EPANUTIN INFATABS 50MG CHEWABLE TABLETS

Active substance: PHENYTOIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Epanutin®
Infatabs 50mg
Chewable Tablets

2”
50.8 mm

(Phenytoin)

• 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.
2”
50.8 mm

• 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.

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• Keep this leaflet. You may need to read it again.

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1. What Epanutin Infatabs are and what they are used for

Epanutin is one of a group of medicines called anti-epileptic drugs; these
medicines are usually used to treat epilepsy and prevent or treat seizures.

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

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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 a condition called trigeminal neuralgia (which causes facial
nerve pain).
You should consult your doctor if you are unsure why you have been given
Epanutin Infatabs.

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Do not take Epanutin
• if you are allergic (hypersensitive) to phenytoin, or any of the other
ingredients of Epanutin Infatabs.
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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).

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2. Before you take Epanutin

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A small number of people being treated with antiepileptics such as phenytoin
have had thoughts of harming or killing themselves. If at any time you have these
thoughts, immediately contact your doctor.
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic
epidermal necrolysis) have been reported with the use of Epanutin, 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 lifethreatening skin rashes are often 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 Epanutin, you must not be re-started on Epanutin at any time.
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This risk of these serious skin side effects 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.

3.641” / 92.481 mm

Taking other medicines
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If you develop a rash or these skin symptoms, stop taking Epanutin, seek urgent
advice from a doctor and tell him that you are taking this medicine. Consult your
doctor before discontinuing Epanutin. If you suddenly stop taking this medicine
you may have a seizure.

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:
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50.8 mm

• 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
vigabatrin).

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1. What Epanutin Infatabs are and what they are used for
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In this leaflet:

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Read all of this leaflet carefully before you start taking this medicine.

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• Medicines used for tuberculosis and other infections (chloramphenicol,
isoniazid, rifampicin, sulphonamides, doxycycline, ciprofloxacin and
nelfinavir).

• 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).
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• 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 such as fluorouracil).

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• Some products available without a prescription (folic acid, theophylline,
vitamin D).

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

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 Infatabs may also interfere with certain laboratory tests that you may be
given.
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Taking Epanutin with food and drink
Epanutin can be used before or after food and drinks. Drinking a lot of alcohol can
also affect the concentration of phenytoin in your blood.

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Important information about some of the ingredients of Epanutin

If you think you might be pregnant, or are planning to get pregnant, tell your
doctor before you take Epanutin.

Epanutin contains sucrose, 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 may be harmful to the teeth.

You should not breast-feed if you are taking Epanutin.
Ask your doctor or pharmacist for advice before taking any medicine.
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Driving and using machines
Epanutin may cause dizziness or drowsiness. If you experience these symptoms,
do not drive or use any tools or machinery and contact your doctor.

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Pregnancy and Breast-feeding

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The colouring agent E110, which is present in the yellow tablets may cause
allergic reactions.

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Your doctor may need to monitor the amount of phenytoin in your blood to help
decide if any of these drugs are affecting your treatment.

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• Muscle relaxants used for surgery (neuromuscular blockers), some
anaesthetics (halothane) and methadone.

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Elderly

Chew the Infatabs or swallow them whole with plenty of water.
It is best to take Epanutin at the same time each day.

The dose of Epanutin for elderly patients who may be taking other medicines may
also need careful consideration and adjustment by their doctor.

Adults
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.
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.
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3. How to take Epanutin

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Always take Epanutin exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are still not sure.
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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.
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• Medicines used for stomach ulcers (omeprazole, sucralfate, the medicines
known as H2 antagonists e.g. cimetidine, ranitidine, famotidine and some
antacids).

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• Medicines used to treat fungal infections (e.g. amphotericin B, fluconazole,
itraconazole, ketoconazole and miconazole).

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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). There is a higher
incidence of this in black patients.
• If you develop potentially life-threatening skin rashes that cause blistering,
(this can affect the mouth and tongue). These may be signs of a condition
known as Stevens Johnson Syndrome, or toxic epidermal necrolysis (TEN).
These have been reported very rarely. Your doctor will stop your treatment
in these cases.
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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 this product, ask your doctor or
pharmacist.

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• 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.

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• 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.
• Skin rash, fever, swollen glands, increase in a type of white blood cell
(eosinophilia) and inflammation of internal organs (liver, lungs, heart, kidneys
and large intestine) as they may be signs of a hypersensitivity reaction.

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• 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. 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:
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• 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 change in taste.
• Effects on your skin: skin rash including measles-like reactions which are mild.

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• 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).
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• 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.

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• Effects on your stomach and intestines: feeling sick, being sick and
constipation.

• Effects on medical tests: Increased levels of blood sugar, or decreased
levels of blood calcium, phosphate, 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 and muscle pain or fractures.

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• 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 and immunoglobin
abnormalities.

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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.

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5. How to store Epanutin
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• 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.

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Keep out of the reach and sight of children.
Store in the original package in order to protect from moisture.
Do not store above 25ºC.
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50.8 mm

Do not use Epanutin after the expiry date which is stamped on the label. 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.

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If you stop taking Epanutin

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4. Possible side effects

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.

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If you forget to take Epanutin

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Ireland
Pfizer Healthcare Ireland
9 Riverwalk
National Digital Park, Citywest Business Campus
Dublin 24, Ireland
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Manufacturer
Pfizer Service Company BVBA
Hoge Wei 10
B-1930 Zaventem
Belgium
Company Contact Address
For further information on your medicine please contact Medical Information at the
following address: Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS.
Telephone: 01304 616161
Leaflet last revised: 10/2012
Ref: EP 3_0

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What Epanutin Infatabs 50mg contain
Each yellow triangular tablet contains 50mg of the active ingredient phenytoin.
The other ingredients are sucrose (icing sugar), maize, starch, saccharin sodium,
spearmint flavour, talc, magnesium stearate, quinoline yellow (E104) and sunset
yellow (E110).
What Epanutin Infatabs look like and contents of the pack
Epanutin Infatabs are spearmint flavoured yellow, triangular chewable tablets with
flat sides, a bevelled edge and breaking line on one side with P-D 007 imprinted
on the other side. Epanutin Infatabs are available in a HDPE bottle containing 200
tablets.

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Marketing Authorisation Holder
UK
Pfizer Limited
Ramsgate Road, Sandwich
Kent
CT13 9NJ, UK

6. Further Information

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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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