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EPANUTIN INFATABS 50MG CHEWABLE TABLETS

Active substance(s): PHENYTOIN

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Package leaflet: Information for the patient

Infatabs 50mg
Chewable Tablets
(Phenytoin)

SUB1055

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What is in this leaflet

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

1. What Epanutin Infatabs are and what they are used for
2. What you need to know before you take Epanutin
3. How to take Epanutin
4. Possible side effects
5. How to store Epanutin
6. Contents of the pack and other information

This medicine contains phenytoin, which is one of a group of medicines called
anti-epileptic drugs; these medicines are usually used to treat epilepsy and
prevent or treat seizures.
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, if you do not feel better or if you feel worse.

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2. What you need to know before you take Epanutin

Warnings and precautions

Do not take Epanutin

Talk to your doctor or pharmacist before you take Epanutin if you suffer from or
have suffered in the past from any of the following conditions:

• if you are allergic (hypersensitive) to phenytoin, or any of the other ingredients
of this medicine (listed in section 6)
• if you are allergic to other medicines for epilepsy
• if you are also taking delavirdine (used for HIV therapy).

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• Liver disease
• Porphyria (an inherited disease that affects haemoglobin biosynthesis)
• Alcohol dependence.
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
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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.
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.

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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.
Black patients may be at greater risk of liver problems, serious skin reactions and
allergic reactions.
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Other medicines and Epanutin
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines including medicines obtained without a prescription.

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• 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 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.

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Epanutin®

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

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• Medicines used for heart and circulation problems (e.g. dicoumarol, digitoxin,
digoxin, mexiletine, nisoldipine, amiodarone, furosemide, quinidine, reserpine,
warfarin, and calcium channel blockers including diltiazem and nifedipine)
• Medicines used for epilepsy (e.g. carbamazepine, lamotrigine, phenobarbital,
sodium valproate and valproic acid, topiramate, oxcarbazepine, succinimides
including ethosuximide and vigabatrin)
• Medicines used to treat fungal infections (e.g. amphotericin B, fluconazole,
itraconazole, ketoconazole, posaconazole, voriconazole and miconazole)

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• Medicines used for sleeplessness, depression and psychiatric disorders
(e.g. chlordiazepoxide, clozapine, diazepam, disulfiram, fluoxetine,
methylphenidate, paroxetine, phenothiazines, quetiapine, trazodone, tricyclic
antidepressants, fluvoxamine, sertraline, viloxazine)
• Medicines used for diabetes (e.g. tolbutamide)
• Some hormone replacement therapies (oestrogens), oral contraceptives (the
birth control pill)
• Medicines used for organ and tissue transplants, to prevent rejection (e.g.
ciclosporin, tacrolimus)
• Medicines used for cancer (antineoplastic agents such as teniposide,
fluorouracil, capecitabine, bleomycin, carboplatin, cisplatin, doxorubicin,
methotrexate)

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• Medicines used to lower high blood cholesterol and triglycerides (e.g.
atorvastatin, fluvastatin, simvastatin)
• Medicines used in the treatment of HIV infection (e.g. delavirdine, efavirenz,
fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir)
• Medicines used to expel parasitic worms from the body (e.g. albendazole,
praziquantel)
• Muscle relaxants used for surgery (neuromuscular blockers), some
anaesthetics e.g. halothane, methadone)
• Some products available without a prescription (e.g. folic acid, vitamin D)
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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Epanutin with food, drink and alcohol
Epanutin can be taken before or after food and drink. Drinking a lot of alcohol can
also affect the concentration of phenytoin in your blood.

Pregnancy and breast-feeding
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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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If you are pregnant, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
You should not breast feed if you are taking Epanutin.

Driving and using machines
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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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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.
The colouring agent sunset yellow (E110), which is present in the yellow tablets
may cause allergic reactions.

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3. How to take Epanutin
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Epanutin contains sucrose and the colouring agent sunset yellow
(E110)

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Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
Chew the Epanutin Infatabs or swallow them whole with plenty of water.
It is best to take Epanutin at the same time each day.
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Adults
The amount of Epanutin needed varies from one person to another. Most adults
need between 200 mg and 500 mg a day either as a single or divided dose.
Occasionally higher doses are needed.
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These include:

• Medicines used for tuberculosis and other infections (e.g. chloramphenicol,
isoniazid, rifampicin, sulfonamides, sulfadiazine, sulfamethiazole,
sulfamethoxazole-trimethoprim, sulfaphenazole, sulfisoxazole, doxycycline
and ciprofloxacin)
• Medicines used for stomach ulcers (e.g. omeprazole, sucralfate, the
medicines known as H2 antagonists including cimetidine, ranitidine,
famotidine and some antacids)
• Medicines used for asthma and bronchitis (e.g. theophylline)
• Medicines used for pain and inflammation (e.g. phenylbutazone, salicylates
including aspirin and steroids)

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Some medicines can affect the way Epanutin works, or Epanutin
itself can reduce the effectiveness of other medicines taken at the
same time.

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If you take more Epanutin than you should

Infants and children usually start on a dose that depends on their weight (5 mg
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 300 mg a day.

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.

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

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Children and adolescents

Older people

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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.

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If you stop taking Epanutin

4. Possible side effects

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 the use of this medicine, ask your doctor or
pharmacist.

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). 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.
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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.
• 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 (Drug
Reaction or rash with Eosinophilia and Systemic Symptoms (DRESS)).

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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:
• 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 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 or liver failure which can lead to death (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.

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• 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.
• 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.
• 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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Reporting of side effects

Ireland

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 (see details below).
By reporting side effects you can help provide more information on the safety of
this medicine.

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

UK
Yellow Card Scheme website: www.mhra.gov.uk/yellowcard

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5. How to store Epanutin

6. Contents of the pack and other information

Keep this medicine out of the sight and reach of children.
Store in the original package in order to protect from moisture.
Do not store above 25ºC.
Do not use this medicine after the expiry date which is printed on the label after
EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help to protect the environment.

What Epanutin Infatabs 50 mg contains

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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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Each yellow triangular tablet contains 50 mg 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).

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Pfizer Limited
Ramsgate Road, Sandwich
Kent
CT13 9NJ
UK

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Ireland

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Pfizer Healthcare Ireland
9 Riverwalk
National Digital Park, Citywest Business Campus
Dublin 24, Ireland

Manufacturer
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Marketing Authorisation Holder
UK

Pfizer Service Company BVBA
Hoge Wei 10
B-1930 Zaventem
Belgium
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For further information on your medicine please contact Medical Information at
Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS.
Telephone: 01304 616161
This leaflet was last revised in Ireland: MM/YYYY
This leaflet was last revised in United Kingdom 09/2015
SUB1055
Ref: EP 6_4

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Company Contact Address

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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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