Active substance: PHENYTOIN SODIUM

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Ref: 0690/071212/1/F


Epanutin 100mg Capsules/Phenytoin Sodium 100mg Capsules
(phenytoin sodium)
Patient Information Leaflet
Your medicine is called Epanutin 100mg Capsules/Phenytoin Sodium 100mg
Capsules, and will be referred to as Epanutin throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
* If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.


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
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.

In this leaflet:
1 What Epanutin is and what it is used for

Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.

2 Before you take Epanutin
3 How to take Epanutin
4 Possible side effects
5 How to store Epanutin
6 Further information


What Epanutin is and what it is used for

Epanutin is one of a group of medicines called anti-epileptic drugs; these
medicines are used to treat epilepsy.
Epanutin can be used to control a variety of epileptic conditions, to control or
prevent seizures during or after brain surgery or severe head injury. Epanutin
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
Epanutin Capsules.


Before you take Epanutin

Do not take Epanutin
* if you are allergic (hypersensitive) to Phenytoin, or any of the other
ingredients of Epanutin Capsules.
Take special care with Epanutin
Medicines are not always suitable for everyone. Your doctor needs to know
before you take Epanutin if you suffer from or have suffered in the past from
any of the following conditions:
* Liver disease.
* Porphyria (an inherited disease that affects haemoglobin biosynthesis).

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.
Epanutin capsules may also interfere with certain laboratory tests that you
may be given.
Taking Epanutin with food and drink
Epanutin 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 and Breast-feeding
If you think you might be pregnant, or are planning to get pregnant, tell your
doctor before you take Epanutin
You should not take Epanutin if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Epanutin may cause dizziness or drowsiness, especially during the first few
weeks of treatment. If you experience these symptoms, do not drive or use
any tools or machinery.
Important information about some of the ingredients of Epanutin
Epanutin contains lactose, a type of sugar. If you have been told that you
have an intolerance to some sugars, contact your doctor before taking this
medicinal product.


How to take Epanutin

It is best to take Epanutin at the same time each day.
Swallow the capsules whole, with plenty of water.

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

The amount of Epanutin 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.

Serious skin side effects can rarely occur during treatment with Epanutin.
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 (HLA-B*1502),discuss this with your doctor
before taking Epanutin.

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.

Taking other medicines
Some medicines can affect the way Epanutin works, or Epanutin 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, lamotrigine, phenobarbital,
sodium valproate and valproic acid, succinimides e.g. ethosuximide and
* 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 ciprofloxacin) and
* Medicines used for stomach ulcers (omeprazole, sucralfate, the medicines
known as H2 antagonists e.g. cimetidine, ranitidine, famotidine and some
* 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).

The dose of Epanutin for elderly patients who may be taking other medicines
may also need careful consideration and adjustment by their doctor.
Always take Epanutin exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are still not sure.
If you take more Epanutin than you should
Epanutin is dangerous in overdose. If you accidentally take too much
Epanutin 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 Epanutin left or not.
If you forget to take Epanutin
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 Epanutin
Do not stop taking Epanutin unless your doctor tells you to. If you suddenly
stop taking this medicine you may have a seizure. Should you need to stop
taking Epanutin, your doctor will have decided which the best method is for
If you have any further questions on how to take this Epanutin, ask your
doctor or pharmacist.

Ref: 0690/071212/1/B


Epanutin 100mg Capsules/Phenytoin Sodium 100mg Capsules
(phenytoin sodium)
Patient Information Leaflet (continued)

Possible side effects

Like all medicines, Epanutin 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 develop a severe skin rash that causes blistering, (this can also
affect the mouth and tongue). These may be signs of a condition known
as Stevens Johnson Syndrome, or toxic epidermal necrolysis (TEN). Your
doctor will stop your treatment in these cases.
* 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
* 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.
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
* Effects on your blood and lymph system: swelling of the lymph glands,
* Effects on your liver and kidneys: 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.
* 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.
* Effects on your bones:
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.
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.



How to store Epanutin
Do not store above 25°C

Do not use this medicine after the expiry date shown on the carton label or
If your doctor tells you to stop taking this medicine, return any unused
capsules to your pharmacist for safe disposal. Only keep this medicine, if
your doctor tells you to.
If your capsules become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.


Further information

What Epanutin contains
Each capsule contains 100mg Phenytoin sodium as the active ingredient.
Your medicine contains the following inactive ingredients:
lactose monohydrate, magnesium stearate, erythrosine (E127), quinoline
yellow (E104), gelatin, sodium dodecylsulfate, printing ink and titanium
dioxide (E171).
What Epanutin looks like and content of the pack
Epanutin Capsules are hard gelatin capsules with a white body and a bright
orange cap, both printed with ‘Epanutin 100’ in black ink.
The capsules contain a fine white powder.
They are available in white plastic tubs of 100 capsules.
Manufacturer and Licence Holder
This medicine is manufactured by Pfizer Manufacturing Deutschland GMBH,
Freiburg, Germany and is procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.


PL 15184/0690
Epanutin 100mg Capsules/Phenytoin Sodium 100mg Capsules

Epanutin is a registered trademark of Parke, Davis & Company LLC.
Revision date: 07/12/12

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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.