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Trileptal® Oxcarbazepine Consumer Medicine Information

Trileptal® Oxcarbazepine Consumer Medicine Information

Trileptal® oxcarbazepine Consumer Medicine Information

What is in this leaflet is a condition in which there Partial seizures may be simple or are repeated convulsions or seizures complex. This leaflet answers some common (fits). Seizures happen because of a • During simple partial seizures, questions about Trileptal. temporary fault in the brain's the patient remains conscious electrical system. It does not contain all the available • In complex partial seizures, the information. It does not take the Normally, brain cells coordinate patient's consciousness is altered. body movements by sending out place of talking to your doctor or Trileptal may be used alone or in signals through the nerves to the pharmacist. combination with other medicines to muscles in an orderly way. The information in this leaflet was treat partial and generalised tonic- last updated on the date listed on the In epilepsy, brain cells send out too clonic seizures in adults and children. many signals in a disorderly fashion. final page. More recent information Ask your doctor if you have any on the medicine may be available. The result can be uncoordinated muscular activity that is called an questions about why this medicine You should ensure that you speak epileptic seizure. has been prescribed for you. to your pharmacist or doctor to Your doctor may have prescribed it Trileptal works by keeping the obtain the most up to date for another purpose. information on the medicine. You brain's overexcitable nerve cells Trileptal is only available with a can also download the most up to under control, thereby, reducing the doctor's prescription. date leaflet from frequency of seizures. www.medsafe.govt.nz. There are two main classes of Trileptal can be used in children aged 1 month and above and in people Those updates may contain important seizures: generalised and partial. older than 65 years of age. information about the medicine and Generalised seizures - There is no evidence that this its use of which you should be aware. involve a wide area of the brain, and All medicines have risks and can affect the whole body. medicine is addictive. benefits. Your doctor has weighed • Tonic-clonic (or grand mal) the risks of you or your child taking seizures are a sub-type of this medicine against the benefits generalised seizure in which the Before you take they expect it will have. sufferer may lose consciousness If you have any concerns about and have generalised jerky Trileptal taking this medicine, ask your muscle contractions. When you must not take it doctor or pharmacist. • Absence (or petit mal) seizures Keep this leaflet with the medicine. are brief, repetitive and involve Do not take Trileptal if you have You may need to read it again. the whole brain. They usually an allergy to: occur in children and the person • oxcarbazepine (the active loses awareness of what is ingredient in Trileptal) happening around them. They • eslcarbazepine (another active tend to stare, and roll back their What Trileptal is used ingredient related to eyes. for oxcarbazepine) Partial seizures - • any of the other ingredients of Trileptal belongs to a group of involve a limited area of the brain Trileptal listed at the end of this medicines called or (i.e. focal origin), may spread to the leaflet antiepileptics. Trileptal is used in whole brain, and may cause a Tell your doctor if you are allergic adults and children to control some generalised tonic-clonic seizure. types of epilepsy. to , the active

TRILEPTAL® 1 ingredient in Tegretol®, another without first checking with your (HRT) for menopause and in oral medicine used to treat epilepsy. doctor. contraceptives (see below) About 25 to 30% of people who are Ask your doctor or pharmacist for • cyclophosphamide, a medicine allergic to carbamazepine are also advice before taking any medicine used to treat some types of cancer allergic to oxcarbazepine (Trileptal). during . and to suppress the immune Symptoms of an allergic reaction Tell your doctor if you are system may include shortness of breath, or plan to • some medicines used to treat wheezing or difficulty breathing; breastfeed. stomach ulcers, including swelling of the face, lips, tongue or The active ingredient in Trileptal omeprazole, lansoprazole and other parts of the body; rash, itching passes into breast milk and may pantoprazole or hives on the skin. possibly affect your baby. • St John's wort, which is found in Tell your doctor if you are of Han You should not take Trileptal many medicines that you can buy Chinese or Thai origin. during breast-feeding. without a prescription in a The risk of serious skin reactions pharmacy, health food shop or Ask your doctor or pharmacist for supermarket may be predicted by testing your advice before taking any medicine • blood. Your doctor should be able to during breast-feeding. proguanil, a medicine used to advise if you need a blood test before treat malaria starting this medicine. Taking other medicines • medicines (such as cyclosporin) Do not take Trileptal after the used to help prevent organ Tell your doctor if you are taking expiry date printed on the pack or transplant rejection or to treat any other medicines, including if the packaging is torn or shows certain problems with the medicines that you buy without a signs of tampering. immune system prescription from a pharmacy, In that case, return it to your supermarket or health food shop. The above medicines may be pharmacist. affected by Trileptal or they may Some medicines and Trileptal may affect how well it works. You may If you are not sure whether you interfere with each other. These need to take different amounts of should start taking Trileptal, talk include: to your doctor or pharmacist. your medicines or you may need to • some other medicines used to take different medicines. Your treat seizures such as Before you start to take it doctor will advise you. phenobarbitone, , Tell your doctor if you are taking Tell your doctor if you have, or carbamazepine, rifampicin and oral contraceptives (birth control have had, any medical conditions, valproic acid pills). especially the following: • and calcium If you begin taking Trileptal while • problems antagonists such as and you are taking birth control pills, the , which are medicines • kidney problems pill may not work as well as it used to treat heart problems and • a low level of sodium in your should. Unplanned can high blood pressure blood happen. Your doctor can suggest • medicines which reduce the level another form of birth control while • problems with your heart of sodium in your blood, e.g. you are taking Trileptal. Tell your doctor if you are diuretic medicines, also called Your doctor and pharmacist have pregnant or intend to become fluid or water tablets, which are more information on medicines to be pregnant. used to help the kidneys get rid of careful with or avoid while taking salt and water by increasing the It is important to control epileptic Trileptal. seizures during pregnancy. However amount of urine produced If you have not told your doctor there may be a risk to your unborn • , a medicine used to about any of the above, tell baby if you take Trileptal or other help you sleep or calm you down antiepileptic medicines during him/her before you take Trileptal. • some medicines used to treat pregnancy. Your doctor will tell you depression, including , the benefits and potential risks , and involved and help you to decide citalopram whether you should take Trileptal. • progesterone, which is often used Do not stop your treatment with in hormone replacement therapy Trileptal during pregnancy

TRILEPTAL® 2 How to take Trileptal Trileptal can be taken either with or If you take too much without food. (overdose) Follow all directions given to you Take the tablets with a full glass of Immediately telephone your doctor by your doctor and pharmacist water. or National Poisons and Hazardous carefully. If you have to divide any tablets, you Chemicals Information Centre, These directions may differ from the can buy a cutter from your Dunedin (Phone 0800 POISON or information contained in this leaflet. pharmacist to make sure the dose is 080 764 766) for advice or go to the If you do not understand the accurate. Accident and Emergency instructions on the label, ask your Department at your nearest doctor or pharmacist for help. How long to take it hospital, if you think you or anyone else may have taken too Continue taking your medicine for much Trileptal. Do this even if How much to take as long as your doctor tells you. there are no signs of discomfort or Before and during your treatment Trileptal helps to control your poisoning. with Trileptal, your doctor may epilepsy but does not cure it. You Keep the telephone numbers for perform blood tests to determine the must take this medicine every day, dose for you. Your doctor will tell these places handy. even if you feel well. you when to have the tests. Some of the symptoms of an Do not stop taking Trileptal or Do not exceed the recommended overdose may include sleepiness, lower the dose without first dose. dizziness, nausea and vomiting, loss checking with your doctor. Do not Adults and Elderly patients: of coordination, hyperactivity and let yourself run out of medicine rolling of the eyes. Your doctor will decide your starting over the weekend or on holidays. dose. The usual starting dose of Stopping your medicine suddenly or Trileptal is 600 mg per day. lowering the dose may cause you to The dose can be gradually increased have seizures. Your doctor will if necessary to the amount needed to While you are taking usually reduce the dose slowly before Trileptal control your seizures. Maintenance you can stop taking it completely. doses are usually between 600 mg and 2400 mg each day. Some people If you forget to take it Things you must do will need higher or lower doses than Tell your doctor immediately if other people. If it is almost time for your next dose of Trileptal, skip the missed you become pregnant while taking Patients with kidney disease dose. Take your next dose at the Trileptal. The starting dose in impaired renal usual time and continue on with Your doctor can discuss with you the function is half the usual starting your normal schedule. risks of taking Trileptal while you are dose. If your next dose of Trileptal is not pregnant. Children: due for quite a while, take a dose Be sure to keep all of your doctor's Your doctor will calculate the dose, as soon as you remember. Then appointments so that your progress depending on the weight of the child. take your next dose at the usual can be checked. Your doctor may recommend thyroid time and continue on with your This helps to provide you with the function testing before therapy and normal schedule. best treatment and to prevent during therapy (especially in children Do not take a double dose to make unwanted side effects from aged 2 years or below). up for the one that you missed. happening. This may increase the chance of you Contact your doctor immediately if How to take it getting an unwanted side effect. at any time you have thoughts of Take Trileptal twice each day, If you are unsure or have forgotten harming or killing yourself. every day, at about the same time to take several doses, contact your A number of people being treated each day, unless your doctor tells doctor. with antiepileptics have had such you otherwise. If you have trouble remembering thoughts or behaviour. Taking your medicine at the same when to take your medicine, ask If you are about to be started on time each day will have the best your pharmacist for some hints. any new medicine, remind your effect. It will also help you remember doctor and pharmacist that you when to take it. are taking Trileptal.

TRILEPTAL® 3 Tell any doctor, dentist or Side effects uncontrollable movements of the pharmacist who treats you that eyes, tremor, clumsiness, painful you are taking Trileptal. Tell your doctor or pharmacist as and swollen joints and lack of soon as possible if you do feel coordination Things you must not do unwell while you are taking The above side effects are usually Do not stop taking Trileptal or Trileptal. mild. They tend to happen at the lower the dose without first All medicines can have unwanted start of treatment and usually lessen checking with your doctor. side effects. Sometimes they are after a while. Do not use Trileptal to treat any serious, most of the time they are not. Tell your doctor immediately or go other complaints unless your You may need medical treatment if to Accident and Emergency at doctor tells you to. you get some of the side effects. your nearest hospital if you notice any of the following: Do not give this medicine to anyone Do not be alarmed by the following else, even if their symptoms seem list of possible side effects. • tiredness, headaches, being short similar to yours or they have the You may not experience any of them. of breath when exercising, same condition as you do. dizziness and looking pale Ask your doctor or pharmacist to • answer any questions you may frequent infections leading to Things to be careful of have. fever, severe chills, sore throat or mouth ulcers Ask your doctor if you can drive a Tell your doctor or pharmacist if • vehicle or operate machines. you notice any of the following and bleeding or bruising more easily Trileptal may make you feel sleepy they worry you: than normal, nose bleeds or dizzy, cause blurred vision or • • tiredness or drowsiness signs of allergy such as swelling double vision, and can make you of the face, lips, eyelids, throat, • lose muscle coordination. dizziness or spinning sensation mouth, tongue or neck Be careful driving, operating • headache accompanied by difficulty in machinery or doing jobs that • weakness, lack of energy breathing, speaking or require you to be alert, until you swallowing • shakiness, clumsiness, lack of know how Trileptal affects you. coordination • skin rash, fever, and pain in the There have been reports of bone muscle or joints • disturbance of balance disorders including osteopenia and • severe itching, rash, or hives, • anxiety, agitation, nervousness, osteoporosis (thinning of the bone) fainting, unconsciousness and fractures in patients on long term depression, mood swings • signs of a serious skin reaction, treatment with Trileptal. • apathy such as painful red areas, severe Children should avoid doing things • increase frequency of seizures, or large blisters, peeling of layers like riding bicycles or climbing especially in children of skin, bleeding in the lips, eyes, trees. • difficulty in concentrating, mouth, nose, nasal passages or This medicine may cause dizziness, forgetfulness, confusion genitals. These signs may be drowsiness or blurred vision in some accompanied by fever and chills, • blurred or double vision people, especially when you first aching muscles and feeling start to use it or when the dose is • involuntary movements of the generally unwell, especially in increased. eyes some Asian populations (e.g. Be careful when drinking • nausea (feeling sick) or vomiting Taiwanese, Malaysian, and Philippine) and in patients with while you are taking Trileptal. • constipation Avoid alcohol as much as possible Chinese ancestry • diarrhoea and ask your doctor for advice. • constant "flu-like" symptoms • pain in the stomach (abdomen) Alcohol may increase the sedative such as chills, fever, sore throat, effects of this medicine. The • acne swollen glands, mouth ulcers, combination could make you feel • hair loss aching joints, lack of energy • sleepier, dizzier or more light headed • weight increased fever with swollen glands than usual. • • in very young children (aged 1 unusual bleeding or bruising, month to less than 4 years): reddish/purplish patches, or lethargy, decreased appetite, unexplained blotches on the skin irritability, vomiting, rapid

TRILEPTAL® 4 • red blotchy rash mainly on face After taking Trileptal Contain 150, 300 or 600 mg of which may be accompanied by oxcarbazepine as the active fatigue, fever, nausea, loss of ingredient. They also contain: Storage appetite (signs of systemic lupus • silica - colloidal anhydrous erythematosus) • Keep your medicine in the • cellulose - microcrystalline • hair loss, weight gain, tiredness, original container until it is time • muscle weakness, feeling cold to take a dose. hypromellose (signs of under active thyroid • Store the medicine in a cool dry • crospovidone gland) place where the temperature stays • stearate below 30°C. • fast, unusually slow, or an • macrogol 8000 (300 mg tablet irregular heart beat • Do not store Trileptal or any only) other medicine in the bathroom or • persistent nausea, vomiting, • macrogol 4000 (150 and 600 mg near a sink. severe abdominal pain, loss of tablets only) appetite, unusual tiredness, • Do not leave it in the car or on • talc - purified yellowing of the skin and/or eyes, window sills. dark urine or pale bowel motions • titanium dioxide Heat and dampness can destroy some (signs of possible or a medicines. • iron oxide yellow CI 77492 (150 serious liver problem) and 300 mg tablets only) Keep Trileptal where children • tiredness, drowsiness, lack of cannot reach it. • iron oxide red CI 77491 (150 and energy, decreased alertness, 600 mg tablets only) confusion, nausea, vomiting, A locked cupboard at least one-and- • iron oxide black CI 77499 (150 blurred vision, muscular a-half metres above the ground is a and 600 mg tablets only) twitching, and increased seizures good place to store medicines. (symptoms of a low level of Trileptal tablets do not contain sodium in the blood) Disposal lactose, sucrose, gluten, tartrazine or any other azo dyes. • flu-like symptoms with yellowing If your doctor tells you to stop of the skin and/or eyes (signs of taking Trileptal or you find that it Sponsor hepatitis) has passed the expiry date, ask your pharmacist what to do with Trileptal is supplied in New Zealand • irregular vaginal bleeding or any medicine you have left over. by: spotting

• thoughts of harming or killing New Zealand Limited yourself, as a small number of PO Box 99102 people being treated with Product description antiepileptics have such thoughts Newmarket or behaviours Auckland 1149 What it looks like The above signs are serious side Telephone 0800 354 335 effects that may require urgent Trileptal tablets: medical attention. Oval tablets marked with a break line This leaflet was prepared in Tell your doctor if you notice on both sides, available in packs of September 2020 based on the anything else that is making you 100 tablets. currently approved data sheet for this feel unwell. Trileptal 150 mg: pale grey/green product. Some people may have other side tablets with a break line on both effects not yet known or mentioned sides, coded TD on one side and CG in this leaflet. on the other Internal document code: (tri080920cNZ.doc) based on DS Trileptal 600 mg: light pink tablets (tri080920iNZ.doc) with a break line on both sides, coded TF/TF on one side and CG/CG on

the other.

Ingredients Trileptal tablets:

TRILEPTAL® 5

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