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TRILEPTAL 300MG FILM COATED TABLETS

Active substance(s): OXCARBAZEPINE / OXCARBAZEPINE / OXCARBAZEPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®

Trileptal 300mg Film-Coated Tablets
(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.
The name of your medicine is Trileptal 300mg Film-Coated Tablets
but will be referred to as Trileptal throughout this leaflet. Please note
that this leaflet also contains information about other strengths
Trileptal 150mg and 600mg Film-Coated Tablets.
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.
Trileptal is for use in adults and in children of 6 years of age and
above.

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

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.

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

In children, your doctor may recommend thyroid function monitoring
before therapy and during therapy.



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 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,

Children and adolescents

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.

3.

How much to take
Dose for adults
 The usual starting dose of Trileptal for adults (including elderly
patients) is 600mg per day.
 Take one 300mg tablet twice daily or two 150mg 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
2,400mg 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 10milligrams per kilogram of bodyweight
per day given in two divided doses. For example, a 30-kg child
would start treatment with one 150mg 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
30milligrams per kilogram of bodyweight per day. The maximum
dose for a child is 46milligrams per kilogram of bodyweight per
day.

How to take Trileptal



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.

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.



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.

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:


If you stop taking Trileptal

trembling; coordination problems; involuntary movement of the
eyes; anxiety and nervousness; depression, mood swing; rash.

5. HOW TO STORE TRILEPTAL
Keep out of the sight and reach of children
Do not take the tablets after the expiry date which is stated on the
carton and blister label after ‘Exp’. The expiry date refers to the last
day of that month.
If the tablets become discoloured or show any signs of deterioration,
seek the advice of your pharmacist.
Remember if your doctor tells you to stop taking this medicine, return
any unused medicine to your pharmacist for safe disposal. Only keep
this medicine if your doctor tells you to.
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.

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.

Very rare:

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

4. POSSIBLE SIDE EFFECTS

6. CONTENTS OF THE PACK AND OTHER
INFORMATION

Other side effects: tell a doctor if they worry you

What Trileptal contains

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

These are usually mild to moderate side effects of Trileptal. Most of
these effects are transient and usually diminish over time.

Each film-coated tablet contains 300mg oxcarbazepine.
The other ingredients are
Tablet core: colloidal anhydrous silica, microcrystalline cellulose,
crospovidone, hypromellose, and magnesium stearate.
Tablet coating: hypromellose, macrogol 8000, titanium dioxide
(E171), yellow iron oxide (E172) and talc.

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).



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

Unknown:


Speech disorder

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 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.

What Trileptal looks like and contents of the pack
Trileptal is yellow, ovaloid, film-coated tablet scored on both sides,
engraved with ‘TE | TE’ on one side and ‘CG | CG’ on the other side.
The tablets come in blister packs of 100 tablets

Manufactured by: Novartis Farmaceutica, S.A., Ronda Santa
Maria, 158 08210 Barbera del Valles, Barcelona, Spain.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
®

Trileptal 300mg Film-Coated Tablets; PL 18799/2197
Leaflet date: 30.05.2017

POM

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 0208 515 3763 to obtain the
leaflet in a format suitable for you.
You can get more information about your epilepsy by contacting
these independent patient groups:
Telephone
N.S.E. The National Society for Epilepsy
01494 601400
B.E.A. The British Epilepsy Association
0808 8005050
E.A.S The Epilepsy Association of Scotland
0808 8002200

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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