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EPANUTIN 25MG HARD CAPSULES

Active substance(s): PHENYTOIN SODIUM

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Epanutin® 25mg Hard Capsules
(phenytoin sodium)
Your medicine is known by the above name but will be referred to as
Epanutin Hard Capsules throughout this:
Patient Information 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 Hard Capsules are and what they are used for
2) What you need to know before you take Epanutin Hard Capsules
3) How to take Epanutin Hard Capsules
4) Possible side effects
5) How to store Epanutin Hard Capsules
6) Contents of the pack and other information

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

2) What you need to know before you take Epanutin Hard
Capsules
Do not take Epanutin Hard Capsules
• if you are allergic to Phenytoin, or any of the other ingredients of this
medicine (listed in section 6).
• if you are allergic to other medicines with a similar chemical structure to
Phenytoin (e.g. hydantoins).
Warnings and precautions
Talk to your doctor or pharmacist before taking Epanutin Hard Capsules.
Medicines are not always suitable for everyone.
Your doctor needs to know before you take Epanutin Hard Capsules if you
suffer from or have suffered in the past from any of the following conditions:
• Liver disease.
• Porphyria (an inherited disease that affects haemoglobin biosynthesis).
A small number of people being treated with antiepileptics such as
phenytoin sodium have had thoughts of harming or killing themselves. If at
any time you have these thoughts, immediately contact your doctor.
Serious skin side effects can rarely occur during treatment with Epanutin
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 Epanutin Hard Capsules.
Other medicines and Epanutin Hard Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Some medicines can affect the way Epanutin Hard Capsules work and
Epanutin Hard Capsules themselves can reduce the effectiveness of
other medicines taken at the same time. These include:
• Medicines used for heart and circulation problems (amiodarone,
digoxin, furosemide, reserpine, warfarin, calcium channel blockers e.g.
diltiazem, mexiletine, nicardipine, nifedipine, nimodipine, and verapamil)
• Medicines used to lower blood cholesterol, (e.g. atorvastatin, fluvastatin
and simvastatin)
• Medicines
used
for
epilepsy
(carbamazepine,
lamotrigine,
oxcarbazepine, phenobarbital, sodium valproate, topiramate and
valproic acid, succinimides e.g. ethosuximide and vigabatrin)
• Medicines used to treat fungal infections (e.g. amphotericin B,
fluconazole, itraconazole, ketoconazole, miconazole, posaconazole and
voriconazole)
• Medicines used for tuberculosis and other infections (chloramphenicol,
clarithromycin, isoniazid, rifampicin, sulphonamides, sulfadiazine,
sulfamethoxazole-trimethoprim, doxycycline, ciprofloxacin, efavirenz,
fosamprenavir, indinavir, lopinavir/ritonavir, ritonavir and saquinavir)
• Medicines used for stomach ulcers (omeprazole, sucralfate, the
medicines known as H2 antagonists e.g. cimetidine and some antacids)
• Medicines used for asthma and bronchitis (theophylline)
• Medicines used for pain and inflammation (salicylates e.g. aspirin and
steroids)
• Medicines used for sleeplessness, depression and psychiatric disorders
(chlordiazepoxide, clozapine, diazepam, disulfiram, fluoxetine,
methylphenidate, paroxetine, phenothiazines, trazodone, tricyclic
antidepressants, fluvoxamine, quetiapine and sertraline)
• Medicines used for diabetes (tolbutamide).
• Some hormone replacement therapies (oestrogens), oral contraceptives
(the birth control pill)
• Medicines used for organ and tissue transplants, to prevent rejection
(ciclosporin and tacrolimus)
• Medicines used for cancer (antineoplastic agents, e.g.bleomycin,
capecitabine, carboplatin, cisplatin, doxorubicin, fluorouracil and
methotrexate)




Muscle relaxants used for surgery (neuromuscular blockers), some
anaesthetic drugs (methadone)
Some products available without a prescription (folic acid, theophylline,
St John’s Wort, vitamin D).

Your doctor may need to test the amount of Phenytoin in your blood to help
decide if any of these medicines are affecting your treatment.
The herbal preparation St John’s wort (Hypericum perforatum) should not
be taken at the same time as this medicine. If you already take St John’s
Wort, consult your doctor before stopping the St John’s Wort preparation.
Epanutin Hard Capsules may also interfere with certain laboratory tests that
you may be given.
Epanutin Hard Capsules with food and drink
Epanutin 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 Epanutin Hard Capsules if you are breast-feeding.
Driving and using machines
Epanutin Hard Capsules may cause dizziness or drowsiness, especially
during the first few weeks of treatment. If you experience these symptoms,
do not drive or use any tools or machinery.
Epanutin Hard Capsules contain lactose, a type of sugar.
If you have been told that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.

3) How to take Epanutin Hard Capsules
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
It is best to take Epanutin Hard Capsules at the same time each day.
Swallow the capsules whole, with plenty of water.
Adults
The amount of Epanutin 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 Epanutin Hard Capsules for elderly patients who may be taking
other medicines may also need careful consideration and adjustment by
their doctor.
If you take more Epanutin Hard Capsules than you should
Epanutin Hard Capsules are dangerous in overdose. If you accidentally
take too much Epanutin Hard Capsules contact your doctor at once or go to
the nearest hospital casualty department. Always take the labelled medicine
package with you, whether there are any Epanutin Hard Capsules left or
not.
If you forget to take Epanutin Hard Capsules
If you forget to take a dose, take it as soon as you remember unless it is
time for your next dose. Do not take a double dose to make up for a
forgotten dose.
If you stop taking Epanutin Hard Capsules
Do not stop taking Epanutin Hard Capsules unless your doctor tells you to.
If you suddenly stop taking this medicine you may have a seizure. Should
you need to stop taking Epanutin Hard Capsules, your doctor will have
decided which is the best method for you.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

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





Skin rash and fever with swollen glands, particularly in the first two
months of treatment, as these may be signs of a hypersensitivity
reaction. If these are severe and you also experience pain and
inflammation of the joints this could be related to a condition called
systemic lupus erythematosus.
If you experience confusion or have a severe mental illness, as this may
be a sign that you have high amounts of phenytoin in your blood. On
rare occasions, when the amount of phenytoin in the blood remains
high, irreversible brain injury has occurred. Your doctor may test your
blood to see how much phenytoin is in the blood and may change your
dose.

Other side-effects that may occur are:
• Effects on your nervous system: Unusual eye movements,
unsteadiness, difficulty in controlling movements, shaking, abnormal or
uncoordinated movements, slurred speech, confusion, pins and needles
or numbness, drowsiness, dizziness, vertigo, sleeplessness,
nervousness, twitching muscles, headaches, and taste change.
• Effects on your skin: skin rash including measles-like reactions which
are mild.
• Effects on your stomach and intestines: feeling sick, being sick and
constipation.
• Effects on your blood and lymph system: swelling of the lymph
glands.
• Effects on your liver and kidney: inflammation of the kidneys and
liver, liver damage (seen as yellowing of the skin and whites of the eye).
• Effects on your reproductive system: changes in the shape of the
penis, painful erection.
• Effects on your hands, face and body: changes in the hands with
difficulty in straightening the fingers, changes in facial features,
enlarged lips or gums, increased or abnormal body or facial hair.
• Effects on medical tests: increased levels of blood sugar, or
decreased levels of blood calcium, folic acid and vitamin D. If you also
do not get enough vitamin D in your diet or from exposure to sunlight,
you may suffer from bone pain or fractures.
• Effects on your respiratory system: problems breathing,
inflammation of the lining of the lung.
• Effects on your immune system: problems with the body’s defence
against infection, inflammation of the wall of the arteries.
• Effects on your bones: There have been reports of bone disorders
including osteopenia and osteoporosis (thinning of the bone) and
fractures. Check with your doctor or pharmacist if you are on long-term
antiepileptic medication, have a history of osteoporosis, or take
steroids.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

5) How to store Epanutin Hard Capsules






Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package in order to
protect from light.
If the capsules become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will
tell you what to do.
Do not throw away any medicines via waste water or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

6) Contents of the pack and other information
What Epanutin Hard Capsules contain
• The active substance is phenytoin sodium. Each capsule contains
25mg phenytoin sodium.
• The other ingredients are lactose monohydrate, magnesium stearate
and sodium lauryl sulfate.
• The gelatin capsule shells contain the colouring titanium dioxide (E171),
patent blue V (E131) and erythrosine (E127).
• The printing ink contains the following: shellac, black iron oxide (E172)
and propylene glycol. It may also contain potassium hydroxide.
What Epanutin Hard Capsules look like and contents of the pack
Epanutin Hard Capsules are hard gelatin capsules, each with a white
opaque body and purple cap, radially printed ‘EPANUTIN 25’ in black ink on
both the body and cap.
Epanutin Hard Capsules are available in packs containing 28 capsules. The
capsules are packed in plastic containers which contains a desiccant. The
desiccant must not be eaten.
PL 10383/2146 Epanutin 25mg Hard Capsules POM
Who makes and repackages your medicine?
Your medicine is manufactured by Pfizer Manufacturing Deutschland GmbH
Betriebsstatte Frieburg, Mooswaldallee 1, D-79090 Freiburg, Germany.
Procured from within the EU and repackaged by Product Licence Holder:
Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex, UB5 5QS.
Leaflet date: 28.05.2016
Epanutin is a registered trademark of Pfizer group of companies.

Phenytoin Sodium Flynn 25mg Hard Capsules
(phenytoin sodium)
Your medicine is known by the above name but will be referred to as
Phenytoin Sodium Flynn Hard Capsules throughout this:
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1) What Phenytoin Sodium Flynn Hard Capsules are and what they are
used for
2) What you need to know before you take Phenytoin Sodium Flynn Hard
Capsules
3) How to take Phenytoin Sodium Flynn Hard Capsules
4) Possible side effects
5) How to store Phenytoin Sodium Flynn Hard Capsules
6) Contents of the pack and other information

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

2) What you need to know before you take Phenytoin Sodium
Flynn Hard Capsules
Do not take Phenytoin Sodium Flynn Hard Capsules
• if you are allergic to Phenytoin, or any of the other ingredients of this
medicine (listed in section 6).
• if you are allergic to other medicines with a similar chemical structure to
Phenytoin (e.g. hydantoins).
Warnings and precautions
Talk to your doctor or pharmacist before taking Phenytoin Sodium Flynn
Hard Capsules.
Medicines are not always suitable for everyone.
Your doctor needs to know before you take Phenytoin Sodium Flynn Hard
Capsules if you suffer from or have suffered in the past from any of the
following conditions:
• Liver disease.
• Porphyria (an inherited disease that affects haemoglobin biosynthesis).
A small number of people being treated with antiepileptics such as
phenytoin sodium have had thoughts of harming or killing themselves. If at
any time you have these thoughts, immediately contact your doctor.
Serious skin side effects can rarely occur during treatment with Phenytoin
Sodium Flynn Hard Capsules. This risk may be associated with a variant in
genes in a subject with Chinese or Thai origin. If you are of such origin and
have been tested previously carrying this genetic variant (HLA-B*1502),
discuss this with your doctor before taking Phenytoin Sodium Flynn Hard
Capsules.
Other medicines and Phenytoin Sodium Flynn Hard Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Some medicines can affect the way Phenytoin Sodium Flynn Hard
Capsules work and Phenytoin Sodium Flynn Hard Capsules
themselves can reduce the effectiveness of other medicines taken at
the same time. These include:
• Medicines used for heart and circulation problems (amiodarone,
digoxin, furosemide, reserpine, warfarin, calcium channel blockers e.g.
diltiazem, mexiletine, nicardipine, nifedipine, nimodipine, and verapamil)
• Medicines used to lower blood cholesterol, (e.g. atorvastatin, fluvastatin
and simvastatin)
• Medicines
used
for
epilepsy
(carbamazepine,
lamotrigine,
oxcarbazepine, phenobarbital, sodium valproate, topiramate and
valproic acid, succinimides e.g. ethosuximide and vigabatrin)
• Medicines used to treat fungal infections (e.g. amphotericin B,
fluconazole, itraconazole, ketoconazole, miconazole, posaconazole and
voriconazole)
• Medicines used for tuberculosis and other infections (chloramphenicol,
clarithromycin, isoniazid, rifampicin, sulphonamides, sulfadiazine,
sulfamethoxazole-trimethoprim, doxycycline, ciprofloxacin, efavirenz,
fosamprenavir, indinavir, lopinavir/ritonavir, ritonavir and saquinavir)
• Medicines used for stomach ulcers (omeprazole, sucralfate, the
medicines known as H2 antagonists e.g. cimetidine and some antacids)
• Medicines used for asthma and bronchitis (theophylline)
• Medicines used for pain and inflammation (salicylates e.g. aspirin and
steroids)
• Medicines used for sleeplessness, depression and psychiatric disorders
(chlordiazepoxide, clozapine, diazepam, disulfiram, fluoxetine,
methylphenidate, paroxetine, phenothiazines, trazodone, tricyclic
antidepressants, fluvoxamine, quetiapine and sertraline)
• Medicines used for diabetes (tolbutamide).
• Some hormone replacement therapies (oestrogens), oral contraceptives
(the birth control pill)






Medicines used for organ and tissue transplants, to prevent rejection
(ciclosporin and tacrolimus)
Medicines used for cancer (antineoplastic agents, e.g.bleomycin,
capecitabine, carboplatin, cisplatin, doxorubicin, fluorouracil and
methotrexate)
Muscle relaxants used for surgery (neuromuscular blockers), some
anaesthetic drugs (methadone)
Some products available without a prescription (folic acid, theophylline,
St John’s Wort, vitamin D).

Your doctor may need to test the amount of Phenytoin in your blood to help
decide if any of these medicines are affecting your treatment.
The herbal preparation St John’s wort (Hypericum perforatum) should not
be taken at the same time as this medicine. If you already take St John’s
Wort, consult your doctor before stopping the St John’s Wort preparation.
Phenytoin Sodium Flynn Hard Capsules may also interfere with certain
laboratory tests that you may be given.
Phenytoin Sodium Flynn Hard Capsules with food and drink
Phenytoin Sodium Flynn Hard Capsules can be taken before or after food
and drinks. Drinking a lot of alcohol can also affect the concentration of
Phenytoin in your blood.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you might be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine. If you find out you are pregnant, then you should
continue to take your medicine until you have spoken to your doctor for
advice. This is because Phenytoin should only be used during pregnancy,
especially early pregnancy, under the advice of your doctor because it can
be harmful to unborn children when taken by a woman during pregnancy.
Do not stop taking your medicine until your doctor tells you to.
Breast-feeding
You should not take Phenytoin Sodium Flynn Hard Capsules if you are
breast-feeding.
Driving and using machines
Phenytoin Sodium Flynn Hard Capsules may cause dizziness or
drowsiness, especially during the first few weeks of treatment. If you
experience these symptoms, do not drive or use any tools or machinery.
Phenytoin Sodium Flynn Hard Capsules contain lactose, a type of
sugar.
If you have been told that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.

3) How to take Phenytoin Sodium Flynn Hard Capsules
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
It is best to take Phenytoin Sodium Flynn Hard Capsules at the same time
each day. Swallow the capsules whole, with plenty of water.
Adults
The amount of Phenytoin Sodium Flynn Hard Capsules needed varies from
one person to another. Most adults need between 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 Hard Capsules for elderly patients
who may be taking other medicines may also need careful consideration
and adjustment by their doctor.
If you take more Phenytoin Sodium Flynn Hard Capsules than you
should
Phenytoin Sodium Flynn Hard Capsules are dangerous in overdose. If you
accidentally take too much Phenytoin Sodium Flynn Hard Capsules contact
your doctor at once or go to the nearest hospital casualty department.
Always take the labelled medicine package with you, whether there are any
Phenytoin Sodium Flynn Hard Capsules left or not.
If you forget to take Phenytoin Sodium Flynn Hard Capsules
If you forget to take a dose, take it as soon as you remember unless it is
time for your next dose. Do not take a double dose to make up for a
forgotten dose.
If you stop taking Phenytoin Sodium Flynn Hard Capsules
Do not stop taking Phenytoin Sodium Flynn Hard Capsules unless your
doctor tells you to. If you suddenly stop taking this medicine you may have
a seizure. Should you need to stop taking Phenytoin Sodium Flynn Hard
Capsules, your doctor will have decided which is the best method for you.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

4) Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Tell your doctor immediately if you experience any of the following
symptoms after taking this medicine. Although they are very rare, these
symptoms can be serious.
• Sudden wheeziness, difficulty in breathing, swelling of eyelids, face or
lips, rash or itching (especially affecting the whole body).
• If you develop a severe skin rash that causes blistering, (this can also
affect the mouth and tongue). These may be signs of a condition known







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

Other side-effects that may occur are:
• Effects on your nervous system: Unusual eye movements,
unsteadiness, difficulty in controlling movements, shaking, abnormal or
uncoordinated movements, slurred speech, confusion, pins and needles
or numbness, drowsiness, dizziness, vertigo, sleeplessness,
nervousness, twitching muscles, headaches, and taste change.
• Effects on your skin: skin rash including measles-like reactions which
are mild.
• Effects on your stomach and intestines: feeling sick, being sick and
constipation.
• Effects on your blood and lymph system: swelling of the lymph
glands.
• Effects on your liver and kidney: inflammation of the kidneys and
liver, liver damage (seen as yellowing of the skin and whites of the eye).
• Effects on your reproductive system: changes in the shape of the
penis, painful erection.
• Effects on your hands, face and body: changes in the hands with
difficulty in straightening the fingers, changes in facial features,
enlarged lips or gums, increased or abnormal body or facial hair.
• Effects on medical tests: increased levels of blood sugar, or
decreased levels of blood calcium, folic acid and vitamin D. If you also
do not get enough vitamin D in your diet or from exposure to sunlight,
you may suffer from bone pain or fractures.
• Effects on your respiratory system: problems breathing,
inflammation of the lining of the lung.
• Effects on your immune system: problems with the body’s defence
against infection, inflammation of the wall of the arteries.
• Effects on your bones: There have been reports of bone disorders
including osteopenia and osteoporosis (thinning of the bone) and
fractures. Check with your doctor or pharmacist if you are on long-term
antiepileptic medication, have a history of osteoporosis, or take
steroids.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

5) How to store Phenytoin Sodium Flynn Hard Capsules






Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package in order to
protect from light.
If the capsules become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will
tell you what to do.
Do not throw away any medicines via waste water or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

6) Contents of the pack and other information
What Phenytoin Sodium Flynn Hard Capsules contain
• The active substance is phenytoin sodium. Each capsule contains
25mg phenytoin sodium.
• The other ingredients are lactose monohydrate, magnesium stearate
and sodium lauryl sulfate.
• The gelatin capsule shells contain the colouring titanium dioxide (E171),
patent blue V (E131) and erythrosine (E127).
• The printing ink contains the following: shellac, black iron oxide (E172)
and propylene glycol. It may also contain potassium hydroxide.
What Phenytoin Sodium Flynn Hard Capsules look like and contents
of the pack
Phenytoin Sodium Flynn hard capsules are hard gelatin capsules, each with
a white opaque body and purple cap, radially printed ‘EPANUTIN 25’ in
black ink on both the body and cap.
Phenytoin Sodium Flynn Hard Capsules are available in packs containing
28 capsules. The capsules are packed in plastic containers which contains
a desiccant. The desiccant must not be eaten.
PL 10383/2146 Phenytoin Sodium Flynn 25mg Hard Capsules POM
Who makes and repackages your medicine?
Your medicine is manufactured by Pfizer Manufacturing Deutschland GmbH
Betriebsstatte Frieburg, Mooswaldallee 1, D-79090 Freiburg, Germany.
Procured from within the EU and repackaged by Product Licence Holder:

Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex, UB5 5QS.
Leaflet date: 28.05.2016
Phenytoin Sodium Flynn is a registered trademark of Flynn Pharma Ltd.,
Ireland.
This product has been imported by Primecrown Ltd from the EU as
Epanutin and has been approved by the MHRA as being equivalent to
Phenytoin Sodium Flynn. Although Flynn Pharma Ltd is the trademark
holder of Flynn, the product has not been manufactured or sold by them.

Phenytoin Sodium Primecrown 25mg Hard Capsules
(phenytoin sodium)
Your medicine is known by the above name but will be referred to as
Phenytoin Sodium Primecrown Hard Capsules throughout this:
Patient Information Leaflet



Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.



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

1) What Phenytoin Sodium Primecrown Hard Capsules are
and what they are used for
Phenytoin Sodium Primecrown Hard Capsules are one of a group of
medicines called anti-epileptic drugs; these medicines are used to treat
epilepsy.
Phenytoin Sodium Primecrown 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 Primecrown 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 Primecrown Hard Capsules.

2) What you need to know before you take Phenytoin Sodium
Primecrown Hard Capsules
Do not take Phenytoin Sodium Primecrown 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
Primecrown Hard Capsules.
Medicines are not always suitable for everyone.
Your doctor needs to know before you take Phenytoin Sodium Primecrown
Hard Capsules if you suffer from or have suffered in the past from any of
the following conditions:
• Liver disease.
• Porphyria (an inherited disease that affects haemoglobin biosynthesis).
A small number of people being treated with antiepileptics such as
phenytoin sodium have had thoughts of harming or killing themselves. If at
any time you have these thoughts, immediately contact your doctor.
Serious skin side effects can rarely occur during treatment with Phenytoin
Sodium Primecrown Hard Capsules. This risk may be associated with a
variant in genes in a subject with Chinese or Thai origin. If you are of such
origin and have been tested previously carrying this genetic variant (HLAB*1502), discuss this with your doctor before taking Phenytoin Sodium
Primecrown Hard Capsules.
Other medicines and Phenytoin Sodium Primecrown Hard Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Some medicines can affect the way Phenytoin Sodium Primecrown
Hard Capsules work and Phenytoin Sodium Primecrown Hard
Capsules themselves can reduce the effectiveness of other medicines
taken at the same time. These include:
• Medicines used for heart and circulation problems (amiodarone,
digoxin, furosemide, reserpine, warfarin, calcium channel blockers e.g.
diltiazem, mexiletine, nicardipine, nifedipine, nimodipine, and verapamil)
• Medicines used to lower blood cholesterol, (e.g. atorvastatin, fluvastatin
and simvastatin)
• Medicines
used
for
epilepsy
(carbamazepine,
lamotrigine,
oxcarbazepine, phenobarbital, sodium valproate, topiramate and
valproic acid, succinimides e.g. ethosuximide and vigabatrin)
• Medicines used to treat fungal infections (e.g. amphotericin B,
fluconazole, itraconazole, ketoconazole, miconazole, posaconazole and
voriconazole)
• Medicines used for tuberculosis and other infections (chloramphenicol,
clarithromycin, isoniazid, rifampicin, sulphonamides, sulfadiazine,
sulfamethoxazole-trimethoprim, doxycycline, ciprofloxacin, efavirenz,
fosamprenavir, indinavir, lopinavir/ritonavir, ritonavir and saquinavir)
• Medicines used for stomach ulcers (omeprazole, sucralfate, the
medicines known as H2 antagonists e.g. cimetidine and some antacids)
• Medicines used for asthma and bronchitis (theophylline)
• Medicines used for pain and inflammation (salicylates e.g. aspirin and
steroids)
• Medicines used for sleeplessness, depression and psychiatric disorders
(chlordiazepoxide, clozapine, diazepam, disulfiram, fluoxetine,
methylphenidate, paroxetine, phenothiazines, trazodone, tricyclic
antidepressants, fluvoxamine, quetiapine and sertraline)
• Medicines used for diabetes (tolbutamide).






Some hormone replacement therapies (oestrogens), oral contraceptives
(the birth control pill)
Medicines used for organ and tissue transplants, to prevent rejection
(ciclosporin and tacrolimus)
Medicines used for cancer (antineoplastic agents, e.g.bleomycin,
capecitabine, carboplatin, cisplatin, doxorubicin, fluorouracil and
methotrexate)
Muscle relaxants used for surgery (neuromuscular blockers), some
anaesthetic drugs (methadone)
Some products available without a prescription (folic acid, theophylline,
St John’s Wort, vitamin D).

Your doctor may need to test the amount of Phenytoin in your blood to help
decide if any of these medicines are affecting your treatment.
The herbal preparation St John’s wort (Hypericum perforatum) should not
be taken at the same time as this medicine. If you already take St John’s
Wort, consult your doctor before stopping the St John’s Wort preparation.
Phenytoin Sodium Primecrown Hard Capsules may also interfere with
certain laboratory tests that you may be given.
Phenytoin Sodium Primecrown Hard Capsules with food and drink
Phenytoin Sodium Primecrown 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 Primecrown Hard Capsules if you
are breast-feeding.
Driving and using machines
Phenytoin Sodium Primecrown 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 Primecrown Hard Capsules contain lactose, a type
of sugar.
If you have been told that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.

3) How to take Phenytoin Sodium Primecrown 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 Primecrown Hard Capsules at the same
time each day. Swallow the capsules whole, with plenty of water.
Adults
The amount of Phenytoin Sodium Primecrown 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 Primecrown 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 Primecrown Hard Capsules than
you should
Phenytoin Sodium Primecrown Hard Capsules are dangerous in overdose.
If you accidentally take too much Phenytoin Sodium Primecrown 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 Primecrown Hard Capsules left or not.
If you forget to take Phenytoin Sodium Primecrown 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 Primecrown Hard Capsules
Do not stop taking Phenytoin Sodium Primecrown 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
Primecrown Hard Capsules, your doctor will have decided which is the best
method for you.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

4) Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.

Tell your doctor immediately if you experience any of the following
symptoms after taking this medicine. Although they are very rare, these
symptoms can be serious.
• Sudden wheeziness, difficulty in breathing, swelling of eyelids, face or
lips, rash or itching (especially affecting the whole body).
• If you develop a severe skin rash that causes blistering, (this can also
affect the mouth and tongue). These may be signs of a condition known
as Stevens Johnson Syndrome, or toxic epidermal necrolysis (TEN).
Your doctor will stop your treatment in these cases.
• If you notice bruising, fever, you are looking pale or you have a severe
sore throat. These may be the first signs of an abnormality of the blood,
including decreases in the number of red cells, white cells or platelets.
Your doctor may take regular blood samples to test for these effects.
• Skin rash and fever with swollen glands, particularly in the first two
months of treatment, as these may be signs of a hypersensitivity
reaction. If these are severe and you also experience pain and
inflammation of the joints this could be related to a condition called
systemic lupus erythematosus.
• If you experience confusion or have a severe mental illness, as this may
be a sign that you have high amounts of phenytoin in your blood. On
rare occasions, when the amount of phenytoin in the blood remains
high, irreversible brain injury has occurred. Your doctor may test your
blood to see how much phenytoin is in the blood and may change your
dose.
Other side-effects that may occur are:
• Effects on your nervous system: Unusual eye movements,
unsteadiness, difficulty in controlling movements, shaking, abnormal or
uncoordinated movements, slurred speech, confusion, pins and needles
or numbness, drowsiness, dizziness, vertigo, sleeplessness,
nervousness, twitching muscles, headaches, and taste change.
• Effects on your skin: skin rash including measles-like reactions which
are mild.
• Effects on your stomach and intestines: feeling sick, being sick and
constipation.
• Effects on your blood and lymph system: swelling of the lymph
glands.
• Effects on your liver and kidney: inflammation of the kidneys and
liver, liver damage (seen as yellowing of the skin and whites of the eye).
• Effects on your reproductive system: changes in the shape of the
penis, painful erection.
• Effects on your hands, face and body: changes in the hands with
difficulty in straightening the fingers, changes in facial features,
enlarged lips or gums, increased or abnormal body or facial hair.
• Effects on medical tests: increased levels of blood sugar, or
decreased levels of blood calcium, folic acid and vitamin D. If you also
do not get enough vitamin D in your diet or from exposure to sunlight,
you may suffer from bone pain or fractures.
• Effects on your respiratory system: problems breathing,
inflammation of the lining of the lung.
• Effects on your immune system: problems with the body’s defence
against infection, inflammation of the wall of the arteries.
• Effects on your bones: There have been reports of bone disorders
including osteopenia and osteoporosis (thinning of the bone) and
fractures. Check with your doctor or pharmacist if you are on long-term
antiepileptic medication, have a history of osteoporosis, or take
steroids.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

5) How to store Phenytoin Sodium Primecrown Hard Capsules






Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package in order to
protect from light.
If the capsules become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will
tell you what to do.
Do not throw away any medicines via waste water or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

6) Contents of the pack and other information
What Phenytoin Sodium Primecrown Hard Capsules contain
• The active substance is phenytoin sodium. Each capsule contains
25mg phenytoin sodium.
• The other ingredients are lactose monohydrate, magnesium stearate
and sodium lauryl sulfate.
• The gelatin capsule shells contain the colouring titanium dioxide (E171),
patent blue V (E131) and erythrosine (E127).
• The printing ink contains the following: shellac, black iron oxide (E172)
and propylene glycol. It may also contain potassium hydroxide.
What Phenytoin Sodium Primecrown Hard Capsules look like and
contents of the pack
Phenytoin Sodium Primecrown Hard Capsules are hard gelatin capsules,
each with a white opaque body and purple cap, radially printed ‘EPANUTIN
25’ in black ink on both the body and cap.
Phenytoin Sodium Primecrown Hard Capsules are available in packs
containing 28 capsules. The capsules are packed in plastic containers
which contains a desiccant. The desiccant must not be eaten.

PL 10383/2146 Phenytoin Sodium Primecrown 25mg Hard Capsules POM
Who makes and repackages your medicine?
Your medicine is manufactured by Pfizer Manufacturing Deutschland GmbH
Betriebsstatte Frieburg, Mooswaldallee 1, D-79090 Freiburg, Germany.
Procured from within the EU and repackaged by Product Licence Holder:
Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex, UB5 5QS.
Leaflet date: 28.05.2016

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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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