Pill Identifier App

PHENYTOIN SODIUM FLYNN 25MG HARD CAPSULES

Active substance: PHENYTOIN SODIUM

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

EPANUTIN™

25mg 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).

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.

Adults

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.

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.

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

Use in children and adolescents

Epanutin Capsules with food and drink
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.

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.

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.

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

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

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 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.

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 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.

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

Other side-effects that may occur are:

If you stop taking Epanutin Capsules

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.

• 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 25 mg phenytoin sodium.
Each capsule also includes gelatin, lactose monohydrate,
magnesium stearate, titanium dioxide (E171), erythrosine
(E127), shellac, black iron oxide (E172), propylene glycol,
sodium lauryl sulphate, patent blue V (E131) and potassium
hydroxide. This medicinal product may also include
Potassium hydroxide.

What Epanutin Capsules look like and contents of
the pack
Each hard gelatin capsule has a white opaque body and
purple cap, radially printed ‘EPANUTIN 25’ on both the body
and cap.
Epanutin Capsules are available in white plastic containers of
28 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.

POM
Epanutin 25mg Hard Capsules PL 40739/0015
Leaflet date: 26 August 2014

Ref: EPA25I/V2

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

CUSTOMER Ennogen Healthcare Limited
DESCRIPTION Epanutin 25mg Hard Capsules
CODE REF. EPA25I-v2 PL 40739-0015
INFORMATION LEAFLET
SPECIALISTS
Clearly mark on amendments
and return to: proofs@technoprint.net
APPROVED AND PROCEED
AMEND AND RE-SUBMIT
AMEND AND PROCEED
Signature:_________________________
Date:______________________________
Please check all information is correct and
there are no spelling errors. Should errors
or omissions be noticed after printing or
publication, Technoprint regret that they
cannot be held responsible.

PRINTER REF. D53640
SIZE 420mm x 180mm
FOLDED SIZE NUMBER OF PAGES 2
LANGUAGE English
PROOF BY Linda Jakeman
PROOF No. 2
DATE 01.09.14
BODY TEXT FONT/SIZE Myriad Pro - Regular - 8.5pt

COLOURS USED
Black

PACKAGE LEAFLET: INFORMATION FOR THE USER

PHENYTOIN
SODIUM FLYNN

25mg Hard Capsules

Your medicine is known by the above name but will be referred to
as Phenytoin Sodium Flynn Hard 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 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.

• 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)

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.

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

Other medicines and Phenytoin Sodium Flynn
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 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, sulfamethoxazoletrimethoprim, doxycycline, ciprofloxacin, efavirenz,
fosamprenavir, indinavir, lopinavir/ritonavir, ritonavir
and saquinavir)

• 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.

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.

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.

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.

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

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 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 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 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.

6. Contents of the pack and other
information
What Phenytoin Sodium Flynn Hard Capsules
contain
Each capsule contains 25 mg phenytoin sodium.
Each capsule also includes gelatin, lactose monohydrate,
magnesium stearate, titanium dioxide (E171), erythrosine
(E127), shellac, black iron oxide (E172), propylene glycol,
sodium lauryl sulphate, patent blue V (E131) and potassium
hydroxide. This medicinal product may also include
Potassium hydroxide.

What Phenytoin Sodium Flynn Hard Capsules look
like and contents of the pack
Each hard gelatin capsule has a white opaque body and
purple cap, radially printed ‘EPANUTIN 25’ on both the body
and cap.
Phenytoin Sodium Flynn Hard Capsules are available in white
plastic containers of 28 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.

POM
Phenytoin Sodium Flynn 25mg Hard Capsules
PL 40739/0015
Leaflet date: 26 August 2014

Ref: PHE25I/V2

CUSTOMER Ennogen Healthcare Limited
DESCRIPTION Phenytoin Sodium Flynn 25mg Hard Capsules
CODE REF. PHE25I-v2 PL 40739-0015
INFORMATION LEAFLET
SPECIALISTS
Clearly mark on amendments
and return to: proofs@technoprint.net
APPROVED AND PROCEED
AMEND AND RE-SUBMIT
AMEND AND PROCEED
Signature:_________________________
Date:______________________________
Please check all information is correct and
there are no spelling errors. Should errors
or omissions be noticed after printing or
publication, Technoprint regret that they
cannot be held responsible.

PRINTER REF. D53639
SIZE 420mm x 180mm
FOLDED SIZE NUMBER OF PAGES 2
LANGUAGE English
PROOF BY Linda Jakeman
PROOF No. 3
DATE 02.09.14
BODY TEXT FONT/SIZE Myriad Pro - Regular - 8.5pt

COLOURS USED
Black

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.

Hide
(web2)