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EPANUTIN 30MG/5ML ORAL SUSPENSION

Active substance(s): PHENYTOIN / PHENYTOIN / PHENYTOIN

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1

Package Leaflet: Information for the patient
UNITED KINGDOM

EPANUTIN® 30 mg/ 5ml
Oral Suspension
(phenytoin)

1. What Epanutin is and what it is
used for
This medicine contains phenytoin, which is one of a
group of medicines called anti-epileptic 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).

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you. You should consult your doctor if you are unsure

• 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 is and what it is used
for
2. W
 hat you need to know before you
take Epanutin
3. How to take Epanutin
4. Possible side effects
5. How to store Epanutin
6. C
 ontents of the pack and other
information

why you have been given Epanutin 30mg/5ml Oral
Suspension if you do not feel better or if you feel worse.

2. What you need to know
before you take Epanutin
Do not take Epanutin
• if you are allergic (hypersensitive) to phenytoin, or
any of the other ingredients of this medicine (listed in
section 6)
• if you are allergic to other medicines for epilepsy
• if you are also taking delavirdine (used for HIV therapy).
Warnings and precautions
Talk to your doctor or pharmacist before you take
Epanutin 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)
• Alcohol dependence.
You should be administered Epanutin with caution if you
suffer from kidney or liver problems.
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
Stevens-Johnson syndrome or toxic epidermal
necrolysis with the use of Epanutin, you must not be
re-started on Epanutin at any time.

2

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.
Black patients may be at greater risk of liver problems,
serious skin reactions and allergic reactions.
Other medicines and Epanutin
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription.
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:
•M
 edicines used for heart and circulation problems
(e.g. dicoumarol, digitoxin, digoxin, mexiletine,
nisoldipine, amiodarone, furosemide, quinidine,
reserpine, warfarin, and calcium channel blockers
including diltiazem and nifedipine)
• Medicines used for epilepsy (e.g. carbamazepine,
lamotrigine, phenobarbital, sodium valproate
and valproic acid, topiramate, oxcarbazepine,
succinimides including ethosuximide and vigabatrin)
• Medicines used to treat fungal infections (e.g.
amphotericin B, fluconazole, itraconazole,
ketoconazole, posaconazole, voriconazole and
miconazole)
• Medicines used for tuberculosis and other infections
(e.g. chloramphenicol, isoniazid, rifampicin,
sulfonamides, sulfadiazine, sulfamethiazole,
sulfamethoxazole-trimethoprim, sulfaphenazole,
sulfisoxazole, doxycycline and ciprofloxacin)
• Medicines used for stomach ulcers
(e.g. omeprazole, sucralfate, the medicines known
as H2 antagonists including cimetidine, ranitidine,
famotidine and some antacids)
• Medicines used for asthma and bronchitis
(e.g. theophylline)
• Medicines used for pain and inflammation
(e.g. phenylbutazone, salicylates including aspirin
and steroids)
• Medicines used for sleeplessness, depression
and psychiatric disorders (e.g. chlordiazepoxide,
clozapine, diazepam, disulfiram, fluoxetine,
methylphenidate, paroxetine, phenothiazines,
quetiapine, trazodone, tricyclic antidepressants,
fluvoxamine, sertraline and viloxazine)
• Medicines used for diabetes (e.g. tolbutamide)

24 Aug 2017

•M
 edicines used for cancer (e.g. antineoplastic agents
e.g. teniposide, fluorouracil), capecitabine, bleomycin,
carboplatin, cisplatin, doxorubicin and methotrexate
• Some hormone replacement therapies (oestrogens),
oral contraceptives (the birth control pill)
• Medicines used for organ and tissue transplants, to
prevent rejection (e.g. ciclosporin, tacrolimus)
• Medicines used to lower high blood cholesterol and
triglycerides (e.g. atorvastatin, fluvastatin, simvastatin)
• Medicines used in the treatment of HIV infection
(e.g. delavirdine, efavirenz, fosamprenavir, indinavir,
lopinavir, nelfinavir, ritonavir, saquinavir)
• Medicines used to expel parasitic worms from the
body (e.g. albendazole, praziquantel)
• Muscle relaxants used for surgery (neuromuscular
blockers), some anaesthetic drugs (e.g. halothane,
methadone)
• Some products available without a prescription (e.g.
folic acid, vitamin D).
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.
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 30 mg/5 ml Oral Suspension, in your blood.
Your doctor or pharmacist will tell you how to take this
medicine with your feeds.
Epanutin 30 mg/5 ml Oral Suspension may also interfere
with certain laboratory tests that you may be given.
Epanutin with food, drink and alcohol
Epanutin can be taken before or after food and drink.
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 are pregnant, think you may be pregnant, or are
planning to have a baby, ask your doctor or pharmacist
for advice before taking this medicine.
If you do get pregnant while you are taking Epanutin you
must tell your doctor straight away. It is important that
your epilepsy remains well controlled, but, as with other
anti-epilepsy treatments, there is a risk of harm to the
foetus.
Make sure you are very clear about the risks and
benefits of taking Epanutin.
You will find more about EPANUTIN on the back of this leaflet

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3

You should not breast-feed if you are taking Epanutin.
Driving and using machines
Epanutin may cause dizziness or drowsiness. If you
experience these symptoms, do not drive or use any
tools or machinery and contact your doctor.
Epanutin contains sucrose, ethanol and the
colouring agents sunset yellow (E110) and
carmoisine (E122).
This medicinal product contains small amounts of
ethanol (alcohol), less than 100 mg per dose.

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
take a double dose to make up for a missed 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. Your doctor will advise you how to stop
taking the medicine.

Epanutin contains sucrose, a type of sugar. If you have
been told that you have an intolerance to some sugars, If you have any further questions on the use of this
contact your doctor before taking this medicinal product. medicine, ask your doctor or pharmacist.
This medicine may be harmful to the teeth.
This medicine contains the colouring agents sunset
yellow (E110) and carmoisine (E122) that may cause
allergic reactions.

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.
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.
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
(10 five-ml spoonfuls of Suspension).
Elderly
Due to decreased clearance of Epanutin, lower or less
frequent dosing may be needed. The dose of Epanutin
for elderly patients who may be taking other medicines
may also need careful consideration and adjustment by
their doctor.
Kidney or liver problems
Make sure your doctor knows if you have liver or kidney
problems as you may need your dose adjusted.
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

24 Aug 2017

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.
•S
 udden wheeziness, difficulty in breathing, swelling
of eyelids, face or lips, rash or itching (especially
affecting the whole body). There is a higher
incidence of this in black patients.
• If you develop potentially life-threatening skin
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.
• 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.
• 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 (Drug Reaction or rash with Eosinophilia
and Systemic Symptoms (DRESS)).
• 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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4

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 measleslike 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 or liver failure
which can lead to death (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,
phosphate, 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. Taking Phenytoin may cause abnormal
thyroid test results.
• 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 and immunoglobin
abnormalities.
• 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 or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report any side effects
directly (see details below). By reporting side effects you
can help provide more information on the safety of
this medicine.
United Kingdom
Yellow Card Scheme website:
www.mhra.gov.uk/yellowcard
Malta
ADR Reporting website:
www.medicinesauthority.gov.mt/adrportal

24 Aug 2017

5. How to store Epanutin
Keep this medicine out of the sight and reach of
children.
Do not store above 25oC
Do not use this medicine after the expiry date which
is printed on the bottle label after EXP. The expiry date
refers to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help protect the environment.

6. Contents of the pack and other
information
What Epanutin 30 mg/5 ml Oral Suspension
contains
Each 5 ml dose contains 30 mg 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 30 mg/5 ml Oral Suspension is a cherry red
liquid and is available in bottles containing 500 ml of
suspension.
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
Manufacturer
Famar Orleans
5 Avenue de Concyr
45071 Orléans
Cedex 02
France
Company Contact Address
For further information on this medicine please contact
Medical Information at Pfizer Limited, Walton Oaks,
Tadworth, Surrey, KT20 7NS; Tel 01304 616161.
This leaflet was last revised in 07/2017
Ref: EP 21_0

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2017-0008061/1

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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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