OXCARBAZEPINE 150MG TABLETS

Active substance: OXCARBAZEPINE

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Trileptal® 150mg Tablets
Trileptal® 300mg Tablets
Trileptal® 600mg Tablets
(oxycarbazepine)
Your medicine is known by one of the above names, but will be referred to as
Trileptal throughout this:
Patient Information Leaflet
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. 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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1) What Trileptal is and what it is used for
2) Before you take Trileptal
3) How to take Trileptal
4) Possible side effects
5) How to store Trileptal
6) Further information

1) What Trileptal is and what it is used for
What Trileptal is
The active ingredient of Trileptal is oxycarbazepine.
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 tonicclonic 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) 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 oxycarbazepine 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 Trileptal (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.






if you notice symptoms of hepatitis, such as jaundice (yellowing of skin or
the whites of the eyes).
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 develop the following symptoms after starting Trileptal, tell your
doctor as soon as possible:
 if you have a fast or unusually slow heart beat.
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 antiinflammatory 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.
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.

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.
 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.
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.

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.
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
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 steriods.

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

If you notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist.

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

5) How to store Trileptal

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 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 beaccompanied 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.

Keep all medicines out of the reach and sight of children.
 Do not usee Trileptal after the expiry date which is printed on the carton,
and on the blister strips. The expiry date refers to the last day of that month.
 Do not store above 30°C.
 If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell 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.

6) Further information
What Trileptal contains:
The active substance in Trileptal tablets is called oxycarbazepine.
Your tablets come in three strengths, containing 150 mg, 300 mg or 600 mg
of oxycarbazepine.
Your tablets contain the following inactive substances: colloidal anhydrous
silica, microcrystalline cellulose, crospovidone, hypromellose, magnesium
stearate, talc, titanium dioxide (E171), yellow iron oxide (E172) for 150mg and
300mg, black iron oxide (E172) for 150mg and 600mg, red iron oxide (E172)
for 150mg and 600mg, macrogol 4000 for 150mg and 600mg and macrogol
8000 for 300mg only.
What Trileptal looks like and contents of the pack
The 150mg is pale grey green, ovaloid, scored on both sides and embossed
with T/D on one side and CG on the other side.
The 300mg tablet is yellow, ovaloid, scored on both sides and embossed with
TE/TE on one side and CG/CG on the other side.
The 600mg tablet is light pink, ovaloid, scored on both sides and embossed
with TF/TF on one side and CG/CG on the other side.
The tablets come in blister packs of:
150mg tablets - 50 tablets.
300mg tablets – 30, 50 or 100 tablets
600mg tablets - 30 tablets
PL 10383/1094
PL 10383/1095
PL 10383/1096
PL 10383/1097

300mg Tablets
600mg Tablets
150mg Tablets
300mg Tablets

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Novartis Pharma AG, Stein, Switzerland.
Procured from within the EU and repackaged by Product Licence Holder:
Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex, UB5 5QS.
Leaflet date: 11.06.2012
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
0808 8002200
Scotland
Trileptal® is a registered trademark of Novartis AG, Basle Switzerland.

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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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