Trileptal Film-Coated Tablets

What TRILEPTAL is

TRILEPTAL contains the active substance oxcarbazepine.

What TRILEPTAL is used for

TRILEPTAL is one of a group of medicines called anticonvulsants or antiepileptics (medicines to treat epilepsy). TRILEPTAL is used to treat partial seizures and generalised tonic-clonic seizures.

Do not take TRILEPTAL:

• If you are hypersensitive (allergic) (experienced rash or any other sign of allergy) to oxcarbazepine (the active substance of TRILEPTAL), eslicarbazepine or to any other ingredients of TRILEPTAL listed in section 6.

Warnings and precautions

Talk to your doctor or pharmacist before taking TRILEPTAL:

• If you have ever shown unusual sensitivity (rash or any other signs of allergy) to carbamazepine, any other antiepileptic medicine or any other medicines. If you are allergic to carbamazepine, the chances are approximately 1 in 4 (25 %) that you may also develop an allergic reaction to oxcarbazepine (TRILEPTAL).
• If you have a serious liver or kidney disease.
• If you are taking diuretics (medicines used to help the kidneys get rid of salt and water by increasing the amount of urine produced).
• If you suffer from a heart failure, shortness of breath and/or swelling of the feet or legs due to fluid build-up.
• If you know that your blood level of sodium is low.
• If you are taking other medicines (see ‘Other medicines and TRILEPTAL’).
• If you are a woman taking a hormonal contraceptive (e.g. “the pill”), TRILEPTAL may render this contraceptive ineffective. Therefore, you should use a different or additional non-hormonal method of contraception while you are taking TRILEPTAL. This should help to prevent an unwanted pregnancy. Tell your doctor at once if you get irregular vaginal bleeding or spotting. If you have any questions about this, ask your doctor or healthcare professional.

If any of the above applies to you, tell your doctor before you take TRILEPTAL.

Do not stop your treatment with TRILEPTAL without first checking with your doctor. To prevent sudden worsening of your seizure, do not discontinue your medicine abruptly.

If you develop any of the following symptoms after starting TRILEPTAL, tell your doctor immediately or go to the emergency department at your nearest hospital:

• If you experience an allergic reaction after starting TRILEPTAL. Symptoms include swelling of lips, eyelids, face, throat, mouth, or sudden breathing problems, fever with swollen glands, rash or skin blistering.
• If you notice symptoms of hepatitis , such as jaundice (yellowing of skin or the whites of the eyes).
• If you experience an increase in the frequency of seizures. This is particularly important for children but may also occur in adults.
• 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, nose bleeds, reddish or purplish patches, or unexplained blotches on the skin.
• A small number of people being treated with antiepileptics such as TRILEPTAL have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
• If you have a fast or unusually slow heart beat.

Children and adolescents

In children, your doctor may recommend thyroid function monitoring before therapy and during therapy.

Other medicines and TRILEPTAL

Always tell your healthcare provider if you are taking, any other medicine. (This includes all complementary or traditional medicines.) This applies especially to:

• Hormonal contraceptives (e.g. the birth-control pill) (see ‘TAKE SPECIAL CARE WITH TRILEPTAL’).
• Other antiepileptic and enzyme inducing medicines such as carbamazepine, phenobarbital, phenytoin or lamotrigine and rifampicin.
• Medicines which reduce the level of sodium in your blood, e.g. diuretics (used to help the kidneys get rid of salt and water by increasing the amount of urine produced).
• Medicines which control the body’s immune system, e.g. ciclosporin and tacrolimus.

TRILEPTAL with food, drink and alcohol: TRILEPTAL can be taken with or without food. Alcohol may increase the sedative effects of TRILEPTAL. Avoid alcohol as much as possible and ask your doctor for advice.

TRILEPTAL and children: TRILEPTAL can be used for children aged 1 month and above.

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice.

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 TRILEPTAL.

Do not stop your treatment with TRILEPTAL during pregnancy without first checking with your doctor.

Ask your doctor, pharmacist or healthcare professional for advice before taking any medicine during pregnancy.

Breastfeeding

The active substance in TRILEPTAL passes into breast milk. This could cause side effects for breastfed babies. Therefore, TRILEPTAL should not be used during breastfeeding. Ask your doctor, pharmacist or healthcare professional for advice before taking any medicine while you are breastfeeding.

Driving and using machines

TRILEPTAL may make you feel sleepy or dizzy, or may cause blurred vision, double vision, lack of muscle coordination or a depressed level of consciousness, especially when starting treatment or increasing the dose. It is important to discuss with your doctor if you can drive a vehicle or operate machines while taking TRILEPTAL.

Do not share medicines prescribed for you with others. Always take TRILEPTAL exactly as your doctor has told you. Check with your doctor if you are not sure. The doctor will decide on the most suitable dosage according to the individual patient’s medical need and response. Always take or give TRILEPTAL exactly as the doctor has instructed you.

How much to take

Dose for adults:

TRILEPTAL should be taken twice a day, every day, at about the same times of the day, unless the doctor tells you otherwise. Taking the medication at the same time each day will have the best effect on controlling epilepsy. It will also help you to remember when to take the medication.

The usual starting dose of TRILEPTAL for adults (including elderly patients) is 600 mg per day. Take one 300 mg twice daily. This dosage may be gradually increased if necessary until the best results are obtained. Maintenance doses are usually between 600 and 2400 mg per day. The dosage is the same if TRILEPTAL is being taken with another antiepileptic.

The starting dose in patients with kidney disease (with impaired renal function) is half the usual starting dose.

Dose for children:

The dosage for children will be calculated by your doctor and depends on your child’s weight. The starting dose is 8 to 10 mg per kg bodyweight per day given in two divided doses. If necessary, this dose may be gradually increased until the best results are obtained. A usual maintenance dose for a child is 30 mg per kg bodyweight per day. The maximum dose for a child is 60 mg per kg bodyweight per day.

How to take TRILEPTAL tablets

Swallow the tablets with a little water. If necessary, the tablets can be broken in half to help swallow them.

When and for how long to take TRILEPTAL:

Your doctor will tell you how long your/your child’s treatment with TRILEPTAL will last. The duration of treatment is based on your/your child’s seizure type; ongoing treatment for many years may be necessary to control the seizures. Do not change the dose or stop treatment without talking to your doctor.

If you take more TRILEPTAL than you should:

If you have taken many more TRILEPTAL tablets than your doctor prescribed, contact the nearest hospital or poison centre immediately.

If you forget to take TRILEPTAL

If you have only 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. Just go back to your regular dosing timetable. Do not double the dose at any time.

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

If you stop taking TRILEPTAL

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.

TRILEPTAL can have side -effects. Not all side-effects reported for TRILEPTAL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TRILEPTAL, please consult your doctor, pharmacist or other health care professional for advice.

Some effects could be serious. Tell your doctor immediately or go to the emergency department at your nearest hospital or healthcare centre if any of the following side- effects occur:

• 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 and joints.
• Severe blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (signs of serious allergic reaction).
• 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, nausea, loss of appetite (signs of systemic lupus erythematosus).
• Lethargy, confusion, muscular twitching or significant worsening of convulsions (symptoms that may be linked to low sodium levels in the blood).
• Flu-like symptoms with jaundice (yellowing of the skin or the whites of the eyes) (signs of hepatitis).
• Severe upper stomach (abdominal) pain, vomiting, loss of appetite (signs of pancreatitis).
• Weight gain, tiredness, hair loss, muscle weakness, feeling cold (signs of under active thyroid gland).
• In very young children (aged 1 month to less than 4 years): lethargy, decreased appetite and irritability.

Other side effects: If any of the following side effects occur, tell your doctor as soon as possible since they may require medical attention.

Frequent : Trembling; problems with coordination; involuntary movement of the eyes; feeling of anxiety and nervousness ; feeling of depression.

Less Frequent : Irregular heart beats or very fast or slow heart rate .

Tell your doctor if you have any of the following side effects and if they worry you:

Frequent : Tiredness; headache; dizziness; drowsiness; nausea; vomiting; double vision.

Common: Weakness; memory disturbances; impaired concentration; apathy; agitation; confusion; blurred vision; constipation; diarrhoea; stomach (abdominal) pain; acne; hair loss; disturbance of balance, weight increased.

Less frequently TRILEPTAL has been associated with high blood pressure and vitamin B9 (folic acid) deficiency. Some of the signs of vitamin B9 deficiency are: diarrhoea, feeling of depression and signs of decrease in the number of blood cells (see subsection ‘Some effects could be serious’).

These are usually mild to moderate side effects of TRILEPTAL. Most of these effects are transient and usually diminish over time. There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures in patients on long term-treatment with TRILEPTAL.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “ 6.04 Adverse Drug Reaction Reporting Form ”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications /Index/8. By reporting side effects, you can help provide more information on the safety of TRILEPTAL.

Tablets: Blister packs: Store at or below 30 °C and protect from moisture. Keep out of the reach and sight of children.

Plastic containers: Store at or below 30 °C and protect from moisture. Keep well closed. Keep out of the reach and sight of children.