OXCARBAZEPINE 150MG TABLETS

Active substance: OXCARBAZEPINE

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PATIENT INFORMATION LEAFLET

 if you notice symptoms of hepatitis, such as jaundice (yellowing of skin or the

Trileptal® 150mg Tablets / Oxcarbazepine 150mg Tablets

 if you notice possible symptoms of blood disorders such as tiredness, being

(oxcarbazepine)

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 develop the following symptoms after starting Trileptal, tell your
doctor as soon as possible:
 if you have a fast or unusually slow heart beat.

This product is available using any of the above names but will be referred to as
Trileptal throughout the following:
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, please tell your doctor or pharmacist.
In this leaflet:
1.
2.
3.
4.
5.
6.

What Trileptal is and what it is used for
Before you take Trileptal
How to take Trileptal
Possible side effects
How to store Trileptal
Further information

whites of the eyes).

Taking other medicines
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.

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.
Patients diagnosed with epilepsy have had repeated seizures, or convulsions.
Seizures happen because of a temporary fault in the brain’s electrical system.
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.

Taking 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
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.
It is important to discuss with your doctor whether you can drive a vehicle or
operate machines while taking this medicine.

2. Before you take Trileptal
Follow all instructions given to you by your doctor carefully, even if they differ from
the information contained in this leaflet.
Do not take Trileptal
 if you are allergic (hypersensitive) to oxcarbazepine or to any other
ingredients of Trileptal tablets (listed in section 6 Further information).
Take special care with Trileptal
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 a kidney disease.
 If you have a 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 a 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 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.
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.

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.
How much to take
Dose for adults
 The usual starting dose of Trileptal for adults (including elderly patients) is
600 mg per day.
 Take one 300 mg tablet twice daily or two 150 mg tablets twice daily or two 150
mg 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 2,400 mg 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 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 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

 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.

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
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 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.
If you notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist.
5. How to store Trileptal

 Do not use Trileptal after the expiry date which is printed on the carton and on
the blister strips.

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

 Return any unused tablets to your pharmacy for safe disposal.
 Keep Trileptal out of the reach and sight of children.
 If your doctor tells you to stop taking the tablets, please take them back to the

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

 If the tablets become discoloured or show any other signs of deterioration, you

If your treatment is stopped, it should be done gradually as instructed by your
doctor.

6. Further Information

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 (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, muscule 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).
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; rash.
Very rare:

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

pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.
should consult your pharmacist who will advise you what to do.

What is in your medicine?
The name of your medicine is Trileptal. Each tablet contains 150mg of
oxcarbazepine as the active ingredient. Oxcarbazepine is an anticonvulsant
medicine, designed to help control seizures or fits in patients that have epilepsy.
The tablets are peach, capsule shaped film-coated tablets marked C breakline G
on one side and T breakline D on the reverse.
Trileptal also contain the following inactive substances:
Colloidal
anhydrous
silica,
microcrystalline
cellulose,
crosspovidone,
hypromellose, magnesium stearate, talc, titanium dioxide (E171), yellow iron oxide
(E172), macrogol 8000.
Trileptal are available in blister packs of 50 tablets.
If you need to, the tablets can be broken in half to make them easier to swallow.
For very young children who cannot swallow tablets, an oral suspension is
available. Please ask your doctor or pharmacist for advice.
The active substance in Trileptal is called oxcarbazepine. Oxcarbazepine is an
anticonvulsant medicine, designed to help control seizures or fits in patients that
have epilepsy.
POM
PL No: 17805/0284
Manufactured by Novartis Pharma S.A.S., 26, rue de la Chapelle, 68330
Huningue, France and procured from within the EU by the Product Licence holder
Delta Pharma (Europe) Ltd, 1Colonial Way, P.O. Box 233, North Watford, Herts
WD24 4EW and repackaged by O.P.D. Laboratories Ltd, Watford, Herts WD24
4PR.
eflet issue and revision date (Ref.) 07.06.12
Trileptal is a registered Trade Mark of Novartis AG, Switzerland.
You can get more information about epilepsy by contacting these independent
patient groups:
Telephone
NS.E The National Society for Epilepsy 01494 873991
BEA. The British Epilepsy Association 0113 2108800
E.A.S. The Epilepsy Association of Scotland 0141 4275225

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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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