Active substance: PHENYTOIN SODIUM

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Assessed against UK PIL dated December 2012

Phenytoin Sodium Flynn 100 mg Hard Capsules/
Epanutin 100 mg Hard Capsules

(Phenytoin Sodium)
Your medicine is called Phenytoin Sodium Flynn 100 mg Hard
Capsules/Epanutin 100 mg Hard Capsules but throughout this leaflet
will be referred to as Phenytoin Sodium/Epanutin

This product is available in other strengths and formats
Read all of this leaflet carefully before you start taking this
• 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. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
• 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
In this leaflet:
1. What Phenytoin Sodium/Epanutin are and what they are used for
2. Before you take Phenytoin Sodium/Epanutin
3. How to take Phenytoin Sodium/Epanutin
4. Possible side effects
5. How to store Phenytoin Sodium/Epanutin
6. Further information
1. What Phenytoin Sodium/Epanutin are and what they are used
Phenytoin Sodium/Epanutin is one of a group of medicines called antiepileptic drugs; these medicines are used to treat epilepsy.

Medicines used for tuberculosis and other infections
(chloramphenicol, isoniazid, rifampicin, sulphonamides,
doxycycline, ciprofloxacin and nelfinavir).
Medicines used for stomach ulcers (omeprazole, sucralfate, the
medicines known as H2 antagonists e.g. cimetidine, ranitidine,
famotidine and some antacids).
Medicines used for asthma and bronchitis (theophylline).
Medicines used for pain and inflammation (phenylbutazone,
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, sertraline and
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).
Medicines used for cancer (antineoplastic agents).
Muscle relaxants used for surgery (neuromuscular blockers), some
anaesthetic drugs (halothane) and methadone
Some products available without a prescription (folic acid,
theophylline, 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.
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
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

Phenytoin Sodium/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. Phenytoin Sodium/Epanutin can also be
used to treat trigeminal neuralgia (facial nerve pain).

Phenytoin Slodium/Epanutin capsules may also interfere with certain
laboratory tests that you may be given.

You should ask your doctor if you are unsure why you have been given
Phenytoin Sodium/Epanutin Capsules.

Taking Phenytoin Sodium/Epanutin with food and drink
Phenytoin Sodium/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.

2. Before you take Phenytoin Sodium/Epanutin
Do not take Phenytoin Sodium/Epanutin
• if you are allergic (hypersensitive) to Phenytoin, or any of the other
ingredients of Phenytoin Sodium/Epanutin Capsules.

Pregnancy and Breast-feeding
If you think you might be pregnant, or are planning to get pregnant, tell
your doctor before you take Phenytoin Sodium/Epanutin

Take special care with Phenytoin Sodium/Epanutin
Medicines are not always suitable for everyone. Your doctor needs to
know before you take Phenytoin Sodium/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 antiepileptics such as
phenytoin sodium have had thoughts of harming or killing themselves.
If at any time you have these thoughts, immediately contact your
Serious skin side effects can rarely occur during treatment with
Pehnytoin Sodium/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 Phenytoin
Taking other medicines
Some medicines can affect the way Phenytoin Sodium/Epanutin
works, or Phenytoin Sodium/Epanutin itself can reduce the
effectiveness of other medicines taken at the same time. These
• Medicines used for heart and circulation problems (dicoumarol,
digitoxin, amiodarone, furosemide, quinidine, reserpine, warfarin,
and calcium channel blockers e.g. diltiazem and nifedipine).
• Medicines used for epilepsy (carbamazepine, lamotrigine,
phenobarbital, sodium valproate and valproic acid, succinimides
e.g. ethosuximide and vigabatrin).
• Medicines used to treat fungal infections (e.g. amphotericin B,
fluconazole, itraconazole, ketoconazole and miconazole).

You should not take Phenytoin Sodium/Epanutin if you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Phenytoin Sodium/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.
Important information about some of the ingredients of Phenytoin
Phenytoin Sodium/Epanutin contains 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 Phenytoin Sodium/Epanutin
It is best to take Phenytoin Sodium/Epanutin at the same time each
Swallow the capsules whole, with plenty of water.
The amount of Phenytoin Sodium/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
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 Phenytoin Sodium/Epanutin for elderly patients who may
be taking other medicines may also need careful consideration and
adjustment by their doctor.

Always take Phenytoin Sodium/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 Phenytoin Sodium/Epanutin than you should
Phenytoin Sodium/Epanutin is dangerous in overdose. If you
accidentally take too much Phenytoin Sodium/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 Phenytoin Sodium/Epanutin left or not.
If you forget to take Phenytoin Sodium/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 Phenytoin Sodium/Epanutin
Do not stop taking Phenytoin Sodium/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 Phenytoin Sodium/Epanutin,
your doctor will have decided which the best method is for you.


If you have any further questions on how to take this Phenytoin
Sodium/Epanutin, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Phenytoin Sodium/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).
• 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 lupusaerythematosus.
state of
• 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
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.
5. How to store Phenytoin Sodium/Epanutin
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 Phenytoin Sodium/Epanutin after the expiry date which is
stamped on the pack. The expiry date refers to the last day of that
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 Phenytoin Sodium/Epanutin contains
Phenytoin Sodium 100 mg Hard Capsules/Epanutin 100 mg Hard
Capsules contain 100 mg of the active ingredient, phenytoin sodium.
The other ingredients are lactose monohydrate and magnesium
The gelatin capsule shells contain the colouring titanium dioxide
(E171), erythrosine (E127) and quinoline yellow (E104).
The printing ink contains the following: shellac, black iron oxide (E172)
butyl alcohol, propylene glycol, dehydrated alcohol, industrial
methylated spirit 74 OP, potassium hydroxide, water, concentrated
ammonia solution and isopropyl alcohol.
What Phenytoin Sodium/Epanutin looks like and contents of the
Phenytoin Sodium/Epanutin 100 mg Hard Capsules are half white, half
orange. 'EPANUTIN 100' is printed on each side of the capsule.
The capsules are packed in a plastic container containing 100
capsules which contains a desiccant. The desiccant should not be
Pfizer Manufacturing Deutschland GmbH
Betriebsstatte Freiburg Mooswaldallee 1
79090 Freiburg,
Procured within the EU
Product Licence holder: Ecosse Pharmaceuticals Limited
3 Young Place, East Kilbride, G75 0TD
Re-packaged by: Munro Wholesale Medical Supplies Limited
3 Young Place, East Kilbride G75 0TD
PL 19065/0394
This leaflet was revised 14/10/2013


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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.