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TRILEPTAL 60MG/ML ORAL SUSPENSION

Active substance(s): OXCARBAZEPINE / OXCARBAZEPINE

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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.

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.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Trileptal works by keeping the brain’s “overexcitable”
nerve cells under control. This suppresses or reduces the
frequency of such seizures.

TRILEPTAL
60 mg/ml Oral Suspension
Oxcarbazepine

Read all of this leaflet carefully before you start
taking this medicine.

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.

– 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.

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

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

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.

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

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

Do not take Trileptal

• if you are allergic (hypersensitive) to oxcarbazepine
or any other ingredients of Trileptal Oral Suspension
(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”),

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.

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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.
Important information about some of the ingredients
of Trileptal
Trileptal oral suspension contains:
• sorbitol. If you have been told by your doctor that you
have an intolerance to some sugars, contact your
doctor before taking this medicine
• ethanol (alcohol), less than 100 mg per dose.
• parahydroxybenzoates (E216 propylhydroxybenzoate
and E218 methylhydroxybenzoate) which may cause
allergic reactions (possibly delayed).

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.
Your dose must be given in millilitres (ml)
The dose that your doctor prescribes you must be given in
millilitres (ml) and not in milligrams (mg). This is
important because the oral dosing syringe which is used
to withdraw the correct dose from the bottle is marked in
ml. If your prescription is in mg, contact your
pharmacist or doctor for advice.

How much to take

Dose for adults
• The usual starting dose of Trileptal for adults
(including elderly patients) is 10 ml oral suspension
(600 mg oxcarbazepine) per day.
• Take one 5 ml dose oral suspension
(300 mg oxcarbazepine) twice daily.
• Your doctor may increase the dose gradually to find the
best dose for you. The best results are usually with
doses between 10 ml and 40 ml oral suspension
(600 mg to 2,400 mg oxcarbazepine) 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 will be calculated by your doctor,
and depends on your child’s 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 dose (2.5 ml oral suspension) 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

For full instructions on how to take Trileptal, see section
Instructions for use at the end of this leaflet.

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 oral
suspension.
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 oral suspension 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
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• 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.

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Production Site:
CTM:

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Adrian Cornago

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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 pancreatitis).
• 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 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

What Trileptal looks like and contents of the pack

Trileptal oral suspension is supplied as an off white to
slightly reddish brown suspension. Discoloration of the
oral suspension to a slightly reddish brown colour is
normal and does not affect the quality of the product.
Trileptal oral suspension is supplied in brown glass
bottles containing 250 ml of oral suspension. The bottles
have a child resistant cap and are packed in a cardboard
box together with a 10 ml dosing syringe and press-in
bottle adaptor. Each pack contains one bottle.
Marketing Authorisation Holder
Novartis Pharmaceuticals UK Ltd,
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
United Kingdom
Manufacturer
Novartis Pharma GmbH,
Roonstrasse 25,
D-90429 Nurnberg,
Germany
Novartis Pharmaceuticals UK Ltd,
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
United Kingdom
This leaflet was last approved in 09/2016.

• Keep out of the reach and sight of children.
• Do not use after the expiry date which is stated on the
outer carton and the bottle. The expiry date refers to
the last day of that month.
• Use within 7 weeks after first opening the bottle.
• After 7 weeks, return any unused oral suspension to
your pharmacy for safe disposal.
• 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.

INSTRUCTIONS FOR USE

Read these instructions carefully so that you
know how to use this medicine.
How to use the medicine kit
There are three parts to the medicine kit:
1. A plastic adapter that you
push into the neck of the
bottle.
The adapter must always
stay in the bottle.
2. A bottle containing 250ml
of the medicine, with a
child resistant cap.
Always replace the cap
after use.

3. A 10ml oral dosing
syringe. This fits into the
plastic adapter to
withdraw the prescribed
dose from the bottle.

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
How to fit the plastic adapter into a new bottle of
medicine
1. Shake the bottle of
medicine vigorously for at
least 10 seconds.
2. Remove the child resistant
cap by pushing it down
firmly and turning it
anti-clockwise (as shown
on the top of the cap).

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Trileptal contains

• The active substance of Trileptal is oxcarbazepine.
Each millilitre of the oral suspension contains 60 mg of
oxcarbazepine.
• The other ingredients are purified water, sorbitol 70%
liquid (non-crystallising), propylene glycol, dispersible
cellulose (containing microcrystalline cellulose and
carmellose sodium), ascorbic acid (E 300),
yellow‑plum-lemon flavour (containing ethanol),
methylparahydroxybenzoate (E 218), macrogol
stearate 400, sorbic acid (E 200), saccharin sodium,
propyl parahydroxybenzoate (E 216).

Note: Keep the cap nearby to close the bottle after
each use.

Preparing a dose of medicine
The medicine can be swallowed directly from the oral
syringe, or mixed in a small glass of water.
1. Shake the bottle
vigorously for at least
10 seconds. Prepare the
dose immediately
afterwards.
2. Push and turn the child
resistant cap to open the
bottle. (Always replace
the cap after use)
3. Check the plunger is fully
down inside the barrel of
the oral syringe.
4. Keep the bottle upright
and insert the oral syringe
firmly into the plastic
adapter.

5. Hold the oral syringe in
place and carefully turn
the bottle upside down.
6. Slowly pull the plunger
down fully so that the
syringe fills with medicine.
Push the plunger back up
completely to expel any
large air bubbles that may
be trapped inside the oral
syringe.

Note: If the prescribed dose is more than 10ml, withdraw
the prescribed dose in two steps. Firstly, fill the syringe to
the 10 ml mark, and take the 10 ml. Then reload the oral
syringe to the required level to take the remaining
amount.
Ask your pharmacist if you are unsure.
8. Carefully turn the bottle
the right way up.
Disconnect the oral
syringe by gently twisting
it out of the plastic
adapter.

9. The dose of medicine can
be swallowed directly
from the oral syringe. The
patient must be sitting
upright and the plunger
must be pushed slowly to
allow the patient to
swallow. Alternatively, the
dose can be mixed in a
small glass of water just
prior to administration.
Stir and drink the entire
mixture right away.
10. Replace the child resistant cap after use, leaving the
adapter in place.
11. Cleaning: After use, wipe the outside of the syringe
with a dry, clean tissue.

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Note: You may not be able to push the adapter down
fully but it will be forced into the bottle when you screw
the cap back on.
To dispense a dose, please follow all the instructions in
Preparing a dose of medicine.

7. Withdrawing the
prescribed dose: Slowly
pull the plunger down.
Pull until the top edge of
the black ring is exactly
level with the marker on
the oral syringe barrel
that indicates the
prescribed dose.

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3. Hold the open bottle
upright on a table. Push
the plastic adapter firmly
into the neck of the bottle
as far as you can.

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Production Site:
CTM:

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Adrian Cornago

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Technical approval Box in case ArtBase is not used.
If a manual signature is given the approver hand-sign
with the name and the date in readable letters.
Technical approval signed by Manufacturing Site
according to the Artwork Process Agreement.

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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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