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MercuryPharma

PATIENT INFORMATION LEAFLET

Phenytoin Sodium 50mg/ml Solution for Injection

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READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

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.

The name of your medicine is Phenytoin Sodium 50mg/ml Solution for Injection. It will be referred to as Phenytoin Injection for ease hereafter.

In this leaflet:

1.    What Phenytoin Injection is and what it is used for

2.    Before you are given Phenytoin Injection

3.    How Phenytoin Injection is given to you

4.    Possible side effects

5.    How to store Phenytoin Injection

6.    Further information

1. WHAT PHENYTOIN INJECTION IS AND WHAT IT IS USED FOR

Phenytoin belongs to a group of drugs known as hydantoins. It is called an anticonvulsant because it works by controlling the overactivity in the brain that can cause epilepsy or seizures (fits).

Phenytoin Injection is used to:

•    Control epileptic fits involving jerking and spasm of the muscles (known as grand mal fits)

•    Prevent and treat fits resulting from brain surgery or head injury.

2. BEFORE YOU ARE GIVEN PHENYTOIN INJECTION

You should not be given Phenytoin Injection if you:

•    know that you have an allergy to phenytoin, or to any of the other ingredients in the formulation (listed at the end of this leaflet), or to any other hydantoin drug (such as ethotoin or methoin)

•    have a slow heart beat or heart problems that interfere with the rate at which your heart beats

•    Adams-Stokes syndrome.

Make sure your doctor knows if you suffer from any of the above before you are given the injection.

Before you are given Phenytoin Injection, you should tell your doctor if you:

•    have low blood pressure or disease of the heart muscle

•    have a disease of the liver or kidneys

•    have diabetes

•    have porphyria (an inherited condition affecting the nervous system and skin)

•    have drank a large amount of alcohol recently, or if you drink large amounts of alcohol regularly or if you have alcohol dependence

•    Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Phenytoin sodium, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk

•    Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes)

•    These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin

•    The highest risk for occurence of serious skin reactions is within the first weeks of treatment

•    if you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Phenytoin sodium, you must not be re-started on Phenytoin sodium at any time

•    If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell that you are taking this medicine.

A small number of people being treated with anti-epileptics such as Phenytoin have had thoughts of harming or killing themselves, if at any time you have these thoughts, immediately contact your doctor.

Tell your doctor if any of these apply to you as special care may be needed. Your doctor will take particular care with this medicine if you are elderly or gravely ill.

Phenytoin may precipitate or aggravate absence seizures and myoclonic seizures (two specific types of epilepsy).

Taking other medicines

A large number of drugs can interact with phenytoin which can significantly alter their effects.

It is very important to tell your doctor if you are taking any other medicines, including medicines obtained without a prescription, or are being treated for any of the conditions listed below. This will allow your doctor to decide whether it is safe for you to be given phenytoin.

The doctor may want to take a sample of your blood before giving you phenytoin to test whether any medicine that you are already taking will be affected by phenytoin.

The most common medicines are listed below and include medicines for: Epilepsy or fits (e.g. carbamazepine, lamotrigine, phenobarbital, sodium valproate and valproic acid, ethosuximide, succinimides and vigabatrin) Corticosteroids e.g. prednisolone (used in numerous situations to aid the body’s healing process)

Fungal infections (e.g. amphotericin B, fluconazole, itraconazole, ketoconazole and miconazole)

Skin diseases (e.g. methoxsalen)

Tuberculosis and other infections (e.g. chloramphenicol, isoniazid, rifampicin, sulphonamides, doxycycline and ciprofloxacin)

Asthma and bronchitis (theophylline)

Diabetes (e.g. tolbutamide)

High blood pressure (e.g. calcium channel blockers like diltiazem, felodipine) Pain and inflammation (e.g. phenylbutazone, salicylates, azapropazone and steroids)

Stomach ulcers and heartburn (e.g. omeprazole, sucralfate, the medicines known as H2 antagonists e.g. cimetidine, some antacids)

Sleeplessness, depression and psychiatric disorders (e.g. chlordiazepoxide, clozapine, diazepam, disulfiram, lithium, methadone, fluoxetine, fluvoxamine, sertraline, haloperidol, levodopa, paroxetine, methylphenidate, phenothiazines, quetiapine, trazodone, reserpine, tricyclic antidepressants and viloxazine)

•    Cancer (Fluorouracil, antineoplastic agents)

•    Organ and tissue transplants, to prevent rejection (ciclosporin)

•    Heart and circulation problems (e.g. dicoumarol, amiodarone, nifedipine, digitoxin, disopyramide, mexiletine, furosemide, and quinidine)

•    Hormone replacement therapies (oestrogens) and oral contraceptives

•    Thyroid disorders (e.g. thyroxine)

•    Some medicines used in operations, e.g. halothane (an anaesthetic) and neuromuscular blockers (used to relax muscles)

•    Some products available without a prescription (folic acid, vitamin D). Blood test may be necessary every six months to monitor the amount of folic acid in the blood.

•    The herbal remedy St. John’s wort (Hypericum perforatum) should not be taken at the same time as this medicine. If you have already taken St. John’s wort, consult your doctor before stopping St. John’s wort preparations.

•    Anticoagulants, e.g. warfarin (as its effect may be enhanced by phenytoin) - Drugs used in Human immunodeficiency virus (HIV) infected patients

(e.g. amprenavir, nelfinavir).

Using Phenytoin Injection with food and drink

Speak to your doctor before being given this medicine if you have recently had a drink of alcohol. Drinking a lot of alcohol can also affect the concentration of Phenytoin in your blood.

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Pregnancy and breast feeding

If you are or think you may be pregnant or are planning to become pregnant, whilst having phenytoin, your doctor will decide if you should continue with this medicine or whether another would be more suitable during your pregnancy.

Do not stop taking phenytoin until you have seen your doctor as it is important to control your fits. If given during pregnancy phenytoin may affect the baby but your doctor may decide that it is very important that you continue with phenytoin. He or she will explain the risks to you.

As phenytoin is released into breast milk, you should not breast-feed if you are taking this medicine.

Driving and using machines

Phenytoin may cause dizziness or drowsiness. If you experience these symptoms, do not drive or use any tools or machinery.

Ask your doctor or pharmacist for advice before taking any medicine. Important information about some of the ingredients of Phenytoin Injection

Propylene glycol, ethanol, sodium hydroxide are all present in this product. This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e. essentially ‘sodium-free’.

This medicinal product contains 10 % vol ethanol (alcohol), i.e. up to 395.75 mg per dose, equivalent to 7.9ml beer, 3.2ml wine per dose.

Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.

3. HOW PHENYTOIN INJECTION IS GIVEN TO YOU

Phenytoin injection is given by a doctor or nurse. It may be given as an injection slowly into a muscle or a large vein. Alternatively, it may be diluted and given as a drip or infusion into one of your large veins (intravenously). The correct dose will be calculated by your doctor according to your body weight. A repeat injection may be given after 30 minutes if necessary.

During your treatment your doctor may monitor your blood levels of phenytoin by taking regular blood samples.

If you think you have been given more Phenytoin Injection than you should have

This is unlikely but if you think that too much of this injection has been administered, tell your doctor immediately.

If you think you have missed a dose of Phenytoin Injection

If you think that you may have missed a dose, tell your doctor immediately.

If you have any further questions on the use of this product ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Phenytoin Injection can cause side-effects, although not everybody gets them.

Important: If you experience any of the following serious side effects contact your doctor immediately.

•    Severe allergic reactions such as swelling of the face, tongue, and/or throat, which may cause difficulty in breathing or swallowing

•    A skin rash. Your doctor may decide to stop your phenytoin treatment, temporarily or permanently depending on the type of rash

•    Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2). Frequency is very rare

•    If you start feeling depressed or have thoughts about suicide.

The following side effects have also been reported:

•    vertigo (a feeling of dizziness or spinning)

•    palpitations or an irregular heart beat

•    faintness or dizziness, drowsiness

•    difficulty in breathing

•    rapid movements of the eyeball, irregular muscle twitches, slurred speech, decreased co-ordination, feeling confused, abnormal sensations (such as tingling of the fingers)

•    difficulty sleeping, nervousness

•    headache, fits

•    signs of nerve disease such as pain, numbness or muscle weakness

•    pain, inflammation or injury at the site of injection

•    a condition which causes inflammation and tissue damage

•    abnormal bruising of the skin

•    a persistent sore throat or unexplained high temperature

•    any signs of anaemia (such as paleness or feeling tired)

•    high blood sugar

•    swollen glands

•    tummy upset, constipation

•    jaundice (yellowing of the skin or the whites of the eyes)

•    thickening of the facial features, swelling of the lips or gums (occurring more frequently in children and people with poor oral hygiene), an increase in body hair

•    thickening and tightness of muscles in the penis or the fingers

•    pains in the joints

•    passing blood in the urine or any problem passing urine

•    cough, wheezing or breathlessness

•    there have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic medication, have a history of osteoporosis, or take steroids.

Tell your doctor immediately if you experience skin discolouration, swelling and pain where the injection was given which then starts to spread down your arm to your hands and fingers. This may mean you have a condition known as “purple glove syndrome”. In most cases this will improve on its own but in some cases it can be serious and require urgent medical treatment.

Please note that Phenytoin can interfere with some laboratory tests e.g. blood tests, urine tests. If you are having a test done, remember to mention that you received treatment with phenytoin.

Please see your doctor if you notice any of these side effects and they cause you concern, or if you notice any side effects not listed in this leaflet. Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE PHENYTOIN INJECTION

Keep this medicine out of the sight and reach of children.

The product should not be used after the expiry date printed on the ampoule (a small bottle) label and carton.

The ampoules should be protected from light and stored at a temperature not greater than 30°C.

If only part of the contents of an ampoule is used, the remaining solution should be discarded.

Solutions in which a haziness or precipitate develops should not be used. The solution should not be mixed with any other drugs.

6. FURTHER INFORMATION

The active substance is phenytoin sodium. Each 1 ml of this solution contains 50mg of phenytoin sodium.

The other ingredients are propylene glycol BP, ethanol BP and sodium hydroxide BP (as a 10% w/v solution) in water for injections BP

What Phenytoin Injection BP looks like and contents of pack:

Phenytoin Injection BP is a clear, colourless, particle-free solution. Each carton contains ten 5ml ampoules of Phenytoin Injection.

Marketing authorisation holder:

Mercury Pharma International Ltd, 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland.

Manufacturer:

Delpharm Tours, Rue Paul Langevin, 37170 Chambray Les Tours, France. This leaflet was last revised in February 2016.

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