TRILEPTAL 150 MG FILM-COATED TABLETS
Active substance: OXCARBAZEPINE
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1
PACKAGE LEAFLET: INFORMATION FOR THE USER
1. WHAT TRILEPTAL IS AND WHAT IT IS USED FOR
What Trileptal is
The active ingredient of Trileptal is oxcarbazepine. Trileptal belongs to a group of medicines called anticonvulsants or antiepileptics.
Trileptal is for use in adults and in children of 6 years of age and above.
2. BEFORE YOU TAKE TRILEPTAL
Follow all instructions given to you by your doctor carefully, even if they differ from the information contained in this leaet.
TRILEPTAL 150 mg lm-coated tablets TRILEPTAL 300 mg lm-coated tablets TRILEPTAL 600 mg lm-coated tablets
Oxcarbazepine
Do not take Trileptal
if you are allergic (hypersensitive) to oxcarbazepine or to any other ingredients of Trileptal tablets (listed in section 6 Further information).
What Trileptal is used for
Medicines such as Trileptal 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 brains 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. Trileptal 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. Trileptal works by keeping the brains overexcitable nerve cells under control. This suppresses or reduces the frequency of such seizures. Trileptal can be used alone or in combination with other antiepileptic medicines. Usually, the doctor will try to nd 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.
Take special care with Trileptal
If any of the following apply to you, tell your doctor before you take Trileptal: 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 (Trileptal). if you have a kidney disease. If you 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 of urine produced). if you have a heart disease, shortness of breath and/or swelling of the feet or legs due to uid 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, Trileptal may stop your contraceptive from working. Use a different or extra (non-hormonal) method of contraception while taking Trileptal. 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. 1215278-1215279 GB TA
Read all of this leaet carefully before you start taking this medicine.
Keep this leaet. 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 or your child. 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 gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist.
In this leaet:
1. What Trileptal is and what it is used for 2. Before you take Trileptal 3. How to take Trileptal 4. Possible side effects 5. How to store Trileptal 6. Further information
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2 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 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 develop the following symptoms after starting Trileptal, tell your doctor as soon as possible: if you have a fast or unusually slow heart beat. to treat mood swings and some types of depression). Medicines that control the bodys immune system, such as ciclosporin and tacrolimus.
How much to take
Dose for adults The usual starting dose of Trileptal for adults (including elderly patients) is 600 mg per day. Take one 300 mg tablet twice daily or two 150 mg tablets twice daily or two 150 mg tablets twice daily. Your doctor may increase the dose gradually to nd the best dose for you. The best results are usually with doses between 600 and 2,400 mg per day. If you take another antiepileptic medicine, the dose is the same. If you have kidney disease (with impaired kidney function), the starting dose is half the usual starting dose. If you have severe liver disease, your doctor may adjust your dose. Dose for children Trileptal 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 nd 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.
Taking Trileptal with food and drink
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.
Pregnancy
Tell your doctor if you 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 benets and potential risks involved and help you to decide whether you should take Trileptal. Do not stop your treatment with Trileptal during pregnancy without rst 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 Trileptal. The active substance in Trileptal 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.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines bought without a prescription. This applies especially to: Hormonal contraceptives, such as the pill (see Take special care with Trileptal). 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-inammatory drugs, such as indometacin. Lithium and monoamine oxidase inhibitors (medicines used
Driving and using machines
Trileptal 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.
How to take Trileptal
3. HOW TO TAKE TRILEPTAL
Always take Trileptal exactly as your doctor or pharmacist has told you, even if this differs from the information given in this leaet. Check with your doctor or pharmacist if you are not sure.
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, Trileptal 1215278-1215279 GB TA is available as an oral suspension.
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3
When and for how long to take Trileptal
Take Trileptal 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 childs treatment with Trileptal will last. The length of treatment will depend on your or your childs 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Trileptal can cause side effects, although not everybody gets them. These side effects may occur with certain frequencies, which are dened as follows: Very common: affects more than 1 patient in 10 Common: affects 1 to 10 patients in 100 Uncommon: affects 1 to 10 patients in 1,000 Very rare: affects less than 1 patient in 10,000 Not known: frequency cannot be estimated from the available data
Flu-like symptoms with jaundice (yellowing of the skin or the whites of the eyes) (signs of hepatitis). Severe upper stomach (abdominal) pain, being sick (vomiting), loss of appetite (signs of inammation 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 Trileptal has to be stopped immediately and how to continue further medical care.
If you take more Trileptal 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 Trileptal may include: drowsiness, dizziness, feeling sick (nausea), being sick (vomiting), increased uncontrolled movements, lethargy, confusion, muscular twitching or signicant worsening of convulsions, problems with coordination and/or involuntary movement of the eyes.
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 difculty 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 including Lyells 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 signicant worsening of convulsions (possible symptoms of low sodium levels in the blood) (see Take special care with Trileptal).
Other side effects: tell a doctor as soon as possible
Common: trembling; coordination problems; involuntary movement of the eyes; anxiety and nervousness; depression; rash. Very rare: 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.
If you forget to take Trileptal
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 double the dose at any time. If you are unsure or have forgotten to take several doses, contact your doctor.
Other side effects: tell a doctor if they worry you:
These are usually mild to moderate side effects of Trileptal. Most of these effects are transient and usually diminish over time. Very common: tiredness; headache; dizziness; drowsiness; feeling sick (nausea); being sick (vomiting); double vision. Common: weakness; memory disturbances; impaired concentration; apathy; agitation; confusion; blurred vision; visual disturbance; constipation; diarrhoea; stomach (abdominal) pain; acne; hair loss, balance disturbances. Uncommon: hives. You may also have raised levels of liver enzymes 1215278-1215279 GB TA while taking Trileptal.
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 product, ask your doctor or pharmacist.
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4 Not known high blood pressure 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 a history of osteoporosis or take steroids. If you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. iron oxide (E 172), talc, titanium dioxide (E 171); for the 300 mg tablet: hypromellose, macrogol 8000, yellow iron oxide (E 172), talc, titanium dioxide (E 171); and for the 600 mg tablet: hypromellose, macrogol 4000, red iron oxide (E 172), black iron oxide (E 172), talc, titanium dioxide (E 171). Denmark Finland France Germany Greece Iceland Ireland Italy Luxembourg Netherlands Portugal Spain Sweden Trileptal Trileptal 150 mg, 300 mg, 600 mg tabletti, kalvopllysteinen Trileptal 150 mg, 300 mg, 600 mg, comprim pellicul Trileptal 150 mg, 300 mg, 600 mg Filmtabletten Trileptal 150mg/, 300mg/, 600mg/ paa e ept dsa Trileptal 150 mg, 300 mg, 600 mg lmuhu taa Trileptal Libertil 150 mg, 300 mg, 600 mg compresse rivestite con lm Trileptal 150 mg, 300 mg, 600 mg Filmtabletten Trileptal 150 mg, 300 mg, 600 mg lmomhulde tabletten Trileptal 150 mg, 300 mg, 600 mg Comprimidos revestidos por pelcula Trileptal 150 mg, 300 mg, 600 mg comprimidos recubiertos con pelcula Trileptal 150 mg, 300 mg, 600 mg lmdragerade tabletter
What Trileptal looks like and contents of the pack
The 150 mg tablet is pale grey green, ovaloid, scored on both sides and embossed with T/D on one side and C/G on the other side. The 300 mg tablet is yellow, ovaloid, scored on both sides, and embossed with TE/TE on one side and CG/CG on the other side. The 600 mg tablet is light pink, ovaloid, scored on both sides, and embossed with TF/TF on one side and CG/CG on the other side. The lm-coated tablets are available in blister packs containing 30, 50, 100, 200 and 500 tablets. Not all pack sizes may be marketed. Trileptal lm-coated tablets come in three strengths 150 mg, 300 mg, 600 mg.
5. HOW TO STORE TRILEPTAL
Keep out of the reach and sight of children. Do not use Trileptal after the expiry date which is stated on the blister and outer carton. The expiry date refers to the last day of that month. Do not use Trileptal if you notice that the pack is damaged or shows signs of tampering. 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.
Marketing Authorisation Holder
Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR United Kingdom
6. FURTHER INFORMATION
What Trileptal contains
The active substance of Trileptal is oxcarbazepine. Trileptal 150 MG FILM-COATED TABLETS Each lm-coated tablet contains 150 mg oxcarbazepine. Trileptal 300 MG FILM-COATED TABLETS Each lm-coated tablet contains 300 mg oxcarbazepine. Trileptal 600 MG FILM-COATED TABLETS Each lm-coated tablet contains 600 mg oxcarbazepine. The other ingredients are: Tablet core: silica colloidal anhydrous, microcrystalline cellulose, hypromellose, crospovidone, magnesium stearate. Tablet coating: for the 150 mg tablet: hypromellose, macrogol 4000, yellow iron oxide (E 172), red iron oxide (E 172), black
Manufacturer
Novartis Pharmaceuticals UK Ltd, Wimblehurst Road, Horsham, West Sussex, RH12 5AB United Kingdom
United Kingdom Trileptal 150 mg, 300 mg, 600 mg lm-coated tablets This leaet was last approved in 02/2012. You can get more information about your epilepsy by contacting these independent patient groups: Telephone N.S.E. The National Society for Epilepsy 01494 601400 B.E.A. The British Epilepsy Association 0808 8005050 E.A.S The Epilepsy Association of Scotland 0808 8002200
1215278-1215279 GB TA
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria Belgium Trileptal 150 mg, 300 mg, 600 mg Filmtabletten Trileptal 150 mg, 300 mg, 600 mg lmomhulde tabletten/comprim pellicul/ Filmtabletten
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PACKAGE LEAFLET: INFORMATION FOR THE USER
1. WHAT TRILEPTAL IS AND WHAT IT IS USED FOR
What Trileptal is
The active ingredient of Trileptal is oxcarbazepine. Trileptal belongs to a group of medicines called anticonvulsants or antiepileptics.
Trileptal is for use in adults and in children of 6 years of age and above.
2. BEFORE YOU TAKE TRILEPTAL
Follow all instructions given to you by your doctor carefully, even if they differ from the information contained in this leaet.
TRILEPTAL 150 mg lm-coated tablets TRILEPTAL 300 mg lm-coated tablets TRILEPTAL 600 mg lm-coated tablets
Oxcarbazepine
Do not take Trileptal
if you are allergic (hypersensitive) to oxcarbazepine or to any other ingredients of Trileptal tablets (listed in section 6 Further information).
What Trileptal is used for
Medicines such as Trileptal 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 brains 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. Trileptal 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. Trileptal works by keeping the brains overexcitable nerve cells under control. This suppresses or reduces the frequency of such seizures. Trileptal can be used alone or in combination with other antiepileptic medicines. Usually, the doctor will try to nd 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.
Take special care with Trileptal
If any of the following apply to you, tell your doctor before you take Trileptal: 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 (Trileptal). if you have a kidney disease. If you 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 of urine produced). if you have a heart disease, shortness of breath and/or swelling of the feet or legs due to uid 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, Trileptal may stop your contraceptive from working. Use a different or extra (non-hormonal) method of contraception while taking Trileptal. 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. 1215278-1215279 GB TA
Read all of this leaet carefully before you start taking this medicine.
Keep this leaet. 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 or your child. 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 gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist.
In this leaet:
1. What Trileptal is and what it is used for 2. Before you take Trileptal 3. How to take Trileptal 4. Possible side effects 5. How to store Trileptal 6. Further information
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2 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 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 develop the following symptoms after starting Trileptal, tell your doctor as soon as possible: if you have a fast or unusually slow heart beat. to treat mood swings and some types of depression). Medicines that control the bodys immune system, such as ciclosporin and tacrolimus.
How much to take
Dose for adults The usual starting dose of Trileptal for adults (including elderly patients) is 600 mg per day. Take one 300 mg tablet twice daily or two 150 mg tablets twice daily or two 150 mg tablets twice daily. Your doctor may increase the dose gradually to nd the best dose for you. The best results are usually with doses between 600 and 2,400 mg per day. If you take another antiepileptic medicine, the dose is the same. If you have kidney disease (with impaired kidney function), the starting dose is half the usual starting dose. If you have severe liver disease, your doctor may adjust your dose. Dose for children Trileptal 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 nd 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.
Taking Trileptal with food and drink
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.
Pregnancy
Tell your doctor if you 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 benets and potential risks involved and help you to decide whether you should take Trileptal. Do not stop your treatment with Trileptal during pregnancy without rst 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 Trileptal. The active substance in Trileptal 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.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines bought without a prescription. This applies especially to: Hormonal contraceptives, such as the pill (see Take special care with Trileptal). 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-inammatory drugs, such as indometacin. Lithium and monoamine oxidase inhibitors (medicines used
Driving and using machines
Trileptal 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.
How to take Trileptal
3. HOW TO TAKE TRILEPTAL
Always take Trileptal exactly as your doctor or pharmacist has told you, even if this differs from the information given in this leaet. Check with your doctor or pharmacist if you are not sure.
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, Trileptal 1215278-1215279 GB TA is available as an oral suspension.
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3
When and for how long to take Trileptal
Take Trileptal 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 childs treatment with Trileptal will last. The length of treatment will depend on your or your childs 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Trileptal can cause side effects, although not everybody gets them. These side effects may occur with certain frequencies, which are dened as follows: Very common: affects more than 1 patient in 10 Common: affects 1 to 10 patients in 100 Uncommon: affects 1 to 10 patients in 1,000 Very rare: affects less than 1 patient in 10,000 Not known: frequency cannot be estimated from the available data
Flu-like symptoms with jaundice (yellowing of the skin or the whites of the eyes) (signs of hepatitis). Severe upper stomach (abdominal) pain, being sick (vomiting), loss of appetite (signs of inammation 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 Trileptal has to be stopped immediately and how to continue further medical care.
If you take more Trileptal 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 Trileptal may include: drowsiness, dizziness, feeling sick (nausea), being sick (vomiting), increased uncontrolled movements, lethargy, confusion, muscular twitching or signicant worsening of convulsions, problems with coordination and/or involuntary movement of the eyes.
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 difculty 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 including Lyells 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 signicant worsening of convulsions (possible symptoms of low sodium levels in the blood) (see Take special care with Trileptal).
Other side effects: tell a doctor as soon as possible
Common: trembling; coordination problems; involuntary movement of the eyes; anxiety and nervousness; depression; rash. Very rare: 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.
If you forget to take Trileptal
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 double the dose at any time. If you are unsure or have forgotten to take several doses, contact your doctor.
Other side effects: tell a doctor if they worry you:
These are usually mild to moderate side effects of Trileptal. Most of these effects are transient and usually diminish over time. Very common: tiredness; headache; dizziness; drowsiness; feeling sick (nausea); being sick (vomiting); double vision. Common: weakness; memory disturbances; impaired concentration; apathy; agitation; confusion; blurred vision; visual disturbance; constipation; diarrhoea; stomach (abdominal) pain; acne; hair loss, balance disturbances. Uncommon: hives. You may also have raised levels of liver enzymes 1215278-1215279 GB TA while taking Trileptal.
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 product, ask your doctor or pharmacist.
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4 Not known high blood pressure 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 a history of osteoporosis or take steroids. If you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. iron oxide (E 172), talc, titanium dioxide (E 171); for the 300 mg tablet: hypromellose, macrogol 8000, yellow iron oxide (E 172), talc, titanium dioxide (E 171); and for the 600 mg tablet: hypromellose, macrogol 4000, red iron oxide (E 172), black iron oxide (E 172), talc, titanium dioxide (E 171). Denmark Finland France Germany Greece Iceland Ireland Italy Luxembourg Netherlands Portugal Spain Sweden Trileptal Trileptal 150 mg, 300 mg, 600 mg tabletti, kalvopllysteinen Trileptal 150 mg, 300 mg, 600 mg, comprim pellicul Trileptal 150 mg, 300 mg, 600 mg Filmtabletten Trileptal 150mg/, 300mg/, 600mg/ paa e ept dsa Trileptal 150 mg, 300 mg, 600 mg lmuhu taa Trileptal Libertil 150 mg, 300 mg, 600 mg compresse rivestite con lm Trileptal 150 mg, 300 mg, 600 mg Filmtabletten Trileptal 150 mg, 300 mg, 600 mg lmomhulde tabletten Trileptal 150 mg, 300 mg, 600 mg Comprimidos revestidos por pelcula Trileptal 150 mg, 300 mg, 600 mg comprimidos recubiertos con pelcula Trileptal 150 mg, 300 mg, 600 mg lmdragerade tabletter
What Trileptal looks like and contents of the pack
The 150 mg tablet is pale grey green, ovaloid, scored on both sides and embossed with T/D on one side and C/G on the other side. The 300 mg tablet is yellow, ovaloid, scored on both sides, and embossed with TE/TE on one side and CG/CG on the other side. The 600 mg tablet is light pink, ovaloid, scored on both sides, and embossed with TF/TF on one side and CG/CG on the other side. The lm-coated tablets are available in blister packs containing 30, 50, 100, 200 and 500 tablets. Not all pack sizes may be marketed. Trileptal lm-coated tablets come in three strengths 150 mg, 300 mg, 600 mg.
5. HOW TO STORE TRILEPTAL
Keep out of the reach and sight of children. Do not use Trileptal after the expiry date which is stated on the blister and outer carton. The expiry date refers to the last day of that month. Do not use Trileptal if you notice that the pack is damaged or shows signs of tampering. 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.
Marketing Authorisation Holder
Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR United Kingdom
6. FURTHER INFORMATION
What Trileptal contains
The active substance of Trileptal is oxcarbazepine. Trileptal 150 MG FILM-COATED TABLETS Each lm-coated tablet contains 150 mg oxcarbazepine. Trileptal 300 MG FILM-COATED TABLETS Each lm-coated tablet contains 300 mg oxcarbazepine. Trileptal 600 MG FILM-COATED TABLETS Each lm-coated tablet contains 600 mg oxcarbazepine. The other ingredients are: Tablet core: silica colloidal anhydrous, microcrystalline cellulose, hypromellose, crospovidone, magnesium stearate. Tablet coating: for the 150 mg tablet: hypromellose, macrogol 4000, yellow iron oxide (E 172), red iron oxide (E 172), black
Manufacturer
Novartis Pharmaceuticals UK Ltd, Wimblehurst Road, Horsham, West Sussex, RH12 5AB United Kingdom
United Kingdom Trileptal 150 mg, 300 mg, 600 mg lm-coated tablets This leaet was last approved in 02/2012. You can get more information about your epilepsy by contacting these independent patient groups: Telephone N.S.E. The National Society for Epilepsy 01494 601400 B.E.A. The British Epilepsy Association 0808 8005050 E.A.S The Epilepsy Association of Scotland 0808 8002200
1215278-1215279 GB TA
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria Belgium Trileptal 150 mg, 300 mg, 600 mg Filmtabletten Trileptal 150 mg, 300 mg, 600 mg lmomhulde tabletten/comprim pellicul/ Filmtabletten
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This information was compiled with utmost care and on completion was subjected to strict internal checks. However, the handling of data always involves a certain degree of risk and the impossibility of error cannot be guaranteed. Therefore we would ask you to check the proof throughly. PharmaDesigners s.a.s. assumes no liability for errors identied only after print approval has be given.
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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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
