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TRIPLEPTAL 600MG FILM-COATED TABLETS

Active substance(s): OXCARBAZEPINE

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Trileptal is for use in adults and in children of 6 years of
age and above.
PACKAGE LEAFLET: INFORMATION FOR THE USER
®

TRILEPTAL 300mg FILMCOATED TABLETS
TRILEPTAL® 600mg FILMCOATED TABLETS
(oxcarbazepine)

The name of your medicine is Trileptal 300mg filmcoated tablets or Trileptal 600mg film-coated tablets.
Your medicine will be referred to as Trileptal throughout
this leaflet.
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 or
your child. 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
(see section 4), please tell your doctor or
pharmacist.
In this leaflet:
1. What Trileptal is and what it is used for
2. What you need to know before you take Trileptal
3. How to take Trileptal
4. Possible side effects
5. How to store Trileptal
6. Contents of the pack and other information
1. WHAT TRILEPTAL IS AND WHAT IT IS USED
FOR
What Trileptal is
The active ingredient of Trileptal is oxcarbazepine.
Trileptal belongs to a group of medicines called
anticonvulsants or antiepileptics.
What Trileptal is used for
Medicines such as Trileptal are the standard treatment
for epilepsy.
Epilepsy is a brain disorder that causes people to have
recurring seizures and convulsions. Seizures happen
because of a temporary fault in the brain’s electrical
activity. Normally brain cells coordinate body
movements by sending out signals through the nerves
to the muscles in an organised, orderly way. In epilepsy,
brain cells send out too many signals in a disorderly
fashion. The result can be uncoordinated muscular
activity that is called an epileptic seizure.
Trileptal is used to treat partial seizures with or without
secondarily generalised tonic-clonic seizures. Partial
seizures involve a limited area of the brain, but may
spread to the whole brain and may cause a generalised
tonic-clonic seizure. There are two types of partial
seizures: simple and complex. In simple partial
seizures, the patient remains conscious, whereas in
complex partial seizures, patients consciousness is
altered.
Trileptal works by keeping the brain’s “overexcitable”
nerve cells under control. This suppresses or reduces
the frequency of such seizures.
Trileptal can be used alone or in combination with other
antiepileptic medicines.
Usually, the doctor will try to find the one medicine that
works best for you or for your child. However, with more
severe epilepsy, a combination of two or more
medicines may be needed to control seizures.

2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE TRILEPTAL
Follow all the doctor’s instructions carefully. They may
differ from the general information contained in this
leaflet.
Monitoring during your treatment with Trileptal
Before and during your treatment with Trileptal, your
doctor may perform blood tests to determine the dose
for you. Your doctor will tell you when to have the tests.
Do not take Trileptal
• if you are allergic (hypersensitive) to
oxcarbazepine or any other ingredients of Trileptal
tablets (listed in section 6 Further information).
If this applies to you, tell your doctor before taking
Trileptal. If you think you may be allergic, ask your
doctor for advice.
Warnings and precautions
If any of the following apply to you, tell your doctor
before you take Trileptal:
• if you have ever shown unusual sensitivity (rash or
any other signs of allergy) to carbamazepine or to
any other medicines. If you are allergic to
carbamazepine, the chances are approximately 1 in
4 (25 %) that you could also have an allergic
reaction to oxcarbazepine (Trileptal).
• if you have kidney disease.
• If you have serious liver disease.
• if you are taking diuretics (medicines used to help
the kidneys get rid of salt and water by increasing
the amount of urine produced).
• if you have heart disease, shortness of breath
and/or swelling of the feet or legs due to fluid buildup.
• if your blood level of sodium is low as shown by
blood tests (see section 4 Possible side effects).
• if you are a woman taking a hormonal
contraceptive (such as “the birth-control pill”)
Trileptal may stop your contraceptive from working.
Use a different or extra (non-hormonal) method of
contraception while taking Trileptal. This should help
to prevent an unwanted pregnancy. Tell your doctor
immediately if you get irregular vaginal bleeding or
spotting. If you have any questions about this, ask
your doctor or health professional.
The risk of serious skin reactions in patients of Han
Chinese or Thai origin associated with carbamazepine
or chemically-related compounds may be predicted by
testing a blood sample of these patients. Your doctor
should be able to advise if a blood test is necessary
before taking oxcarbazepine.
If you develop any of the following symptoms after
starting Trileptal, tell your doctor immediately or go
to the emergency department at your nearest
hospital:
• if you experience an allergic reaction after starting
Trileptal. Symptoms include swelling of lips, eyelids,
face, throat, mouth, or sudden breathing problems,
fever with swollen glands, rash or skin blistering.
• if you notice symptoms of hepatitis, such as
jaundice (yellowing of skin or the whites of the eyes).
• if you experience an increase in the frequency of
seizures. This is particularly important for children
but may also occur in adults.
• if you notice possible symptoms of blood disorders
such as tiredness, being short of breath when
exercising, looking pale, headache, chills, dizziness,
frequent infections leading to fever, sore throat,
mouth ulcers, bleeding or bruising more easily than
normal, nose bleeds, reddish or purplish patches, or
unexplained blotches on the skin.
• a small number of people being treated with
antiepileptics such as Trileptal have had thoughts of
harming or killing themselves. If at any time you



have these thoughts, immediately contact your
doctor.
if you have a fast or unusually slow heart beat.




Children and adolescents
In children, your doctor may recommend thyroid
function monitoring before therapy and during therapy.
Other medicines and Trileptal
Tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes
medicines bought without a prescription.
This applies especially to:
• Hormonal contraceptives, such as the pill (see Take
special care with Trileptal).
• Other antiepileptic medicines, such as
carbamazepine, phenobarbital, phenytoin or
lamotrigine.
• Medicines that reduce the level of sodium in your
blood, such as diuretics (used to help the kidneys
get rid of salt and water by increasing the amount of
urine produced), desmopressin and non-steroidal
anti-inflammatory drugs, such as indometacin.
• Lithium and monoamine oxidase inhibitors
(medicines used to treat mood swings and some
types of depression).
• Medicines that control the body’s immune system,
such as ciclosporin and tacrolimus.
Trileptal with food and drink
Trileptal can be taken with or without food.
Alcohol may increase the sedative effects of Trileptal.
Avoid alcohol as much as possible and ask your doctor
for advice.
Pregnancy, breast-feeding and fertility
Pregnancy
Tell your doctor if you are pregnant or planning to
become pregnant.
It is important to control epileptic seizures during
pregnancy. However, there may be a risk to your baby if
you take antiepileptic medicines during pregnancy. Your
doctor will tell you the benefits and potential risks
involved and help you to decide whether you should
take Trileptal.
Do not stop your treatment with Trileptal during
pregnancy without first checking with your doctor.
Ask your doctor or pharmacist for advice before taking
any medicine during pregnancy.
Breast-feeding
You should not breast-feed while taking Trileptal. The
active substance in Trileptal passes into breast milk.
This could cause side effects for breast-fed babies. Ask
your doctor or pharmacist for advice before taking any
medicine while you are breast-feeding.
Driving and using machines
Trileptal may make you feel sleepy or dizzy, or may
cause blurred vision, double vision, lack of muscle
coordination or a depressed level of consciousness,
especially when starting treatment or increasing the
dose. It is important to discuss with your doctor whether
you can drive a vehicle or operate machines while
taking this medicine.
3. HOW TO TAKE TRILEPTAL
Always take Trileptal exactly as your doctor or
pharmacist has told you, even if this differs from the
information given in this leaflet. Check with your doctor
or pharmacist if you are not sure.
How much to take
Dose for adults
• The usual starting dose of Trileptal for adults
(including elderly patients) is 600 mg per day.
• Take one 300 mg tablet twice daily or two 150 mg
tablets twice daily.




Your doctor may increase the dose gradually to find
the best dose for you. The best results are usually
with doses between 600 and 2,400 mg per day.
If you take another antiepileptic medicine, the dose
is the same.
If you have kidney disease (with impaired kidney
function), the starting dose is half the usual starting
dose.
If you have severe liver disease, your doctor may
adjust your dose.

Dose for children
Trileptal can be taken by children aged 6 years or
above.
The dosage for children depends on their weight.
• The starting dose is 8 to 10 milligrams per kilogram
of bodyweight per day given in two divided doses.
For example, a 30-kg child would start treatment
with one 150 mg tablet twice daily.
• Your doctor may increase the dose gradually to find
the best dose for your child. The best results are
usually with a dose of 30 milligrams per kilogram of
bodyweight per day. The maximum dose for a child
is 46 milligrams per kilogram of bodyweight per day.
How to take Trileptal
• Swallow the tablets with a little water.
• If necessary, the tablets can be broken in half to
help swallow them. Do not break the tablets to take
only half of the dose. The score line was not
designed for dividing the tablet into equal doses.
• For small children who cannot swallow tablets, or
who cannot be given the necessary dose in tablet
form, Trileptal is available as an oral suspension.
When and for how long to take Trileptal
Take Trileptal twice a day, every day, at about the same
time of day, unless the doctor tells you otherwise. This
will have the best effect on controlling epilepsy. It will
also help you to remember when to take the tablet(s).
Your doctor will tell you how long your or your child’s
treatment with Trileptal will last. The length of treatment
will depend on your or your child’s seizure type.
Treatment may be needed for many years to control the
seizures. Do not change the dose or stop treatment
without talking to your doctor.
If you take more Trileptal than you should
If you have taken more tablets than your doctor
prescribed, contact the nearest hospital or your doctor
immediately. Symptoms of overdose with Trileptal may
include: drowsiness, dizziness, feeling sick (nausea),
being sick (vomiting), increased uncontrolled
movements, lethargy, confusion, muscular twitching or
significant worsening of convulsions, problems with
coordination and/or involuntary movement of the eyes.
If you forget to take Trileptal
If you have forgotten one dose, take it as soon as you
remember. However, if it is time for your next dose, do
not take the missed dose. Go back to your regular
dosing timetable. Do not double the dose at any time.
If you are unsure or have forgotten to take several
doses, contact your doctor.
If you stop taking Trileptal
Do not stop taking your medicine unless your doctor
tells you to.
To prevent sudden worsening of your seizures, never
discontinue your medicine abruptly.
If your treatment is stopped, it should be done gradually
as instructed by your doctor.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Trileptal can cause side effects,
although not everybody gets them. These side effects
may occur with certain frequencies, which are defined
as follows:
• Very common: affects more than 1 patient in 10
• Common: affects 1 to 10 patients in 100
• Uncommon: affects 1 to 10 patients in 1,000
• Very rare: affects less than 1 patient in 10,000
• Not known: frequency cannot be estimated from the
available data
Some side effects could be serious: get medical
help immediately
The following are signs of very rare, but potentially
serious side effects that may require urgent medical
treatment.
• Swelling of the lips, eyelids, face, throat or mouth,
accompanied by difficulty in breathing, speaking or
swallowing (signs of anaphylactic reactions and
angioedema) or other signs of hypersensitivity
reactions such as skin rash, fever, and pain in the
muscles and joints.
• Severe blistering of the skin and/or mucous
membranes of the lips, eyes, mouth, nasal
passages or genitals (signs of serious allergic
reaction including Lyell’s syndrome, StevensJohnson syndrome and erythema multiforme).
• Tiredness, shortness of breath when exercising,
looking pale, headache, chills, dizziness, frequent
infections leading to fever, sore throat, mouth
ulcers, bleeding or bruising more easily than
normal, nose bleeds, reddish or purplish patches, or
unexplained blotches on the skin (signs of a
decrease in the number of blood platelets or
decrease in the number of blood cells).
• Red blotchy rash mainly on face which may be
accompanied by fatigue, fever, feeling sick (nausea)
or loss of appetite (signs of systemic lupus
erythematosus).
• Lethargy, confusion, muscle twitching or significant
worsening of convulsions (possible symptoms of
low sodium levels in the blood) (see Take special
care with Trileptal).
• Flu-like symptoms with jaundice (yellowing of the
skin or the whites of the eyes) (signs of hepatitis).
• Severe upper stomach (abdominal) pain, being sick
(vomiting), loss of appetite (signs of inflammation of
the pancreas).
• Weight gain, tiredness, hair loss, muscle weakness,
feeling cold (signs of under active thyroid gland).
Tell your doctor immediately or go to the
emergency department at your nearest hospital if
you get any of the above side effects. The doctor will
also decide whether Trileptal has to be stopped
immediately and how to continue further medical care.
Other side effects: tell a doctor as soon as possible
Common:
• trembling; coordination problems; involuntary
movement of the eyes; anxiety and nervousness;
depression, mood swing; rash.
Very rare:
• irregular heart beat or a very fast or slow heart rate.
Unknown:
• Speech disorder
Tell your doctor as soon as possible if you get any
of the above side effects. They may require medical
attention.
Other side effects: tell a doctor if they worry you
These are usually mild to moderate side effects of
Trileptal. Most of these effects are transient and usually
diminish over time.

Very common:
• tiredness; headache; dizziness; drowsiness; feeling
sick (nausea); being sick (vomiting); double vision.
Common:
• weakness; memory disturbances; impaired
concentration; apathy; agitation; confusion; blurred
vision; visual disturbance; constipation; diarrhoea;
stomach (abdominal) pain; acne; hair loss, balance
disturbances.
Uncommon:
• hives. You may also have raised levels of liver
enzymes while taking Trileptal.
Not known:
• high blood pressure, fall.
Tell your doctor if any of the above side effects gets
severe.
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 (see below).
By reporting side effects, you can help provide more
information on the safety of this medicine.
United
Yellow Card Scheme
Kingdom
Website: www.mhra.gov.uk/yellowcard
5. HOW TO STORE TRILEPTAL






Do not store above 30°C.
Keep out of the reach and sight of children.
Do not use Trileptal after the expiry date which is
stated on the blister and outer carton after EXP. The
expiry date refers to the last day of that month.
Do not use Trileptal if you notice that the pack is
damaged or shows signs of tampering.
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 Trileptal contains
• Trileptal 300mg Film-Coated Tablets
Each film-coated tablet contains 300 mg
oxcarbazepine.
• Trileptal 600mg Film-Coated Tablets
Each film-coated tablet contains 600 mg
oxcarbazepine.
• The active substance of Trileptal is oxcarbazepine.
• The other ingredients are:
Tablet core: colloidal anhydrous silica,
microcrystalline cellulose, hypromellose,
crospovidone, magnesium stearate.
Tablet coating: hypromellose, talc, titanium dioxide
(E171), yellow iron oxide (E172) for 300mg, black
iron oxide (E172) for 600mg, red iron oxide (E172)
for 600mg, macrogol 4000 for 600mg and macrogol
8000 for 300mg only.
What Trileptal looks like and contents of the pack
The 300mg tablet is yellow, film-coated, ovaloid, scored
on both sides and embossed with TE/TE on one side
and CG/CG on the other side.
The 600mg tablet is light pink, film-coated, ovaloid,
scored on both sides and embossed with TF/TF on one
side and CG/CG on the other side.

The film-coated tablets are available in blister packs
containing 50 tablets.
Trileptal film-coated tablets come in two strengths
300mg, 600mg.
Manufacturer
Trileptal is manufactured by Novartis Pharma GmbH,
90327 Nürnberg, Germany.
Procured from within the EU and repackaged in the UK
by the Parallel Import Product Licence holder: CD
Pharma Ltd, Unit 3, Manor Point, Manor Way,
Borehamwood, Herts. WD6 1EE.
Trileptal 300mg film-coated tablets
Trileptal 600mg film-coated tablets

PL 20492/0274
PL 20492/0275

Trileptal is a registered trademark of Novartis AG.
Date of preparation: 06th August 2015

POM

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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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