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PHENYTOIN SODIUM ENNOGEN 100MG HARD CAPSULES

Active substance(s): PHENYTOIN SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

EPANUTIN™

100mg Hard Capsules
(phenytoin sodium)
Your medicine is known by the above name, but will be
referred to as Epanutin Capsules throughout this leaflet.

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist.

• This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.

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

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

2. What you need to know before
you take Epanutin Capsules
Do not take Epanutin Capsules
• if you are allergic to Phenytoin, or any of the other
ingredients of this medicine (listed in section 6).
• if you are allergic to other medicines with a similar
chemical structure to Phenytoin (e.g. hydantoins).

Warnings and precautions
Talk to your doctor or pharmacist before taking
Epanutin Capsules.
Medicines are not always suitable for everyone. Your doctor
needs to know before you take Epanutin Capsules if you
suffer from or have suffered in the past from any of the
following conditions:
• Liver disease.
• Porphyria (an inherited disease that affects
haemoglobin biosynthesis).
A small number of people being treated with antiepileptics
such as phenytoin sodium have had thoughts of harming or
killing themselves. If at any time you have these thoughts,
immediately contact your doctor.

Serious skin side effects can rarely occur during treatment
with Epanutin Capsules. This risk may be associated with
a variant in genes in a subject with Chinese or Thai origin.
If you are of such origin and have been tested previously
carrying this genetic variant (HLA-B* 1502), discuss this with
your doctor before taking Epanutin Capsules.

• Medicines used for sleeplessness, depression and
psychiatric disorders (chlordiazepoxide, clozapine,
diazepam, disulfiram, fluoxetine, methylphenidate,
paroxetine, phenothiazines, trazodone, tricyclic
antidepressants, fluvoxamine, quetiapine and sertraline)

Other medicines and Epanutin Capsules

• Some hormone replacement therapies (oestrogens), oral
contraceptives (the birth control pill)

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 Capsules
work and Epanutin Capsules themselves can reduce the
effectiveness of other medicines taken at the same time.
These include:

• Medicines used for diabetes (tolbutamide).

• 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)

• Medicines used for heart and circulation problems
(amiodarone, digoxin, furosemide, reserpine, warfarin,
calcium channel blockers e.g. diltiazem, mexiletine,
nicardipine, nifedipine, nimodipine, and verapamil)

• Muscle relaxants used for surgery (neuromuscular
blockers), some anaesthetic drugs (methadone)

• Medicines used to lower blood cholesterol, (e.g.
atorvastatin, fluvastatin and simvastatin)

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.

• 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, sulfamethoxazoletrimethoprim, doxycycline, ciprofloxacin, efavirenz,
fosamprenavir, indinavir, lopinavir/ritonavir, ritonavir and
saquinavir)
• Medicines used for stomach ulcers (omeprazole,
sucralfate, the medicines known as H2 antagonists e.g.
cimetidine and some antacids)
• Medicines used for asthma and bronchitis (theophylline)
• Medicines used for pain and inflammation (salicylates
e.g. aspirin and steroids)

• Some products available without a prescription (folic acid,
theophylline, St John’s Wort, 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.
Epanutin Capsules may also interfere with certain laboratory
tests that you may be given.

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 Capsules if you are
breast-feeding.

Driving and using machines
Epanutin Capsules may cause dizziness or drowsiness,
especially during the first few weeks of treatment. If you
experience these symptoms, do not drive or use any tools
or machinery.

Epanutin Capsules contain lactose, a type of sugar.
If you have been told that you have an intolerance to
some sugars, contact your doctor before taking this
medicinal product.

3. How to take Epanutin Capsules
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
It is best to take Epanutin Capsules at the same time
each day.
Swallow the capsules whole, with plenty of water.

Epanutin Capsules with food and drink

Adults

Epanutin Capsules can be taken before or after food
and drinks. Drinking a lot of alcohol can also affect the
concentration of Phenytoin in your blood.

The amount of Epanutin Capsules 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.

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

You will find more about Epanutin™
Capsules on the back of this leaflet

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 Capsules for elderly patients who
may be taking other medicines may also need careful
consideration and adjustment by their doctor.

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

If you forget to take Epanutin Capsules
If you forget to take a dose, take it as soon as you remember
unless it is time for your next dose. Do not take a double
dose to make up for a forgotten dose.

If you stop taking Epanutin Capsules
Do not stop taking Epanutin Capsules unless your doctor
tells you to. If you suddenly stop taking this medicine you
may have a seizure. Should you need to stop taking Epanutin
Capsules, your doctor will have decided which is the best
method for you.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Tell your doctor immediately if you experience any of the
following symptoms after taking this medicine. Although
they are very rare, these symptoms can be serious.

• Sudden wheeziness, difficulty in breathing, swelling of
eyelids, face or lips, rash or itching (especially affecting the
whole body).
• If you develop a severe skin rash that causes blistering,
(this can also affect the mouth and tongue). These may be
signs of a condition known as Stevens Johnson Syndrome,
or toxic epidermal necrolysis (TEN). Your doctor will stop
your treatment in these cases.
• If you notice bruising, fever, you are looking pale or you
have a severe sore throat. These may be the first signs of
an abnormality of the blood, including decreases in the
number of red cells, white cells or platelets. Your doctor
may take regular blood samples to test for these effects.
• Skin rash and fever with swollen glands, particularly in
the first two months of treatment, as these may be signs
of a hypersensitivity reaction. If these are severe and you
also experience pain and inflammation of the joints this
could be related to a condition called systemic lupus
erythematosus.
• If you experience confusion or have a severe mental
illness, as this may be a sign that you have high amounts
of phenytoin in your blood. On rare occasions, when
the amount of phenytoin in the blood remains high,
irreversible brain injury has occurred. Your doctor may test
your blood to see how much phenytoin is in the blood and
may change your dose.

Other side-effects that may occur are:
• Effects on your nervous system: Unusual eye movements,
unsteadiness, difficulty in controlling movements, shaking,
abnormal or uncoordinated movements, slurred speech,
confusion, pins and needles or numbness, drowsiness,
dizziness, vertigo, sleeplessness, nervousness, twitching
muscles, headaches and taste change.
• Effects on your skin: skin rash including measles-like
reactions which are mild.
• Effects on your stomach and intestines: feeling sick,
being sick and constipation.

• Effects on your blood and lymph system: swelling of the
lymph glands.
• Effects on your liver and kidney: inflammation of the
kidneys and liver, liver damage (seen as yellowing of the
skin and whites of the eye).
• Effects on your reproductive system: changes in the
shape of the penis, painful erection.
• Effects on your hands, face and body: changes in the
hands with difficulty in straightening the fingers, changes
in facial features, enlarged lips or gums, increased or
abnormal body or facial hair.
• Effects on medical tests: increased levels of blood sugar,
or decreased levels of blood calcium, folic acid and vitamin
D. If you also do not get enough vitamin D in your diet or
from exposure to sunlight, you may suffer from bone pain
or fractures.
• Effects on your respiratory system: problems breathing,
inflammation of the lining of the lung.
• Effects on your immune system: problems with the
body’s defence against infection, inflammation of the wall
of the arteries.
• Effects on your bones: There have been reports of
bone disorders including osteopenia and osteoporosis
(thinning of the bone) and fractures. Check with your
doctor or pharmacist if you are on long-term antiepileptic
medication, have a history of osteoporosis, or take steroids.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Epanutin Capsules
Keep out of the sight and reach of children.
Do not store above 25oC. Store in the original package in
order to protect from light.
Do not use Epanutin Capsules after the expiry date which is
stated on the label. The expiry date refers to the last day of
that month.
If the capsules show signs of deterioration or discolouration,
you should seek the advice of your pharmacist who will tell
you what to do.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. Contents of the pack and other
information
What Epanutin Capsules contain
Each capsule contains 100 mg phenytoin sodium.
Each capsule also includes gelatin, lactose monohydrate,
magnesium stearate, titanium dioxide (E171),
erythrosine (E127), quinoline yellow (E104), and sodium
dodecylsulphate.

What Epanutin Capsules look like and contents of
the pack
Each hard gelatin capsule has a white opaque body and
orange cap, radially printed ‘EPANUTIN 100’ on both the body
and cap.
Epanutin Capsules are available in white plastic containers of
100 capsules.
The capsules are packed in a white plastic container which
contains a desiccant. The desiccant should not be eaten.

Who manufactured your medicine
Manufactured by
Pfizer Manufacturing Deutschland GmbH,
Betriebsstatte Freiburg, Mooswaldallee 1,
79090 Freiburg, Germany.
Procured from within the EU and repackaged
by Product Licence Holder Ennogen Healthcare Limited,
Unit G4 Riverside Industrial Estate,
Riverside Way, Dartford, Kent DA1 5BS.
PL 40739/0012

POM

Leaflet date: 3 August 2016

Ref: EPA100G/v3

Epanutin is a registered trademark of
Parke, Davis & Company LLC.

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.

What is in this leaflet
1. What Phenytoin Sodium Flynn 100mg Hard
Capsules are and what they are used for
2. What you need to know before you take
Phenytoin Sodium Flynn 100mg Hard Capsules
3. How to take Phenytoin Sodium Flynn 100mg
Hard Capsules
4. Possible side effects
5. How to store Phenytoin Sodium Flynn 100mg
Hard Capsules
6. Contents of the pack and other information

1. What Phenytoin Sodium Flynn
100mg Hard Capsules are and what
they are used for
Phenytoin Sodium Flynn 100mg Hard Capsules are one
of a group of medicines called anti-epileptic drugs; these
medicines are used to treat epilepsy.
Phenytoin Sodium Flynn 100mg Hard Capsules can be used
to control a variety of epileptic conditions, to control or
prevent seizures during or after brain surgery or severe head
injury. Phenytoin Sodium Flynn 100mg Hard Capsules can
also be used to treat trigeminal neuralgia (facial nerve pain).
You should ask your doctor if you are unsure why you have
been given Phenytoin Sodium Flynn 100mg Hard Capsules.

2. What you need to know before you
take Phenytoin Sodium Flynn
100mg Hard Capsules
Do not take Phenytoin Sodium Flynn 100mg
Hard Capsules
• if you are allergic to Phenytoin, or any of the other
ingredients of this medicine (listed in section 6).
• if you are allergic to other medicines with a similar
chemical structure to Phenytoin (e.g. hydantoins).

Warnings and precautions
Talk to your doctor or pharmacist before taking Phenytoin
Sodium Flynn 100mg Hard Capsules.
Medicines are not always suitable for everyone. Your doctor
needs to know before you take Phenytoin Sodium Flynn
100mg Hard Capsules if you suffer from or have suffered in
the past from any of the following conditions:
• Liver disease.
• Porphyria (an inherited disease that affects
haemoglobin biosynthesis).

A small number of people being treated with antiepileptics
such as phenytoin sodium have had thoughts of harming or
killing themselves. If at any time you have these thoughts,
immediately contact your doctor.

• Medicines used for stomach ulcers (omeprazole,
sucralfate, the medicines known as H2 antagonists e.g.
cimetidine and some antacids)

Serious skin side effects can rarely occur during treatment
with Phenytoin Sodium Flynn 100mg Hard Capsules. This
risk may be associated with a variant in genes in a subject
with Chinese or Thai origin. If you are of such origin and have
been tested previously carrying this genetic variant (HLA-B*
1502), discuss this with your doctor before taking Phenytoin
Sodium Flynn 100mg Hard Capsules.

• Medicines used for pain and inflammation (salicylates
e.g. aspirin and steroids)

Other medicines and Phenytoin Sodium Flynn
100mg Hard Capsules

• Medicines used for diabetes (tolbutamide).

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 100mg Hard Capsules work and Phenytoin Sodium
Flynn 100mg Hard Capsules themselves can reduce the
effectiveness of other medicines taken at the same time.
These include:
• Medicines used for heart and circulation problems
(amiodarone, digoxin, furosemide, reserpine, warfarin,
calcium channel blockers e.g. diltiazem, mexiletine,
nicardipine, nifedipine, nimodipine, and verapamil)
• Medicines used to lower blood cholesterol, (e.g.
atorvastatin, fluvastatin and simvastatin)
• Medicines used for epilepsy (carbamazepine, lamotrigine,
oxcarbazepine, phenobarbital, sodium valproate,
topiramate and valproic acid, succinimides e.g.
ethosuximide and vigabatrin)
• Medicines used to treat fungal infections (e.g.
amphotericin B, fluconazole, itraconazole, ketoconazole,
miconazole, posaconazole and voriconazole)
• Medicines used for tuberculosis and other infections
(chloramphenicol, clarithromycin, isoniazid, rifampicin,
sulphonamides, sulfadiazine, sulfamethoxazoletrimethoprim, doxycycline, ciprofloxacin, efavirenz,
fosamprenavir, indinavir, lopinavir/ritonavir, ritonavir
and saquinavir)

• Medicines used for asthma and bronchitis (theophylline)

• Medicines used for sleeplessness, depression and
psychiatric disorders (chlordiazepoxide, clozapine,
diazepam, disulfiram, fluoxetine, methylphenidate,
paroxetine, phenothiazines, trazodone, tricyclic
antidepressants, fluvoxamine, quetiapine and sertraline)
• Some hormone replacement therapies (oestrogens), oral
contraceptives (the birth control pill)
• Medicines used for organ and tissue transplants, to
prevent rejection (ciclosporin and tacrolimus)
• Medicines used for cancer (antineoplastic agents,
e.g. bleomycin, capecitabine, carboplatin, cisplatin,
doxorubicin, fluorouracil and methotrexate)
• Muscle relaxants used for surgery (neuromuscular
blockers), some anaesthetic drugs (methadone)
• Some products available without a prescription (folic acid,
theophylline, St John’s Wort, vitamin D).
Your doctor may need to test the amount of Phenytoin in
your blood to help decide if any of these medicines are
affecting your treatment.
The herbal preparation St John’s wort (Hypericum
perforatum) should not be taken at the same time as this
medicine. If you already take St John’s Wort, consult your
doctor before stopping the St John’s Wort preparation.

Phenytoin Sodium Flynn 100mg Hard Capsules
with food and drink
Phenytoin Sodium Flynn 100mg Hard Capsules can be taken
before or after food and drinks. Drinking a lot of alcohol can
also affect the concentration of Phenytoin in your blood.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you might be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine. If you
find out you are pregnant, then you should continue to take
your medicine until you have spoken to your doctor for
advice. This is because Phenytoin 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 100mg Hard
Capsules if you are breast-feeding.

Driving and using machines
Phenytoin Sodium Flynn 100mg Hard Capsules may cause
dizziness or drowsiness, especially during the first few weeks
of treatment. If you experience these symptoms, do not drive
or use any tools or machinery.

Phenytoin Sodium Flynn 100mg Hard Capsules
contain lactose, a type of sugar.
If you have been told that you have an intolerance to
some sugars, contact your doctor before taking this
medicinal product.

Phenytoin Sodium Flynn 100mg Hard Capsules may also
interfere with certain laboratory tests that you may be given.

You will find more about Phenytoin Sodium Flynn
100mg Hard Capsules on the back of this leaflet

3. How to take Phenytoin Sodium
Flynn 100mg Hard Capsules
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
It is best to take Phenytoin Sodium Flynn 100mg Hard
Capsules at the same time each day.
Swallow the capsules whole, with plenty of water.

Adults
The amount of Phenytoin Sodium Flynn 100mg Hard
Capsules 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 100mg Hard Capsules
for elderly patients who may be taking other medicines
may also need careful consideration and adjustment by
their doctor.

If you take more Phenytoin Sodium Flynn 100mg
Hard Capsules than you should
Phenytoin Sodium Flynn 100mg Hard Capsules are
dangerous in overdose. If you accidentally take too much
Phenytoin Sodium Flynn 100mg Hard Capsules contact
your doctor at once or go to the nearest hospital casualty
department. Always take the labelled medicine package
with you, whether there are any Phenytoin Sodium Flynn
100mg Hard Capsules left or not.

If you forget to take Phenytoin Sodium Flynn
100mg Hard Capsules
If you forget to take a dose, take it as soon as you remember
unless it is time for your next dose. Do not take a double
dose to make up for a forgotten dose.

If you stop taking Phenytoin Sodium Flynn
100mg Hard Capsules
Do not stop taking Phenytoin Sodium Flynn 100mg Hard
Capsules unless your doctor tells you to. If you suddenly stop
taking this medicine you may have a seizure. Should you
need to stop taking Phenytoin Sodium Flynn 100mg Hard
Capsules, your doctor will have decided which is the best
method for you.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Tell your doctor immediately if you experience any of the
following symptoms after taking this medicine. Although
they are very rare, these symptoms can be serious.
• Sudden wheeziness, difficulty in breathing, swelling of
eyelids, face or lips, rash or itching (especially affecting the
whole body).
• If you develop a severe skin rash that causes blistering,
(this can also affect the mouth and tongue). These may be
signs of a condition known as Stevens Johnson Syndrome,
or toxic epidermal necrolysis (TEN). Your doctor will stop
your treatment in these cases.
• If you notice bruising, fever, you are looking pale or you
have a severe sore throat. These may be the first signs of
an abnormality of the blood, including decreases in the
number of red cells, white cells or platelets. Your doctor
may take regular blood samples to test for these effects.
• Skin rash and fever with swollen glands, particularly in
the first two months of treatment, as these may be signs
of a hypersensitivity reaction. If these are severe and you
also experience pain and inflammation of the joints this
could be related to a condition called systemic lupus
erythematosus.

• If you experience confusion or have a severe mental
illness, as this may be a sign that you have high amounts
of phenytoin in your blood. On rare occasions, when
the amount of phenytoin in the blood remains high,
irreversible brain injury has occurred. Your doctor may test
your blood to see how much phenytoin is in the blood and
may change your dose.

Other side-effects that may occur are:
• Effects on your nervous system: Unusual eye movements,
unsteadiness, difficulty in controlling movements, shaking,
abnormal or uncoordinated movements, slurred speech,
confusion, pins and needles or numbness, drowsiness,
dizziness, vertigo, sleeplessness, nervousness, twitching
muscles, headaches and taste change.
• Effects on your skin: skin rash including measles-like
reactions which are mild.
• Effects on your stomach and intestines: feeling sick,
being sick and constipation.
• Effects on your blood and lymph system: swelling of the
lymph glands.
• Effects on your liver and kidney: inflammation of the
kidneys and liver, liver damage (seen as yellowing of the
skin and whites of the eye).
• Effects on your reproductive system: changes in the
shape of the penis, painful erection.
• Effects on your hands, face and body: changes in the
hands with difficulty in straightening the fingers, changes
in facial features, enlarged lips or gums, increased or
abnormal body or facial hair.
• Effects on medical tests: increased levels of blood sugar,
or decreased levels of blood calcium, folic acid and vitamin
D. If you also do not get enough vitamin D in your diet or
from exposure to sunlight, you may suffer from bone pain
or fractures.

• Effects on your respiratory system: problems breathing,
inflammation of the lining of the lung.
• Effects on your immune system: problems with the
body’s defence against infection, inflammation of the wall
of the arteries.

6. Contents of the pack and other
information
What Phenytoin Sodium Flynn 100mg Hard
Capsules contain

• 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.

Each capsule contains 100 mg phenytoin sodium.

Reporting of side effects

What Phenytoin Sodium Flynn 100mg Hard
Capsules look like and contents of the pack

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 100mg Hard Capsules
Keep out of the sight and reach of children.
Do not store above 25oC. Store in the original package in
order to protect from light.
Do not use Phenytoin Sodium Flynn 100mg Hard Capsules
after the expiry date which is stated on the label. The expiry
date refers to the last day of that month.
If the capsules show signs of deterioration or discolouration,
you should seek the advice of your pharmacist who will tell
you what to do.
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.

Each capsule also includes gelatin, lactose monohydrate,
magnesium stearate, titanium dioxide (E171),
erythrosine (E127), quinoline yellow (E104), and sodium
dodecylsulphate.

Each hard gelatin capsule has a white opaque body and
orange cap, radially printed ‘EPANUTIN 100’ on both the body
and cap.
Phenytoin Sodium Flynn 100mg Hard Capsules are available
in white plastic containers of 100 capsules.
The capsules are packed in a white plastic container which
contains a desiccant. The desiccant should not be eaten.

Who manufactured your medicine
Manufactured by Pfizer Manufacturing Deutschland GmbH,
Betriebsstatte Freiburg,
Mooswaldallee 1,
79090 Freiburg, Germany
Procured from within the EU and repackaged by
Product Licence Holder Ennogen Healthcare Limited,
Unit G4 Riverside Industrial Estate,
Riverside Way,
Dartford, Kent DA1 5BS.
PL 40739/0012
Leaflet date: 3 August 2016

POM
Ref: PHE100G/v3

PACKAGE LEAFLET: INFORMATION FOR THE USER

PHENYTOIN
SODIUM ENNOGEN

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.

What is in this leaflet
1. What Phenytoin Sodium Ennogen 100mg Hard
Capsules are and what they are used for
2. What you need to know before you take
Phenytoin Sodium Ennogen 100mg Hard
Capsules
3. How to take Phenytoin Sodium Ennogen
100mg Hard Capsules
4. Possible side effects
5. How to store Phenytoin Sodium Ennogen
100mg Hard Capsules
6. Contents of the pack and other information

1. What Phenytoin Sodium Ennogen
100mg Hard Capsules are and what
they are used for
Phenytoin Sodium Ennogen 100mg Hard Capsules are one
of a group of medicines called anti-epileptic drugs; these
medicines are used to treat epilepsy.
Phenytoin Sodium Ennogen 100mg Hard Capsules can be
used to control a variety of epileptic conditions, to control or
prevent seizures during or after brain surgery or severe head
injury. Phenytoin Sodium Ennogen 100mg Hard Capsules
can also be used to treat trigeminal neuralgia (facial nerve pain).
You should ask your doctor if you are unsure why you have
been given Phenytoin Sodium Ennogen 100mg Hard Capsules.

2. What you need to know before you
take Phenytoin Sodium Ennogen
100mg Hard Capsules
Do not take Phenytoin Sodium Ennogen 100mg
Hard Capsules
• if you are allergic to Phenytoin, or any of the other
ingredients of this medicine (listed in section 6).
• if you are allergic to other medicines with a similar
chemical structure to Phenytoin (e.g. hydantoins).

Warnings and precautions
Talk to your doctor or pharmacist before taking Phenytoin
Sodium Ennogen 100mg Hard Capsules.
Medicines are not always suitable for everyone. Your doctor
needs to know before you take Phenytoin Sodium Ennogen
100mg Hard Capsules if you suffer from or have suffered in
the past from any of the following conditions:
• Liver disease.
• Porphyria (an inherited disease that affects
haemoglobin biosynthesis).

A small number of people being treated with antiepileptics
such as phenytoin sodium have had thoughts of harming or
killing themselves. If at any time you have these thoughts,
immediately contact your doctor.

• Medicines used for stomach ulcers (omeprazole,
sucralfate, the medicines known as H2 antagonists e.g.
cimetidine and some antacids)

Serious skin side effects can rarely occur during treatment
with Phenytoin Sodium Ennogen 100mg Hard Capsules. This
risk may be associated with a variant in genes in a subject
with Chinese or Thai origin. If you are of such origin and have
been tested previously carrying this genetic variant (HLA-B*
1502), discuss this with your doctor before taking Phenytoin
Sodium Ennogen 100mg Hard Capsules.

• Medicines used for pain and inflammation (salicylates
e.g. aspirin and steroids)

Other medicines and Phenytoin Sodium Ennogen
100mg Hard Capsules

• Medicines used for diabetes (tolbutamide).

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
Ennogen 100mg Hard Capsules work and Phenytoin
Sodium Ennogen 100mg Hard Capsules themselves can
reduce the effectiveness of other medicines taken at the
same time. These include:
• Medicines used for heart and circulation problems
(amiodarone, digoxin, furosemide, reserpine, warfarin,
calcium channel blockers e.g. diltiazem, mexiletine,
nicardipine, nifedipine, nimodipine, and verapamil)
• Medicines used to lower blood cholesterol, (e.g.
atorvastatin, fluvastatin and simvastatin)
• Medicines used for epilepsy (carbamazepine, lamotrigine,
oxcarbazepine, phenobarbital, sodium valproate,
topiramate and valproic acid, succinimides e.g.
ethosuximide and vigabatrin)
• Medicines used to treat fungal infections (e.g.
amphotericin B, fluconazole, itraconazole, ketoconazole,
miconazole, posaconazole and voriconazole)
• Medicines used for tuberculosis and other infections
(chloramphenicol, clarithromycin, isoniazid, rifampicin,
sulphonamides, sulfadiazine, sulfamethoxazoletrimethoprim, doxycycline, ciprofloxacin, efavirenz,
fosamprenavir, indinavir, lopinavir/ritonavir, ritonavir
and saquinavir)

• Medicines used for asthma and bronchitis (theophylline)

• Medicines used for sleeplessness, depression and
psychiatric disorders (chlordiazepoxide, clozapine,
diazepam, disulfiram, fluoxetine, methylphenidate,
paroxetine, phenothiazines, trazodone, tricyclic
antidepressants, fluvoxamine, quetiapine and sertraline)
• 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 Ennogen 100mg Hard Capsules may also
interfere with certain laboratory tests that you may be given.

Phenytoin Sodium Ennogen 100mg Hard
Capsules with food and drink
Phenytoin Sodium Ennogen 100mg Hard Capsules can
be taken before or after food and drinks. Drinking a lot of
alcohol can also affect the concentration of Phenytoin in
your blood.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you might be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine. If you
find out you are pregnant, then you should continue to take
your medicine until you have spoken to your doctor for
advice. This is because Phenytoin 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 Ennogen 100mg
Hard Capsules if you are breast-feeding.

Driving and using machines
Phenytoin Sodium Ennogen 100mg Hard Capsules may
cause dizziness or drowsiness, especially during the first few
weeks of treatment. If you experience these symptoms, do
not drive or use any tools or machinery.

Phenytoin Sodium Ennogen 100mg Hard
Capsules contain lactose, a type of sugar.
If you have been told that you have an intolerance to
some sugars, contact your doctor before taking this
medicinal product.

You will find more about Phenytoin Sodium Ennogen
100mg Hard Capsules on the back of this leaflet

3. How to take Phenytoin Sodium
Ennogen 100mg Hard Capsules
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
It is best to take Phenytoin Sodium Ennogen 100mg Hard
Capsules at the same time each day.
Swallow the capsules whole, with plenty of water.

Adults
The amount of Phenytoin Sodium Ennogen 100mg Hard
Capsules 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 Ennogen 100mg Hard
Capsules for elderly patients who may be taking other
medicines may also need careful consideration and
adjustment by their doctor.

If you take more Phenytoin Sodium Ennogen
100mg Hard Capsules than you should
Phenytoin Sodium Ennogen 100mg Hard Capsules are
dangerous in overdose. If you accidentally take too much
Phenytoin Sodium Ennogen 100mg Hard Capsules contact
your doctor at once or go to the nearest hospital casualty
department. Always take the labelled medicine package
with you, whether there are any Phenytoin Sodium Ennogen
100mg Hard Capsules left or not.

If you forget to take Phenytoin Sodium Ennogen
100mg Hard Capsules
If you forget to take a dose, take it as soon as you remember
unless it is time for your next dose. Do not take a double
dose to make up for a forgotten dose.

If you stop taking Phenytoin Sodium Ennogen
100mg Hard Capsules
Do not stop taking Phenytoin Sodium Ennogen 100mg Hard
Capsules unless your doctor tells you to. If you suddenly
stop taking this medicine you may have a seizure. Should
you need to stop taking Phenytoin Sodium Ennogen 100mg
Hard Capsules, your doctor will have decided which is the
best method for you.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Tell your doctor immediately if you experience any of the
following symptoms after taking this medicine. Although
they are very rare, these symptoms can be serious.
• Sudden wheeziness, difficulty in breathing, swelling of
eyelids, face or lips, rash or itching (especially affecting the
whole body).
• If you develop a severe skin rash that causes blistering,
(this can also affect the mouth and tongue). These may be
signs of a condition known as Stevens Johnson Syndrome,
or toxic epidermal necrolysis (TEN). Your doctor will stop
your treatment in these cases.
• If you notice bruising, fever, you are looking pale or you
have a severe sore throat. These may be the first signs of
an abnormality of the blood, including decreases in the
number of red cells, white cells or platelets. Your doctor
may take regular blood samples to test for these effects.
• Skin rash and fever with swollen glands, particularly in
the first two months of treatment, as these may be signs
of a hypersensitivity reaction. If these are severe and you
also experience pain and inflammation of the joints this
could be related to a condition called systemic lupus
erythematosus.

• If you experience confusion or have a severe mental
illness, as this may be a sign that you have high amounts
of phenytoin in your blood. On rare occasions, when
the amount of phenytoin in the blood remains high,
irreversible brain injury has occurred. Your doctor may test
your blood to see how much phenytoin is in the blood and
may change your dose.

Other side-effects that may occur are:
• Effects on your nervous system: Unusual eye movements,
unsteadiness, difficulty in controlling movements, shaking,
abnormal or uncoordinated movements, slurred speech,
confusion, pins and needles or numbness, drowsiness,
dizziness, vertigo, sleeplessness, nervousness, twitching
muscles, headaches and taste change.
• Effects on your skin: skin rash including measles-like
reactions which are mild.
• Effects on your stomach and intestines: feeling sick,
being sick and constipation.
• Effects on your blood and lymph system: swelling of the
lymph glands.
• Effects on your liver and kidney: inflammation of the
kidneys and liver, liver damage (seen as yellowing of the
skin and whites of the eye).
• Effects on your reproductive system: changes in the
shape of the penis, painful erection.
• Effects on your hands, face and body: changes in the
hands with difficulty in straightening the fingers, changes
in facial features, enlarged lips or gums, increased or
abnormal body or facial hair.
• Effects on medical tests: increased levels of blood sugar,
or decreased levels of blood calcium, folic acid and vitamin
D. If you also do not get enough vitamin D in your diet or
from exposure to sunlight, you may suffer from bone pain
or fractures.

• Effects on your respiratory system: problems breathing,
inflammation of the lining of the lung.
• Effects on your immune system: problems with the
body’s defence against infection, inflammation of the wall
of the arteries.

6. Contents of the pack and other
information
What Phenytoin Sodium Ennogen 100mg Hard
Capsules contain

• 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.

Each capsule contains 100 mg phenytoin sodium.

Reporting of side effects

What Phenytoin Sodium Ennogen 100mg Hard
Capsules look like and contents of the pack

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
Ennogen 100mg Hard Capsules
Keep out of the sight and reach of children.
Do not store above 25oC. Store in the original package in
order to protect from light.
Do not use Phenytoin Sodium Ennogen 100mg Hard
Capsules after the expiry date which is stated on the label.
The expiry date refers to the last day of that month.
If the capsules show signs of deterioration or discolouration,
you should seek the advice of your pharmacist who will tell
you what to do.
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.

Each capsule also includes gelatin, lactose monohydrate,
magnesium stearate, titanium dioxide (E171),
erythrosine (E127), quinoline yellow (E104), and sodium
dodecylsulphate.

Each hard gelatin capsule has a white opaque body and
orange cap, radially printed ‘EPANUTIN 100’ on both the body
and cap.
Phenytoin Sodium Ennogen 100mg Hard Capsules are
available in white plastic containers of 100 capsules.
The capsules are packed in a white plastic container which
contains a desiccant. The desiccant should not be eaten.

Who manufactured your medicine
Manufactured by Pfizer Manufacturing Deutschland GmbH,
Betriebsstatte Freiburg,
Mooswaldallee 1,
79090 Freiburg, Germany
Procured from within the EU and repackaged by
Product Licence Holder Ennogen Healthcare Limited,
Unit G4 Riverside Industrial Estate,
Riverside Way,
Dartford, Kent DA1 5BS.
PL 40739/0012
Leaflet date: 3 August 2016

POM
Ref: PHENN100G/v1

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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