Skip to Content

PHENYTOIN SODIUM FLYNN 50 MG HARD CAPSULES

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE
USER
UNITED KINGDOM

1. What Phenytoin Sodium Flynn Hard
Capsules are and what they are used for

PHENYTOIN SODIUM
FLYNN
50 mg Hard Capsules

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)
Read all of this leaflet carefully before you start
taking this medicine.
 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. Do
not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
 If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

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).

2. Before you take Phenytoin Sodium Flynn
Hard Capsules
Do not 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. Further information



if you are allergic (hypersensitive) to Phenytoin,
or any of the other ingredients of Phenytoin
Sodium Flynn Hard Capsules.

Take special care with 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.

Medicines used for heart and circulation
problems (dicoumarol, digitoxin, amiodarone,
furosemide, quinidine, reserpine, warfarin, and
calcium channel blockers e.g. diltiazem and
nifedipine).



Medicines used for epilepsy (carbamazepine,
lamotrigine, phenobarbital, sodium valproate
and valproic acid, succinimides e.g.
ethosuximide and vigabatrin).



Medicines used to treat fungal infections (e.g.
amphotericin B, fluconazole, itraconazole,
ketoconazole and miconazole).

You should ask your doctor if you are unsure why
you have been given Phenytoin Sodium Flynn Hard
Capsules.

In this leaflet:
1. What Phenytoin Sodium Flynn Hard Capsules
are and what they are used for
2. Before you take Phenytoin Sodium Flynn Hard
Capsules

Taking 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 tuberculosis and other
(chloramphenicol, isoniazid, sulphonamides
rifampicin, doxycycline, ciprofloxacin and
nelfinavir).
Medicines used for stomach ulcers
(omeprazole, sucralfate, the medicines known
as H2 antagonists e.g. cimetidine, ranitidine,
famotidine and some antacids).



Medicines used for asthma and bronchitis
(theophylline).



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



Medicines used for sleeplessness, depression
and psychiatric disorders (chlordiazepoxide,
clozapine, diazepam, disulfi ram, fluoxetine,
methylphenidate, paroxetine, phenothiazines,
trazodone, tricyclic antidepressants,
fluvoxamine, sertraline and viloxazine).




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).



Medicines used for cancer antineoplastic
agents)





Muscle relaxants used for surgery
(neuromuscular blockers), some anaesthetic
drugs (halothane) and methadone
Some products available without a prescription
(folic acid, theophylline, 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.

Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.
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.
Taking 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 think you might be pregnant, or are planning
to get pregnant, tell your doctor before you take
Phenytoin Sodium Flynn Hard Capsules.
You should not take Phenytoin Sodium Flynn Hard
Capsules if you are breast-feeding.

Children
Infants and children usually start on a dose that
depends on their weight (5 mg 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.
Always take Phenytoin Sodium Flynn Hard
Capsules exactly as your doctor has told you. You
should check with your doctor or pharmacist if you
are still not sure.
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
many Phenytoin Sodium Flynn Hard Capsules
contact your doctor at once or go to the nearest
hospital casualty department.

Ask your doctor or pharmacist for advice before
taking any medicine.

Always take the labelled medicine package with
you, whether there are any Phenytoin Sodium
Flynn Hard Capsules left or not.

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.

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 missed
dose.

Important information about some of the
ingredients of Phenytoin Sodium Flynn Hard
Capsules
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.

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 the best method is for you.

3. How to take Phenytoin Sodium Flynn Hard
Capsules
It is best to take Phenytoin Sodium Flynn Hard
Capsules at the same time each day.

If you have any further questions on how to take
these Phenytoin Sodium Flynn Hard Capsules, ask
your doctor or pharmacist.

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 200 mg and
500 mg a day either as a single or divided dose.
Occasionally higher doses are needed.

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

4. Possible side effects



Effects on your blood and lymph system:
swelling of the lymph glands.

Like all medicines, Phenytoin Sodium Flynn Hard
Capsules can cause side effects, although not
everybody gets them.



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).

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.


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.



Sudden wheeziness, difficulty in breathing,
swelling of eyelids, face or lips, rash or itching
(especially affecting the whole body).
















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 a state of 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
measleslike reactions which are mild.
Effects on your stomach and intestines:
feeling sick, being sick and constipation.









Effects on your reproductive system and
breasts: 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.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
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 store above 25°C. Store in the original
package in order to protect from light.

Manufacturer
Goedecke GmbH
Mooswaldallee 1
D-79090
Freiburg
Germany
Leaflet last revised 21/11/2013

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.
Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures will help to protect the
environment.
6. Further Information
What Phenytoin Sodium Flynn Hard Capsules
contain
Each capsule contains 50 mg of phenytoin sodium.
The other ingredients are lactose monohydrate,
magnesium stearate, gelatin and sodium
laurilsulfate.
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) 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 50 mg Hard Capsules are
half white and half flesh-coloured marked with
“Epanutin 50” and available in packs containing 28
capsules. The capsules are packed in a plastic
container which contains a desiccant. The
desiccant should not be eaten.
Phenytoin Sodium Flynn 50 mg Hard Capsules
PL 39467/0149

POM
Procured from within the EU by PL holder
PilsCo Ltd, 9-15 Springburn Place,
East Kilbride, G74 5NU.
Repackaged by Cross Healthcare Ltd., Unit 2a,
Bandeath Industrial Estate, Stirling, FK7 7NP.

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.

Hide