Skip to Content

UK Edition. Click here for US version.

EPANUTIN 100MG HARD CAPSULES

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

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Assessed against
the UK PIL dated
March 2016

MOCK UP

Package Leaflet: Information for the User

Epanutin® 100 mg Hard Capsules
(phenytoin sodium)
By Caroline McDermott at 5:04 pm, Sep 07, 2

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 100 mg Hard Capsules are and what they are used for
2) What you need to know before you take Epanutin 100 mg Hard
Capsules
3) How to take Epanutin 100 mg Hard Capsules
4) Possible side effects
5) How to store Epanutin 100 mg Hard Capsules
6) Contents of the pack and other information
1) WHAT EPANUTIN 100 MG HARD CAPSULES ARE AND WHAT
THEY ARE USED FOR
Epanutin 100 mg Hard Capsules are one of a group of medicines called
anti-epileptic drugs; these medicines are used to treat epilepsy.
Epanutin 100 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 100 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 100 mg Hard Capsules.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPANUTIN
100 MG HARD CAPSULES
Do not take Epanutin 100 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 100 mg Hard
Capsules.
Medicines are not always suitable for everyone. Your doctor needs to
know before you take Epanutin 100 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
100 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 (HLAB*1502), discuss this with your doctor before taking Epanutin 100 mg
Hard Capsules.
Other medicines and Epanutin 100 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 100 mg Hard Capsules
work and Epanutin 100 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 100 mg Hard Capsules may also interfere with certain
laboratory tests that you may be given.
Epanutin 100 mg Hard Capsules with food and drink
Epanutin 100 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 100 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 100 mg Hard Capsules if you are breastfeeding.
Driving and using machines
Epanutin 100 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 100 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 100 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 100 mg Hard Capsules at the same time each
day.
Swallow the capsules whole, with plenty of water.

Adults
The amount of Epanutin 100 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 100 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 100 mg Hard Capsules than you should
Epanutin 100 mg Hard Capsules are dangerous in overdose. If you
accidentally take too much Epanutin 100 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 100 mg Hard Capsules left or not.
If you forget to take Epanutin 100 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 100 mg Hard Capsules
Do not stop taking Epanutin 100 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 100 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.
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 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 100 MG HARD CAPSULES
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Do not use Epanutin 100 mg Hard Capsules after the expiry date
which is stamped on the pack. The expiry date refers to the last day of
that month.
• Store in the original package to protect from light.
• 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
What Epanutin 100 mg Hard Capsules contain
The active substance is phenytoin sodium. Each hard capsule contains
100 mg phenytoin sodium.
The other ingredients are:
Core: Lactose monohydrate, Magnesium stearate
Shell: Gelatin, Erythrosine (E127), Quinoline yellow (E104), Titanium
dioxide (E171)
Printing ink: Black printing ink.
What Epanutin 100 mg Hard Capsules look like and contents of the
pack
Epanutin 100 mg Hard Capsules are hard gelatin capsules with a white
opaque body and orange cap, radially printed 'EPANUTIN 100'.
Manufactured by
Pfizer Manufacturing Deutschland GmbH, Betriebsstätte 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 xxxxxxxxxx
PL 33532/0423
Leaflet dated 5th September 2016
Leaflet coded xxxxxxxx
Epanutin® is a registered trademark of xxxxxxxxxxxxxxxxxxxx

POM

Package Leaflet: Information for the User

Phenytoin Sodium Flynn 100 mg Hard Capsules
(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.
• The name of this medicine is Phenytoin Sodium Flynn 100 mg Hard
Capsules. It will be referred to as Phenytoin Sodium Flynn Hard
Capsules throughout the remainder of this leaflet.
• This product is also available in other strengths.
What is in this leaflet:
1) What Phenytoin Sodium Flynn Hard Capsules are and what they are
used for
2) What you need to know before you take Phenytoin Sodium Flynn Hard
Capsules
3) How to take Phenytoin Sodium Flynn Hard Capsules
4) Possible side effects
5) How to store Phenytoin Sodium Flynn Hard Capsules
6) Contents of the pack and other information
1) WHAT PHENYTOIN SODIUM FLYNN HARD CAPSULES ARE
AND WHAT THEY ARE USED FOR
Phenytoin Sodium Flynn Hard Capsules are one of a group of medicines
called anti-epileptic drugs; these medicines are used to treat epilepsy.
Phenytoin Sodium Flynn 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. Phenytoin Sodium Flynn 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
Phenytoin Sodium Flynn Hard Capsules.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHENYTOIN
SODIUM FLYNN HARD CAPSULES
Do not take Phenytoin Sodium Flynn 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 Phenytoin Sodium Flynn
Hard Capsules.
Medicines are not always suitable for everyone. Your doctor needs to
know before you take Phenytoin Sodium Flynn 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
Phenytoin Sodium Flynn 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
Phenytoin Sodium Flynn Hard Capsules.
Other medicines and Phenytoin Sodium Flynn 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 Phenytoin Sodium Flynn Hard
Capsules work and Phenytoin Sodium Flynn 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.
Phenytoin Sodium Flynn Hard Capsules may also interfere with certain
laboratory tests that you may be given.
Phenytoin Sodium Flynn Hard Capsules with food and drink
Phenytoin Sodium Flynn 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 Phenytoin Sodium Flynn 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 Phenytoin Sodium Flynn Hard Capsules if you are
breast-feeding.
Driving and using machines
Phenytoin Sodium Flynn 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.
Phenytoin Sodium Flynn 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 PHENYTOIN SODIUM FLYNN 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 Phenytoin Sodium Flynn Hard Capsules at the same
time each day.
Swallow the capsules whole, with plenty of water.
Adults
The amount of Phenytoin Sodium Flynn 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 Phenytoin Sodium Flynn 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 Phenytoin Sodium Flynn Hard Capsules than you
should
Phenytoin Sodium Flynn Hard Capsules are dangerous in overdose. If
you accidentally take too much Phenytoin Sodium Flynn 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 Phenytoin Sodium Flynn Hard Capsules left or not.
If you forget to take Phenytoin Sodium Flynn 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 Phenytoin Sodium Flynn Hard Capsules
Do not stop taking Phenytoin Sodium Flynn 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 Phenytoin Sodium Flynn
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.
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 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 PHENYTOIN SODIUM FLYNN HARD
CAPSULES
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Do not use Phenytoin Sodium Flynn Hard Capsules after the expiry
date which is stamped on the pack. The expiry date refers to the last
day of that month.
• Store in the original package to protect from light.
• 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
What Phenytoin Sodium Flynn Hard Capsules contain
The active substance is phenytoin sodium. Each hard capsule contains
100 mg phenytoin sodium.
The other ingredients are:
Core: Lactose monohydrate, Magnesium stearate
Shell: Gelatin, Erythrosine (E127), Quinoline yellow (E104), Titanium
dioxide (E171)
Printing ink: Black printing ink.
What Phenytoin Sodium Flynn Hard Capsules look like and
contents of the pack
Phenytoin Sodium Flynn Hard Capsules are hard gelatin capsules with a
white opaque body and orange cap, radially printed 'EPANUTIN 100'.
Manufactured by
Pfizer Manufacturing Deutschland GmbH, Betriebsstätte 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
POM
Repackaged by xxxxxxxxxx
PL 33532/0423
Leaflet dated 5th September 2016
Leaflet coded xxxxxxxx
Flynn® is a registered trademark of xxxxxxxxxxxxxxxxxxxx
Epanutin® is a registered trademark of xxxxxxxxxxxxxxxxxxxx

Package Leaflet: Information for the User

Phenytoin Sodium Flynn 100 mg Hard Capsules
(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.
• The name of this medicine is Phenytoin Sodium Flynn 100 mg Hard
Capsules. It will be referred to as Phenytoin Sodium Flynn Hard
Capsules throughout the remainder of this leaflet.
• This product is also available in other strengths.
What is in this leaflet:
1) What Phenytoin Sodium Flynn Hard Capsules are and what they are
used for
2) What you need to know before you take Phenytoin Sodium Flynn Hard
Capsules
3) How to take Phenytoin Sodium Flynn Hard Capsules
4) Possible side effects
5) How to store Phenytoin Sodium Flynn Hard Capsules
6) Contents of the pack and other information
1) WHAT PHENYTOIN SODIUM FLYNN HARD CAPSULES ARE
AND WHAT THEY ARE USED FOR
Phenytoin Sodium Flynn Hard Capsules are one of a group of medicines
called anti-epileptic drugs; these medicines are used to treat epilepsy.
Phenytoin Sodium Flynn 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. Phenytoin Sodium Flynn 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
Phenytoin Sodium Flynn Hard Capsules.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHENYTOIN
SODIUM FLYNN HARD CAPSULES
Do not take Phenytoin Sodium Flynn 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 Phenytoin Sodium Flynn
Hard Capsules.
Medicines are not always suitable for everyone. Your doctor needs to
know before you take Phenytoin Sodium Flynn 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
Phenytoin Sodium Flynn 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
Phenytoin Sodium Flynn Hard Capsules.
Other medicines and Phenytoin Sodium Flynn 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 Phenytoin Sodium Flynn Hard
Capsules work and Phenytoin Sodium Flynn 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.
Phenytoin Sodium Flynn Hard Capsules may also interfere with certain
laboratory tests that you may be given.
Phenytoin Sodium Flynn Hard Capsules with food and drink
Phenytoin Sodium Flynn 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 Phenytoin Sodium Flynn 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 Phenytoin Sodium Flynn Hard Capsules if you are
breast-feeding.
Driving and using machines
Phenytoin Sodium Flynn 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.
Phenytoin Sodium Flynn 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 PHENYTOIN SODIUM FLYNN 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 Phenytoin Sodium Flynn Hard Capsules at the same
time each day.
Swallow the capsules whole, with plenty of water.
Adults
The amount of Phenytoin Sodium Flynn 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 Phenytoin Sodium Flynn 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 Phenytoin Sodium Flynn Hard Capsules than you
should
Phenytoin Sodium Flynn Hard Capsules are dangerous in overdose. If
you accidentally take too much Phenytoin Sodium Flynn 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 Phenytoin Sodium Flynn Hard Capsules left or not.
If you forget to take Phenytoin Sodium Flynn 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 Phenytoin Sodium Flynn Hard Capsules
Do not stop taking Phenytoin Sodium Flynn 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 Phenytoin Sodium Flynn
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.
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 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 PHENYTOIN SODIUM FLYNN HARD
CAPSULES
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Do not use Phenytoin Sodium Flynn Hard Capsules after the expiry
date which is stamped on the pack. The expiry date refers to the last
day of that month.
• Store in the original package to protect from light.
• 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
What Phenytoin Sodium Flynn Hard Capsules contain
The active substance is phenytoin sodium. Each hard capsule contains
100 mg phenytoin sodium.
The other ingredients are:
Core: Lactose monohydrate, Magnesium stearate
Shell: Gelatin, Erythrosine (E127), Quinoline yellow (E104), Titanium
dioxide (E171)
Printing ink: Black printing ink.
What Phenytoin Sodium Flynn Hard Capsules look like and
contents of the pack
Phenytoin Sodium Flynn Hard Capsules are hard gelatin capsules with a
white opaque body and orange cap, radially printed 'EPANUTIN 100'.
Manufactured by
Pfizer Manufacturing Deutschland GmbH, Betriebsstätte 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
POM
Repackaged by xxxxxxxxxx
PL 33532/0423
Leaflet dated 5th September 2016
Leaflet coded xxxxxxxx
Flynn® is a registered trademark of xxxxxxxxxxxxxxxxxxxx

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.

Hide