EPANUTIN 100MG CAPSULES

Active substance: PHENYTOIN SODIUM

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Package leaflet: Information for the user

Epanutin®
100mg Hard 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 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

The name of your medicine is Epanutin 100mg
Hard Capsules but will be referred to as Epanutin
throughout this leaflet.

1. What Epanutin are and what they are used
for
Epanutin are one of a group of medicines called
anti-epileptic drugs; these medicines are 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 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. 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.
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 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 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 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.
Breast-feeding
You should not take Epanutin if you are breastfeeding.
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 sure.
It is best to take Epanutin at the same time each
day.
Swallow the capsules whole, with plenty of water.
Adults
The amount 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.
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 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 are 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.

Other side-effects that may occur are:

5. How to store Epanutin



Keep out of the sight and reach of children.

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
dose.










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.

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
By reporting side effects, you can help provide
more information on the safety of this medicine.

Do not store above 25° C. Store in the original
package in order to protect from light.
Do not use Epanutin 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 contains
Each capsule contains 100mg of 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 Capsules are hard gelatin capsules
containing a white powder with a white opaque
body and orange cap, radially printed ‘EPANUTIN
100’, contained in a white plastic container with a
white plastic cap.
Each pack contains 100 capsules
Manufactured by: Goedecke AG, 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
Epanutin™ 100mg Capsules PL 18799/1526

POM

Leaflet date: 03.11.2014
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.

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