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EPANUTIN 100 MG HARD CAPSULES

Active substance(s): PHENYTOIN SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

EPANUTIN® 100 MG HARD CAPSULES

Revision Date: 31.03.2016
Leaflet Reference: EPA100

(phenytoin sodium)
Your medicine is known by the above name, but will be referred to as
Epanutin® throughout this 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.






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).



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.

You should ask your doctor if you are unsure why you have been given
Epanutin®.

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.

®

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPANUTIN

®

Do not take Epanutin®



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).

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

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).

®

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.

Warnings and precautions
Talk to your doctor or pharmacist before taking Epanutin®.

Pregnancy and breast-feeding

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:

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




Liver disease.
Porphyria (an inherited disease that affects haemoglobin
biosynthesis).

®

advice. This is because Epanutin 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.

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.

Breast-feeding
®

You should not take Epanutin if you are breast-feeding.

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®.

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.

Other medicines and Epanutin®

Epanutin® contains lactose, a type of sugar.

Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.

If you have been told that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.

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:





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.

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)

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.

1

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 are any Epanutin® left or not.

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 longterm antiepileptic medication, have a history of osteoporosis, or take
steroids.

Reporting of side effects

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 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.

If you stop taking Epanutin®

5. HOW TO STORE EPANUTIN®

If you forget to take 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.

Do not use this medicine after the last day of the month shown in the
expiry date. This will be printed on the outside of the pack.
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package to protect from
light.

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

If you notice that your capsules have become discoloured or show any
other signs of deterioration, consult a pharmacist who will advise you
what to do.

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

If your doctor tells you to stop taking the capsules, please take them back
to the pharmacist for safe disposal. Only keep the capsules if your doctor
tells you to.

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.









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.

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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Epanutin® contains
Each capsule contains 100 mg of the active ingredient, phenytoin sodium.
The medicine also contains the inactive ingredients: lactose monohydrate,
magnesium stearate. The gelatin capsule shells contain, titanium dioxide
(E171), erythrosine (E127) and quinoline yellow (E104). The printing ink
contains the following: shellac, black iron oxide (E172), N-butyl alcohol,
propelyne glycol, methyl alcohol, isopropyl alcohol, purified water,
dehydrated alcohol, butyl alcohol, ammonia solution, potassium
hydroxide.
What Epanutin® looks like and contents of the pack
Epanutin® 100mg Hard Capsules are half white and half orange hard
capsules marked with “Epanutin 100” in black printing ink and are
available in bottles of 100 capsules. The bottle contains a desiccant and it
should not be eaten.
Epanutin® 100mg Hard Capsules are manufactured by Pfizer
Manufacturing Deutschland GmbH, Betriebsstätte Freiburg
Mooswaldallee 1, 79090, Freiburg, Germany and are procured from within
the EU and repackaged by the Product Licence holder: Beachcourse
Limited, 20 Alliance Court, London W3 0RB.

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.

PL 16378/0547

POM

Revision date: 31.03.2016
Leaflet reference: EPA100
Epanutin® is a registered trademark of the Pfizer group of companies.

2

PACKAGE LEAFLET: INFORMATION FOR THE USER

PHENYTOIN SODIUM FLYNN 100 MG HARD CAPSULES

Revision Date: 31.03.2016
Leaflet Reference: PHEN100

(phenytoin sodium)
Your medicine is known by the above name, but will be referred to as
Phenytoin Sodium Flynn throughout this 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.





What is in this leaflet:




1. What Phenytoin Sodium Flynn is and what it is used for
2. What you need to know before you take Phenytoin Sodium Flynn



3. How to take Phenytoin Sodium Flynn
4. Possible side effects
5. How to store Phenytoin Sodium Flynn
6. Contents of the pack and other information




1. WHAT PHENYTOIN SODIUM FLYNN IS AND WHAT IT IS USED
FOR



Phenytoin Sodium Flynn is one of a group of medicines called antiepileptic drugs; these medicines are used to treat epilepsy.



Phenytoin Sodium Flynn 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 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.

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.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHENYTOIN
SODIUM FLYNN
Do not take Phenytoin Sodium Flynn



Phenytoin Sodium Flynn may also interfere with certain laboratory tests
that you may be given.

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).

Phenytoin Sodium Flynn with food and drink
Phenytoin Sodium Flynn can be taken before or after food and drinks.
Drinking a lot of alcohol can also affect the concentration of Phenytoin in
your blood.

Warnings and precautions
Talk to your doctor or pharmacist before taking Phenytoin Sodium Flynn.

Pregnancy and breast-feeding

Medicines are not always suitable for everyone. Your doctor needs to
know before you take Phenytoin Sodium Flynn if you suffer from or have
suffered in the past from any of the following conditions:



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 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.

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. 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.

Breast-feeding
You should not take Phenytoin Sodium Flynn if you are breast-feeding.
Driving and using machines
Phenytoin Sodium Flynn 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.

Other medicines and Phenytoin Sodium Flynn
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.

Phenytoin Sodium Flynn contains lactose, a type of sugar.

Some medicines can affect the way Phenytoin Sodium Flynn works
and Phenytoin Sodium Flynn itself can reduce the effectiveness of
other medicines taken at the same time. These include:




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).

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

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)

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 at the same time each day.
Swallow the capsules whole, with plenty of water.

1

Adults



The amount of Phenytoin Sodium Flynn 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 Phenytoin Sodium Flynn 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 than you should
Phenytoin Sodium Flynn is dangerous in overdose. If you accidentally
take too much Phenytoin Sodium Flynn 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 left or not.

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 longterm 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.

If you forget to take Phenytoin Sodium Flynn
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.

5. HOW TO STORE PHENYTOIN SODIUM FLYNN
Do not use this medicine after the last day of the month shown in the
expiry date. This will be printed on the outside of the pack.

If you stop taking Phenytoin Sodium Flynn
Do not stop taking Phenytoin Sodium Flynn 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, your doctor will
have decided which is the best method for you.

Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package to protect from
light.

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

If you notice that your capsules have become discoloured or show any
other signs of deterioration, consult a pharmacist who will advise you
what to do.

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

If your doctor tells you to stop taking the capsules, please take them back
to the pharmacist for safe disposal. Only keep the capsules if your doctor
tells you to.

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.

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.










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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Phenytoin Sodium Flynn contains
Each capsule contains 100 mg of the active ingredient, phenytoin sodium.
The medicine also contains the inactive ingredients: lactose monohydrate,
magnesium stearate. The gelatin capsule shells contain, titanium dioxide
(E171), erythrosine (E127) and quinoline yellow (E104). The printing ink
contains the following: shellac, black iron oxide (E172), N-butyl alcohol,
propelyne glycol, methyl alcohol, isopropyl alcohol, purified water,
dehydrated alcohol, butyl alcohol, ammonia solution, potassium
hydroxide.
What Phenytoin Sodium Flynn looks like and contents of the pack
Phenytoin Sodium Flynn 100mg Hard Capsules are half white and half
orange hard capsules marked with “Epanutin 100” in black printing ink
and are available in bottles of 100 capsules. The bottle contains a
desiccant and it should not be eaten.
Phenytoin Sodium Flynn 100mg Hard Capsules are manufactured by
Pfizer Manufacturing Deutschland GmbH, Betriebsstätte Freiburg
Mooswaldallee 1, 79090, Freiburg, Germany and are procured from within
the EU and repackaged by the Product Licence holder: Beachcourse
Limited, 20 Alliance Court, London W3 0RB.

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).

PL 16378/0547
Revision date: 31.03.2016
Leaflet reference: PHEN100

2

POM

Expand view ⇕

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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