Skip to Content

PHENYTOIN SODIUM PHARMARAM 100MG HARD CAPSULES

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

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user



Epanutin® 100mg Hard Capsules

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 100mg Hard Capsules but will be
referred to as Epanutin throughout the remainder of this leaflet.
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 Hard Capsules are one of a group of medicines called antiepileptic 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).








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 H 2 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.

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

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

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPANUTIN®

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.

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 Hard Capsules work
and Epanutin 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)

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 contains 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 Hard Capsules are dangerous in overdose. If you accidentally
take too much Epanutin contact your doctor at once or go to the nearest
hospital casualty department. Always take the labelled medicine package
with you, whether there are any Epanutin Hard Capsules 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.

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.

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.



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.

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 store above 25°C. Store in the original package in order to
protect from light.

4. POSSIBLE SIDE EFFECTS

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

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.

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.
If the capsules becomes discoloured or show any other signs of
deterioration, you should seek the advice of your doctor or pharmacist
who will advise you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Epanutin contains
Each hard capsule contains 100mg of the active ingredient, phenytoin
sodium.
The other ingredients are lactose monohydrate, magnesium stearate,
erythrosine (E127), quinolone yellow (E104), gelatin, sodium lauryl
sulphate, titanium dioxide (E171) and black printing ink.
What Epanutin looks like and the contents of the pack
Epanutin 100mg capsules are half white and half orange marked with
'Epanutin 100' in black printing ink containing white powder.
Epanutin is available in packs containing 100 capsules.
POM

PL No: 33652/0066 – Epanutin® 100mg Hard Capsules

Manufactured by: Pfizer manufacturing Deutschland GmbH, Freiburg,
Germany and procured from within the EU by the Product Licence Holder
Pharmaram Limited, Unit F4 Tom Bill Way, Ivanhoe Business Park,
Ashby de la Zouch, Leicestershire LE65 2UY, United Kingdom.

Epanutin® is a registered trademark of Flynn Pharma Ltd.
Revision date: 1st November 2016

P-PILEPAN100MGX100 (ES) V1

Package leaflet: Information for the user



Phenytoin Sodium Pharmaram 100mg Hard Capsules
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 Phenytoin Sodium Pharmaram 100mg
Hard Capsules but will be referred to as Phenytoin Sodium Pharmaram
throughout the remainder of this leaflet.



What is in this leaflet:
1. What Phenytoin Sodium Pharmaram is and what it is used for
2. What you need to know before you take Phenytoin Sodium
Pharmaram
3. How to take Phenytoin Sodium Pharmaram
4. Possible side effects
5. How to store Phenytoin Sodium Pharmaram
6. Contents of the pack and other information




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



Phenytoin Sodium Pharmaram Hard Capsules are one of a group of
medicines called anti-epileptic drugs; these medicines are used to treat
epilepsy.
Phenytoin Sodium Pharmaram 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 Pharmaram 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 Pharmaram.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHENYTOIN
SODIUM PHARMARAM
Do not take Phenytoin Sodium Pharmaram
• 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
Pharmaram.
Medicines are not always suitable for everyone. Your doctor needs to
know before you take Phenytoin Sodium Pharmaram 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 Pharmaram. 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
Pharmaram.










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 H 2 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 Pharmaram capsules may also interfere with certain
laboratory tests that you may be given.
Phenytoin Sodium Pharmaram with food and drink
Phenytoin Sodium Pharmaram 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 Phenytoin Sodium Pharmaram if you are breastfeeding.
Driving and using machines
Phenytoin Sodium Pharmaram 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 Pharmaram contains 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.

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

3. HOW TO TAKE PHENYTOIN SODIUM PHARMARAM

Some medicines can affect the way Phenytoin Sodium Pharmaram
Hard Capsules work and Phenytoin Sodium Pharmaram Hard
Capsules themselves can reduce the effectiveness of other
medicines taken at the same time. These include:

It is best to take Phenytoin Sodium Pharmaram at the same time each
day.

Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.

Swallow the capsules whole, with plenty of water.

Adults
The amount of Phenytoin Sodium Pharmaram 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 Pharmaram 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 Pharmaram than you should
Phenytoin Sodium Pharmaram Hard Capsules are dangerous in
overdose. If you accidentally take too much Phenytoin Sodium
Pharmaram 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 Pharmaram Hard
Capsules left or not.
If you forget to take Phenytoin Sodium Pharmaram
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.







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 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 PHARMARAM
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

If you stop taking Phenytoin Sodium Pharmaram
Do not stop taking Phenytoin Sodium Pharmaram 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 Pharmaram, 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.

Do not store above 25°C. Store in the original package in order to
protect from light.
Do not use Phenytoin Sodium Pharmaram after the expiry date which is
stamped on the pack. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

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.

If the capsules becomes discoloured or show any other signs of
deterioration, you should seek the advice of your doctor or pharmacist
who will advise you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Phenytoin Sodium Pharmaram contains
Each hard capsule contains 100mg of the active ingredient, phenytoin
sodium.
The other ingredients are lactose monohydrate, magnesium stearate,
erythrosine (E127), quinolone yellow (E104), gelatin, sodium lauryl
sulphate, titanium dioxide (E171) and black printing ink.
What Phenytoin Sodium Pharmaram looks like and the contents of
the pack
Phenytoin Sodium Pharmaram 100mg capsules are half white and half
orange marked with 'Epanutin 100' in black printing ink containing white
powder.
Phenytoin Sodium Pharmaram is available in packs containing 100
capsules.
POM

PL No: 33652/0066 – Phenytoin Sodium Pharmaram
100mg Hard Capsules

Manufactured by: Pfizer manufacturing Deutschland GmbH, Freiburg,
Germany and procured from within the EU by the Product Licence Holder
Pharmaram Limited, Unit F4 Tom Bill Way, Ivanhoe Business Park,
Ashby de la Zouch, Leicestershire LE65 2UY, United Kingdom.
Revision date: 1st November 2016

P-PILPHENSODRAM100MGX100 (ES) V1

Package leaflet: Information for the user



Phenytoin Sodium Flynn 100mg Hard Capsules



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 Phenytoin Sodium Flynn 100mg Hard
Capsules but will be referred to as Phenytoin Sodium Flynn throughout
the remainder of this leaflet.




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 Hard Capsules are one of a group of medicines
called anti-epileptic drugs; these medicines are used to treat epilepsy.











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 H 2 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)

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).

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
Phenytoin Sodium Flynn.

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

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

Do not take Phenytoin Sodium Flynn
• 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.
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:
• 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.
Other medicines and Phenytoin Sodium Flynn
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)

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 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.
Phenytoin Sodium Flynn contains 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
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.

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 Hard Capsules are 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 Hard Capsules left or not.
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.
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.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.












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 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 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
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.

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.

Do not use Phenytoin Sodium Flynn after the expiry date which is
stamped on the pack. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
If the capsules becomes discoloured or show any other signs of
deterioration, you should seek the advice of your doctor or pharmacist
who will advise you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Phenytoin Sodium Flynn contains
Each hard capsule contains 100mg of the active ingredient, phenytoin
sodium.
The other ingredients are lactose monohydrate, magnesium stearate,
erythrosine (E127), quinolone yellow (E104), gelatin, sodium lauryl
sulphate, titanium dioxide (E171) and black printing ink.
What Phenytoin Sodium Flynn looks like and the contents of the
pack
Phenytoin Sodium Flynn 100mg capsules are half white and half orange
marked with 'Epanutin 100' in black printing ink containing white powder.
Phenytoin Sodium Flynn is available in packs containing 100 capsules.
POM

PL No: 33652/0066 – Phenytoin Sodium Flynn 100mg Hard
Capsules

Manufactured by: Pfizer manufacturing Deutschland GmbH, Freiburg,
Germany and procured from within the EU by the Product Licence Holder
Pharmaram Limited, Unit F4 Tom Bill Way, Ivanhoe Business Park,
Ashby de la Zouch, Leicestershire LE65 2UY, United Kingdom.

Phenytoin Sodium Flynn is a registered trademark of Flynn Pharma Ltd.
Revision date: 1st November 2016

P-PILPHENSODFLYNN100MGX100 (ES) V2.2

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