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PHENYTOIN SODIUM FLYNN 100 MG HARD CAPSULES

Active substance(s): PHENYTOIN SODIUM / PHENYTOIN SODIUM / PHENYTOIN SODIUM

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Assessed against UK PIL dated March 2016

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Package leaflet: Information for the user
UNITED KINGDOM

Phenytoin Sodium
Flynn
100mg Hard Capsules
Phenytoin Sodium

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

This version replaces the previously approved leaflet in var
0003
Other medicines and Phenytoin Sodium Flynn Hard Capsules
1. What Phenytoin Sodium Flynn Hard Capsules are
Tell your doctor or pharmacist if you are taking, have recently taken
and what they are used for
or might take any other medicines. Some medicines can affect

By Carthika Kanagasabai at

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.

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)

• M
 uscle 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.

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

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 300 mg 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.

• S
 udden 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 this medicine 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.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help to protect the environment.

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

• T
 he active substance is phenytoin sodium.
• The other ingredients are lactose monohydrate, magnesium
stearate and sodium lauryl sulfate.
• The gelatin capsule shells contain the colouring titanium dioxide
(E171), erythrosine (E127) and quinoline yellow (E104).
• The printing ink.

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” and
available in packs containing 100 capsules.
The capsules are packed in a plastic container which contains a
desiccant. The desiccant should not be eaten.
Manufacturer
Pfizer Manufacturing Deutschland GmbH
Frieburg site, Mooswaldallee 1, D-79090 Freiburg
Germany
Procured from within the EU by the Product Licence holder:
Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2B, Draycott Avenue, Kenton,
Middlesex, HA3 0BU, United Kingdom
Re-packaged by:
Glenmark Pharmaceuticals s.r.o., Fibichova 143,
566 17, Vysoke Myto, Czech Republic
Phenytoin Sodium Flynn 100 mg Hard Capsules
PL 25258/0176
This leaflet was last revised 26.07.2016

PRODUCT:

Amends:

Phenytoin Sodium Flynn 100mg
Hard Capsules Leaflet UK
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Expand Transcript

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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