1. WHAT OXCARBAZEPINE IS AND WHAT IT IS USED FOR

Transcription

1 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.

2 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.

3 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

4 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.

5 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 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