Phenytoin 250mg / 5ml Solution for Injection (Beacon Pharmaceuticals)

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Phenytoin 250mg/5ml Solution For Injection

(Referred to in this leaflet as Phenytoin Injection)

Please read this leaflet carefully before receiving Phenytoin Injection. If you have already received Phenytoin Injection because of the urgency of your condition, you should still read this leaflet. This is particularly important if you are to continue to be given phenytoin Keep the leaflet in case you want to refer to it again If you want to know more about Phenytoin Injection or have any questions, you should ask your doctor. In this leaflet: 1. What Phenytoin Injection is used for 2. Before you are given Phenytoin Injection 3. How Phenytoin Injection should be given 4. Possible side effects 5. Storing Phenytoin Injection 6. Further information What Phenytoin Injection Is Used For

Phenytoin belongs to a group of medicines called anti-epileptic drugs.

Phenytoin injection is used to treat: severe epileptic seizures or fits (status epilepticus) and prevent seizures for short periods of time when anti-epileptics drugs cannot be taken by mouth or prevent seizures during or after brain surgery and/or severe head injury specific changes in the rhythm of the heart (cardiac arrhythmias), particularly when these are caused by the drug digoxin. Before You Are Given Phenytoin Injection You must NOT be given Phenytoin Injection and you should talk to your doctor immediately if you have: shown signs of hypersensitivity (severe allergy) to phenytoin, phenytoin sodium, other similar drugs (hydantoins) or any of the other ingredients in this medicine a heart condition called heart block Before you are given Phenytoin Injection, tell your doctor if you: have low blood pressure or heart failure have liver disease have diabetes have porphyria (an inherited blood disease) are due to have a surgical procedure, or if you are to be given the anaesthetic agent halothane as this may increase phenytoin levels are (or think you might be) pregnant or are breast-feeding drink large amounts of alcohol. You should limit the amount of alcohol you drink whilst being treated with phenytoin as the concentration in your blood can be altered with excess alcohol.

A small number of people being treated with anti-epileptics such as phenytoin have had thoughts of harming themselves. If at any time you have these thoughts, immediately contact your doctor. Taking/using other medicines

Before you are given Phenytoin Injection, tell your doctor if you taking medicines used to treat: epilepsy (carbamazepine, lamotrigine, phenobarbital, sodium valproate, succinimides e.g. ethosuximide, and vigabatrin) fungal infections (amphotericin B, fluconazole, itraconazole, ketoconazole, miconazole) tuberculosis or other infections (chloramphenicol, isoniazid, rifampicin, sulphonamides, doxycycline and ciprofloxacin) pain and inflammation (phenylbutazone, steroids and salicylates e.g.aspirin) stomach ulcers (omeprazole, sucralfate, medicines known as H2 antagonists e.g. cimetidine, and some antacids) sleeplessness, depression or psychiatric disorders (chlordiazepoxide, clozapine, diazepam, disulfiram, fluoxetine, methylphenidate, paroxetine, phenothiazines, trazodone, tricyclic antidepressants and viloxazine) heart and circulatory problems (dicoumarol, amiodarone, reserpine, digitoxin, furosemide, quinidine, warfarin and calcium channel blockers e.g. diltiazem, nifedipine) diabetes (tolbutamide), cancer, asthma or bronchitis (theophylline) Phenytoin may also interact with: hormone replacement therapy (oestrogens) the pill (oral contraceptive) methadone halothane (anaesthetic) muscle relaxants used in surgery ciclosporin (to prevent rejection of organ transplants) vitamin supplements such as Vitamin D and folic acid the herbal preparation St John’s wort.

Tell your doctor if you are taking, or have recently taken, any other medicines, including ones you have bought yourself.

Phenytoin may also interfere with certain laboratory tests that you may be given.

How Phenytoin Injection Should Be Given

You will be in hospital when you are given this medicine. Your doctor will decide on the dose and how it will be given to you.

A diluted solution will be either injected into one of your veins or, more rarely, into your muscle. The medicine is injected slowly into your vein or given as an infusion (drip) over a period of time.

Your heart rhythm, blood pressure and breathing will be monitored.

As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much, however tell your doctor or nurse if you have any concerns.

Possible Side Effects

As with all medicines, phenytoin may cause some side effects in some patients.

Serious side effects

If any of the following happen, tell a doctor or nurse IMMEDIATELY as you may need urgent medical attention:

symptoms of a severe hypersensitivity syndrome which may include: itchy rash, swelling of the face, lips, tongue or throat (which may cause difficulty in swallowing or breathing), raised red patches on the skin, joint pain or fever irritation or burning sensation at the site of the injection rashes, which may be severe, resulting in painful reddening and blistering of the skin, eyes, mouth, anus or genital region and may lead to skin shedding. chest pains, palpitations or feeling faint joint pains If you experience any of the following side effects tell your doctor or nurse as soon as possible:

Effects on the nervous system including:

difficulty in controlling movements unsteadiness, shaking, nervousness uncoordinated movements unusual eye movements confusion, dizziness, slurred speech pins and needles, twitching muscles drowsiness, headaches sleeplessness loss of feeling in the hands and feet.

These effects may occur when the amount of phenytoin in your blood is too high. If you suffer with kidney or liver disease or are elderly you may experience these side effects at lower doses of phenytoin.

Very high amounts can cause extreme confusion, psychosis or encephalopathy (a brain disease), which may lead to irreversible brain injury. Your doctor should measure the amount of phenytoin in your blood and adjust your dose if necessary.

Effects on the skin:

minor skin rashes such as measles-like rash or dermatitis.

Tell your doctor if a rash does not clear up, recurs or you show signs of a serious reaction.

Other side effects: disorders or swelling of the lymph glands (part of your body’s defence system) blood disorders, which may be noticed as bruising, paleness, fever or sore throat liver damage or inflammation which may be recognised by yellowing of the eyes and skin inflammation of the kidneys breathing problems feeling sick, vomiting or constipation increased levels of blood sugar, decreased levels of folic acid and calcium the amount of vitamin D in your body may be altered. Other rare side effects: changes in the hand with difficulty straightening the fingers changes to facial features, enlarged gums or lips abnormal facial or body hair changes to the shape of the penis and painful erection.

Tell your doctor or nurse as soon as possible if you notice these or any side effect not mentioned in this leaflet.

Storing Phenytoin Injection

Keep out of the sight and reach of children.

Keep in the original packaging.

Do not use after the expiry date printed on the carton.

Further Information What is in this medicine:

Each 5 ml ampoule contains 250mg of the active ingredient phenytoin sodium.

The ampoules also contain propylene glycol, ethanol, sodium hydroxide and water.

What this medicine looks like and contents of the pack:

Phenytoin Injection is a clear liquid. Each pack contains 1 or 50 ampoules.

Marketing authorisation holder: Beacon Pharmaceuticals Ltd. Tunbridge Wells Kent TN1 1YG Manufacturer: Laboratorio Reig Jofr?, S.A Spain

Date of approval: 09/09/2008

Phenytoin 250mg 5ml Solution for Injection Beacon Pharmaceuticals

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