Phenytoin Sodium Milpharm 50 Mg Film-Coated Tablets
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Package leaflet: Information for the user
Phenytoin Sodium Milpharm 50 mg film-coated tablets
phenytoin sodium
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Phenytoin Milpharm tablets are and what they are used for
2. What you need to know before you take Phenytoin Milpharm tablets
3. How to take Phenytoin Milpharm tablets
4. Possible side effects
5. How to store Phenytoin Milpharm tablets
6. Contents of the pack and other information
1. What Phenytoin Milpharm tablets are and what they are used for
The name of your medicine is Phenytoin Sodium Milpharm 50 mg film-coated tablets (referred to as Phenytoin tablets or as Phenytoin throughout this leaflet).Phenytoin is one of a group of medicines called anti-epileptic drugs; these medicines are used to treat epilepsy.
Phenytoin Milpharm can be used to control a variety of epileptic conditions, to control or prevent seizures during or after brain surgery or severe head injury. Phenytoin can also be used to treat trigeminal neuralgia (facial nerve pain).
You should ask your doctor if you are unsure why you have been given Phenytoin.
2. What you need to know before you take Phenytoin Milpharm tablets
Do not take Phenytoin Milpharm tablets
• If you are allergic to phenytoin, or any of the other ingredients of Phenytoin Milpharm tablets (listed in section 6).
• If you are allergic to other medicines with a similar chemical structure to phenytoin (e.g. hydantoins)
• If you have severe damage to the blood cells and bone marrow
• If you have grade II and grade III AV block (disorder of heart beat regulation)
• If you have a type of disorder that causes fainting and sometimes fits called Strokes-Adams syndrome.
• If you suffer from sinus bradycardia (slow heart rate of less than 50 beats per minute), sick sinus syndrome or sino-atrial block (disorders of heart beat regulation)
• If you have a had attack within the last three months
• If the output of your heart is poor (ask your doctor).
Warnings and precautions
A small number of people being treated with antiepileptics such as phenytoin sodium have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
Phenytoin Milpharm tablets should not be given in
• heart failure (inability of heart to pump properly)
• impaired breathing function
• severe hypotension (systolic blood pressure less than 90 mm Hg)
• the following heart rhythm disturbances:
- grade I AV block
- atrial fibrillation
- atrial flutter
Phenytoin Milpharm tablets should be given with special precaution if you suffer from or have suffered in the past from any of the following conditions:
• impaired liver function
• impaired kidney function
your doctor will take blood and urine samples to monitor your liver and kidney function. If you are diabetic you are more likely to get hyperglycaemia (high blood sugar).
• Porphyria (an inherited disease that affects haemoglobin biosynthesis)
Serious skin side effects can rarely occur during treatment with phenytoin. This risk may be associated with a variant in genes in a subject with Chinese or Thai origin. If you are of such origin and have been tested previously carrying this genetic variant (HLAB* 1502), discuss this with your doctor before taking Phenytoin Milpharm.
• Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Phenytoin, 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
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accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin.
• The highest risk for occurrence 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, you must not be re-started on Phenytoin at any time.
• If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell him that you are taking this medicine.
Important information regarding treatment
• If you suffer from slow hydroxylation
Slow hydroxylation is an inherited disorder. It affects the way your body uses and reacts to medicine.
If you suffer from slow hydroxylation you should therefore take care. You may develop signs of overdose even at moderate doses. In this case your dose should be reduced. Your doctor will take a blood sample to check that the levels of phenytoin are not too high.
• If you suddenly stop taking Phenytoin Milpharm tablets
- you may suffer seizures more often
- you may develop status epilepticus (a state of persistent seizure).
To avoid these problems your doctor may:
- reduce your dose of Phenytoin slowly
- start the new antiepileptic medication at a low dose and gradually increase it.
Phenytoin blood levels
Phenytoin is a medicine with a narrow range between an effective dose and one that is ineffective or cause side effects. The absorption of phenytoin may also vary from day to day so you should try to be consistent in taking your dose [for example at a similar time each day]. If you have to switch to a different formulation containing phenytoin, your doctor may monitor the levels of phenytoin in your blood for a week or two to check that the optimal dose is being prescribed.
Other medicines and Phenytoin Milpharm tablets Some medicines can affect the way Phenytoin Milpharm works, or Phenytoin Milpharm itself can reduce the effectiveness of other medicines taken at the same time.
These include:
• Medicines used for heart and circulation problems (dicoumarol, digitoxin, amiodarone, furosemide, quinidine, reserpine, warfarin, and calcium channel blockers e.g. diltiazem and nifedipine).
• Medicines used for epilepsy (carbamazepine, oxcarbazepine, eslicarbazepine, zonisamide, topiramate, tigabine, lamotrigine, phenobarbital, sodium valproate and valproic acid, succinimides e.g. ethosuximide and vigabatrin).
• Medicines used to treat fungal infections (e.g. amphotericin B, fluconazole, itraconazole, ketoconazole and miconazole).
• Medicines used for tuberculosis and other infections (chloramphenicol, isoniazid, rifampicin, sulphonamides, doxycycline and nelfinavir).
• Medicines used for stomach ulcers (omeprazole, sucralfate, the medicines known as H2 antagonists e.g. cimetidine, ranitidine, famotidine and some antacids).
• Medicines used for asthma and bronchitis (theophylline).
• Medicines used for pain and inflammation (phenylbutazone, salicylates e.g.aspirin and steroids).
• Medicines used for sleeplessness, depression and psychiatric disorders (chlordiazepoxide, clozapine, diazepam, disulfiram, fluoxetine, methylphenidate, paroxetine, phenothiazines, trazodone, tricyclic antidepressants, fluvoxamine, sertraline and viloxazine).
• Medicines used for diabetes (tolbutamide).
• Some hormone replacement therapies (oestrogens), oral contraceptives (the birth control pill).
• Medicines used for organ and tissue transplants, to prevent rejection (ciclosporin).
• Medicines used for cancer (antineoplastic agents)
• Muscle relaxants used for surgery (neuromuscular blockers), some anaesthetic drugs (halothane) and methadone
• Some products available without a prescription (folic acid, theophylline, vitamin D).
Your doctor may need to test the amount of Phenytoin in your blood to help decide if any of these medicines are affecting your treatment.
The herbal preparation St John’s wort (Hypericum perforatum) should not be taken at the same time as this medicine. If you already take St John’s wort, consult your doctor before stopping the St John’s wort preparation.
Phenytoin may also interfere with certain laboratory tests that you may be given.
Tell your doctor or pharmacist if you are taking have recently taken or might take any other medicines.
Phenytoin Milpharm with food, drink and alcohol
Phenytoin can be taken before or after food and drinks. Drinking a lot of alcohol can also affect the concentration of Phenytoin in your blood.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Phenytoin tablets should not be taken during pregnancy, unless you are told otherwise by your doctor, because it might increase the risk of birth defects.
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If treatment with Phenytoin Milpharm tablets is essential, your doctor will prescribe the lowest effective daily dose to control your seizures. Pregnancy may also alter the effectiveness of Phenytoin Milpharm tablets, so you may need blood tests and your dose of Phenytoin Milpharm tablets may have to be adjusted.
If you take Phenytoin Milpharm tablets to treat your seizures, do not interrupt the therapy during pregnancy without consulting first your doctor, as any abrupt discontinuation of treatment or uncontrolled dose reduction can cause recurrence of seizures, which may harm you and/or your unborn child.
You should not take Phenytoin Milpharm if you are breast-feeding. Driving and using machines
Phenytoin may cause symptoms like dizziness or drowsiness, especially during the first few weeks of treatment or following a dose increase. Patients are advised not to drive or use machines until it is established that their ability to perform such activities is not affected.
3. How to take Phenytoin Milpharm tablets.
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
It is best to take Phenytoin at the same time each day.
Swallow the tablets whole, with plenty of water.
Adults
The amount of Phenytoin needed varies from one person to another. Most adults need between 200mg and 500mg a day either as a single or divided dose. Occasionally higher doses are needed.
Children
Infants and children usually start on a dose that depends on their weight (5mg per day for every kg they weigh) and is given as a divided dose, twice a day. The dose is then adjusted up to a maximum of 300mg a day.
Elderly
The dose of Phenytoin for elderly patients who may be taking other medicines may also need careful consideration and adjustment by their doctor.
If you take more Phenytoin Milpharm tablets than you should
Phenytoin is dangerous in overdose. If you accidentally take too much Phenytoin contact your doctor at once or go to the nearest hospital casualty department. Always take the labelled medicine package with you, whether there is any Phenytoin left or not.
If you forget to take Phenytoin Milpharm tablets
If you forget to take a dose, take it as soon as you remember unless it is time for your next dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Phenytoin Milpharm tablets
Do not stop taking Phenytoin Milpharm unless your doctor tells you to. If you suddenly stop taking this medicine you may have a seizure. Should you need to stop taking Phenytoin, your doctor will have decided which the best method is for you.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Tell your doctor immediately if you experience any of the
following symptoms after taking this medicine. Although they are
very rare, these symptoms can be serious.
• Sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).
• If you notice bruising, fever, you are looking pale or you have a severe sore throat. These may be the first signs of an abnormality of the blood, including decreases in the number of red cells, white cells or platelets. Your doctor may take regular blood samples to test for these effects.
• Skin rash and fever with swollen glands, particularly in the first two months of treatment, as these may be signs of a hypersensitivity reaction. If these are severe and you also experience pain and inflammation of the joints this could be related to a condition called systemic lupus erythematosus.
• If you experience confusion or have a severe mental illness, as this may be a sign that you have high amounts of phenytoin in your blood. On rare occasions, when the amount of phenytoin in the blood remains high, irreversible brain injury has occurred. Your doctor may test your blood to see how much phenytoin is in the blood and may change your dose.
Tell your doctor immediately if you experience any of the
following symptoms after taking this medicine. Although they are
rare, these symptoms can be serious.
• Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2).
Other side-effects that may occur are:
• Effects on your nervous system: Unusual eye movements, unsteadiness, difficulty in controlling movements, shaking, abnormal or uncoordinated movements, slurred speech, confusion, pins and needles or numbness, drowsiness, dizziness, vertigo, sleeplessness, nervousness, twitching muscles, headaches and taste change.
• Effects on your skin: skin rash including measles-like reactions which are mild.
• Effects on your stomach and intestines: feeling sick, being sick and constipation.
• Effects on your blood and lymph system: swelling of the lymph glands,
• Effects on your liver and kidney: inflammation of the kidneys and liver, liver damage (seen as yellowing of the skin and whites of the eye).
• Effects on your reproductive system and breasts: changes in the shape of the penis, painful erection.
• Effects on your hands, face and body: changes in the hands with difficulty in straightening the fingers, changes in facial features, enlarged lips or gums, increased or abnormal body or facial hair. 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.
• Effects on medical tests: increased levels of blood sugar, or decreased levels of blood calcium, folic acid and vitamin D. If you also do not get enough vitamin D in your diet or from exposure to sunlight, you may suffer from bone pain or fractures.
• Effects on your respiratory system: problems breathing, inflammation of the lining of the lung.
• Effects on your immune system: problems with the body’s defence against infection, inflammation of the wall of the arteries.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
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 Milpharm tablets
Keep this medicine out of the sight and reach of children
Store in the original package in order to protect from moisture. Keep the HDPE container tightly closed
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month.
Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Phenytoin Milpharm contain
• The active substance is phenytoin sodium. Each film-coated tablet contains 50 mg of phenytoin sodium.
• The other ingredient are Tablet core:
Mannitol Crospovidone Magnesium stearate Croscarmellose sodium
Tablet coat:
Hypromellose Macrogol 400 Titanium dioxide Sodium lauryl sulfate
What Phenytoin Milpharm tablets look like and contents of the pack
White to off-white, oval shaped, film-coated tablets debossed with ‘C’ on one side and ‘69’ on the other side. The tablets size is 10.1 mm x 5.6 mm.
Polyamide / aluminium / PVC / aluminium blister pack:
10, 14, 20, 28, 30, 50, 60, 84, 100, 112, 200 and 250 film-coated tablets
HDPE container with a polypropylene closure and silica gel desiccant:
30 film-coated tablets Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited Ares Block
Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom
Manufacturer
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta
Or
Milpharm Limited Ares Block
Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom