 g Net Wt.

  

  

Nutr-E-Sol

Generic Name: vitamin e (Oral route)

VYE-ta-min E

Commonly used brand name(s)

In the U.S.

Alpha-E Aqua Gem-E Aquasol E D-Alpha Gems E-400 E-600 E-Gems Formula E 400 Gamma E-Gems Gamma E Plus Key-E Natural Vitamin Blend E-400IU Nutr-E-Sol

Available Dosage Forms:

Liquid Solution Tablet Capsule, Liquid Filled Tablet, Chewable Powder for Solution Capsule

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin E (class)

Uses For Nutr-E-Sol

Vitamins are compounds that you must have for growth and health. They are needed in only small amounts and are available in the foods that you eat. Vitamin E prevents a chemical reaction called oxidation, which can sometimes result in harmful effects in your body. It is also important for the proper function of nerves and muscles.

Some conditions may increase your need for vitamin E. These include:

Intestine disease Liver disease Pancreas disease Surgical removal of stomach

Increased need for vitamin E should be determined by your health care professional.

Infants who are receiving a formula that is not fortified with vitamin E may be likely to have a vitamin E deficiency. Also, diets high in polyunsaturated fatty acids may increase your need for vitamin E.

Claims that vitamin E is effective for treatment of cancer and for prevention or treatment of acne, aging, loss of hair, bee stings, liver spots on the hands, bursitis, diaper rash, frostbite, stomach ulcer, heart attacks, labor pains, certain blood diseases, miscarriage, muscular dystrophy, poor posture, sexual impotence, sterility, infertility, menopause, sunburn, and lung damage from air pollution have not been proven. Although vitamin E is being used to prevent certain types of cancer, there is not enough information to show that this is effective.

Lack of vitamin E is extremely rare, except in people who have a disease in which it is not absorbed into the body.

Vitamin E is available without a prescription.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Vitamin E is found in various foods including vegetable oils (corn, cottonseed, soybean, safflower), wheat germ, whole-grain cereals, and green leafy vegetables. Cooking and storage may destroy some of the vitamin E in foods.

Vitamin supplements alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods. For example, small amounts of fat are needed so that vitamin E can be absorbed into the body.

The daily amount of vitamin E needed is defined in several different ways.

For U.S.— Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy). Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs). For Canada— Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Vitamin E is available in various forms, including d- or dl-alpha tocopheryl acetate, d- or dl-alpha tocopherol, and d- or dl-alpha tocopheryl acid succinate. In the past, the RDA for vitamin E have been expressed in Units. This term has been replaced by alpha tocopherol equivalents (alpha-TE) or milligrams (mg) of d-alpha tocopherol. One Unit is equivalent to 1 mg of dl-alpha tocopherol acetate or 0.6 mg d-alpha tocopherol. Most products available in stores continue to be labeled in Units.

Normal daily recommended intakes in milligrams (mg) of alpha tocopherol equivalents (mg alpha-TE) and Units for vitamin E are generally defined as follows:

                                                  Persons U.S. Canada mg alpha-TE Units mg alpha-TE Units   Infants and children

BritLofex Tablets 0.2mg
1. Name Of The Medicinal Product

BritLofex Tablets 0.2mg

2. Qualitative And Quantitative Composition

Lofexidine hydrochloride 0.2mg

3. Pharmaceutical Form

Film-coated tablet.

Peach coloured, round tablet.

4. Clinical Particulars 4.1 Therapeutic Indications

To relieve symptoms in patients undergoing opiate detoxification.

4.2 Posology And Method Of Administration

The recommended route of administration is by mouth.

ADULTS

The dosage of lofexidine should be titrated according to the patient's response. Initial dosage should be 0.8mg per day in divided doses. The dosage may be increased by increments of 0.4 to 0.8mg per day up to a maximum of 2.4mg daily. Maximum single dose should not exceed 4 x 0.2mg tablets (0.8mg). Each patient should be assessed on an individual basis; those undergoing acute detoxification will usually require the highest recommended dose and dosage increments to provide optimum relief at the time of expected peak withdrawal symptoms.

In cases where no opiate use occurs during detoxification, a duration of treatment of 7-10 days is recommended. In some cases the physician may consider longer treatment is warranted.

CHILDREN:

Safety and effectiveness in children has not been established.

ELDERLY:

There is no experience of dosing in the elderly from clinical studies. Should use in the elderly be necessary it is advised that special caution is observed in the presence of heart disease or anti-hypertensive therapy.

4.3 Contraindications

BritLofex tablets are contraindicated in patients who are allergic to lofexidine or to other imidazoline derivatives or to any excipients of BritLofex.

4.4 Special Warnings And Precautions For Use

As with other hypotensive agents, therapy with lofexidine should not be discontinued abruptly. Dosage should be reduced gradually over a period of 2-4 days or longer, to minimise blood pressure elevation and associated signs and symptoms. Lofexidine should be used with caution in patients with severe coronary insufficiency, recent myocardial infarction, cerebrovascular disease or chronic renal failure and in patients with bradycardia or hypotension. Blood pressure and pulse rate should be assessed frequently. Patients with a history of depression should be carefully observed during long-term therapy with lofexidine.

There have been reports of QT prolongation during lofexidine treatment. Whilst the nature of the relationship between lofexidine and these ECG changes is not yet clear, it would be prudent to avoid the use of lofexidine in patients at risk of QT prolongation i.e. those with known QT problems, metabolic disturbances, pre-existing cardiovascular disease, relevant family history or those taking other drugs known to prolong the QT interval.

This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Allergic reactions may occur due to the presence of E110 (Sunset Yellow).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Lofexidine may enhance the CNS depressive effects of alcohol, barbiturates and other sedatives.

Lofexidine may enhance the effects of anti-hypertensive drug therapy.

Concomitant use of tricyclic antidepressants may reduce the efficacy of lofexidine.

Concomitant use of drug which prolong the QT interval or cause electrolyte imbalance should be avoided.

4.6 Pregnancy And Lactation

Pregnancy:

The safety of lofexidine in pregnant women has not been established. High doses of lofexidine given to pregnant dogs and rabbits caused a reduction in foetal weight and increased abortions. Lofexidine should only be administered during pregnancy if the benefit outweighs the potential risk to mother and foetus.

Lactation:

It is not known whether this drug is excreted in human milk and caution should be exercised when it is administered to a nursing woman.

4.7 Effects On Ability To Drive And Use Machines

Lofexidine may have a sedative effect. If affected, patients should be advised not to drive or operate machines.

4.8 Undesirable Effects

The adverse effects of the drug are primarily related to its central alpha-adrenergic agonist effects:

Very common (

Common (

Uncommon (

Rare (

Very rare (<1/10,000)

Not known (cannot be estimated from the available data)

Immune system disorders:

Not known:

Allergic reactions may occur due to the presence of E110 (Sunset Yellow).

Nervous system disorders:

Very common:

Dizziness has been reported following treatment with lofexidine.

Drowsiness and related symptoms including sedation and somnolence have been reported.

Cardiac disorders:

Very common:

Bradycardia has been reported.

Not known:

There have been reports of QT prolongation during lofexidine treatment.

Vascular disorders:

Very common:

Hypotension has been reported

General disorders and administration site conditions:

Very common:

Dryness of mucous membranes especially the mouth, throat and nose has been reported.

4.9 Overdose

Overdosage may cause hypotension, bradycardia and sedation. Gastric lavage should be carried out where appropriate. In most cases, all that is required are general supportive measures.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic Group: Drugs used in opioid dependence

ATC Classification: N07BC04

Lofexidine hydrochloride is an orally active imidazoline adrenergic alpha-2-receptor agonist; and is believed to have a high affinity for 2A receptor subtypes resulting in less anti-hypertensive activity than clonidine, a non-selective alpha-2-receptor agonist. Hypotension may occur in susceptible subjects, accompanied by a decrease in heart rate.

Abrupt discontinuation of lofexidine has been, in some cases, associated with a transient increase in blood pressure to higher than pre-treatment levels.

5.2 Pharmacokinetic Properties

Lofexidine is extensively absorbed and achieves peak plasma concentration at 3 hours after administration of a single dose. The elimination half-life is 11 hours with accumulation occurring up to four days with repeat dosing. Lofexidine undergoes extensive metabolism in the liver and excretion is mainly by the kidney.

5.3 Preclinical Safety Data

Animal toxicology. Lofexidine was tolerated at high dosage in singe dose toxicity studies in animals, the LD50 being >77 mg/kg. With repeat dosing in mice, rats and dogs symptoms related to the pharmacology of the drug (ataxia, sedation, tremor, unkempt appearance and exhaustion) appeared.

Studies of mutagenicity are incomplete but lofexidine did not display mutagenicity in the Ames test. Long-term studies in rats showed no evidence of carcinogenicity.

High doses of lofexidine given to pregnant rats and rabbits caused a reduction in the foetal weight and increased abortions. No teratogenic effects were found.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Lactose (monohydrate)

Citric acid

Povidone

Microcrystalline cellulose

Calcium stearate

Sodium lauryl sulphate

Purified water

Film Coat:

Opadry OY-S-9480 Brown

containing

Hydroxypropylmethyl cellulose

Titanium dioxide

Propylene glycol

Indigo Carmine (E132)

Sunset Yellow (E110)

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store below 25?C. Store in original package.

6.5 Nature And Contents Of Container

Aluminium foil/aluminium foil blister strips

Aluminium foil/PVC blister strips

6.6 Special Precautions For Disposal And Other Handling

No special instructions.

7. Marketing Authorisation Holder

Britannia Pharmaceuticals Limited

Park View House

65 London Road

Newbury

Berkshire

RG14 1JN

United Kingdom

8. Marketing Authorisation Number(S)

PL 04483/0036

9. Date Of First Authorisation/Renewal Of The Authorisation

October 1990

10. Date Of Revision Of The Text

29 June 2010

Solifenacin
Pronunciation: SOE-li-FEN-a-sinGeneric Name: SolifenacinBrand Name: VESIcare

Nuvigil
Pronunciation: ar-moe-DAF-i-nilGeneric Name: ArmodafinilBrand Name: Nuvigil

Impavido

Impavido may be available in the countries listed below.

Ingredient matches for Impavido Miltefosine

Miltefosine is reported as an ingredient of Impavido in the following countries:

Colombia Germany

International Drug Name Search

Furosemide 20mg Tablets
1. Name Of The Medicinal Product

Furosemide 20mg Tablets.

2. Qualitative And Quantitative Composition

Each tablet contains 20mg furosemide.

For excipients, see 6.1

3. Pharmaceutical Form

Tablet.

Appearance: A white, circular, flat bevelled edge tablet with 'F' scoreline 20' embossed on one face and plain on the reverse.

4. Clinical Particulars 4.1 Therapeutic Indications

In the treatment of oedema associated with congestive heart failure, cirrhosis of the liver, renal disease including nephrotic syndrome.

In the treatment of peripheral oedema due to mild to moderate hypertension (alone, or in combination with other antihypertensive agents in the treatment of more severe cases).

Management of oliguria due to acute or chronic renal insufficiency.

4.2 Posology And Method Of Administration

Adults: The usual initial daily dose is 40mg. This may require adjustment until the effective dose is achieved. In mild cases 20mg daily or 40mg on alternate days may be sufficient, whereas in cases of resistant oedema daily doses of 80mg and above may be used.

In patients with chronic renal insufficiency, an initial daily dose of 250mg is employed. If a satisfactory diuresis is not produced then the dose may be increased in steps of 250mg at four to six hourly intervals up to a maximum daily dose of 1,500 mg in 24 hours. In exceptional cases up to 2,000 mg in 24 hours may be given.

Children: The oral dose for children ranges from 1-3mg/kg body weight daily, up to a maximum total dose of 40mg per day.

Elderly: The usual adult dose, but caution is advised as furosemide is excreted more slowly in the elderly.

Method of administration: Oral – the tablets should be swallowed with water.

4.3 Contraindications

Furosemide is contra-indicated in the presence of anuria, electrolyte deficiency, precoma associated with hepatic cirrhosis, digitalis intoxication, porphyria and hypersensitivity to furosemide or sulphonamides.

4.4 Special Warnings And Precautions For Use

Where indicated, steps should be taken to correct hypotension or hypovolaemia before commencing therapy. Regular monitoring of fluid and electrolyte balance is recommended.

Use with caution in patients with impaired hepatic or renal function, diabetes mellitus or adrenal disease.

Use with care in elderly patients or those with prostatic hypertrophy or impairment of micturition.

Latent diabetes may become manifest or the insulin requirements of diabetic patients may increase.

Hypotension may occur if ACE inhibitors are added to furosemide therapy. The dose of furosemide should be reduced or the drug stopped before initiating the ACE inhibitor.

Use with caution in patients with a history of gout. Discontinue furosemide if bone marrow depression occurs.

This product contains lactose. Patients with rare herditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Furosemide may enhance the toxicity of cardiac glycosides by electrolyte disturbance particularly potassium and magnesium.

The action of antihypertensive agents such as methyldopa may be enhanced by furosemide. The nephrotoxic effect of cephaloridine and the aminoglycoside antibiotics may be increased by furosemide.

The action of diuretics such as furosemide may be antagonised by certain non-steroidal anti-inflammatory agents.

The renal clearance of lithium is decreased by furosemide, resulting in increased and possibly toxic serum levels. Concomitant administration should be avoided unless plasma levels can be monitored.

Concurrent administration of glucocorticoids may cause sodium retention and exacerbate potassium loss.

Furosemide decreases the effects of some drugs (e.g. antidiabetics and pressor amines) and may potentiate the effects of others (e.g. salicylates, theophylline, and curare type muscle relaxants).

Resultant hypokalaemia may potentiate cardiac toxicity of certain drugs such as antihistamines and antiarrythmics. It may also antagonise the action of antiarrhythmics such as lidocaine, mexiletine and tocainide.

4.6 Pregnancy And Lactation

Furosemide has been given after the first trimester of pregnancy for oedema, hypertension and toxaemia of pregnancy without causing foetal or new-born adverse effects. However, it should only be given during pregnancy if strictly indicated and for short-term treatment.

As it may inhibit lactation and passes into breast milk, furosemide should be used with caution in nursing mothers.

4.7 Effects On Ability To Drive And Use Machines

Reduced mental alertness and rarely dizziness and blurred vision have been reported. Patients so affected should not drive or operate machines.

4.8 Undesirable Effects

Furosemide is generally well tolerated. Fluid and electrolyte imbalance is the most common side effect. Uncommonly nausea, diarrhoea, blurred vision, dizziness, headache, pancreatitis, photosensitivity, vasculitis and interstitial nephritis have occurred very rarely. The incidence of allergic reactions such as skin rashes is very low, but when these occur treatment should be withdrawn.

A transient rise in creatinine may occur as may hypotension and liver dysfunction. Muscle spasm and paraesthesia have also been reported. Hyperuricaemia may be induced and precipitate gout in some patients.

Temporary increase in plasma cholesterol and triglyceride concentrations may occur. Latent diabetes may become manifest and the insulin requirements of diabetic patients may increase.

Bone marrow depression is a rare complication and treatment should be withdrawn. The haemopoeitic status should therefore be regularly monitored.

Calcium depletion may occur and nephrocalcinosis has been reported in premature infants.

Tinnitus and deafness have occurred, usually with large parenteral doses and rapid administration and in renal impairment.

4.9 Overdose

In cases of overdosage there is a danger of dehydration and electrolyte depletion due to excessive diuresis. Treatment should be aimed at fluid replacement and correction of electrolyte imbalance. Gastric lavage may be useful if ingestion is recent.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Furosemide is one of the high ceiling diuretics, a term used to denote a group of diuretics that have a distinctive action on renal tubular function. The peak diuresis is far greater than that observed with other agents.

The main site of action is the thick ascending loop of Henle where they inhibit electrolyte re-absorption. It increases renal blood flow without increasing the filtration rate. Such a change in renal haemodynamics reduces fluid and electrolyte re-absorption in the proximal tubule and may augment the initial diuretic response.

Furosemide is an inhibitor of carbonic anhydrase but this activity is too weak to contribute to a proximal diuresis except when massive doses are employed. Furosemide enhances the excretion of both calcium and magnesium to an extent approximately proportional to the increase in sodium excretion. Unlike the thiazides, high ceiling diuretics do not increase calcium re-absorption in the distal tubule. The calciuric action of these agents is the basis for their use in symptomatic hypercalcaemia.

5.2 Pharmacokinetic Properties

Furosemide is incompletely but fairly rapidly absorbed from the gastrointestinal tract. Bioavailability is about 65%. It has a biphasic half-life in plasma with a terminal elimination phase up to about 2 hours but this is prolonged in neonates, and in patients with hepatic and renal insufficiency.

It is extensively bound to plasma proteins but is rapidly secreted by the organic acid transport system of the proximal tubule. In this manner it gains access to the tubular fluid and eventually to its site of action more distally.

It is mainly excreted in the urine largely unchanged, but also in the form of glucuronide and free amine metabolites. Variable amounts are also excreted in the bile. Furosemide crosses the placental barrier and is excreted in milk. Non renal elimination is considerably increased in renal failure. The clearance of furosemide is not increased by haemodialysis.

5.3 Preclinical Safety Data

Not relevant

6. Pharmaceutical Particulars 6.1 List Of Excipients

Lactose monohydrate

Magnesium stearate (E470b)

Sodium starch glycollate

Maize starch.

Starch paste 15%

6.2 Incompatibilities

Not Applicable

6.3 Shelf Life

Tablet container: 5 Years

Blister: 2 Years

6.4 Special Precautions For Storage

Tablet containers: Do not store above 25°C. Store in the original container. Keep the container tightly closed.

Blister packs: Do not store above 25°C. Store in the original package.

6.5 Nature And Contents Of Container

Tablet container and cap (polypropylene container with low density polyethylene cap)

Pack sizes: 28, 56, 100, 250, 500 and 1000 tablets.

Blister (250 (?m white opaque PVC and 20 (?m hard temper aluminium foil).

Pack sizes: 28 and 56 tablets.

6.6 Special Precautions For Disposal And Other Handling

Not applicable

7. Marketing Authorisation Holder

Aurobindo Pharma Limited

Ares,

Odyssey Business Park,

West End Road,

South Ruislip HA4 6QD,

United Kingdom

8. Marketing Authorisation Number(S)

PL 20532/0039

9. Date Of First Authorisation/Renewal Of The Authorisation

28/10/2005

10. Date Of Revision Of The Text

30/11/2007

Advil Children's

Generic Name: ibuprofen (Oral route)

eye-bue-PROE-fen

Oral route(Tablet;Suspension;Capsule, Liquid Filled;Tablet, Chewable)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Ibuprofen is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s)

In the U.S.

Addaprin Advil A-G Profen Bufen Genpril Haltran I-Prin Midol Motrin Nuprin Proprinal Q-Profen

In Canada

Actiprofen Advil Children's Advil Pediatric Children's Motrin Children's Motrin Berry Flavor Children's Motrin Bubble Gum Flavor Children's Motrin Grape Flavor Equate Children's Ibuprofen - Berry - Dye Free Infants' Motrin Teddy's Choice Children's Ibuprofen - Berry Teddy's Choice Children's Ibuprofen - Bubble Gum Teddy's Choice Children's Ibuprofen - Grape

Available Dosage Forms:

Suspension Tablet Capsule, Liquid Filled Tablet, Chewable Capsule

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Uses For Advil Children's

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, and helps to relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis), such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it .

In addition, ibuprofen can be used to treat fever, menstrual cramps, and other conditions as determined by your doctor .

This medicine is available both over-the-counter (OTC) and with your doctor's prescription .

Before Using Advil Children's

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ibuprofen in children below 6 months of age. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of ibuprofen in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require adjustment of dosage in patients receiving ibuprofen .

Pregnancy Pregnancy Category Explanation 1st Trimester C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. 2nd Trimester C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. 3rd Trimester D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Ketorolac Pentoxifylline

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abciximab Ardeparin Argatroban Beta Glucan Bivalirudin Certoparin Cilostazol Citalopram Clopidogrel Clovoxamine Dabigatran Etexilate Dalteparin Danaparoid Desirudin Dipyridamole Enoxaparin Escitalopram Femoxetine Flesinoxan Fluoxetine Fluvoxamine Fondaparinux Ginkgo Heparin Lepirudin Methotrexate Nadroparin Nefazodone Parnaparin Paroxetine Pemetrexed Protein C Reviparin Rivaroxaban Sertraline Sibutramine Tacrolimus Ticlopidine Tinzaparin Tirofiban Vilazodone Zimeldine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol Acetohexamide Alacepril Alprenolol Amikacin Amiloride Arotinolol Aspirin Atenolol Azilsartan Medoxomil Azosemide Befunolol Bemetizide Benazepril Bendroflumethiazide Benzthiazide Betaxolol Bevantolol Bisoprolol Bopindolol Bucindolol Bumetanide Bupranolol Buthiazide Candesartan Cilexetil Canrenoate Captopril Carteolol Carvedilol Celiprolol Chlorothiazide Chlorpropamide Chlorthalidone Cilazapril Clopamide Cyclopenthiazide Cyclosporine Delapril Desipramine Desvenlafaxine Dilevalol Duloxetine Enalaprilat Enalapril Maleate Eprosartan Esmolol Ethacrynic Acid Fosinopril Furosemide Gliclazide Glimepiride Glipizide Gliquidone Glyburide Hydrochlorothiazide Hydroflumethiazide Imidapril Indapamide Irbesartan Labetalol Landiolol Levobetaxolol Levobunolol Lisinopril Lithium Losartan Mepindolol Methyclothiazide Metipranolol Metolazone Metoprolol Milnacipran Moexipril Nadolol Nebivolol Nipradilol Olmesartan Medoxomil Oxprenolol Penbutolol Pentopril Perindopril Phenytoin Pindolol Piretanide Polythiazide Propranolol Quinapril Ramipril Sotalol Spirapril Spironolactone Tacrine Talinolol Tasosartan Telmisartan Temocapril Tertatolol Timolol Tolazamide Tolbutamide Torsemide Trandolapril Triamterene Trichlormethiazide Valsartan Venlafaxine Voriconazole Xipamide Zofenopril Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Anemia or Asthma or Bleeding problems or Blood clots or Edema (fluid retention or body swelling) or Heart attack, history of or Heart disease (e.g., congestive heart failure) or High blood pressure or Kidney disease or Liver disease (e.g., hepatitis) or Stomach or intestinal ulcers or bleeding or Stroke, history of—Use with caution. This medicine may make these conditions worse . Aspirin sensitivity, history of—This medicine should NOT be used in patients with this condition . Diabetes—Use with caution. The suspension form of this medicine contains sugar . Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)—This medicine should NOT be used to relieve pain right before or after the surgery . Proper Use of ibuprofen

This section provides information on the proper use of a number of products that contain ibuprofen. It may not be specific to Advil Children's. Please read with care.

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients .

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine .

To lessen stomach upset, you may take this medicine with food or milk .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets and suspension): For fever: Children over 2 years of age—Use and dose must be determined by your doctor. Children 6 months of age up to 2 years—Dose is based on body weight and body temperature, and must be determined by your doctor. For fever lower than 102.5 °F (39.2 °C), the dose usually is 5 milligrams (mg) per kilogram (kg) (about 2.2 mg per pound) of body weight. For higher fever, the dose usually is 10 mg per kg (about 4.5 mg per pound) of body weight. The medicine may be given every six to eight hours, as needed, up to 40 mg per kg per day. Infants younger than 6 months of age—Use and dose must be determined by your doctor . For menstrual cramps: Adults—400 milligrams (mg) every four hours, as needed. Children—Use and dose must be determined by your doctor . For mild to moderate pain: Adults and teenagers—400 milligrams (mg) every four to six hours, as needed. Children over 6 months of age—Dose is based on body weight and must be determined by your doctor. The dose usually is 10 milligrams (mg) per kilogram (kg) of body weight every six to eight hours, as needed, up to 40 mg per kg per day. Infants younger than 6 months of age—Use and dose must be determined by your doctor . For osteoarthritis and rheumatoid arthritis: Adults and teenagers—1200 milligrams (mg) up to 3200 mg per day divided into three or four equal doses. Children—Dose is based on body weight and must be determined by your doctor. The dose usually is 30 milligrams (mg) to 40 mg per kilogram (kg) of body weight per day, divided into three or four doses. Infants younger than 6 months of age—Use and dose must be determined by your doctor . Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Advil Children's

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects .

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk .

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (a steroid or a blood thinner) .

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, white spots in mouth or on lips, or unusual tiredness or weakness .

Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; bleeding or bruising; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs .

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in skin color of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once .

Some people who have used this medicine had symptoms of meningitis. If you have fever, headache, nausea, vomiting, and stiff neck or back while using this medicine, check with your doctor right away .

Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away .

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor) .

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure .

Advil Children's Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Abdominal pain acid or sour stomach belching bloating cloudy urine decrease in amount of urine decrease in urine output or decrease in urine-concentrating ability diarrhea difficulty having a bowel movement (stool) excess air or gas in stomach or intestines full feeling heartburn indigestion itching skin pain or discomfort in chest, upper stomach, or throat pale skin passing gas nausea noisy, rattling breathing rash with flat lesions or small raised lesions on the skin shortness of breath swelling of face, fingers, hands, feet, lower legs, or ankles troubled breathing at rest troubled breathing with exertion unusual bleeding or bruising unusual tiredness or weakness vomiting weight gain Less common Abdominal cramps stomach soreness or discomfort Rare Agitation back, leg, or stomach pains bleeding gums blistering, peeling, loosening of skin blood in urine or stools bloody, black, or tarry stools blurred vision burning feeling in chest or stomach change in vision chest pain chills clay-colored stools coma confusion constipation cough or hoarseness dark urine decreased urine output depression difficulty breathing difficulty swallowing dilated neck veins dizziness dry mouth extreme fatigue fast, irregular, pounding, or racing heartbeat or pulse fever with or without chills frequent urination general body swelling general feeling of tiredness or weakness hair loss, thinning of hair headache hives or welts hostility impaired vision increased blood pressure increased volume of pale, dilute urine irregular breathing irritability itching joint or muscle pain lab results that show problems with liver lethargy light-colored stools loss of appetite lower back or side pain muscle twitching nosebleeds painful or difficult urination pains in stomach, side, or abdomen, possibly radiating to the back pinpoint red spots on skin puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue rash red skin lesions, often with a purple center red, irritated eyes redness of skin seizures severe abdominal pain, cramping, burning severe and continuing nausea sore throat sores, ulcers, or white spots in mouth or on lips stiff neck or back stomach upset stupor swollen or painful glands tenderness in stomach area thirst tightness in chest unpleasant breath odor upper right abdominal pain vomiting of blood vomiting of material that looks like coffee grounds wheezing yellow eyes and skin Symptoms of overdose Bluish lips or skin difficulty sleeping disorientation dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly drowsiness to profound coma hallucination lightheadedness or fainting mood or other mental changes muscle tremors not breathing rapid, deep breathing restlessness slow or irregular heartbeat stomach cramps sudden fainting sweating

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Continuing ringing or buzzing or other unexplained noise in ears hearing loss nervousness Rare Crying depersonalization discouragement dry eyes dysphoria euphoria feeling sad or empty lack of appetite loss of interest or pleasure mental depression paranoia quick to react or overreact rapidly changing moods runny nose sleepiness or unusual drowsiness sleeplessness sneezing stuffy nose trouble concentrating trouble sleeping unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Advil Children's side effects (in more detail)

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Doxazosin 1mg, 2mg, 4mg Tablets

DOXAZOSIN 1 MG TABLETS

DOXAZOSIN 2 MG TABLETS

DOXAZOSIN 4 MG TABLETS

(as mesilate)

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 further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not pass it onto others. It may harm them, even if their symptoms are the same as yours. In this leaflet: 1. What DOXAZOSIN is and what it is used for 2. Before you take DOXAZOSIN 3. How to take DOXAZOSIN 4. Possible side effects 5. Storing DOXAZOSIN 6. Further information

The name of your medicine is DOXAZOSIN 1 mg Tablets, DOXAZOSIN 2 mg Tablets, DOXAZOSIN 4 mg Tablets (referred to as DOXAZOSIN throughout this leaflet).

What Doxazosin Is And What It Is Used For

Doxazosin is one of a group of medicines called alpha-blockers.

DOXAZOSIN tablets are used to treat high blood pressure (hypertension) or the symptoms caused by enlargement of the prostate gland in men.

In patients taking DOXAZOSIN to treat high blood pressure (hypertension) DOXAZOSIN works by relaxing blood vessels so that blood passes through them more easily. This helps to lower blood pressure.

In patients with enlargement of the prostate gland, DOXAZOSIN is taken to treat frequent and/or poor passing of urine. This is common in patients with enlargement of the prostate gland. DOXAZOSIN works by relaxing muscle around the bladder exit and prostate gland so urine is passed more easily.

Before You Take Doxazosin Do not take DOXAZOSIN if you: have ever had an allergic reaction (hypersensitivity) to doxazosin or any of the other ingredients of DOXAZOSIN tablets.

This may have been itching, reddening of the skin or difficulty in breathing.

are breastfeeding. are aged under 16 years of age Take special care with DOXAZOSIN: If you have liver disease tell your doctor before you start taking your tablets. If you are pregnant or trying to become pregnant tell your doctor before you start taking your tablets.

If you are undergoing eye surgery because of cataract (cloudiness of the lens) please inform your eye specialist before the operation that you are using or have previously used DOXAZOSIN. This is because DOXAZOSIN may cause complications during the surgery which can be managed if your specialist is prepared in advance.

When you start to take DOXAZOSIN you may experience faintness or dizziness caused by low blood pressure, when getting up from sitting or lying down. If you feel faint or dizzy, you should sit or lie down until you feel better and avoid situations where you might fall or hurt yourself.

Taking other medicines:

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light headedness, which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking drugs for erectile dysfunction (impotence) with alpha-blockers. In order to reduce the likelihood that these symptoms occur, you should be on a regular daily dose of your alpha-blocker before you start drugs for erectile dysfunction.

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

Driving and using machines:

Take care if you drive or operate machinery. Your tablets may affect your ability to drive or operate machinery safely, particularly when you first start to take them. They may make you feel weak or dizzy. If affected, do not drive or operate machinery and contact your doctor immediately.

Important information about some of the ingredients of DOXAZOSIN:

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How To Take Doxazosin Adults and Elderly:

Always take DOXAZOSIN exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

DOXAZOSIN is usually taken once daily. DOXAZOSIN may be taken in the morning or the evening.

You can take your tablets before or after food.

You should take your tablets at the same time each day with a small amount of water.

The initial dose of DOXAZOSIN is 1mg once daily. Thereafter the dose may be gradually increased (within 1-2 weeks interval) to the usual dose (2mg or 4mg daily).

In some circumstances the dose may be increased to a maximum of 8mg daily if you are being treated for prostate enlargement, or to a maximum of 16mg if you are being treated for high blood pressure.

Children:

This medicine is not recommended for children.

You have been given a calendar pack that will help you remember to take your tablets. If you are taking more than one tablet a day, you must ignore the marking for the day, printed on the back of the blister.

Because high blood pressure is treated in order to prevent problems from arising, you may have no symptoms at all while taking DOXAZOSIN. Even if this is so and you feel well, you should not stop taking your blood pressure medication unless instructed to by your doctor.

Don't change the dose or stop taking the tablets without first checking with your doctor.

Don't wait until your tablets are finished before seeing your doctor.

If you have impression that the effect of DOXAZOSIN is too strong or too weak, talk to your doctor or pharmacist.

If you forget to take DOXAZOSIN:

If you miss a dose just carry on with the next one as normal. Do not take a double dose to make up for the missed one.

If you take more DOXAZOSIN than you should:

Too many tablets at once may make you unwell. If several tablets are taken it may be dangerous.

Tell your doctor immediately or go to your nearest hospital casualty department.

Possible Side Effects

Like all medicines, DOXAZOSIN can have side effects but not everybody gets them.

Most undesirable effects are usually mild and tend to wear off as treatment goes on. It is important to tell your doctor if any unwanted effect causes you concern, including those which may not be listed below.

Problems DOXAZOSIN may cause are:

allergic reaction, with symptoms such as skin rash, itching, which may be accompanied by shortness of breath, difficulty breathing, swelling of the face, tongue and throat. If any of these symptoms occur, STOP taking DOXAZOSIN and seek medical attention immediately. The following events have been reported in patients with high blood pressure being treated with doxazosin, but these may be due to the underlying disease rather than the medicine: chest pain, angina, a feeling of increased, decreased or irregular heart beat, palpitations, heart attack or stroke. Contact your doctor immediately if any of these occur. low white blood cells (which may result in increasing frequency of infection, sore throat, mouth ulcer, high temperature or stomach upset); low blood platelets [which may result in bruising or bleeding easily, nose bleeds (epistaxis)].

If any of these occur contact your doctor.

Other side effects

generally feeling unwell, weakness, tirednesssleepiness, swelling of feet or lower legs (oedema), weight gain

headache , dizziness or faintness, especially on getting up from a sitting or lying position, tremor, tingling or altered sensitivity of the hands and feet vertigo, ringing in the ears (tinnitus) digestive system complaints, including stomach/abdominal pains, constipation, diarrhoea, feeling/being sick, heartburn and wind, dry mouth nasal stuffiness, runny nose and/or sneezing (rhinitis), wheeze, cough painful persistent erection of the penis, erection difficulties (when a man cannot get, or keep a hard, erect penis suitable for sexual activity), discomfort or enlargement of the breasts in men (gynaecomastia), cloudy urine following sexual climax, little or no semen ejaculated at sexual climax painful joints, painful muscles, muscle cramps, muscle weakness, back pain or general pain low blood pressure, hot flushes agitation, anxiety, depression or nervousness, sleeplessness hair loss loss of appetite liver enzyme increases, jaundice (yellowing of the skin or whites of the eyes), hepatitis or bile disorder blurred vision urinary incontinence, urinary disorder or blood in urine

If any of the side - effects become serious, or you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Storing Doxazosin

There are no special precautions for storage. Keep out of the reach and sight of children.

Check the expiry date on the label. Do not use the tablets if the expiry date has passed.

Further Information What DOXAZOSIN contains

The active substance is: doxazosin. Each tablet contains 1mg, 2mg, or 4mg of doxazosin (as mesilate).

The other ingredients are: Lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate, sodium starch glycolate (type A) and colloidal anhydrous silica.

What DOXAZOSIN looks like and contents of the pack

DOXAZOSIN comes in three different strengths:

Doxazosin 1 mg tablet is a round white to off-white tablet scored on one side.

Doxazosin 2 mg tablet is a white to off-white capsule shaped tablet scored on one side.

Doxazosin 4 mg tablet is a white to off-white capsule shaped tablet, scored on both sides, with embossement "D4" on one side.

Doxazosin 1 mg, 2 mg and 4 mg tablets are available in calendar packs of 28 tablets in foil blister strips.

The manufacturer / holder of the marketing authorization is: Dexcel-Pharma Ltd. 1 Cottesbrooke Park Heartlands Business Park Daventry Northamptonshire NN11 8YL England

This leaflet was last approved in October 2009.

1217420114-E

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