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TRILEPTAL 60 MG-ML ORAL SUSPENSION

Active substance(s): OXCARBAZEPINE

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INSTRUCTIONS FOR USE.
Read these instructions carefully so that you
know how to use this medicine.

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.

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

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.

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
Trileptal contains the active substance oxcarbazepine. Trileptal belongs to a
group of medicines called anticonvulsants or antiepileptics.

8. Carefully turn the bottle the right way up.
Disconnect the oral syringe by gently
twisting it out of the plastic adapter.

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.

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.

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.

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).

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

Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
• 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 only. Do not pass it on
to others. It may harm them, even if their symptoms are the same as
yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.

In this leaflet:
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.

How to fit the plastic adapter into a new bottle of
medicine

(oxcarbazepine)

Your medicine is called Trileptal 60 mg/ml Oral Suspension, and will be
referred to as Trileptal throughout this leaflet.

There are three parts to the medicine kit:

2. A bottle containing 250ml of the medicine,
with a child resistant cap.
Always replace the cap after use.

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.

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.
If you have any questions about how Trileptal works or why this medicine has
been prescribed for you, ask your doctor.

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)

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Ref:1775/260218/1/F

Patient Information Leaflet

How to use the medicine kit

1. A plastic adapter that you push into the
neck of the bottle.
The adapter must always stay in the
bottle.

Trileptal ® 60 mg/ml Oral Suspension

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.

2

What you need to know before you take Trileptal

Follow all your doctor’s instructions carefully, even if 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 to oxcarbazepine, or any of the other ingredients of this
medicine (listed in section 6) or if you are allergic to eslicarbazepine.
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
Talk to your doctor or pharmacist before taking 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, have recently taken or might
take any other medicines.
This applies especially to:
• Hormonal contraceptives, such as the pill (see Warnings and precautions).
• Other antiepileptic medicines and enzyme inducing medicines, such as
carbamazepine, phenobarbital, phenytoin or lamotrigine and rifampicin.
• 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 medicines, 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.

Page 1

Pregnancy, breast-feeding and fertility
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.

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.



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.

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, problems with coordination and/or involuntary
movement of the eyes, muscular twitching or significant worsening of
convulsions, headache, loss of consciousness, coma,
• feeling sick (nausea), being sick (vomiting), increased uncontrolled
movements,
• lethargy, double vision, narrowing of black part of the eye, blurred vision,
• tiredness,
• short and shallow breathing (respiratory rate depression),
• irregular heart beat (QTc prolonged interval),
• trembling, headache, coma, decreased consciousness, uncontrollable
movements of mouth, tongue and limbs,
• aggression, agitation, confusion,
• low blood pressure,
• breathlessness.

Common (may affect up to 1 in 10 people):
• trembling; coordination problems; involuntary movement of the eyes;
anxiety and nervousness; depression, mood swing; rash.

Do not stop your treatment with Trileptal during pregnancy without first
checking with your doctor.
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 this 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.
Page 2

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 dosingtimetable. Do not take a double dose to make up for a
forgotten dose.
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 medicine, ask your doctor
or pharmacist.

4

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Tell your doctor immediately or go to the emergency
department at your nearest hospital if you get any of
the following side effects:
The following are signs of very rare (may affect up to 1 in 10,000 people), but
potentially serious side effects that may require urgent medical treatment.The
doctor will also decide whether Trileptal has to be stopped immediately and
how to continue further medical care.
• 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
Warnings and precautions).
• 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 as soon as possible if you get any of the following side
effects, they may require medical attention:

Very rare (may affect up to 1 in 10,000 people):
• irregular heart beat or a very fast or slow heart rate.
Other side effects that may occur:
These are usually mild to moderate side effects of Trileptal. Most of these
effects are transient and usually diminish over time.
Very common (may affect more than 1 in 10 people):
• tiredness; headache; dizziness; drowsiness; feeling sick (nausea); being
sick (vomiting); double vision.
Common (may affect up to 1 in 10 people):
• weakness; memory disturbances; impaired concentration; apathy;
agitation; confusion; blurred vision; visual disturbance; constipation;
diarrhoea; stomach (abdominal) pain; acne; hair loss, balance
disturbances.
Uncommon (may affect up to 1 in 100 people):
• hives. You may also have raised levels of liver enzymes while taking
Trileptal.
Not known (frequency cannot be estimated from the available data):
• high blood pressure, speech disorder.
• 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 on this leaflet. You can also report side
effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information on the
safety of this medicine.

5










6

Contents of the pack and other information

What Trileptal contains:
• The active substance of Trileptal is oxcarbazepine.
• One ml contains 60 mg oxcarbazepine.
• Also contains: propyl parahydroxybenzoate (E216),
methyl parahydroxybenzoate (E218), purified water, sorbitol solution 70%
(non-crystallising), propylene glycol, dispersible cellulose (containing
microcrystalline cellulose and carmellose sodium), ascorbic acid (E 300),
yellow plum-lemon flavour containing ethanol, macrogol stearate 400,
sorbic acid (E 200), saccharin sodium.
What Trileptal looks like and contents of the pack:
Trileptal 60 mg/ml 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 60 mg/ml 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.
Manufacturer and Licence Holder
Manufactured by Novartis Pharma GmbH, Nurnberg, Germany, Roonstråsse
25, D-90429 Nurnberg, Germany and are procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM

PL 15184/1775

Trileptal 60 mg/ml Oral Suspension

Trileptal is a registered trademark of Novartis AG.
Leaflet revision date: 26/02/18

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you

How to store Trileptal

Keep out of the sight and reach of children.
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 this medicine after the expiry date shown on the bottle and
carton label. The expiry date refers to the last day of that month. If your
doctor tells you to stop using the medicine, take the suspension back to the
pharmacist for safe disposal. Only keep the medicine if your doctor tells
you to do so.
Do not use this medicine if you notice that the pack is damaged or shows
signs of tampering.
If the suspension becomes discoloured or shows any signs of
deterioration, ask your pharmacist who will advise you what to do.
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.

Ref:1775/260218/1/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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