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. Before you take Trileptal
3. How to take Trileptal
4. Possible side effects
5. How to store Trileptal
6. Further 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, please tell your doctor or
pharmacist.

Medicines such as Trileptal are the standard treatment for epilepsy.
Patients diagnosed with epilepsy have had repeated seizures,
or convulsions. Seizures happen because of a temporary fault in
the brain’s electrical system. 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.
Trileptal is for use in adults and in children of 6 years of age and
above.

2. BEFORE YOU TAKE TRILEPTAL

Follow all instructions given to you by your doctor carefully,
even if they differ from the information contained in this leaflet.

Do not take Trileptal

• if you are allergic (hypersensitive) to oxcarbazepine or to any
other ingredients of Trileptal tablets (listed in section 6 Further
information).

Take special care with Trileptal
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).

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• if you have a kidney disease.
• If you have a 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 a 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 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).
764497 GB

• 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 develop the following symptoms after starting
Trileptal, tell your doctor as soon as possible:
• if you have a fast or unusually slow heart beat.

Taking other medicines
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.

Taking Trileptal with food and drink

Check with your doctor or pharmacist if you are not sure.

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.

How much to take
Dose for adults

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.
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.

• 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.

Approval Box and Ready for Print Box only to be used
in case AWF is not used.
Phone contact:
+39 0818706419
e-mail contact:
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Typesetting order / CTM-Owner: 764497 - N. Gargiulo
Material No.:

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LEAFLET TRILEPTAL FCT
ALL DOSAGES - GB

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148 x 314.96 mm

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• 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
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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).
• 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; rash.

Very rare:

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

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.

Approval Box and Ready for Print Box only to be used
in case AWF is not used.
Phone contact:
+39 0818706419
e-mail contact:
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Typesetting order / CTM-Owner: 764497 - N. Gargiulo
Material No.:

764497 GB

Dimension:

Product:
ISO-Code:



5595/Z

Colours:

LEAFLET TRILEPTAL FCT
ALL DOSAGES - GB

Approval Box and Ready for Print Box only to be used
in case AWF is not used.

148 x 314.96 mm

Drawing No.:

Replaced No.: n.a.

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GB

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Proof date:

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Fonts:

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Receiving Plant:

Smallest font size/line spacing/scale: 9 pt/10.8 pt/100%
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Body text (News Gothic Condensed)

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Item no. (News Gothic Condensed)

This information was compiled with utmost care and on completion was subjected to strict internal checks. However, the handling
of data always involves a certain degree of risk and the impossibility of error cannot be guaranteed. Therefore we would ask you to
check the proof throughly. PharmaDesigners s.a.s. assumes no liability for errors identified only after print approval has be given.

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If you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

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.

6. FURTHER INFORMATION
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,
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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.

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

This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria

Trileptal 150 mg, 300 mg, 600 mg
Filmtabletten

Belgium

Trileptal 150 mg, 300 mg, 600 mg filmomhulde
tabletten/comprimé pelliculé/ Filmtabletten

Denmark Trileptal
Finland

Trileptal 150 mg, 300 mg, 600 mg tabletti,
kalvopäällysteinen

France

Trileptal 150 mg, 300 mg, 600 mg,
comprimé pelliculé

Germany

Trileptal 150 mg, 300 mg, 600 mg
Filmtabletten

Greece

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

Trileptal 150mg/ΤΑΒ, 300mg/ΤΑΒ,
600mg/ΤΑΒ Εpικaλυµµένa µe λeptό
υµένιο dιsκίa

Iceland

This leaflet was last approved in 04/2013.

Trileptal 150 mg, 300 mg, 600 mg
filmuhúðuð tafla

Ireland Trileptal
Luxembourg

Trileptal 150 mg, 300 mg, 600 mg
Filmtabletten

Netherlands

Trileptal 150 mg, 300 mg, 600 mg
filmomhulde tabletten

Portugal

Trileptal 150 mg, 300 mg, 600 mg
Comprimidos revestidos por película

Spain

Trileptal 150 mg, 300 mg, 600 mg
comprimidos recubiertos con película

Sweden

Trileptal 150 mg, 300 mg, 600 mg
filmdragerade tabletter

United Kingdom

Trileptal 150 mg, 300 mg, 600 mg
film-coated tablets

764497 GB

Approval Box and Ready for Print Box only to be used
in case AWF is not used.
Phone contact:
+39 0818706419
e-mail contact:
pharmadesigners@libero.it

Typesetting order / CTM-Owner: 764497 - N. Gargiulo
Material No.:

764497 GB

Dimension:

Product:
ISO-Code:



5595/Z

Colours:

LEAFLET TRILEPTAL FCT
ALL DOSAGES - GB

Approval Box and Ready for Print Box only to be used
in case AWF is not used.

148 x 314.96 mm

Drawing No.:

Replaced No.: n.a.

TVT compatible
YES
NO

PMS BLACK C

GB

Code-No.::

n.a.

Proof date:

02.07.2013

Visual Code: n.a.

Colour/Technical: CUTTING

Fonts:

News Gothic Condensed, News Gothic Condensed Bold

Receiving Plant:

Smallest font size/line spacing/scale: 9 pt/10.8 pt/100%
Smallest font size:

7 pt

Smallest vectorized text:

Torre

Technical approval. To be signed by Manufacturing Site.

Body text (News Gothic Condensed)

n.a.

Item no. (News Gothic Condensed)

This information was compiled with utmost care and on completion was subjected to strict internal checks. However, the handling
of data always involves a certain degree of risk and the impossibility of error cannot be guaranteed. Therefore we would ask you to
check the proof throughly. PharmaDesigners s.a.s. assumes no liability for errors identified only after print approval has be given.

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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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