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EPANUTIN 300 MG HARD CAPSULES

Active substance(s): PHENYTOIN SODIUM / PHENYTOIN SODIUM / PHENYTOIN SODIUM

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Assessed against
the UK PIL dated
March 2016

Package Leaflet: Information for the user

MOCK UP

Epanutin® 300 mg Hard Capsules
By Caroline McDermott at 9:20 am, Oct 12, 2016
(phenytoin sodium)

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.
 This product is also available in other strengths
What is in this leaflet:
1) What Epanutin 300 mg Hard Capsules are and what they are used for
2) What you need to know before you take Epanutin 300 mg Hard
Capsules
3) How to take Epanutin 300 mg Hard Capsules
4) Possible side effects
5) How to store Epanutin 300 mg Hard Capsules
6) Contents of the pack and other information
1) WHAT EPANUTIN 300 MG HARD CAPSULES ARE AND WHAT
THEY ARE USED FOR
Epanutin 300 mg Hard Capsules are one of a group of medicines called
anti-epileptic drugs; these medicines are used to treat epilepsy.
Epanutin 300 mg Hard Capsules 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 300 mg Hard Capsules 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 300 mg Hard Capsules.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPANUTIN
300 MG HARD CAPSULES
Do not take Epanutin 300 mg Hard Capsules
 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 300 mg Hard
Capsules.
Medicines are not always suitable for everyone. Your doctor needs to
know before you take Epanutin 300 mg Hard Capsules 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
300 mg Hard Capsules.
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 300 mg Hard Capsules.
Other medicines and Epanutin 300 mg Hard Capsules
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 300 mg Hard Capsules
work and Epanutin 300 mg Hard Capsules 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 300 mg Hard Capsules may also interfere with certain
laboratory tests that you may be given.
Epanutin 300 mg Hard Capsules with food and drink
Epanutin 300 mg Hard Capsules 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 Epanutin 300 mg Hard Capsules 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 300 mg Hard Capsules if you are breastfeeding.
Driving and using machines
Epanutin 300 mg Hard Capsules 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 300 mg Hard Capsules 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 300 MG HARD CAPSULES
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 300 mg Hard Capsules at the same time each
day.
Swallow the capsules whole, with plenty of water.

Adults
The amount of Epanutin 300 mg Hard Capsules needed varies from one
person to another. Most adults need between 200 mg and 500 mg 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
(5 mg 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 300 mg a
day.
Elderly
The dose of Epanutin 300 mg Hard Capsules for elderly patients who
may be taking other medicines may also need careful consideration and
adjustment by their doctor.
If you take more Epanutin 300 mg Hard Capsules than you should
Epanutin 300 mg Hard Capsules are dangerous in overdose. If you
accidentally take too much Epanutin 300 mg Hard Capsules 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 300 mg Hard Capsules left or not.
If you forget to take Epanutin 300 mg Hard Capsules
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 300 mg Hard Capsules
Do not stop taking Epanutin 300 mg Hard Capsules 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 300 mg Hard
Capsules, 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.

 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 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 300 MG HARD CAPSULES





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 this medicine after the expiry date which is stated on the
carton. The expiry date refers to the last day of that month.
 If your capsules become discoloured or show any signs of
deterioration, return them to your pharmacist.
 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

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.

What Epanutin 300 mg Hard Capsules contain
The active substance is phenytoin sodium. Each hard capsule contains
300 mg phenytoin sodium.

 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.

The other ingredients are:
Core: lactose monohydrate, magnesium stearate, silica
Shell: gelatin, sodium laurilsulfate, titanium dioxide (E171), patent blue V
(E131), quinoline yellow (E104)
Printing ink: shellac, black iron oxide (E172), propylene glycol and
potassium hydroxide.

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.

PL 33532/0500

What Epanutin 300 mg Hard Capsules look like and contents of the
pack
Epanutin 300 mg Hard Capsules are half white and half green hard
capsules marked with “Epanutin 300” in black ink.
Epanutin 300 mg Hard Capsules are available in packs containing
28 capsules.
Manufactured by
Pfizer Manufacturing Deutschland GmbH, Betriebsstatte Freiburg,
Mooswaldallee 1, 79090 Freiburg, Germany.
Procured from within the EU by the product licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER
Repackaged by MPT Pharma Ltd.

POM

Leaflet dated 25th August 2016
Leaflet coded xxxxxxxx
Epanutin® is a registered trademark of Parke, Davis & Company LLC,
USA.

Expand Transcript

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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