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PHENYTOIN SODIUM MILPHARM 100MG FILM-COATED TABLETS

Active substance(s): PHENYTOIN SODIUM

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Phenytoin sodium Milpharm 100mg film-coated tablets
(phenytoin sodium)
Patient Information Leaflet
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
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 filmcoated tablets (referred to as Phenytoin Milpharm 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 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 Milpharm tablets if:
• If you are allergic (hypersensitive) to phenytoin, or any of the other
ingredients of Phenytoin Milpharm tablets (listed in section 6).
• If you are allergic (hypersensitive) 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).
Take special care with Phenytoin Milpharm 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 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 tablets.
• Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic
epidermal necrolysis) have been reported with the use of Phenytoin
Milpharm 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).
• These potentially life-threatening skin rashes are often accompanied by
flulike 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 tablets, you must not be re-started on
Phenytoin tablets 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 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.
Taking Phenytoin Milpharm tablets with food and drink
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
Tell your doctor if you think you might be pregnant, or are planning to
become pregnant, before you take Phenytoin Milpharm tablets. Phenytoin
Milpharm 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 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 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 tablets if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.

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 Milpharm 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 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
missed dose.
If you stop taking Phenytoin Milpharm tablets
Do not stop taking Phenytoin Milpharm 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 how to take 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, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via: Yellow Card Scheme Website:
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 out of the sight and reach of children.
• Store in the original package in order to protect from moisture.
• Do not use this medicine after the expiry date (EXP) which is stated on
the carton and foil.
• If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to
do.
• 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 tablets contain
• The active substance is phenytoin sodium. Each film-coated tablet
contains 100 mg of phenytoin sodium.
• The other ingredients are
Tablet Core: Mannitol, Crospovidone (Type B), Crospovidone (Type A),
Croscarmellose sodium, Magnesium stearate.
Tablet Coat: Hypromellose, Macrogol 400, Titanium dioxide (E171) and
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 '70' on the other side.
Phenytoin tablets are available in blister packs of 50, 100 and 200 tablets.
PL 10383/2118 Phenytoin sodium Milpharm 100mg film-coated tablets
POM
Who makes and repackages your medicine?
Your medicine is manufactured by APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta.
Procured from within the EU and repackaged by Product Licence Holder:
Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex, UB5 5QS.
Leaflet date: 26.05.2015

Phenytoin sodium Primecrown 100mg film-coated tablets
(phenytoin sodium)
Patient Information Leaflet
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
What is in this leaflet:
1) What Phenytoin Primecrown tablets are and what they are used for
2) What you need to know before you take Phenytoin Primecrown tablets
3) How to take Phenytoin Primecrown tablets
4) Possible side effects
5) How to store Phenytoin Primecrown tablets
6) Contents of the pack and other information

1) What Phenytoin Primecrown tablets are and what they are
used for
The name of your medicine is Phenytoin Sodium Milpharm 100 mg filmcoated tablets (referred to as Phenytoin Primecrown 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 Primecrown 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
Primecrown tablets
DO NOT take Phenytoin Primecrown tablets if:
• If you are allergic (hypersensitive) to phenytoin, or any of the other
ingredients of Phenytoin Primecrown tablets (listed in section 6).
• If you are allergic (hypersensitive) 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).
Take special care with Phenytoin Primecrown 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 Primecrown 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 Primecrown 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 Primecrown tablets.
• Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic
epidermal necrolysis) have been reported with the use of Phenytoin
Primecrown 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).
• These potentially life-threatening skin rashes are often accompanied by
flulike 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 tablets, you must not be re-started on
Phenytoin tablets 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 Primecrown 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 Primecrown tablets
Some medicines can affect the way Phenytoin Primecrown works, or
Phenytoin Primecrown 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 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.
Taking Phenytoin Primecrown tablets with food and drink
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
Tell your doctor if you think you might be pregnant, or are planning to
become pregnant, before you take Phenytoin Primecrown tablets.
Phenytoin Primecrown 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 Primecrown 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 Primecrown tablets may have to be
adjusted.
If you take Phenytoin Primecrown 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 Primecrown tablets if you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
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 Primecrown 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 Primecrown 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 Primecrown 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
missed dose.
If you stop taking Phenytoin Primecrown tablets
Do not stop taking Phenytoin Primecrown 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.

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, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via: Yellow Card Scheme Website:
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 Primecrown tablets
• Keep out of the sight and reach of children.
• Store in the original package in order to protect from moisture.
• Do not use this medicine after the expiry date (EXP) which is stated on
the carton and foil.
• If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to
do.
• 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 Primecrown tablets contain
• The active substance is phenytoin sodium. Each film-coated tablet
contains 100 mg of phenytoin sodium.
• The other ingredients are
Tablet Core: Mannitol, Crospovidone (Type B), Crospovidone (Type A),
Croscarmellose sodium, Magnesium stearate.
Tablet Coat: Hypromellose, Macrogol 400, Titanium dioxide (E171) and
Sodium lauryl sulfate.
What Phenytoin Primecrown 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.
Phenytoin tablets are available in blister packs of 50, 100 and 200 tablets.

If you have any further questions on how to take this medicine, ask your
doctor or pharmacist.

PL 10383/2118 Phenytoin sodium Milpharm 100mg film-coated tablets
POM

4) Possible side effects

Who makes and repackages your medicine?
Your medicine is manufactured by APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta.
Procured from within the EU and repackaged by Product Licence Holder:
Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex, UB5 5QS.

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,

Leaflet date: 26.05.2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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