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PHENYTOIN SODIUM FLYNN 300 MG HARD CAPSULES

Active substance(s): PHENYTOIN SODIUM

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Epanutin® 300 mg Hard Capsules

2460
25.05.16[10]

(phenytoin sodium)
PATIENT INFORMATION LEAFLET
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.
The name of your medicine is Epanutin 300 mg Hard Capsules but will be
referred to as Epanutin throughout this leaflet.
Epanutin Capsules are also available in other strengths.
What is in this leaflet:
1. What Epanutin is and what it is 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 IS AND WHAT IT IS USED FOR
Epanutin is 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 works and Epanutin itself
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. If you find out you are pregnant, then you should
continue to take your medicine until you have spoken to your doctor for
advice. This is because Phenytoin should only be used during pregnancy,
especially early pregnancy, under the advice of your doctor because it can
be harmful to unborn children when taken by a woman during pregnancy.
Do not stop taking your medicine until your doctor tells you to.
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 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 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.

5. HOW TO STORE EPANUTIN
Keep out of the sight and reach of children.

If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

Do not use Epanutin after the expiry date which is on the pack. The expiry
date refers to the last day of that month.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.

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.

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.

If your capsules become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.

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 or pharmacist. 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Epanutin contains
Epanutin contains phenytoin sodium as active ingredient.
Each hard capsule contains 300 mg phenytoin sodium.
The other ingredients are lactose monohydrate, magnesium stearate and
silica.
The gelatin capsule shells contain sodium lauryl sulphate, titanium dioxide
(E171), patent blue V (E131) and quinoline yellow (E104).
The printing ink contains the following: shellac, black iron oxide (E172) and
propylene glycol.
It may also contain potassium hydroxide.
What Epanutin looks like and contents of the pack
Epanutin capsules are hard gelatin capsules with a white opaque body and
green cap, radially printed in black ink 'EPANUTIN 300' on both cap and
body.
They are available in blister packs of 28 capsules.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Pfizer Manufacturing Deutschland GmbH, Mooswaldallee
1, D-79090, Freiburg, Germany. Procured from within the EU by Product
Licence holder Tenolol Ltd., 5 Sandridge Close, Harrow, Middlesex HA1
1XD. Repackaged by Servipharm Ltd.
POM

PL No: 30900/2460

Leaflet revision and issue date (Ref) 25.05.16[10]
Epanutin is a trademark 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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