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PHENYTOIN SODIUM 100MG HARD CAPSULES

Active substance: PHENYTOIN SODIUM

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

PACKAGE LEAFLET: INFORMATION FOR THE USER
EPANUTIN® 100MG Hard Capsules
(phenytoin sodium)



This product is available as Epanutin 100mg Hard Capsules
but will be referred to as Epanutin throughout this leaflet.



Read all of this leaflet carefully before you start taking this
medicine.
 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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
 If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Epanutin is and what it is used for
2. Before you take Epanutin
3. How to take Epanutin
4. Possible side effects
5. How to store Epanutin
6. Further information
1.

What Epanutin is and what it is used for

Epanutin is one of a group of medicines called anti-epileptic drugs;
these medicines are used to treat epilepsy.
Epanutin can be used to control a variety of epileptic conditions, to
control or prevent seizures during or after brain surgery or severe
head injury. Epanutin can also be used to treat trigeminal neuralgia
(facial nerve pain).
You should ask your doctor if you are unsure why you have been
given Epanutin.
2.

Before you take Epanutin

Do not take Epanutin
 if you are allergic (hypersensitive) to Phenytoin, or any of
the other ingredients of Epanutin.
Take special care with 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 (HLAB*
1502), discuss this with your doctor before taking Epanutin.
Taking other medicines
Some medicines can affect the way Epanutin works, or
Epanutin itself can reduce the effectiveness of other
medicines taken at the same time. These include:





Medicines used for heart and circulation problems
(dicoumarol, digitoxin, amiodarone, furosemide, quinidine,
reserpine, warfarin, and calcium channel blockers e.g.
diltiazem and nifedipine).
Medicines used for epilepsy (carbamazepine, lamotrigine,
phenobarbital, sodium valproate and valproic acid,
succinimides e.g. ethosuximide and vigabatrin).
Medicines used to treat fungal infections (e.g. amphotericin
B, fluconazole, itraconazole, ketoconazole and
miconazole).










Medicines used for tuberculosis and other infections
(chloramphenicol, isoniazid, rifampicin, sulphonamides,
doxycycline, ciprofloxacin and nelfinavir).
Medicines used for stomach ulcers (omeprazole, sucralfate,
the medicines known as H2 antagonists e.g. cimetidine,
ranitidine, famotidine and some antacids).
Medicines used for asthma and bronchitis (theophylline).
Medicines used for pain and inflammation (phenylbutazone,
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, sertraline and viloxazine).
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).
Medicines used for cancer (antineoplastic agents).
Muscle relaxants used for surgery (neuromuscular
blockers), some anaesthetic drugs (halothane) and
methadone
Some products available without a prescription (folic acid,
theophylline, vitamin D).

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.

4.

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

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.

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.
Important information about some of the ingredients of
Epanutin
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

It is best to take Epanutin at the same time each day.

Possible side effects

Like all medicines, Epanutin can cause side effects, although not
everybody gets them.

Other side-effects that may occur are:


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.






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 missed dose.

If you have any further questions on how to take this Epanutin, ask
your doctor or pharmacist.

Ask your doctor or pharmacist for advice before taking any
medicine.



If you take more Epanutin than you should
Epanutin is dangerous in overdose. If you accidentally take too
much Epanutin contact your doctor at once or go to the nearest
hospital casualty department. Always take the labelled medicine
package with you, whether there is any Epanutin left or not.

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.

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



Always take Epanutin exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are still not sure.

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 the best method is for you.

Pregnancy and Breast-feeding
If you think you might be pregnant, or are planning to get pregnant,
tell your doctor before you take Epanutin



Elderly
The dose of Epanutin for elderly patients who may be taking other
medicines may also need careful consideration and adjustment by
their doctor.

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.

Taking 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.



Children
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.




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 and breasts:
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.

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
5.

How to store Epanutin

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Do not store above 25°C.
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.
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.

Further information

What Epanutin contains
Each hard capsule contains 100mg phenytoin sodium.
The other ingredients are lactose monohydrate, magnesium
stearate, erythrosine E127, quinoline yellow E104, gelatin, sodium
dodecyl sulphate and titanium dioxide E171.
What Epanutin looks like and contents of the pack
Epanutin capsules are half white and half orange hard capsules
printed with ‘Epanutin 100’ in black on both halves containing white
powder. Epanutin is available in packs containing 100 capsules.
Manufacturer and Product Licence holder
Epanutin is made by Pfizer Manufacturing Deutschland GMBH ,
Freiburg, Germany. Procured from within the EU and repackaged
by the Parallel Import Product Licence holder: G. Pharma Ltd.,
Dakota Avenue, Salford M50 2PU.
PL 16369/1350

POM

IMPORTANT
This medicine is for YOUR use only. It can only be prescribed by a
doctor. Never give it to anyone else. It may harm them even if their
symptoms are the same as yours. This leaflet does not contain the
complete information about your medicine. If you have any
questions, or are not sure about anything, ask your doctor or
pharmacist who has access to additional information.
Date of revision of this leaflet: 19th November 2012
‘Epanutin’ is a registered trade mark of the Pfizer Group of
Companies



PACKAGE LEAFLET: INFORMATION FOR THE USER
EPANUTIN® 100MG Hard Capsules
(phenytoin sodium)



This product is available as Epanutin 100mg Hard Capsules
but will be referred to as Epanutin throughout this leaflet.



Read all of this leaflet carefully before you start taking this
medicine.
 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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
 If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Epanutin is and what it is used for
2. Before you take Epanutin
3. How to take Epanutin
4. Possible side effects
5. How to store Epanutin
6. Further information
1.

What Epanutin is and what it is used for

Epanutin is one of a group of medicines called anti-epileptic drugs;
these medicines are used to treat epilepsy.
Epanutin can be used to control a variety of epileptic conditions, to
control or prevent seizures during or after brain surgery or severe
head injury. Epanutin can also be used to treat trigeminal neuralgia
(facial nerve pain).
You should ask your doctor if you are unsure why you have been
given Epanutin.
2.

Before you take Epanutin

Do not take Epanutin
 if you are allergic (hypersensitive) to Phenytoin, or any of
the other ingredients of Epanutin.
Take special care with 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 (HLAB*
1502), discuss this with your doctor before taking Epanutin.
Taking other medicines
Some medicines can affect the way Epanutin works, or
Epanutin itself can reduce the effectiveness of other
medicines taken at the same time. These include:





Medicines used for heart and circulation problems
(dicoumarol, digitoxin, amiodarone, furosemide, quinidine,
reserpine, warfarin, and calcium channel blockers e.g.
diltiazem and nifedipine).
Medicines used for epilepsy (carbamazepine, lamotrigine,
phenobarbital, sodium valproate and valproic acid,
succinimides e.g. ethosuximide and vigabatrin).
Medicines used to treat fungal infections (e.g. amphotericin
B, fluconazole, itraconazole, ketoconazole and
miconazole).










Medicines used for tuberculosis and other infections
(chloramphenicol, isoniazid, rifampicin, sulphonamides,
doxycycline, ciprofloxacin and nelfinavir).
Medicines used for stomach ulcers (omeprazole, sucralfate,
the medicines known as H2 antagonists e.g. cimetidine,
ranitidine, famotidine and some antacids).
Medicines used for asthma and bronchitis (theophylline).
Medicines used for pain and inflammation (phenylbutazone,
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, sertraline and viloxazine).
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).
Medicines used for cancer (antineoplastic agents).
Muscle relaxants used for surgery (neuromuscular
blockers), some anaesthetic drugs (halothane) and
methadone
Some products available without a prescription (folic acid,
theophylline, vitamin D).

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.

4.

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

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.

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.
Important information about some of the ingredients of
Epanutin
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

It is best to take Epanutin at the same time each day.

Possible side effects

Like all medicines, Epanutin can cause side effects, although not
everybody gets them.

Other side-effects that may occur are:


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.






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 missed dose.

If you have any further questions on how to take this Epanutin, ask
your doctor or pharmacist.

Ask your doctor or pharmacist for advice before taking any
medicine.



If you take more Epanutin than you should
Epanutin is dangerous in overdose. If you accidentally take too
much Epanutin contact your doctor at once or go to the nearest
hospital casualty department. Always take the labelled medicine
package with you, whether there is any Epanutin left or not.

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.

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



Always take Epanutin exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are still not sure.

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 the best method is for you.

Pregnancy and Breast-feeding
If you think you might be pregnant, or are planning to get pregnant,
tell your doctor before you take Epanutin



Elderly
The dose of Epanutin for elderly patients who may be taking other
medicines may also need careful consideration and adjustment by
their doctor.

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.

Taking 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.



Children
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.




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 and breasts:
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.

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
5.

How to store Epanutin

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C.
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.
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.

Further information

What Epanutin contains
Each hard capsule contains 100mg phenytoin sodium.
The other ingredients are lactose monohydrate, magnesium
stearate, erythrosine E127, quinoline yellow E104, gelatin, sodium
dodecyl sulphate and titanium dioxide E171.
What Epanutin looks like and contents of the pack
Epanutin capsules are half white and half orange hard capsules
printed with ‘Epanutin 100’ in black on both halves containing white
powder. Epanutin is available in packs containing 100 capsules.
Manufacturer and Product Licence holder
Epanutin is made by Pfizer Manufacturing Deutschland GMBH ,
Freiburg, Germany. Procured from within the EU and repackaged
by the Parallel Import Product Licence holder: G. Pharma Ltd.,
Dakota Avenue, Salford M50 2PU.
PL 16369/1350

POM

IMPORTANT
This medicine is for YOUR use only. It can only be prescribed by a
doctor. Never give it to anyone else. It may harm them even if their
symptoms are the same as yours. This leaflet does not contain the
complete information about your medicine. If you have any
questions, or are not sure about anything, ask your doctor or
pharmacist who has access to additional information.
Date of revision of this leaflet: 19th November 2012
‘Epanutin’ is a registered trade mark of the Pfizer Group of
Companies



PACKAGE LEAFLET: INFORMATION FOR THE USER
PHENYTOIN SODIUM 100MG Hard Capsules
(phenytoin sodium)



This product is available as Phenytoin Sodium 100mg Hard
Capsules but will be referred to as Phenytoin Sodium
throughout this leaflet.



Read all of this leaflet carefully before you start taking this
medicine.
 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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
 If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.









In this leaflet:
1. What Phenytoin Sodium is and what it is used for
2. Before you take Phenytoin Sodium
3. How to take Phenytoin Sodium
4. Possible side effects
5. How to store Phenytoin Sodium
6. Further information
1.





Medicines used to treat fungal infections (e.g. amphotericin
B, fluconazole, itraconazole, ketoconazole and
miconazole).
Medicines used for tuberculosis and other infections
(chloramphenicol, isoniazid, rifampicin, sulphonamides,
doxycycline, ciprofloxacin and nelfinavir).
Medicines used for stomach ulcers (omeprazole, sucralfate,
the medicines known as H2 antagonists e.g. cimetidine,
ranitidine, famotidine and some antacids).
Medicines used for asthma and bronchitis (theophylline).
Medicines used for pain and inflammation (phenylbutazone,
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, sertraline and viloxazine).
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).
Medicines used for cancer (antineoplastic agents).
Muscle relaxants used for surgery (neuromuscular
blockers), some anaesthetic drugs (halothane) and
methadone
Some products available without a prescription (folic acid,
theophylline, vitamin D).

What Phenytoin Sodium is and what it is used for

Phenytoin Sodium is one of a group of medicines called antiepileptic drugs; these medicines are used to treat epilepsy.
Phenytoin Sodium 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 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.
2.

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.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.

Do not take Phenytoin Sodium
 if you are allergic (hypersensitive) to Phenytoin, or any of
the other ingredients of Phenytoin Sodium.
Take special care with Phenytoin Sodium
Medicines are not always suitable for everyone. Your doctor needs
to know before you take Phenytoin Sodium 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. 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 Phenytoin
Sodium.
Taking other medicines
Some medicines can affect the way Phenytoin Sodium works,
or Phenytoin Sodium itself can reduce the effectiveness of
other
medicines taken at the same time. These include:




If you stop taking Phenytoin Sodium
Do not stop taking Phenytoin Sodium 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, your
doctor will have decided which the best method is for you.
If you have any further questions on how to take this Phenytoin
Sodium, ask your doctor or pharmacist.
Possible side effects

Like all medicines, Phenytoin Sodium can cause side effects, although not everybody gets them.

Other side-effects that may occur are:

Pregnancy and Breast-feeding
If you think you might be pregnant, or are planning to get pregnant,
tell your doctor before you take Phenytoin Sodium
You should not take Phenytoin Sodium if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
Phenytoin Sodium 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.

How to take Phenytoin Sodium

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



Swallow the capsules whole, with plenty of water.
Medicines used for heart and circulation problems
(dicoumarol, digitoxin, amiodarone, furosemide, quinidine,
reserpine, warfarin, and calcium channel blockers e.g.
diltiazem and nifedipine).
Medicines used for epilepsy (carbamazepine, lamotrigine,
phenobarbital, sodium valproate and valproic acid,
succinimides e.g. ethosuximide and vigabatrin).

Adults
The amount of Phenytoin Sodium 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.








If you forget to take Phenytoin Sodium
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 missed dose.

3.

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



If you take more Phenytoin Sodium than you should
Phenytoin Sodium is dangerous in overdose. If you accidentally
take too much Phenytoin Sodium contact your doctor at once or go
to the nearest hospital casualty department. Always take the
labelled medicine package with you, whether there is any
Phenytoin Sodium left or not.

Important information about some of the ingredients of
Phenytoin Sodium
Phenytoin Sodium 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.

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



Always take Phenytoin Sodium exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are still not
sure.

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.

Before you take Phenytoin Sodium



Elderly
The dose of Phenytoin Sodium for elderly patients who may be
taking other medicines may also need careful consideration and
adjustment by their doctor.

4.
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.



Children
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.



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 and breasts:
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.

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
5.

How to store Phenytoin Sodium

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C.
Do not use Phenytoin Sodium 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.

Further information

What Phenytoin Sodium contains
Each hard capsule contains 100mg phenytoin sodium.
The other ingredients are lactose monohydrate, magnesium
stearate, erythrosine E127, quinoline yellow E104, gelatin, sodium
dodecyl sulphate and titanium dioxide E171.
What Phenytoin Sodium looks like and contents of the pack
Phenytoin Sodium capsules are half white and half orange hard
capsules printed with ‘Epanutin 100’ in black on both halves
containing white powder. Phenytoin Sodium is available in packs
containing 100 capsules.
Manufacturer and Product Licence holder
Phenytoin Sodium is made by Pfizer Manufacturing Deutschland
GMBH , Freiburg, Germany. Procured from within the EU and
repackaged by the Parallel Import Product Licence holder: G.
Pharma Ltd., Dakota Avenue, Salford M50 2PU.
PL 16369/1350

POM

IMPORTANT
This medicine is for YOUR use only. It can only be prescribed by a
doctor. Never give it to anyone else. It may harm them even if their
symptoms are the same as yours. This leaflet does not contain the
complete information about your medicine. If you have any
questions, or are not sure about anything, ask your doctor or
pharmacist who has access to additional information.
Date of revision of this leaflet: 19th November 2012
‘Phenytoin Sodium’ is a registered trade mark of the Pfizer Group
of



PACKAGE LEAFLET: INFORMATION FOR THE USER
PHENYTOIN SODIUM 100MG Hard Capsules
(phenytoin sodium)



This product is available as Phenytoin Sodium 100mg Hard
Capsules but will be referred to as Phenytoin Sodium
throughout this leaflet.



Read all of this leaflet carefully before you start taking this
medicine.
 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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
 If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.









In this leaflet:
1. What Phenytoin Sodium is and what it is used for
2. Before you take Phenytoin Sodium
3. How to take Phenytoin Sodium
4. Possible side effects
5. How to store Phenytoin Sodium
6. Further information
1.





Medicines used to treat fungal infections (e.g. amphotericin
B, fluconazole, itraconazole, ketoconazole and
miconazole).
Medicines used for tuberculosis and other infections
(chloramphenicol, isoniazid, rifampicin, sulphonamides,
doxycycline, ciprofloxacin and nelfinavir).
Medicines used for stomach ulcers (omeprazole, sucralfate,
the medicines known as H2 antagonists e.g. cimetidine,
ranitidine, famotidine and some antacids).
Medicines used for asthma and bronchitis (theophylline).
Medicines used for pain and inflammation (phenylbutazone,
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, sertraline and viloxazine).
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).
Medicines used for cancer (antineoplastic agents).
Muscle relaxants used for surgery (neuromuscular
blockers), some anaesthetic drugs (halothane) and
methadone
Some products available without a prescription (folic acid,
theophylline, vitamin D).

What Phenytoin Sodium is and what it is used for

Phenytoin Sodium is one of a group of medicines called antiepileptic drugs; these medicines are used to treat epilepsy.
Phenytoin Sodium 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 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.
2.

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.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.

Do not take Phenytoin Sodium
 if you are allergic (hypersensitive) to Phenytoin, or any of
the other ingredients of Phenytoin Sodium.
Take special care with Phenytoin Sodium
Medicines are not always suitable for everyone. Your doctor needs
to know before you take Phenytoin Sodium 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. 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 Phenytoin
Sodium.
Taking other medicines
Some medicines can affect the way Phenytoin Sodium works,
or Phenytoin Sodium itself can reduce the effectiveness of
other
medicines taken at the same time. These include:




If you stop taking Phenytoin Sodium
Do not stop taking Phenytoin Sodium 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, your
doctor will have decided which the best method is for you.
If you have any further questions on how to take this Phenytoin
Sodium, ask your doctor or pharmacist.
Possible side effects

Like all medicines, Phenytoin Sodium can cause side effects, although not everybody gets them.

Other side-effects that may occur are:

Pregnancy and Breast-feeding
If you think you might be pregnant, or are planning to get pregnant,
tell your doctor before you take Phenytoin Sodium
You should not take Phenytoin Sodium if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
Phenytoin Sodium 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.

How to take Phenytoin Sodium

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



Swallow the capsules whole, with plenty of water.
Medicines used for heart and circulation problems
(dicoumarol, digitoxin, amiodarone, furosemide, quinidine,
reserpine, warfarin, and calcium channel blockers e.g.
diltiazem and nifedipine).
Medicines used for epilepsy (carbamazepine, lamotrigine,
phenobarbital, sodium valproate and valproic acid,
succinimides e.g. ethosuximide and vigabatrin).

Adults
The amount of Phenytoin Sodium 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.








If you forget to take Phenytoin Sodium
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 missed dose.

3.

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



If you take more Phenytoin Sodium than you should
Phenytoin Sodium is dangerous in overdose. If you accidentally
take too much Phenytoin Sodium contact your doctor at once or go
to the nearest hospital casualty department. Always take the
labelled medicine package with you, whether there is any
Phenytoin Sodium left or not.

Important information about some of the ingredients of
Phenytoin Sodium
Phenytoin Sodium 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.

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



Always take Phenytoin Sodium exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are still not
sure.

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.

Before you take Phenytoin Sodium



Elderly
The dose of Phenytoin Sodium for elderly patients who may be
taking other medicines may also need careful consideration and
adjustment by their doctor.

4.
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.



Children
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.



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 and breasts:
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.

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
5.

How to store Phenytoin Sodium

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C.
Do not use Phenytoin Sodium 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.

Further information

What Phenytoin Sodium contains
Each hard capsule contains 100mg phenytoin sodium.
The other ingredients are lactose monohydrate, magnesium
stearate, erythrosine E127, quinoline yellow E104, gelatin, sodium
dodecyl sulphate and titanium dioxide E171.
What Phenytoin Sodium looks like and contents of the pack
Phenytoin Sodium capsules are half white and half orange hard
capsules printed with ‘Epanutin 100’ in black on both halves
containing white powder. Phenytoin Sodium is available in packs
containing 100 capsules.
Manufacturer and Product Licence holder
Phenytoin Sodium is made by Pfizer Manufacturing Deutschland
GMBH , Freiburg, Germany. Procured from within the EU and
repackaged by the Parallel Import Product Licence holder: G.
Pharma Ltd., Dakota Avenue, Salford M50 2PU.
PL 16369/1350

POM

IMPORTANT
This medicine is for YOUR use only. It can only be prescribed by a
doctor. Never give it to anyone else. It may harm them even if their
symptoms are the same as yours. This leaflet does not contain the
complete information about your medicine. If you have any
questions, or are not sure about anything, ask your doctor or
pharmacist who has access to additional information.
Date of revision of this leaflet: 19th November 2012
‘Phenytoin Sodium’ is a registered trade mark of the Pfizer Group
of

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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