Phenytoin Sodium Milpharm 100mg Film-Coated Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Phenytoin sodium Milpharm 100 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 100 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 tablets can be used to control a variety of epileptic conditions (tonic-clonic seizures and partial seizures), 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 tablets.
Note: Phenytoin sodium is not effective in absence status epilepticus or in the prophylaxis and treatment of febrile convulsions.
2. What you need to know before you take Phenytoin Milpharm tablets
Do not take Phenytoin tablets
• Ifyouare allergic to phenytoin, or any of the other ingredients of Phenytoin tablets (listed in section 6).
• Ifyouare allergic to other medicines with a similar chemical structure to phenytoin (e.g. hydantoins)
• Ifyouhave severe damage to the blood cells and bone marrow
• Ifyouhave grade II and grade III AV block (disorder of heart beat regulation)
• Ifyouhave a type of disorder that causes fainting and sometimes fits called Strokes-Adams syndrome.
• Ifyousuffer 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)
• Ifyouhave a had attack within the last three months
• Iftheoutput of your heart is poor (ask your doctor).
Take special care with Phenytoin tablets
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 tablets should not be given in
• heartfailure (inability of heart to pump properly)
• impairedbreathing function
• severehypotension (systolic blood pressure less than 90 mm Hg)
• thefollowing heart rhythm disturbances:
- grade I AV block
- atrial fibrillation
- atrial flutter
Phenytoin tablets should be given with special precaution if you suffer from or have suffered in the past from any of the following conditions:
• impairedliver function
• impairedkidney 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 tablets.
• Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Phenytoin tablets, 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).
• Thesepotentially life-threatening skin rashes are often accompanied by flulike symptoms. The rash may progress to widespread blistering or peeling of the skin.
• Thehighest risk for occurrence of serious skin reactions is within the first weeks of treatment.
• Ifyouhave developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Phenytoin tablets, you must not be re-started on Phenytoin tablets at any time.
• Ifyoudevelop 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
• Ifyousuffer 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.
• Ifyousuddenly stop taking Phenytoin 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 tablets
Some medicines can affect the way Phenytoin works, or Phenytoin 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).
• Somehormone 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)
• Musclerelaxants used for surgery (neuromuscular blockers), some anaesthetic drugs (halothane) and methadone
• Someproducts 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 tablets 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 with food, drink and alcohol
Phenytoin tablets 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.
If treatment with Phenytoin tablets is essential, your doctor will prescribe the lowest effective daily dose to control your seizures. Pregnancy may also alter the effectiveness of Phenytoin tablets, so you may need blood tests and your dose of Phenytoin tablets may have to be adjusted.
If you take Phenytoin 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 tablets if you are breast-feeding.
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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 tablets at the same time each day.
Swallow the tablets whole, with plenty of water.
Prevention and treatment of seizures
a) Slow titration
Adults and adolescents over 12 years of age (i.e. with over 50 kg bodyweight) take up to 3 tablets (corresponding to 300 mg phenytoin) single or divided in up to three doses.
Dose is adjusted according to clinical requirements and according to controls of phenytoin plasma concentration (especially when higher doses are applied). Children up to 12 years receive 2 mg phenytoin/kg bodyweight per day. The daily dose can be increased in 1 mg/day increments every 3 days according to phenytoin plasma concentration.
b) Maintenance dose
The maintenance dose is determined individually according to seizure control, undesirable effects and phenytoin plasma concentration.
c) Rapid Saturation
Rapid saturation should be performed only in in-patients using phenytoin plasma controls.
Adults and adolescents over 12 years of age (i.e. with over 50 kg bodyweight) take up to 10 tablets (corresponding to 1 g phenytoin) divided in three doses (4 tablets, 3 tablets, 3 tablets) every 2 hours. After the second day the dosing procedure is the same as with slow titration.
Children up to 12 years receive 5-8 mg phenytoin/kg bodyweight on the 1st day of treatment.
From the 2nd day on, children > 6 years receive 2 tablets (corresponding to 200 mg phenytoin) per day.
In children below 6 years, dose from the 2nd day on is determined according to phenytoin plasma concentration.
Trigeminal neuralgia:
Adults take 3 tablets per day (corresponding to 300 mg phenytoin) as a single or up to 3 divided doses.
Dose is adjusted according to clinical requirements and according to controls of phenytoin plasma concentration (especially when higher doses are applied).
Duration of administration
The tablets should be swallowed with a sufficient quantity of liquid (e.g. water). Duration of administration is dependent on the underlying disease and the course of the illness. If the medicinal product is well-tolerated, it can be used indefinitely.
If you take more Phenytoin tablets than you should
Phenytoin is dangerous in overdose. If you accidentally take too many Phenytoin tablets contact your doctor at once or go to the nearest hospital casualty department. Always take the labelled medicine package with you, whether there are any Phenytoin tablets left or not.
If you forget to take Phenytoin 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 tablets
Do not stop taking Phenytoin tablets 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 tablets, your doctor will decide which method is best 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.
• Suddenwheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).
• Ifyounotice 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.
• Skinrash 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.
• Ifyouexperience 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:
• Effectson 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.
• Effectson your skin: skin rash including measles-like reactions which are mild.
• Effectson your stomach and intestines: feeling sick, being sick and constipation.
• Effectson your blood and lymph system: swelling of the lymph glands,
• Effectson your liver and kidney: inflammation of the kidneys and liver, liver damage (seen as yellowing of the skin and whites of the eye).
• Effectson your reproductive system and breasts: changes in the shape of the penis, painful erection.
• Effectson 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.
• Effectson 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.
• Effectson your respiratory system: problems breathing, inflammation of the lining of the lung.
• Effectson 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 bottle tightly closed.
Do not use this medicine after the expiry date (EXP) which is stated on the carton and foil
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 tablets contain
• Theactive substance is phenytoin sodium. Each film-coated tablet contains 100 mg of phenytoin sodium.
• Theother ingredients are Tablet core:
Mannitol Crospovidone Magnesium stearate Croscarmellose sodium Tablet coat:
Hypromellose Macrogol 400 Titanium dioxide Sodium lauryl sulfate
What Phenytoin tablets look like and contents of the pack
White to off-white, oval shaped, film-coated tablets debossed with 'C' on one side and '70' on the other side.
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 dessicant:
30 film-coated tablets Not all pack sizes may be marketed.
Marketing Authorisation Holder Milpharm Limited Ares, Odyssey Business Park West End Road South 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, Odyssey Business Park West End Road South Ruislip HA4 6QD United Kingdom