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TRILEPTAL 60 MG/ML ORAL SUSPENSION

Active substance(s): OXCARBAZEPINE

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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
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.

How to fit the plastic adapter into a new bottle
of medicine
1. Shake the bottle of
medicine 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).

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

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.
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 well.
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.
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.
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.

PATIENT INFORMATION LEAFLET

Ref: 1467/270416/1/F

®

Trileptal 60 mg/ml Oral Suspension
(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.
Your medicine is called Trileptal 60 mg/ml Oral
Suspension and will be referred to as Trileptal
throughout the rest of this leaflet.
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
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 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”),
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 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.
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.

(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.






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.
If your medicine becomes discoloured or shows
any other signs of deterioration, consult your
pharmacist who will tell you what to do.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Trileptal contains
• The active substance of Trileptal is
oxcarbazepine
• One ml conatins 60mg oxcarbazepine
• The other ingredients are purified water, sorbitol
solution 70% (non-crystallising), propylene
glycol, dispersible cellulose, ascorbic acid
(E300), yellow-plum-lemon flavour (containing
ethanol), methyl parahydroxybenzoate (E218),
macrogol stearate 400, ethanol, sorbic acid
(E200), saccharin sodium, propyl
parahydroxybenzoate (E216).
What Trileptal looks like and contents of the
pack
• Trileptal is supplied as an off-white to slightly
reddish brown oral 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 amber
glass bottles containing 250ml of oral
suspension. The bottles have a child
resistant cap and are packed in a cardboard
box together with a 10ml dosing syringe and
press-in bottle adaptor. Each pack contains one
bottle.

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.

Manufacturer and Licence Holder
This medicine is manufactured by Novartis
Pharma GmbH, Roonstrasse 25, D-90429
Nurnberg, Germany and is procured from within
the EU. Product Licence Holder Lexon (UK)
Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE and
repackaged by Lexon (UK) Limited, B98 0RE.

Very common:
• tiredness; headache; dizziness; drowsiness;
feeling sick (nausea); being sick (vomiting);
double vision.

If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

Common:
• weakness; memory disturbances; impaired
concentration; apathy; agitation; confusion;
blurred vision; visual disturbance; constipation;
diarrhoea; stomach (abdominal) pain; acne; hair
loss, balance disturbances.

POM
PL 15184/1467 - Trileptal 60mg/ml Oral
Suspension
Trileptal is a registered trademark of Novartis AG.

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

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,
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.
5. HOW TO STORE TRILEPTAL

• KEEP OUT OF THE SIGHT AND REACH 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.

Leaflet revision date: 27/04/2016

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref: 1467/270416/1/B

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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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