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EPANUTIN 300MG HARD CAPSULES

Active substance(s): PHENYTOIN SODIUM

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Epanutin® 300mg Hard Capsules
(Phenytoin Sodium)
Your medicine is available as the above name but will be referred to as
Epanutin Capsules throughout this:
Patient Information Leaflet
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 Capsules are and what they are used for
2) What you need to know before you take Epanutin Capsules
3) How to take Epanutin Capsules
4) Possible side effects
5) How to store Epanutin Capsules
6) Contents of the pack and other information

1) What Epanutin Capsules are and what they are used for
Epanutin Capsules are one of a group of medicines called anti-epileptic
drugs; these medicines are used to treat epilepsy.
Epanutin 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 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 Capsules.

2) What you need to know before you take Epanutin Capsules
Do not take Epanutin 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 Capsules.
Medicines are not always suitable for everyone. Your doctor needs to know
before you take Epanutin Capsules if you suffer from or have suffered in the
past from any of the following conditions:
• Liver disease.
• Kidney 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
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 (HLA-B*1502), discuss this with your
doctor before taking Epanutin Capsules.
Other medicines and Epanutin 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 Capsules work and
Epanutin 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)

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,
sulfamethoxazole-trimethoprim, doxycycline, ciprofloxacin, efavirenz,
fosamprenavir, indinavir, lopinavir/ritonavir, ritonavir and saquinavir)

Medicines used for stomach ulcers (omeprazole, sucralfate, the
medicines known as H 2 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 Capsules may also interfere with certain laboratory tests that you
may be given.
Epanutin Capsules with food and drink
Epanutin 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. 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.
Breast-feeding
You should not take Epanutin Capsules if you are breast-feeding.
Driving and using machines
Epanutin 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.
Epanutin Capsules 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 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 Capsules at the same time each day.
Swallow the capsules whole, with plenty of water.
Adults
The amount of Epanutin 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 and patients with kidney or liver disease
The dose of Epanutin Capsules for elderly patients, patients with kidney or
liver disease, or those who may be taking other medicines may also need
careful consideration and adjustment by their doctor.
If you take more Epanutin Capsules than you should
Epanutin Capsules are dangerous in overdose. If you accidentally take too
much Epanutin 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 Capsules left or not.
If you forget to take Epanutin 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 Capsules
Do not stop taking Epanutin 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 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.

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 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 and abnormal thyroid
function test results. 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.
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:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the
Google Play or Apple App Store. By reporting side effects you can help
provide more information on the safety of this medicine.

5) How to store Epanutin capsules
• 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 capsules after the expiry date which is stamped 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.

6) Contents of the pack and other information
What Epanutin capsules contains
Each hard capsule contains 300 mg of the active ingredient phenytoin
sodium.
The other ingredients are lactose monohydrate, magnesium stearate and
silica.
The gelatin capsules shells contain sodium lauryl sulphate and the colouring
titanium dioxide (E171), patent blue V (E131), and quinoline yellow (E104).
The printing ink contains the following: shellac, black iron oxide (E172) and
propylene glycol. It may also contain potassium hydroxide.
What Epanutin capsules looks like and contents of the pack
Epanutin capsules are half white and half green hard capsules marked with
“Epanutin 300”.
They are available in blister packs containing 28 capsules.
PL 10383/2062

Epanutin 300mg Hard Capsules

POM

Your medicine is manufactured by Goedecke GmbH Mooswaldallee 1
D-79090 Freiburg, Germany. Procured from within the EU and repackaged
by the Product Licence holder: Primecrown Ltd., 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet Date: 20.12.2017
Epanutin is a registered Trade Mark of Parke Davis & Co. LLC, USA.

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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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