Oxcarbazepine Teva 150 Mg Film-Coated Tablets
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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