PACKAGE LEAFLET: INFORMATION FOR THE USER
Oxcarbazepine 150/300/600 mg Film-Coated Tablets
(Oxcarbazepine)
Read all of this leaflet carefully before you start taking this medicine.
▪ Keep this leaflet. You may want to read it again
▪ If you have 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 Oxcarbazepine is and what it is used for
2. Before you take Oxcarbazepine.
3. How to take Oxcarbazepine.
4. Possible side effects.
5. How to store Oxcarbazepine.
6. Further information.
1. WHAT OXCARBAZEPINE IS AND WHAT IT IS USED FOR
Oxcarbazepine film-coated tablets contain the active ingredient oxcarbazepine.
Oxcarbazepine belongs to a group of medicines called anticonvulsants which are used in the
treatment of epilepsy. Oxcarbazepine is designed to help control seizures or fits in patients
that have epilepsy. Oxcarbazepine is used to treat certain types of epilepsy in adults and
children from 6 years old.
Your doctor may prescribe Oxcarbazepine film-coated tablets alone or along with other
epilepsy medicine.
2. BEFORE YOU TAKE OXCARBAZEPINE
Do not take Oxcarbazepine if you are allergic (hypersensitive) to oxcarbazepine or any of
the other ingredients of this medicinal product.
Take special care with Oxcarbazepine:
if you are allergic (e.g. have ever developed a rash or other hypersensitivity reaction) to
carbamazepine, a similar anticonvulsant, as there is approximately a 1 in 4 (25%) chance
you may be allergic to oxcarbazepine too.
if you develop an inflammation of the liver or a severe skin reaction (see under Possible
side effects).
if you have a renal disease associated with a low level of sodium (salt) in your blood.
Oxcarbazepine can lower the sodium levels in your blood further which may lead to
symptoms of sodium shortage (see under Possible side effects). If you have a renal
disease your doctor may examine your blood before and at regular intervals after starting
treatment with Oxcarbazepine.
If you are taking other medicine that can lower sodium levels in the blood (e.g. diuretics
and non-steroid anti-inflammatory drugs (NSAIDS) such as indomethacin and ibuprofen).
See under Taking other medicines.
if you have heart problems such as heart failure, (breathlessness and swollen ankles). Your
doctor will measure your weight regularly to make sure that you do not retain water.
if you have a heart rhythm disorder.
if you are using hormonal contraceptives (see under Taking other medicines).
if you are planning to become pregnant (see under Pregnancy and breast feeding).
Tell your doctor if this applies to you.
A small number of people being treated with anti-epileptics such as Oxcarbazepine have had
thoughts of harming or killing themselves. If at any time you have these thoughts,
immediately contact your doctor.
Taking other medicines
Tell your doctor if you are already taking any of the following medicines as they may interact
with Oxcarbazepine:
other anticonvulsants (e.g. Phenobarbital, Phenytoin, Carbamazepine, Lamotrigine and
Valproic acid). Your doctor may need to adjust the dosage of these medicines when they
are given in combination with Oxcarbazepine. In combination with lamotrigine there is an
increased possibility of side effects like nausea, somnolence, dizziness and headache can
occur.
hormonal contraceptives (like the “pill”). Oxcarbazepine can stop these medicines
working properly. Another form of contraception should also be used.
medicine to treat mental illness such as lithium and MAOIs (Monoamine Oxidase
Inhibitors), like phenelzine and moclobemide. Combination with lithium might increase
the occurrence of side effects.
medicine that can lower sodium levels in the blood (e.g. diuretics and non-steroid antiinflammatory drugs such as indomethacin and ibuprofen). Oxcarbazepine can lower the
sodium levels in your blood further which may lead to symptoms of sodium shortage (see
Possible side effects). Your doctor should examine your blood before and at regular
intervals after starting treatment with Oxcarbazepine.
Immunosupressants (e.g. ciclosporin, tacrolimus)
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines including those obtained without a prescription.
Taking Oxcarbazepine with food and drink
Oxcarbazepine can be taken with or without food.
Take special care if drinking alcohol while taking Oxcarbazepine as it may make you feel
very drowsy.
Pregnancy and breast feeding
Contact your doctor if you become pregnant, think you might be pregnant or are planning to
become pregnant while taking Oxcarbazepine. It is important that seizures during pregnancy
are controlled but Oxcarbazepine may affect the growth of your unborn baby.
Your doctor will discuss the benefits and possible risks of the use Oxcarbazepine during
pregnancy.
Oxcarbazepine should not be used during breast feeding.
Driving and using machines
You should be aware that Oxcarbazepine can cause side effects like dizziness and drowsiness
which can influence your ability to drive or operate machines. Do not drive or operate
machines if you experience such side effects.
Important information about some of the ingredients of Oxcarbazepine
Oxcarbazepine contains lactose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE OXCARBAZEPINE
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.
Always take Oxcarbazepine exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Where the required dose cannot be administered using whole tablets, other oxcarbazepine
containing pharmaceutical forms are available.
Your doctor will probably start treatment with a low dose and, if necessary gradually increase
it to suit your own needs. The usual doses are as follows:
Adults
The usual starting dose is 300 mg twice daily. If needed your doctor may increase the dose
every week with a maximum of 600 mg daily. The usual maintenance dose is between 600 mg
and 2400 mg daily.
If you are also taking other anticonvulsant medicines, your doctor may need to reduce their
dose or increase the dose of Oxcarbazepine more slowly.
If other anticonvulsive medicines are replaced by Oxcarbazepine their dose will be decreased
gradually.
Children of 6 years and older
The usual starting dose is 8-10 mg/kg of body weight daily, divided into two doses. If needed
your doctor may increase the dose approximately every week by 10 mg/kg/day of body
weight daily up to a maximum daily dose of 46 mg/kg of body weight per day. The usual
maintenance dose in combination with other anticonvulsive medicines is 30 mg/kg body
weight daily.
Children under 6 years
Oxcarbazepine is not recommended for children under 6 years old since it has not been shown
to be a safe and effective treatment in this age group.
For children who cannot swallow tablets or where the required dose cannot be administered
using tablets, other oxcarbazepine containing pharmaceutical forms are available.
Patients with kidney problems
If you have kidney problems your doctor will start treatment with half the normal starting
dose and increase the dose of Oxcarbazepine more slowly than that stated above.
Patients with severe liver problems
If you have severe liver problems, you should take the treatment as prescribed by your doctor.
Where the required dose cannot be administered using tablets, other oxcarbazepine containing
pharmaceutical forms are available.
Method of administration:
Swallow the film-coated tablet with a glass of water. Do not crush or chew them. The filmcoated tablets can be broken into two equal halves to make swallowing easier.
If you take more Oxcarbazepine than you should:
If you have taken more Oxcarbazepine than you should contact your doctor or pharmacist
straight away. Symptoms of overdose are drowsiness, dizziness, nausea, vomiting, an
abnormal degree of muscular or bodily activity, lack of co-ordination of movements and
uncontrolled eye movements.
If you forget to take Oxcarbazepine:
Take it as soon as you remember. However, if it is almost time for your next dose, do not take
the missed dose, take the next dose on time. Do not take a double dose to make up for
forgotten doses.
If you stop taking Oxcarbazepine
Do not stop taking Oxcarbazepine suddenly without consulting your doctor since this could
lead to a sudden increase in seizures/convulsions. If your treatment with Oxcarbazepine is
stopped your doctor will do this slowly.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Oxcarbazepine can cause side effects, although not everybody gets them.
Tell your doctor or go to your nearest hospital casualty department straight away if you
have any of the following side effects:
a severe skin reaction like:
a severe hypersensitivity reaction with (high) fever, red stains on the skin, painful
joints and/or inflammation of the eyes.
a severe acute hypersensitivity reaction with fever and blistering/peeling of the skin.
red (moist) irregular spots.
This effect is very rare and seen in less than 1 in 10,000 patients, but you may need medical
attention. If such skin reaction has occurred during use of oxcarbazepine, you must not use
oxcarbazepine. Your doctor may decide to withdraw treatment with oxcarbazepine.
signs of inflammation of the liver (yellowing of the skin or whites of the eyes).
This effect is very rare and seen in less than 1 in 10,000 patients, but your liver function may
need to be checked.
Swollen face, tongue or throat, difficulty in swallowing or nettle rash with difficulty in
breathing. This effect is very rare and seen in less than 1 in 10,000 patients.
Tell your doctor as soon as possible if you have any of the following side effects:
if you notice any an irregular heartbeat. This effect is very rare and seen in less than 1 in
10,000 patients, but you may need medical attention.
If you feel confused, sick or vomit, experience a decreased level of consciousness, suffer
from blurred vision or notice worsening of your convulsions (these are symptoms of a low
sodium level in the blood). This effect is very rare and seen in less than 1 in 10,000
patients, but you may need medical attention.
Other side effects that can occur:
Very common side effects (seen in more than 1 in 10 patients) include:
feeling dizzy, tired or drowsy, double vision, feeling or being sick and headaches.
Common side effects (seen in less than 1 in 10 but more than 1 in 100 patients) include:
low sodium (salt) levels in the blood, feeling confused, depressed, agitated or other mood
changes, blurred vision, uncontrolled eye movement or other eyesight changes, loss of coordination, shaking, difficulty concentrating, memory loss, dizziness, diarrhoea or
constipation, stomach pain, skin rash, acne, hair loss, or feeling weak.
Uncommon side effects (seen in less than 1 in 100 but more than 1 in 1000 patients) include:
itchy skin, and blood changes such as a low white cell count, and raised liver enzymes.
Very rare side effects (seen in less than 1 in 10,000 patients) include:
blood changes such as a reduction in the number of cells (platelets) that help your blood clot,
inflammation of the pancreas and changes to your immune system that may cause joint pain,
fever and changes in the way that your liver works.
If any side effects get serious, or if you notice any side effects not mentioned in this
leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE OXCARBAZEPINE
Keep out of the reach and sight of children.
Do not use Oxcarbazepine after the expiry date which is stated on the polypropylene tablet
container / blister and the carton. The expiry date refers to the last day of that month.
Do not store above 30ºC.
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 Oxcarbazepine contains
The active substance is 150/300/600 mg of oxcarbazepine per tablet.
The other ingredients are (tablet core): crospovidone, hypromellose, microcrystalline
cellulose, colloidal anhydrous silica and magnesium stearate, (tablet coating): black iron oxide
(E172), red iron oxide (E172), yellow iron oxide (E172), hypromellose, lactose monohydrate,
macrogol 4000 and titanium dioxide (E171).
What Oxcarbazepine looks like and contents of the pack
Film-coated tablet.
The film-coated tablets are oblong, buff-coloured and have a scoreline on each side.
The 150 mg/ 300 mg/ 600 mg film-coated tablets are marked ‘OX/150’/‘OX 300’/‘OX/600’
on one side and ‘G/G’ on the other side. The scoreline is only to facilitate breaking for ease of
swallowing and not to divide into equal doses.
Oxcarbazepine film-coated tablets are available in plastic tablet containers of 100, 200 and
500 tablets and blisters of 10, 20, 30, 50, 100 and 200 tablets.*
*Not all pack sizes may be marketed.
Oxcarbazepine film-coated tablets are available as Oxcarbazepine 150 mg / 300 mg and 600
mg film-coated tablets.
The marketing authorisation holder is:
To be completed nationally.
The manufacturer is:
To be completed nationally.
This medicinal product is authorised in the Member States of the EEA under the
following names:
The Netherlands
Oxcarbazepine 150mg, 300mg 600mg filmomhulde tabletten
France
OXCARBAZEPINE QUALIMED 150 mg, 300 mg, 600 mg comprimé pelliculé
This leaflet was last approved: September 2008