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TRILEPTAL 150 MG FILM-COATED TABLETS

Active substance: OXCARBAZEPINE

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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

PACKAGE LEAFLET:
INFORMATION FOR THE USER

TRILEPTAL 150 mg
film-coated tablets
TRILEPTAL 300 mg
film-coated tablets
TRILEPTAL 600 mg
film-coated tablets

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

Oxcarbazepine

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.

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

Phone contact:
+39 0818706419
e-mail contact:
pharmadesigners@libero.it
Live Text:
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Comp. Description:

LEAFLET TRILEPTAL FCT
ALL DOSAGES GB

Comp. No. New:
Comp. No. Old:
Format/Dimension:
Tech. Drawing No.:

1270757 GB TA
n.a.
148 x 630 mm
5666/O

Min. Font Size Text:
Proof No.: 3
Braille:

9 pt
07.10.2014
n.a.

Yes /
1270757



No

Production Site:
CTM:

Cutting

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.

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2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE TRILEPTAL

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N. Gargiulo

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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.
Trileptal is for use in adults and in children of 6 years of age and
above.

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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 build-up.
• 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 nonsteroidal 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).
1270757 GB TA

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, Stevens-Johnson 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).

Phone contact:
+39 0818706419
e-mail contact:
pharmadesigners@libero.it
Live Text:
WO:



Comp. Description:

LEAFLET TRILEPTAL FCT
ALL DOSAGES GB

Comp. No. New:
Comp. No. Old:
Format/Dimension:
Tech. Drawing No.:

1270757 GB TA
n.a.
148 x 630 mm
5666/O

Min. Font Size Text:
Proof No.: 3
Braille:

9 pt
07.10.2014
n.a.

Yes /
1270757



No

Production Site:
CTM:

Torre
N. Gargiulo

Printing Colours:

Black

Technical Colours:

Cutting

F Giordano
.

! PLEASE TURN OVERPRINTING ON !

• 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.

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.

Uncommon:
Not known:

6. CONTENTS OF THE PACK AND OTHER
INFORMATION

Common:

• weakness; memory disturbances; impaired concentration;
apathy; agitation; confusion; blurred vision; visual disturbance;
constipation; diarrhoea; stomach (abdominal) pain; acne; hair loss,
balance disturbances.
• hives. You may also have raised levels of liver enzymes while taking
Trileptal.
• high blood pressure, fall.

Tell your doctor if any of the above side effects gets
severe.

• irregular heart beat or a very fast or slow heart rate.

Unknown:

Reporting of side effects

• Speech disorder
Tell your doctor as soon as possible if you get any of the above
side effects. They may require medical attention.

5. HOW TO STORE TRILEPTAL

• Keep out of the reach and sight of children.
• Do not use after the expiry date which is stated on the blister and
the outer carton. 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.

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.

Very rare:

By reporting side effects, you can help provide more information on
the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

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).

What Trileptal contains

• The active substance of Trileptal is oxcarbazepine.
• Trileptal 150 MG FILM-COATED TABLETS
Each film-coated tablet contains 150 mg oxcarbazepine.
• Trileptal 300 MG FILM-COATED TABLETS
Each film-coated tablet contains 300 mg oxcarbazepine.
• Trileptal 600 MG FILM-COATED TABLETS
Each film-coated tablet contains 600 mg oxcarbazepine.
• The other ingredients are:
Tablet core: silica colloidal anhydrous, microcrystalline cellulose,
hypromellose, crospovidone, magnesium stearate.
Tablet coating: for the 150 mg tablet: hypromellose,
macrogol 4000, yellow iron oxide (E 172), red iron oxide (E 172),

black iron oxide (E 172), talc, titanium dioxide (E 171); for the
300 mg tablet: hypromellose, macrogol 8000, yellow iron oxide
(E 172), talc, titanium dioxide (E 171); and for the 600 mg tablet:
hypromellose, macrogol 4000, red iron oxide (E 172), black iron
oxide (E 172), talc, titanium dioxide (E 171).

What Trileptal looks like and contents of the pack

The 150 mg tablet is pale grey green, ovaloid, scored on both sides
and embossed with T/D on one side and C/G on the other side.
The 300 mg tablet is yellow, ovaloid, scored on both sides,
and embossed with TE/TE on one side and CG/CG on the other side.
The 600 mg tablet is light pink, 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 30,
50, 100, 200 and 500 tablets.
Not all pack sizes may be marketed.
Trileptal film-coated tablets come in three strengths 150 mg, 300 mg,
600 mg.

This leaflet was last approved in 09/2014.
You can get more information about your epilepsy by contacting these
independent patient groups:
Telephone
01494 601400
N.S.E. The National Society for Epilepsy
0808 8005050
B.E.A. The British Epilepsy Association
0808 8002200
E.A.S The Epilepsy Association of Scotland

Marketing Authorisation Holder

Novartis Pharmaceuticals UK Ltd,
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
United Kingdom

Manufacturer

Novartis Pharmaceuticals UK Ltd,
Wimblehurst Road, Horsham, West Sussex, RH12 5AB
United Kingdom
Novartis Pharmaceuticals UK Ltd,
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
United Kingdom

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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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