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Active substance(s): PHENYTOIN SODIUM

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Package leaflet: Information for the user

Epanutin® 100mg 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
• 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.
The name of your medicine is Epanutin 100mg
capsules but will be referred to as Epanutin
throughout this leaflet.
What is in this leaflet:
1. What Epanutin is and what it is used for
2. What you need to know before you take
3. How to take Epanutin
4. Possible side effects
5. How to store Epanutin
6. Contents of the pack and other information

1. What Epanutin is and what it is used for
Epanutin is one of a group of medicines called anti-epileptic
drugs; this medicine is 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.

2. What you need to know before you take Epanutin
Do not take Epanutin
• 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.
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
A small number of people being treated with anti-epileptics such
as phenytoin sodium have had thoughts of harming or killing
themself. 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 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.
Other medicines and Epanutin
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 work and
Epanutin itself 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)
• Medicines used for epilepsy (carbamazepine, lamotrigine,
oxcarbazepine, phenobarbital, sodium valproate, topiramate

and valproic acid, succinimides e.g. ethosuximide and
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, sulfamethoxazole-trimethoprim,
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
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 given.
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 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. If you find out you are
pregnant, then you should continue to take your medicine until

you have spoken to your doctor for advice. This is because
phenytoin should only be used during pregnancy, especially early
pregnancy, under the advice of your doctor because it can be
harmful to unborn children when taken by a woman during
pregnancy. Do not stop taking your medicine until your doctor
tells you to.
You should not take Epanutin if you are breast-feeding.
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.
Epanutin contain 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.
3. How to take Epanutin
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not
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
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.
The dose of Epanutin for elderly patients who may be taking other
medicines may also need careful consideration and adjustment
by their doctor.
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 are 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 forgotten 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 is the best method for you.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

4. Possible side effects
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).
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

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
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
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 anti-epileptic medication, have a
history of osteoporosis, or take steroids.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at:
By reporting side effects you can help provide more information
on the safety of this medicine.
5. How to store Epanutin
Keep out of the sight and reach of children.
Do not store above 25ºC. Store in the original package in order to
protect from light.
Do not take this medicine after the expiry date which is stated on
the carton and bottle label after ‘Exp’. The expiry date refers to
the last day of that month.
If the capsules become discoloured or show any signs of
deterioration, seek the advice of your pharmacist.
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

6. Contents of the pack and other information
What Epanutin contains
The active ingredient in Epanutin is phenytoin sodium.
Each capsule contains 100mg phenytoin sodium.
The other ingredients are: lactose monohydrate, magnesium
stearate, and sodium dodecyl sulphate.
The gelatin capsule shells contain erythrosine (E127), quinoline
yellow (E104), and titanium dioxide (E171) as colouring agents.
The printing ink contains shellac, black iron oxide (E172) and
propylene glycol.
What Epanutin looks like and contents of the pack
Epanutin is hard gelatin capsule containing a white powder with a
white opaque body and orange cap, radially marked
‘EPANUTIN 100’, contained in a white plastic container with a
white plastic cap.
Each pack contains 100 capsules
Manufactured by: Pfizer Manufacturing Deutschland GmbH,
Freiburg, Germany.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Epanutin® 100mg capsules PL 18799/1526
Leaflet date: 16.05.2016


Epanutin is a registered trademark of Pfizer.

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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.