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EPANUTIN 100 MG CAPSULES

Active substance(s): PHENYTOIN SODIUM

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Package leaflet: Information for the user



UNITED KINGDOM

EPANUTIN 100 MG
CAPSULES
(phenytoin sodium)
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
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.
What is in this leaflet:
1)
What Epanutin 100 mg Capsules are and what they are
used for
2)
What you need to know before you take Epanutin 100
mg Capsules
3)
How to take Epanutin 100 mg Capsules
4)
Possible side effects
5)
How to store Epanutin 100 mg Capsules
6)
Contents of the pack and other information

1) WHAT EPANUTIN 100 MG CAPSULES ARE AND
WHAT THEY ARE USED FOR
Epanutin 100 mg Capsules are one of a group of medicines
called anti-epileptic drugs; these medicines are used to treat
epilepsy.
Epanutin 100 mg Capsules 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 100 mg Capsules
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 100 mg Capsules.

2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE
EPANUTIN 100 MG CAPSULES
Do not take Epanutin 100 mg Capsules



if you are allergic to Phenytoin, or any of the other
ingredients of this medicine (listed in section 6).
if you are allergic to other medicines with a similar chemical
structure to Phenytoin (e.g. hydantoins).

Warnings and precautions
Talk to your doctor or pharmacist before taking Epanutin 100 mg
Capsules.
Medicines are not always suitable for everyone. Your doctor
needs to know before you take Epanutin 100 mg Capsules 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).
















Medicines used for epilepsy (carbamazepine, lamotrigine,
oxcarbazepine, phenobarbital, sodium valproate,
topiramate and valproic acid, succinimides e.g.
ethosuximide and vigabatrin)
Medicines used to treat fungal infections (e.g. amphotericin
B, fluconazole, itraconazole, ketoconazole, miconazole,
posaconazole and voriconazole)
Medicines used for tuberculosis and other infections
(chloramphenicol, clarithromycin, isoniazid, rifampicin,
sulphonamides, sulfadiazine, sulfamethoxazoletrimethoprim, doxycycline, ciprofloxacin, efavirenz,
fosamprenavir, indinavir, lopinavir/ritonavir, ritonavir and
saquinavir)
Medicines used for stomach ulcers (omeprazole, sucralfate,
the medicines known as H2 antagonists e.g. cimetidine and
some antacids)
Medicines used for asthma and bronchitis (theophylline)
Medicines used for pain and inflammation (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, quetiapine and sertraline)
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 and tacrolimus)
Medicines used for cancer (antineoplastic agents, e.g.
bleomycin, capecitabine, carboplatin, cisplatin, doxorubicin,
fluorouracil and methotrexate)
Muscle relaxants used for surgery (neuromuscular
blockers), some anaesthetic drugs (methadone)
Some products available without a prescription (folic acid,
theophylline, St John’s Wort, 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.
Epanutin 100 mg Capsules may also interfere with certain
laboratory tests that you may be given.

Epanutin 100 mg Capsules with food and drink
Epanutin 100 mg Capsules 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 are pregnant or breast-feeding, think you might be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.

Breast-feeding
You should not take Epanutin 100 mg Capsules if you are breastfeeding.

Driving and using machines

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.

Epanutin 100 mg Capsules 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.

Serious skin side effects can rarely occur during treatment with
Epanutin 100 mg Capsules.
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 Epanutin 100
mg Capsules.

Epanutin 100 mg Capsules contain lactose, a type of
sugar.

Other medicines and Epanutin 100 mg Capsules
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Some medicines can affect the way Epanutin 100 mg
Capsules work and Epanutin 100 mg Capsules themselves
can reduce the effectiveness of other medicines taken at the
same time. These include:

Medicines used for heart and circulation problems
(amiodarone, digoxin, furosemide, reserpine, warfarin,
calcium channel blockers e.g. diltiazem, mexiletine,
nicardipine, nifedipine, nimodipine, and verapamil)

Medicines used to lower blood cholesterol, (e.g.
atorvastatin, fluvastatin and simvastatin)

If you have been told that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.

3) HOW TO TAKE EPANUTIN 100 MG CAPSULES
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not
sure.
It is best to take Epanutin 100 mg Capsules at the same time
each day.
Swallow the capsules whole, with plenty of water.

Adults
The amount of Epanutin 100 mg Capsules 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.

Use in children and adolescents



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.

Elderly
The dose of Epanutin 100 mg Capsules for elderly patients who
may be taking other medicines may also need careful
consideration and adjustment by their doctor.

If you take more Epanutin 100 mg Capsules than you
should
Epanutin 100 mg Capsules are dangerous in overdose. If you
accidentally take too much Epanutin 100 mg Capsules 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 Epanutin 100 mg Capsules left or not.

If you forget to take Epanutin 100 mg Capsules
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 forgotten dose.

If you stop taking Epanutin 100 mg Capsules
Do not stop taking Epanutin 100 mg Capsules 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 100 mg
Capsules, your doctor will have decided which is the best method
for you.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.





Reporting of side effects
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 via
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 EPANUTIN 100 MG CAPSULES






4) POSSIBLE SIDE EFFECTS
Like all medicines, Epanutin 100 mg Capsules 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 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.
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: 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.



Do not store above 25°C.
Store in the original package in order to protect from light.
Keep out of the sight and reach of children.
Do not use Epanutin 100 mg Capsules after the expiry date
on the pack. The expiry date refers to the last day of that
month.
Medicines should not be disposed of via waste water or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
If the medicine becomes discoloured or shows any other
signs of deterioration, you should seek the advice of your
pharmacist who will advise you what to do.

6) CONTENTS OF THE PACK AND OTHER
INFORMATION
What Epanutin 100 mg Capsules contain
Epanutin 100 mg Capsules contain 100 mg of the active
ingredient, phenytoin sodium.
The other ingredients are lactose monohydrate and magnesium
stearate.
The capsule shell contains: gelatin, titanium dioxide (E171),
erythrosine (E127) and quinoline yellow (E104).
The printing ink components are, depending on the ink used:
shellac, black iron oxide (E172) and N-butyl alcohol, propylene
glycol, industrial methylated spirit 74 OP, isopropyl alcohol and
water, or shellac, dehydrated alcohol, isopropyl alcohol, butyl
alcohol, propylene glycol, concentrated ammonia solution, black
iron oxide (E172), potassium hydroxide and water.

What Epanutin 100 mg Capsules look like and contents of
the pack
Epanutin 100 mg Capsules is a white powder in a hard gelatin
capsule with a white opaque body and orange cap, radially
printed 'EPANUTIN 100' available in packs containing 100
capsules. The capsules are packed in a plastic container which
contains a desiccant. The desiccant should not be eaten.

Manufacturer
This product is manufactured by:
Pfizer Manufacturing Deutschland GmbH,
Betriebsstätte Freiburg Mooswaldallee 1,
79090 Freiburg,
Germany.
It is procured within the EU and repackaged by
Mediwin Limited, Product Licence Holder Mediport Limited,
13 Martello Enterprise Centre, Courtwick Lane, Littlehampton,
West Sussex, BN17 7PA, United Kingdom.

POM

PL 18980/0846

Date of leaflet preparation: 08/10/2014

PIL_8340189800846_S0003

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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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