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OXCARBAZEPINE TEVA 150 MG FILM-COATED TABLETS

Active substance(s): OXCARBAZEPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
OXCARBAZEPINE TEVA 150 mg, 300 mg AND 600 mg FILM-COATED TABLETS

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 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:
1.
What Oxcarbazepine Teva Film-coated Tablets are and what they are used for
2.
Before you take Oxcarbazepine Teva Film-coated Tablets
3.
How to take Oxcarbazepine Teva Film-coated Tablets
4.
Possible side effects
5.
How to store Oxcarbazepine Teva Film-coated Tablets
6.
Further information

1.

WHAT OXCARBAZEPINE TEVA FILM-COATED TABLETS ARE AND WHAT
THEY ARE USED FOR



Oxcarbazepine belongs to a group of medicines called anticonvulsants, which are used in the
treatment of epilepsy. It is designed to help control seizures or fits in patients who have
epilepsy
Oxcarbazepine is used to treat certain types of epilepsy in adults and children aged 6 years and
over
Your doctor may prescribe oxcarbazepine alone or in combination with other epilepsy
medicines.




2.

BEFORE YOU TAKE OXCARBAZEPINE TEVA FILM-COATED TABLETS

Do NOT take Oxcarbazepine Teva Film-coated Tablets

If you are allergic (hypersensitive) to oxcarbazepine or to any of the other ingredients of this
medicine.
Take special care with Oxcarbazepine Teva Film-coated Tablets
Tell your doctor if any of the below apply to you.

If you are allergic (e.g. you have had a rash or other signs of allergy) to carbamazepine, a
similar anticonvulsant medicine, or to any other medicines. If you are allergic to
carbamazepine, there is approximately a 1 in 4 (25%) risk that you are also allergic to
oxcarbazepine

If you have or ever have had liver disease or a serious skin reaction (see '4. Possible side
effects')

If you have or ever have had kidney disease associated with low blood sodium (salt) levels.
Oxcarbazepine can reduce your blood sodium levels, which can lead to sodium deficiency (see
'4. Possible side effects'). If you have kidney disease, your doctor may arrange for you to have
blood tests before and regularly during your treatment with oxcarbazepine

If you are taking medicines that reduce your sodium levels (e.g. diuretics ('water pills') or
painkillers (NSAIDs such as indometacin or ibuprofen)): see 'Taking other medicines'






If you have heart problems or heart failure (breathlessness and swollen ankles). Your doctor
will check your weight regularly in order to make sure your body isn't retaining water
If you have an abnormal heart rhythm
If you are on hormonal contraceptives ('the pill'): see 'Taking other medicines'
If you are planning to become pregnant (see 'Pregnancy and breast-feeding').

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.
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 taking any of the following, as they may interact with oxcarbazepine:

Other anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine, lamotrigine or valproic
acid). Your doctor may need to adjust your dose of these medicines if you take oxcarbazepine
at the same time. With lamotrigine, the risk of side effects such as nausea, sleepiness, dizziness
and headache may be increased

Hormonal contraceptives ('the pill'), as oxcarbazepine may reduce their effectiveness.
Additional effective contraceptive measures should be taken to prevent pregnancy

Medicines for mental illness such as lithium and MAO (monoamine oxidase) inhibitors (e.g.
phenelzine, moclobemide). Combination with lithium may increase the occurrence of side
effects

Medicines that reduce your blood sodium levels such as diuretics ('water pills') or painkillers
(NSAIDs, e.g. indometacin or ibuprofen). Oxcarbazepine may lower your blood sodium levels
further, which can lead to symptoms of sodium deficiency (see '4. Possible side effects'). Your
doctor will check your sodium levels before and regularly during your treatment with
oxcarbazepine

Medicines which block the body's natural defenses (immunosuppressants such as ciclosporin
and tacrolimus).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Taking Oxcarbazepine Teva Film-coated Tablets with food and drink
Your tablets can be taken with or without food.
You should take care if you consume alcohol whilst on oxcarbazepine, as it could make you drowsy.
Pregnancy and breast-feeding
Please contact your doctor if you are pregnant, think you are pregnant or are planning to become
pregnant during treatment with oxcarbazepine. It is important to control epileptic fits during
pregnancy, but oxcarbazepine may affect the growth of your unborn baby.
Your doctor will explain the benefits and risks of oxcarbazepine use during pregnancy.
You should not breast-feed during treatment with oxcarbazepine.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Oxcarbazepine may cause side effects such as dizziness and drowsiness, if affected do not drive or
operate machinery.

Important information about some of the ingredients of Oxcarbazepine Teva Film-coated
Tablets
Patients who are intolerant to lactose should note that Oxcarbazepine Film-coated Tablets contain a
small amount of lactose. If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.
This medicinal product contains sunset yellow (E110) and may cause allergic reactions.

3.

HOW TO TAKE OXCARBAZEPINE TEVA FILM-COATED TABLETS

Always take Oxcarbazepine Film-coated Tablets exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
For doses not practicable with this strength, other pharmaceutical forms and strengths are available.
Your doctor will probably start you on a low dose, and, if necessary, increase it slowly to the most
appropriate dose. The usual dose is:
Adults:
The usual starting dose is 300 mg twice a day. If necessary, your doctor may increase your dose on a
weekly basis in steps of at most 600 mg a day. The usual maintenance dose range is 600 to 2400 mg a
day.
If you are also taking other anticonvulsants, your doctor may need to reduce the dose of these other
medicines or increase the dose of oxcarbazepine more slowly.
If other medicines are being replaced by oxcarbazepine, the dose of these medicines should be
reduced slowly.
Children aged 6 years and over:
The usual starting dose is 8-10 mg/kg body weight a day, divided into 2 doses. If necessary, your
doctor may increase the dose on a weekly basis in steps of at most 10 mg/kg a day up to a maximum
of 46 mg/kg body weight a day. The usual maintenance dose in combination with other
anticonvulsants is 30 mg/kg body weight a day.
Children aged under 6 years:
Oxcarbazepine is not recommended for children aged under 6 years as its safety and efficacy have not
been established in this age group.
Other pharmaceutical forms of oxcarbazepine are available for patients unable to swallow tablets or if
the required dose cannot be achieved with tablets.
Patients with kidney disease:
If you have kidney problems (reduced kidney function), your doctor will start you on half the normal
dose (see above) and increase the dose more slowly.
Patients with severe liver disease:
If you have severe liver problems, you must follow your doctor's advice.
For doses not practicable with this strength, other pharmaceutical forms and strengths are available.
Method of administration:
Take the film-coated tablet with a glass of water. Do not crush or chew the tablets. The film-coated
tablets can be broken in half to ease swallowing.

If you take more Oxcarbazepine than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed
any of the tablets, contact your nearest hospital casualty department or your doctor immediately.
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so
that they know which tablets were consumed.
An overdose can cause drowsiness, dizziness, nausea, vomiting, abnormal muscle and body activity,
uncoordinated movements and involuntary eye movements.
If you forget to take Oxcarbazepine
If you forget to take a dose, take one as soon as you remember, unless it is almost time for you to take
your next dose. Take your next dose as usual. Do not take a double dose to make up for a forgotten
tablet.
If you stop taking Oxcarbazepine
Do not stop taking Oxcarbazepine, unless your doctor tells you to, as stopping it could cause a sudden
worsening of your seizures. Your doctor will decide when and how to stop your treatment.
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.
Contact your doctor or go to the nearest casualty department if any of the following occur:

A severe skin reaction such as:
a severe allergic reaction with (high) fever, red spots on the skin, painful limbs and/or
eye pain
a sudden, severe allergic reaction with fever and blisters and scales on the skin
red (moist) irregular patches
This side effect is very rare and occurs in fewer than 1 in 10,000 patients, but may require
medical attention. If a reaction of this type develops while you are on oxcarbazepine, you must
not use oxcarbazepine again

Signs of inflammation of the liver (such as yellowing of the skin or whites of the eyes)
This side effect is very rare and occurs in fewer than 1 in 10,000 patients, but your liver
function may need to be monitored

Swelling of the face, tongue or throat, difficulty swallowing or nettle rash (hives) with
difficulty breathing, or other signs of allergic reactions such as a skin rash, fever or pain in the
joints
This side effect is very rare and occurs in fewer than 1 in 10,000 patients.
Contact your doctor immediately if any of the following occur:

If you notice your heartbeat becoming irregular
This side effect is very rare and occurs in fewer than 1 in 10,000 patients, but may require
medical attention

If you feel confused or sick, if you are sick, if you experience a lowered state of consciousness,
if you have blurred vision or if you have more frequent seizures (these are symptoms of low
sodium levels in your blood)
This side effect is very rare and occurs in fewer than 1 in 10,000 patients, but may require
medical attention

If you notice symptoms suggestive of blood disorders such as tiredness, shortness of breath
during exercise, 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

This side effect is very rare and occurs in fewer than 1 in 10,000 patients, but may require
medical attention.
Other side effects may occur:
Very common (affecting more than one user in 10):

Dizziness, tiredness or sleepiness, headache

Double vision

Feeling or being sick.
Common (affecting one to 10 users in 100):

Low sodium (salt) levels in the blood

Confusion, depression, apathy, agitation or other mood disorders

Blurred vision, uncontrolled eye movements or other sight disorders

Loss of co-ordination, trembling, inability to concentrate, memory disorders

Diarrhoea or constipation, abdominal pain

Rash, acne

Hair loss

Feeling weak.
Uncommon (affecting one to 10 users in 1,000):

Itching

Blood changes such as decreased numbers of white blood cells and increased liver enzyme
levels.
Very rare (affecting less than one user in 10,000):

Blood changes such as decreased numbers of the cells involved in clotting (platelets),
inflammation of the pancreas and changes in the immune system with possible pain in the
limbs, fever and changes in liver function.
Unknown (the frequency cannot be estimated from the available data):

High blood pressure

Hypothyroidism (disorder in which the thyroid gland does not make enough thyroid hormone)

Decreased level of thyroid hormone (T4) in blood.
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 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 OXCARBAZEPINE TEVA FILM-COATED TABLETS

Keep out of the reach and sight of children.
Do not use Oxcarbazepine Teva Film-coated Tablets after the expiry date which is stated on the
blister and carton after EXP. The expiry date refers to the last day of the month.
This medicinal product does not require any special storage conditions.

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 Teva Film-coated Tablets contain

The active substance is oxcarbazepine. Each film-coated tablet contains either 150, 300 or
600 mg oxcarbazepine.


The other ingredients are:
Tablet core: lactose monohydrate, maize starch, crospovidone, povidone (K-30), cellulose
microcrystalline, sodium starch glycolate (type A), silica colloidal anhydrous and magnesium
stearate.
Film-coating: hypromellose, macrogol 6000, macrogol 400, titanium dioxide (E171), iron
oxide yellow (E172), sunset yellow aluminium lake (E110).

What Oxcarbazepine Teva Film-coated Tablets look like and contents of the pack

Film-coated tablet

Oxcarbazepine Teva 150 mg Film-coated Tablets are yellow to dark yellow, film coated
capsule shaped tablets. One side of the tablet is scored in half and debossed with "9" on one
side of the score and "3" on the other. The other side of the tablet is scored in half and debossed
with "72" on one side of the score and "81" on the other. The tablet can be divided into equal
halves.

Oxcarbazepine Teva 300 mg Film-coated Tablets are yellow to dark yellow, film coated
capsule shaped tablets. One side of the tablet is scored in half and debossed with "9" on one
side of the score and "3" on the other. The other side of the tablet is scored in half and debossed
with "72" on one side of the score and "82" on the other. The tablet can be divided into equal
halves.

Oxcarbazepine Teva 600 mg Film-coated Tablets are yellow to dark yellow, film coated
capsule shaped tablets. One side of the tablet is scored in half and debossed with "9" on one
side of the score and "3" on the other. The other side of the tablet is scored in half and debossed
with "72" on one side of the score and "83" on the other. The tablet can be divided into equal
halves.





Oxcarbazepine Teva 150 mg Film-coated Tablets are available in pack sizes of 1, 30, 50, 56,
100, 200 & 500 film-coated tablets. Hospital pack: 500 film-coated tablets.
Oxcarbazepine Teva 300 mg Film-coated Tablets are available in pack sizes of 1, 30, 50, 56,
100, 200 & 500 film-coated tablets. Hospital packs: 50 & 500 film-coated tablets.
Oxcarbazepine Teva 600 mg Film-coated Tablets are available in pack sizes of 1, 30, 50, 56,
100, 200 & 500 film-coated tablets. Hospital packs: 50 & 500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised in May 2015

PL 00289/1084, 1085 and 1086

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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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