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TRILEPTAL 150MG TABLETS

Active substance(s): OXCARBAZEPINE / OXCARBAZEPINE / OXCARBAZEPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Do not take Trileptal Tablets


TRILEPTAL® 150MG TABLETS
(oxcarbazepine)

Your medicine is available as the name Trileptal 150mg
Tablets but throughout this leaflet will be referred to as
Trileptal Tablets.

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.
2.
3.
4.
5.
6.

What Trileptal Tablets are and what they are used for
What you need to know before you take Trileptal Tablets
How to take Trileptal Tablets
Possible side effects
How to store Trileptal Tablets
Contents of the pack and other information

Medicines such as Trileptal Tablets 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 Tablets are 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.

Warnings and precautions
If any of the following apply to you, tell your doctor
before you take Trileptal Tablets:

Alcohol may increase the sedative effects of Trileptal Tablets.
Avoid alcohol as much as possible and ask your doctor for
advice.











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 Tablets are for use in adults and in children of 6
years of age and above.

2. What you need to know before you take
Trileptal Tablets
Follow all the doctor’s instructions carefully. They may differ
from the general information contained in this leaflet.

Monitoring during your treatment with Trileptal
Tablets
Before and during your treatment with Trileptal Tablets, your
doctor may perform blood tests to determine the dose for
you. Your doctor will tell you when to have the tests.

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 Tablets).
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 Tablets may
stop your contraceptive from working. Use a different or
extra (non-hormonal) method of contraception while
taking Trileptal Tablets. 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 Tablets, tell your doctor
immediately or go to the emergency department at
your nearest hospital:







Trileptal Tablets work by keeping the brain’s “overexcitable”
nerve cells under control. This suppresses or reduces the
frequency of such seizures.
Trileptal Tablets can be used alone or in combination with
other antiepileptic medicines.



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 Tablets with food and drink

What Trileptal Tablets are

What Trileptal Tablets are used for



If this applies to you, tell your doctor before taking Trileptal
Tablets. If you think you may be allergic, ask your doctor for
advice.

1. What Trileptal Tablets are and what they
are used for
The active ingredient of Trileptal Tablets is oxcarbazepine.
Trileptal Tablets belong to a group of medicines called
anticonvulsants or antiepileptics.

if you are allergic (hypersensitive) to oxcarbazepine or
any other ingredients of Trileptal Tablets (listed in
section 6 Contents of the pack and other information).





if you experience an allergic reaction after starting
Trileptal Tablets. 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 Tablets 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.

Trileptal Tablets can be taken with or without food.

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 Tablets.
Do not stop your treatment with Trileptal Tablets 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 Tablets. The
active substance in Trileptal Tablets 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 Tablets 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 Tablets
Always take Trileptal Tablets 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 Tablets 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.

Children and adolescents

Dose for children

Other medicines and Trileptal Tablets

The dosage for children depends on their weight.

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

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.

Page 1 of 2

Trileptal Tablets can be taken by children aged 6 years or
above.





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
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 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 Tablets






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 Tablets are available as an oral suspension.

When and for how long to take Trileptal Tablets

Take Trileptal Tablets 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 Tablets 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 Tablets 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 Tablets 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 Tablets

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.









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 Tablets).
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 Tablets have 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







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.
If your doctor tells you to stop taking the tablets, please
take them back to the pharmacist for safe disposal. Only
keep the tablets if your doctor tells you to.
If the tablets become discoloured or show signs of
deterioration, you should seek the advice of your
pharmacist.

6. Contents of the pack and other
information
What Trileptal Tablets contain

The active substance in Trileptal Tablets is called
oxcarbazepine.
Your tablets contain 150mg of oxcarbazepine.
They also contain the following inactive substances:
colloidal anhydrous silica, microcrystalline cellulose,
crospovidone, hypromellose, magnesium stearate,
macrogol 4000, talc, titanium dioxide (E171),
yellow iron oxide (E172), red iron oxide (E172) and
black iron oxide (E172).

What Trileptal Tablets look like and contents of the
pack
The 150mg tablets are pale grey green, ovaloid, film-coated
tablets marked “C” and “G” on one side and “T” and “D” on
the other with a score through the middle on both sides.
The tablets come in blister packs of 50 tablets.

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

Manufacturer

Your medicine is manufactured by: Novartis Pharma S.A.S.,
26, rue de la Chapelle, 69330 Huningue, France.

If you are unsure or have forgotten to take several doses,
contact your doctor.

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

Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster DN3 1QR.

If you stop taking Trileptal Tablets

Very common:

Product Licence holder: Landmark Pharma Ltd.,
7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

To prevent sudden worsening of your seizures, never
discontinue your medicine abruptly.

Common:

Do not stop taking your medicine unless your doctor tells you
to.





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 Tablets 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).

tiredness; headache; dizziness; drowsiness; feeling sick
(nausea); being sick (vomiting); double vision.

POM

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 Tablets.
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 Kingdom

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

5. How to store Trileptal Tablets






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
Trileptal® is a registered trademark of Novartis AG.
Leaflet revision date: 23.03.16

Not known:


PL No: 21828/0031

Do not store above 30ºC.
KEEP ALL MEDICINES OUT OF THE SIGHT AND
REACH OF CHILDREN.
Do not use after the expiry date printed on the carton or
blister strip. The expiry date refers to the last day of
that month.
Do not use Trileptal Tablets if you notice that the pack is
damaged or shows signs of tampering.

Page 2 of 2

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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