Active substance: PHENYTOIN SODIUM

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Epanutin® 50 mg Hard Capsules


(phenytoin sodium)
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 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 Epanutin 50 mg Hard Capsules but will be
referred to as Epanutin throughout this leaflet.
Epanutin Capsules are also available in other strengths.
In this leaflet:
1. What Epanutin is and what they are used for
2. Before you take Epanutin
3. How to take Epanutin
4. Possible side effects
5. How to store Epanutin
6. Further information
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
Do not take Epanutin
- if you are allergic (hypersensitive) to Phenytoin, or any of the other
ingredients of Epanutin.
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).
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.
Serious skin side effects can rarely occur during treatment with Epanutin.
This risk may be associated with a variant in genes in a subject of 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.
Taking other medicines
Some medicines can affect the way Epanutin works and 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, sulphonamides, rifampicin, doxycycline, ciprofloxacin and
- 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
- 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.
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
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 may also interfere with certain laboratory tests that you may be
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.
It is best to take Epanutin at the same time each day.
Swallow the capsules whole, with plenty of water.
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.
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.
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 many
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 you.
If you have any further questions on how to take Epanutin, ask your doctor
or pharmacist.

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 a state of 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
- 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.
- 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.
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package in order to protect
from light.
Do not use Epanutin after the expiry date which is on the pack. The expiry
date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
If your capsules become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.

What Epanutin contains
Epanutin contains phenytoin sodium as active ingredient.
Each hard capsule contains 50 mg phenytoin sodium.
The other ingredients are lactose monohydrate, magnesium stearate and
sodium lauryl sulphate.
The gelatin capsules shells contain titanium dioxide (E171), erythrosine
(E127) and quinoline yellow (E104).
Printing ink contains the following shellac, black iron oxide (E172) and
propylene glycol.
It may also contain potassium hydroxide.
What Epanutin looks like and contents of the pack
Epanutin is supplied as a white powder in a hard gelatin capsule with a
white opaque body and flesh-coloured cap, radially printed in black ink
'EPANUTIN 50' on both cap and body.
Available in plastic bottle containing 28 hard capsules with a dessicant.
The desiccant should not be eaten.
Manufactured by Pfizer Manufacturing Deutschland GmbH, Mooswaldallee
1, D-79090, Freiburg, Germany. Procured from within the EU by Product
Licence holder Tenolol Ltd., 5 Sandridge Close, Harrow, Middlesex HA1
1XD. Repackaged by Servipharm Ltd.

PL No: 30900/2458

Leaflet revision and issue date (Ref) 24.03.14[3]
Epanutin is a trademark of Parke, Davis & Company LLC.

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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.