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PACKAGE LEAFLET: INFORMATION FOR THE USER

Oxcarbazepine 150 mg film-coated tablets Oxcarbazepine 300 mg film-coated tablets Oxcarbazepine 600 mg film-coated tablets

Oxcarbazepine

What is in this leaflet

1.    What Oxcarbazepine film-coated tablets are and what they are used for

2.    What you need to know before you take Oxcarbazepine film-coated tablets

3.    How to take Oxcarbazepine film-coated tablets

4.    Possible side effects

5.    How to store Oxcarbazepine film-coated tablets

6.    Contents of the pack and other information

1.    What Oxcarbazepine film-coated tablets are and what they are used for

What Oxcarbazepine film-coated tablets are

The active ingredient of Oxcarbazepine film-coated tablets is oxcarbazepine. Oxcarbazepine belongs to a group of medicines called anticonvulsants or antiepileptics.

What Oxcarbazepine film-coated tablets are used for

Medicines such as Oxcarbazepine 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.

Oxcarbazepine 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.

Oxcarbazepine works by keeping the brain's “overexcitable” nerve cells under control. This suppresses or reduces the frequency of such seizures.

Oxcarbazepine film-coated tablets 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.

Oxcarbazepine film-coated tablets are for use in adults and in children of 6 years of age and above.

Follow all instructions given to you by your doctor carefully, even if they differ from the information contained in this leaflet.

2.    What you need to know before you take Oxcarbazepine film-coated tablets Do not take Oxcarbazepine film-coated tablets

-    if you are allergic to oxcarbazepine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Oxcarbazepine film-coated tablets,

-    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.

-    ifyouhaveakidney disease.

-    ifyou 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 ofurine produced).

-    ifyou 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. Oxcarbazepine may stop your contraceptive from working. Use a different or extra (non-hormonal) method of contraception while taking Oxcarbazepine film-coated tablets. 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 Oxcarbazepine film-coated tablets, tell your doctor immediately or go to the emergency department at your nearest hospital:

-    if you experience an allergic reaction after starting oxcarbazepine. Symptoms include swelling of lips, eyelids, face, throat, mouth, or sudden breathing problems, fever with swollen glands, rash or skin blistering.

-    ifyou 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, nosebleeds, reddish orpurplish patches, or unexplained blotches on the skin.

-    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.

If you develop the following symptoms after starting Oxcarbazepine film-coated tablets, tell your doctor as soon as possible:

-    ifyou have a fast or unusually slow heart beat.

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.

Other medicines and Oxcarbazepine film-coated tablets

Tell your doctor or pharmacist ifyou 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, 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 ofdepression).

-    Medicines that control the body's immune system, such as ciclosporin and tacrolimus.

Oxcarbazepine film-coated tablets with food, drink and alcohol

Oxcarbazepine film-coated tablets can be taken with or without food.

Alcohol may increase the sedative effects of Oxcarbazepine. Avoid alcohol as much as possible and ask your doctor for advice.

Pregnancy and breast-feeding

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

Pregnancy

Tell your doctor ifyou 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 Oxcarbazepine film-coated tablets .

Do not stop your treatment with Oxcarbazepine film-coated tablets 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 Oxcarbazepine. The active substance in Oxcarbazepine film-coated tablets 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

Oxcarbazepine film-coated tablets 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 Oxcarbazepine film-coated tablets

Always take this medicine 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 Oxcarbazepine film-coated tablets for adults (including elderly patients) is 600 mg per day.

-    Takeone300mgtablettwicedailyortwo 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 2400 mg per day.

-    If you take another antiepileptic medicine, the oxcarbazepine dose is the same.

-    If you have kidney disease (with impaired kidney function), the starting dose is half the usual starting dose.

-    If youhave severe liver disease, your doctor may adjust your dose.

Dose for children

Oxcarbazepine film-coated tablets 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.

Howto take Oxcarbazepine film-coated tablets

-    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, oxcarbazepine is available as an oral suspension.

When and for how long to take Oxcarbazepine film-coated tablets

Take Oxcarbazepine film-coated tablets 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 Oxcarbazepine film-coated tablets 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 Oxcarbazepine film-coated tablets 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 oxcarbazepine 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 Oxcarbazepine film-coated tablets

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 take a double dose to make up a forgotten dose.

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

If you stop taking Oxcarbazepine film-coated tablets

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.

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 andjoints.

-    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' under Section 2).

-    Flu-like symptoms with jaundice (yellowing of the skin or the whites of the eyes) (signs ofhepatitis).

-    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 Oxcarbazepine film-coated tablets has to be stopped immediately and how to continue further medical care.

Other side effects: tell a doctor as soon as possible Common (may affect up to 1 in 10 people):

-    trembling; coordination problems; involuntary movement of the eyes; anxiety and nervousness; depression, rash.

Very rare (may affect up to 1 in 10,000 people):

-    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 Oxcarbazepine film-coated tablets. Most of these effects are transient and usually diminish overtime.

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 Oxcarbazepine film-coated tablets.

Not known (frequency cannot be estimated from the available data):

-    highbloodpressure.

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 ahistory of osteoporosis, ortake 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 (Website: www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety ofthis medicine.

5.    How to store Oxcarbazepine film-coated tablets

-    Keep this medicine out of the sight and reach of children.

-    Do not use this medicine after the expiry date which is stated on the blister and the outer carton. The expiry date refers to the last day of that month.

-    This medicinal product does not require any special storage conditions.

-    Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.

-    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information

What Oxcarbazepine film-coated tablets contains

-    The active substance is oxcarbazepine.

-    The other ingredients are:

o Tablet core: silica (dental type, E551), microcrystalline cellulose (E460), hypromellose (E464), crospovidone (E1202), magnesium stearate (E470b). o Tablet coating: hypromellose (E464), titanium dioxide (E 171), macrogol 8000, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172, only in the 150 mg tablets), talc (E553b).

What Oxcarbazepine film-coated tablets looks like and contents of the pack

The 150 mg tablets are pale grey green colored, oval shaped, biconvex film-coated tablets, of approximately 4.4 mm thickness, approximately 11.1 mm length and approximately 5.6 mm width, scored on both sides and debossed with '150' on one side of the score line on one side ofthe tablet.

The 300 mg tablets are yellow colored, oval shaped, biconvex film-coated tablets, of approximately 5.4 mm thickness, approximately 15.1 mm length and approximately 6.6 mm width, scored on both sides and debossed with '300' on one side of the score line on one side ofthe tablet.

The 600 mg tablets are pink colored, oval shaped, biconvex film-coated tablets, of approximately 7.0 mm thickness, approximately 18.6 mm length and approximately 8.1 mm width, scored on both sides and debossed with '600' on one side of the score line on one side ofthe tablet.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

The film-coated tablets are available in blisters containing 10, 20, 30, 50, 60, 90, 100 and 200 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder Jubilant Pharmaceuticals nv Axxes Business Park Guldensporenpark 22, block C 9820 Merelbeke Belgium

Manufacturer

PSI Supply nv

Axxes Business Park

Guldensporenpark 22, block C

9820 Merelbeke

Belgium

This medicinal product is authorised in the Member States of the EEA under the following names:

The Netherlands    Oxcarbazepine Jubilant 150/300/600 mg filmomhulde tabletten

Denmark    Oxcarbazepin Jubilant 150/300/600mgfilmovertruknetabletter

United Kingdom    Oxcarbazepine Jubilant 150/300/600 mg film-coated tablets

Malta    Oxcarbazepine Jubilant 150/300/600mgfilm-coatedtablets

Cyprus    Oxcarbazepine Jubilant 300/600 mg film-coated tablets

Latvia    Oxcarbazepine Jubilant 300/600 mg apvalkotas tablets

Lithuania    Oxcarbazepine Jubilant 300/600 mg plevele dengtos tabletes

Estonia    Oxcarbazepine Jubilant 300/600 mg ohukese polumeerikattega

tabletid

This leaflet was last revised in 12/2013.