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EPANUTIN 100MG HARD CAPSULES

Active substance(s): PHENYTOIN SODIUM

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EPANUTIN® 100mg HARD CAPSULES
(phenytoin sodium)
Patient Information Leaflet

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

000-0000D

This medicine is known as the above name but will be referred throughout this leaflet as Epanutin.
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.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

What is in this leaflet:
1. What Epanutin is and what it is used for
2. What you need to know before you take Epanutin
3. How to take Epanutin
4. Possible side effects
5. How to store Epanutin
6. Contents of the pack and other information
1. What Epanutin is and what it is used for
Epanutin is one of a group of medicines called anti-epileptic drugs; these medicines are used to treat
epilepsy.
Epanutin can be used to control a variety of epileptic conditions, to control or prevent seizures during or after
brain surgery or severe head injury. Epanutin can also be used to treat trigeminal neuralgia (facial nerve
pain).
You should ask your doctor if you are unsure why you have been given Epanutin capsules.
2. What you need to know before you take Epanutin
Do not take Epanutin
• if you are allergic to Phenytoin, or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other medicines with a similar chemical structure to Phenytoin (e.g. hydantoins).

PROOF HISTORY:
v.2 - waymade - 26/08/14

Warnings and precautions
Talk to your doctor or pharmacist before taking Epanutin.

WARNING!

Medicines are not always suitable for everyone. Your doctor needs to know before you take Epanutin if you
suffer from or have suffered in the past from any of the following conditions:
• Liver disease.
• Porphyria (an inherited disease that affects haemoglobin biosynthesis).
A small number of people being treated with antiepileptics such as phenytoin sodium have had thoughts of
harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
Serious skin side effects can rarely occur during treatment with Epanutin. This risk may be associated with a
variant in genes in a subject with Chinese or Thai origin. If you are of such origin and have been tested
previously carrying this genetic variant (HLA-B*1502), discuss this with your doctor before taking Epanutin.

UK PIL DATED FEBRUARY 2014
REPORTING OF SIDE EFFECTS

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 may also interfere with certain laboratory tests that you may be given.
Epanutin with food and drink
Epanutin can be taken before or after food and drinks. Drinking a lot of alcohol can also affect the
concentration of Phenytoin in your blood.
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 Epanutin if you are breast-feeding.
Driving and using machines
Epanutin may cause dizziness or drowsiness, especially during the first few weeks of treatment. If you
experience these symptoms, do not drive or use any tools or machinery.
Epanutin contains lactose, a type of sugar.
If you have been told that you have an intolerance to some sugars, contact your doctor before taking this
medicinal product.
3. How to take Epanutin
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
It is best to take Epanutin at the same time each day.
Swallow the capsules whole, with plenty of water.

Colour
Swatch

Black

WARNING!

Some medicines can affect the way Epanutin work and Epanutin itself 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 Epanitin in your blood to help decide if any of these medicines
are affecting your treatment.

TVT CHECKED

DATE:
DATE:
26/08/14
CODE:

06464/2756D

DT

DATE OF PROOF:

PRODUCT: Epanutin caps

ARTWORKER:

CUSTOMER
APPROVED:
05-0269
CUSTOMER: Waymade

PRE-PRESS NO.:

Q.A.
APPROVED:

Other medicines and Epanutin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

I¤€-‚œ

Leaflet Flat Size = 148 x 400

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Adults
The amount of Epanutin needed varies from one person to another. Most adults need between 200mg and
500mg a day either as a single or divided dose. Occasionally higher doses are needed.
Use in children and adolescents
Infants and children usually start on a dose that depends on their weight (5mg per day for every kg they
weigh) and is given as a divided dose, twice a day. The dose is then adjusted up to a maximum of 300mg a
day.
Elderly
The dose of Epanutin for elderly patients who may be taking other medicines may also need careful
consideration and adjustment by their doctor.

If you stop taking Epanutin
Do not stop taking Epanutin unless your doctor tells you to. If you suddenly stop taking this medicine you
may have a seizure. Should you need to stop taking Epanutin, your doctor will have decided which is the
best method for you.
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.

TVT CHECKED

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.





06464/2756D
CODE:

UK PIL DATED FEBRUARY 2014
REPORTING OF SIDE EFFECTS

Epanutin caps
PRODUCT:



5. How to store Epanutin
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 after the expiry date which is stamped on the pack. The expiry date refers to
the last day of that month.
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.
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 contains
Each Epanutin Hard Capsule contains 100mg of the active ingredient, phenytoin sodium.
The other ingredients are gelatin, lactose monohydrate and magnesium stearate
The gelatin capsule shells contain the colouring titanium dioxide (E171), erythrosine (E127) and quinoline
yellow (E104).
The printing ink contains the following: shellac, black iron oxide (E172), propylene glycol.
What Epanutin looks like and contents of the pack
Epanutin Hard Capsules are half white and half orange hard capsules marked with ‘Epanutin 100’ in black
printing ink and available in plastic bottles containing 100 capsules.
Contains a desiccant. The desiccant should not be eaten.
POM

PL No: 06464/2756

Colour
Swatch

Black

This product is manufactured by Pfizer Manufacturing Deutschland GmbH, Mooswaldellee, 79090 Frieburg,
Germany and procured within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 26.08.2014
Epanutin is a registered trademark of Park, Davis & Co. LLC

000-0000D

WARNING!

DATE:
DATE:
26/08/14
DATE OF PROOF:

ARTWORKER:

DT

CUSTOMER
APPROVED:
Q.A.
APPROVED:
05-0269
PRE-PRESS NO.:

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.



CUSTOMER: Waymade

WARNING!

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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

PROOF HISTORY:
v.2 - waymade - 26/08/14

I¤€-‚œ

Leaflet Flat Size = 148 x 400

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

27mm

PHENYTOIN SODIUM FLYNN 100mg HARD CAPSULES
(phenytoin sodium)
Patient Information Leaflet

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

000-0000D

This medicine is known as the above name but will be referred throughout this leaflet as Phenytoin Sodium
Flynn Hard Capsules.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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).

PROOF HISTORY:
v.2 - waymade - 26/08/14

WARNING!

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.

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.
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.

Colour
Swatch

Black

WARNING!

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.
UK PIL DATED FEBRUARY 2014
REPORTING OF SIDE EFFECTS

DATE:
DATE:
26/08/14
CODE:

06464/2756D

DT

DATE OF PROOF:

PRODUCT: Phenytoin sodium flynn caps

ARTWORKER:

CUSTOMER
APPROVED:
CUSTOMER: Waymade

05-0269

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.

PRE-PRESS NO.:

Q.A.
APPROVED:

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

£‹„µ†æ

Leaflet Flat Size = 148 x 400

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

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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 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.

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 stamped on the
pack. The expiry date refers to the last day of that month.
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.
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 Phenytoin Sodium Flynn Hard Capsule contains 100mg of the active ingredient, phenytoin sodium.
The other ingredients are gelatin, lactose monohydrate and magnesium stearate
The gelatin capsule shells contain the colouring titanium dioxide (E171), erythrosine (E127) and quinoline
yellow (E104).
The printing ink contains the following: shellac, black iron oxide (E172), propylene glycol.
What Phenytoin Sodium Flynn Hard Capsules look like and contents of the pack
Phenytoin Sodium Flynn 100mg Hard Capsules are half white and half orange hard capsules marked with
‘Epanutin 100’ in black printing ink and available in plastic bottles containing 100 capsules.
Contains a desiccant. The desiccant should not be eaten.
POM

Colour
Swatch

PL No: 06464/2756

This product is manufactured by Pfizer Manufacturing Deutschland GmbH, Mooswaldellee, 79090 Frieburg,
Germany and procured from within the EU as Epanutin® and repackaged in the UK equivalent to Phenytoin
Sodium Flynn by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR.
Leaflet revision and issue date (Ref.) 26.08.2014
Epanutin® is a registered trademark in Spain.
Epanutin® is available as Phenytoin Sodium Flynn in the UK and is marketed by Flynn Pharma Limited.
000-0000D

Black

WARNING!

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.

UK PIL DATED FEBRUARY 2014
REPORTING OF SIDE EFFECTS

DATE:
DATE:
26/08/14
06464/2756D
CODE:

DT

DATE OF PROOF:

Phenytoin sodium flynn caps
PRODUCT:

ARTWORKER:

CUSTOMER
APPROVED:
Q.A.
APPROVED:
05-0269
PRE-PRESS NO.:
CUSTOMER: Waymade

WARNING!

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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.

PROOF HISTORY:
v.2 - waymade - 26/08/14

£‹„µ†æ

Leaflet Flat Size = 148 x 400

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.

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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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