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PHENYTOIN SODIUM FLYNN 100 MG HARD CAPSULES

Active substance: PHENYTOIN SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Epanutin 100 mg Hard Capsules
(Phenytoin Sodium)




Your medicine is called Epanutin 100 mg Hard Capsules but
throughout this leaflet will be referred to as Epanutin
This product is available in other strengths and formats
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
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 Capsules.
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 capsules 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 breast-feeding.
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 of 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.
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.













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. 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.
5. How to store 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 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
Epanutin 100 mg Hard Capsules contain 100 mg of the active
ingredient, phenytoin sodium.
The other ingredients are lactose monohydrate, magnesium stearate
and sodium lauryl sulphate.
The capsule shells contain the colouring titanium dioxide (E171),
gelatin, erythrosine (E127) and quinoline yellow (E104).
The printing ink contains the following: shellac, black iron oxide (E172),
potassium hydroxide and propylene glycol.
What Epanutin looks like and contents of the pack
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
eaten.
Manufacturer
Pfizer Manufacturing Deutschland GmbH, Betriebsstatte Freiburg,
Mooswaldallee 1, D-79090 Freiburg, Germany.
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 19065/0391

POM

This leaflet was revised 16/07/2014
E0391/3(E)
Epanutin® is a registered trade mark of Parke, Davis & Company LLC.

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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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