EPANUTIN 30MG/5ML ORAL SUSPENSION

Active substance: PHENYTOIN

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1

et
UNITED KINGDOM

Epanutin™ 30mg/5ml
Oral Suspension
phenytoin
Read all of this leaflet carefully before
you start taking this medicine.
•  eep this leaflet. You may need to read it
K
again.
I
• f you have any further questions, ask
your doctor or pharmacist.
•  his medicine has been prescribed for you.
T
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
• f any of the side effects gets serious, or
I
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
W
1.  hat Epanutin is and what it
is used for
2. Before you take Epanutin
3. How to take Epanutin
4. Possible side effects
5. How to store Epanutin
6. Further information

1.  hat Epanutin is and what it
W
is used for
Epanutin is one of a group of medicines called antiepileptic drugs; these medicines are used to treat
epilepsy.
Epanutin can be used to control epilepsy, 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 consult your doctor if you are unsure
why you have been given Epanutin 30mg/5ml Oral
Suspension.

2. Before you take Epanutin
Do not take Epanutin

•  you are allergic (hypersensitive) to Phenytoin, or
if
any of the other ingredients of Epanutin 30mg/5ml
Suspension.

Take special care with 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 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
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 life-threatening
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 StevensJohnson 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.
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.

Taking other medicines

Some medicines can affect the way Epanutin
works, or Epanutin itself can reduce the
effectiveness of other medicines taken at the
same time. These include:
• 
Drugs used for heart and circulation problems
(dicoumarol, digitoxin, amiodarone, furosemide,
quinidine, reserpine, warfarin, and calcium
channel blockers e.g. diltiazem and nifedipine).
Drugs used for epilepsy (carbamazepine,
• 
lamotrigine, phenobarbital, sodium valproate and
valproic acid, succinimides e.g. ethosuximide and
vigabatrin).
• 
Drugs used to treat fungal infections (e.g.
amphotericin B, fluconazole, itraconazole,
ketoconazole and miconazole).
Drugs used for tuberculosis and other infections
• 
(chloramphenicol, isoniazid, rifampicin,
sulphonamides, doxycycline, ciprofloxacin and
nelfinavir).
• 
Drugs used for stomach ulcers (omeprazole,
sucralfate, the medicines known as H2
antagonists e.g. cimetidine, ranitidine, famotidine
and some antacids).
• 
Drugs used for asthma and bronchitis
(theophylline).
Drugs used for pain and inflammation
• 
(phenylbutazone, salicylates e.g. aspirin and
steroids).
• 
Drugs used for sleeplessness, depression and
psychiatric disorders (chlordiazepoxide, clozapine,
diazepam, disulfiram, fluoxetine, methylphenidate,
paroxetine, phenothiazines, trazodone, tricyclic
antidepressants, fluvoxamine, sertraline and
viloxazine).
Drugs used for diabetes (tolbutamide).
• 
• 
Drugs used for cancer (antineoplastic agents such
as fluorouracil).
Some hormone replacement therapies
• 
(oestrogens), oral contraceptives (the
birth control pill).

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• 
Drugs used for organ and tissue transplants, to
prevent rejection (ciclosporin).
Muscle relaxants used for surgery (neuromuscular
• 
blockers), methadone and some products
available without a prescription (folic acid,
theophylline, vitamin D).
Some anaesthetic drugs (halothane).
• 
Your doctor may need to test the amount of
phenytoin in your blood to help decide if any of
these drugs are affecting your treatment.
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.
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.
If you are being fed by a tube this can affect the
concentrations of phenytoin, the active ingredient of
Epanutin 30mg/5ml Oral Suspension, in your blood.
Your doctor or pharmacist will tell you how to take
this medicine with your feeds.
Epanutin 30mg/5ml Oral Suspension may also
interfere with certain laboratory tests that you may
be given.

Taking Epanutin with food and drink
Epanutin can be used before or after food and
drinks.
Drinking a lot of alcohol can also affect the
concentration of phenytoin in your blood. Talk to
your doctor or pharmacist for advice.

Pregnancy and Breast-feeding
If you think you might be pregnant, or are planning
to get pregnant, tell your doctor before you take
Epanutin.
You should not take Epanutin if you are breastfeeding.
Ask your doctor or pharmacist for advice before taking
any medicine.

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.
You will find more about EPANUTIN on the back of this leaflet

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Do not take a double dose to make up for a
missed dose.

This medicinal product contains small amounts of
ethanol (alcohol), less than 100 mg per dose.
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. This medicine may be harmful to
the teeth.
This medicine contains azo colouring agents (E110
and E122) that may cause allergic reactions.

If you stop taking Epanutin

Important information about some of
the ingredients of Epanutin

3. How to take Epanutin
Shake the bottle vigorously before you
measure your dose. Always use a medicine spoon
or measure.
It is best to take Epanutin at the same time each day.

Adults
The amount of Epanutin needed varies from one
person to another. Most adults need between
200mg and 500mg a day (between 7 and 17 five-ml
spoonfuls of Suspension) either as a single or divided
dose. Occasionally higher doses are needed.

Children
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 (10 five-ml spoonfuls of Suspension).

Elderly
The dose of Epanutin for elderly patients who may
be taking other medicines may also need careful
consideration and adjustment by their doctor.
Always take Epanutin exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are still not sure.
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 is 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 stop taking Epanutin unless your doctor tells
you to. If you suddenly stop taking this medicine you
may have a seizure.
If you have any further questions on how to take this
product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Epanutin 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).
•  you develop potentially life-threatening skin
If
rashes that cause 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). These have
been reported very rarely. Your doctor will stop
your treatment in these cases.
•  you notice bruising, fever, you are looking pale
If
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.
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.

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5. How to store Epanutin
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.
• 
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 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.
• 
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.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

Keep out of the reach and sight of children.
Do not store above 25°C.
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. Further information
What Epanutin 30mg/5ml Oral
Suspension contains
Each 5ml dose contains 30mg of the active
ingredient phenytoin.
The other ingredients are aluminium magnesium
silicate, sodium benzoate (E211), citric acid
monohydrate, carmellose sodium, glycerol,
polysorbate 40, sucrose, ethanol (each 5 ml dose
contains 0.493% of ethanol), vanillin, banana flavour,
orange oil, carmoisine (E122), sunset yellow (E110)
and purified water.

What Epanutin looks like and contents
of the pack
Epanutin 30mg/5ml Oral Suspension is a cherry red
liquid and is available in bottles containing 500ml of
suspension.

Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Manufacturer
McNeil Manufacturing, 5 Avenue de Concyr, 45071
Orleans, Cedex 02, France.

Contact information
For further information on this medicine please
contact Pfizer Medical Information
on 01304 616161.
Date leaflet last revised: 10/2013
Ref: EP 14_0.
F309885

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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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