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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 pharmacist. signals through the nerves to the muscles in an orderly way. combination with other medicines to 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 Trileptal works by keeping the Your doctor may have prescribed it 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..com.au. There are two main classes of Trileptal can be used in children aged Those updates may contain important seizures: generalised and partial. 1 month and above and in people older than 65 years of age. information about the medicine and Generalised seizures - its use of which you should be aware. involve a wide area of the brain, and There is no evidence that this 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 • eslicarbazepine (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 ingredient in Tegretol® and Teril®,

TRILEPTAL® 1 which are other medicines used to It is important to control epileptic salt and water by increasing the treat epilepsy. seizures during . However amount of urine produced About 25 to 30% of people who are there may be a risk to your unborn • , a medicine used to allergic to carbamazepine are also baby if you take Trileptal or other help you sleep or calm you down allergic to oxcarbazepine (Trileptal). antiepileptic medicines during pregnancy. Your doctor will tell you • some medicines used to treat Symptoms of an allergic reaction the benefits and potential risks depression, including , may include shortness of breath, involved and help you to decide , and wheezing or difficulty breathing; whether you should take Trileptal. citalopram swelling of the face, lips, tongue or • progesterone, which is often used Do not stop your treatment with other parts of the body; rash, itching in hormone replacement therapy Trileptal during pregnancy or hives on the skin. (HRT) for menopause and in oral without first checking with your Tell your doctor if you are of Han contraceptives (see below) doctor. Chinese or Thai origin. • cyclophosphamide, a medicine Ask your doctor or pharmacist for The risk of serious skin reactions used to treat some types of cancer advice before taking any medicine may be predicted by testing your and to suppress the immune during pregnancy. blood. Your doctor should be able to system Tell your doctor if you are advise if you need a blood test before • some medicines used to treat or plan to starting this medicine. stomach ulcers, including breastfeed. Do not take Trileptal after the omeprazole, lansoprazole and expiry date printed on the pack or The active ingredient in Trileptal pantoprazole passes into breast milk and may if the packaging is torn or shows • St John's wort, which is found in possibly affect your baby. signs of tampering. many medicines that you can buy In that case, return it to your You should not take Trileptal without a prescription in a pharmacist. during breast-feeding. pharmacy, health food shop or If you are not sure whether you Ask your doctor or pharmacist for supermarket should start taking Trileptal, talk advice before taking any medicine • proguanil, a medicine used to to your doctor or pharmacist. during breast-feeding. treat malaria

Taking other medicines • medicines (such as cyclosporin) Before you start to take it used to help prevent organ Tell your doctor if you have, or Tell your doctor if you are taking transplant rejection or to treat have had, any medical conditions, any other medicines, including certain problems with the especially the following: medicines that you buy without a immune system prescription from a pharmacy, • problems The above medicines may be supermarket or health food shop. affected by Trileptal or they may • kidney problems Some medicines and Trileptal may affect how well it works. You may • a low level of sodium in your interfere with each other. These need to take different amounts of blood include: your medicines or you may need to • problems with your heart • some other medicines used to take different medicines. Your doctor will advise you. Tell your doctor if you have an treat seizures such as intolerance to sorbitol, fructose, or phenobarbitone, , Tell your doctor if you are taking parabens. In that case, you should carbamazepine, rifampicin and oral contraceptives (birth control not take Trileptal oral suspension, valproic acid pills). but you can take Trileptal tablets. • and calcium If you begin taking Trileptal while Each mL of Trileptal oral suspension antagonists such as and you are taking birth control pills, the contains 175 mg of sorbitol. Sorbitol , which are medicines pill may not work as well as it is converted by the liver to fructose. used to treat heart problems and should. Unplanned can If people with intolerance to fructose high blood pressure happen. Your doctor can suggest take sorbitol, it can lead to stomach • medicines which reduce the level another form of birth control while upset and diarrhoea. 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 Trileptal.

TRILEPTAL® 2 If you have not told your doctor each day, unless your doctor tells Do not stop taking Trileptal or about any of the above, tell him/ you otherwise. lower the dose without first her before you take Trileptal. Taking your medicine at the same checking with your doctor. Do not time each day will have the best let yourself run out of medicine effect. It will also help you remember over the weekend or on holidays. when to take it. Stopping your medicine suddenly or How to take Trileptal Trileptal can be taken either with or lowering the dose may cause you to without food. have seizures. Your doctor will Follow all directions given to you usually reduce the dose slowly before by your doctor and pharmacist Tablets you can stop taking it completely. carefully. Take the tablets with a full glass of These directions may differ from the water. If you forget to take it information contained in this leaflet. If you have to divide any tablets, you If it is almost time for your next If you do not understand the can buy a cutter from your dose of Trileptal, skip the missed instructions on the label, ask your pharmacist to make sure the dose is dose. Take your next dose at the doctor or pharmacist for help. accurate. usual time and continue on with Oral suspension: your normal schedule. How much to take The bottle is supplied with an oral If your next dose of Trileptal is not Before and during your treatment dosing syringe and a press-in bottle due for quite a while, take a dose with Trileptal, your doctor may adaptor. Diagrams and instructions as soon as you remember. Then perform blood tests to determine the on how to use the dispensing system take your next dose at the usual dose for you. Your doctor will tell can be found in the carton. time and continue on with your normal schedule. you when to have the tests. Shake the bottle well and measure Do not exceed the recommended the dose immediately afterwards. Do not take a double dose to make dose. The dose that your doctor prescribes up for the one that you missed. Adults and Elderly patients: you should be given in millilitres This may increase the chance of you getting an unwanted side effect. Your doctor will decide your starting (mL) and not in milligrams (mg). dose. The usual starting dose of This is important because the oral If you are unsure or have forgotten Trileptal is 600 mg per day (or 10 dosing syringe which is used to to take several doses, contact your mL of the oral suspension). withdraw the correct dose from the doctor. bottle is marked in mL. The dose can be gradually increased If you have trouble remembering if necessary to the amount needed to If your prescription is in mg, when to take your medicine, ask control your seizures. Maintenance contact your doctor or pharmacist your pharmacist for some hints. doses are usually between 600 mg for advice. and 2400 mg each day (or 10 mL and Withdraw the prescribed amount If you take too much 40 mL for the oral suspension). Some of oral suspension from the bottle (overdose) people will need higher or lower using the oral dosing syringe Immediately telephone your doctor doses than other people. supplied. or Poisons Information Centre Patients with kidney disease Swallow the dose directly from the (Phone 13 11 26) for advice or go to The starting dose in impaired renal syringe or, if you prefer, mix it in a Accident and Emergency at your function is half the usual starting small glass of water and drink it nearest hospital, if you think you dose. right away. or anyone else may have taken too much Trileptal. Do this even if Children: Close the bottle and wipe the outside of the oral syringe with a there are no signs of discomfort or Your doctor will calculate the dose, dry, clean tissue. poisoning. depending on the weight of the child. Keep the telephone numbers for Your doctor may recommend thyroid How long to take it these places handy. function testing before therapy and during therapy (especially in children Continue taking your medicine for Some of the symptoms of an aged 2 years or below). as long as your doctor tells you. overdose may include sleepiness, Trileptal helps to control your dizziness, nausea and vomiting, loss How to take it epilepsy but does not cure it. You of coordination, hyperactivity and rolling of the eyes. Take Trileptal twice each day, must take this medicine every day, every day, at about the same time even if you feel well.

TRILEPTAL® 3 While you are taking require you to be alert, until you • shakiness, trembling, clumsiness, Trileptal know how Trileptal affects you. lack of coordination There have been reports of bone • disturbance of balance Things you must do disorders including osteopenia and • anxiety, agitation, nervousness, osteoporosis (thinning of the bone) depression, mood swings Tell your doctor immediately if and fractures in patients on long term you become pregnant while taking treatment with Trileptal. • apathy Trileptal. • increase frequency of seizures, Children should avoid doing things especially in children Your doctor can discuss with you the like riding bicycles or climbing risks of taking Trileptal while you are trees. • difficulty in concentrating, pregnant. forgetfulness, confusion This medicine may cause dizziness, Be sure to keep all of your doctor's drowsiness or blurred vision in some • blurred or double vision appointments so that your progress people, especially when you first • involuntary movements of the can be checked. start to use it or when the dose is eyes increased. This helps to provide you with the • memory disturbance best treatment and to prevent Be careful when drinking • nausea (feeling sick) or vomiting unwanted side effects from while you are taking Trileptal. happening. Avoid alcohol as much as possible • constipation Contact your doctor immediately if and ask your doctor for advice. • diarrhoea at any time you have thoughts of Alcohol may increase the sedative • pain in the stomach (abdomen) harming or killing yourself. effects of this medicine. The • acne A number of people being treated combination could make you feel with antiepileptics have had such sleepier, dizzier or more light headed • hair loss thoughts or behaviour. than usual. • weight increased If you are about to be started on • in very young children (aged 1 any new medicine, remind your month to less than 4 years): doctor and pharmacist that you lethargy, decreased appetite, are taking Trileptal. Side effects irritability, vomiting, rapid uncontrollable movements of the Tell any doctor, dentist or Tell your doctor or pharmacist as eyes, tremor, clumsiness, painful pharmacist who treats you that soon as possible if you do feel and swollen joints, and lack of you are taking Trileptal. unwell while you are taking coordination Trileptal. Things you must not do The above side effects are usually All medicines can have unwanted mild. They tend to happen at the start Do not stop taking Trileptal or side effects. Sometimes they are of treatment and usually lessen after lower the dose without first serious, most of the time they are not. a while. checking with your doctor. You may need medical treatment if Tell your doctor immediately or go Do not use Trileptal to treat any you get some of the side effects. to Accident and Emergency at other complaints unless your Do not be alarmed by the following your nearest hospital if you notice doctor tells you to. list of possible side effects. any of the following: Do not give this medicine to anyone You may not experience any of them. • tiredness, headaches, being short else, even if their symptoms seem Ask your doctor or pharmacist to of breath when exercising, similar to yours or they have the answer any questions you may dizziness and looking pale same condition as you do. have. • frequent infections leading to Things to be careful of Tell your doctor or pharmacist if fever, severe chills, sore throat or you notice any of the following and mouth ulcers Ask your doctor if you can drive a they worry you: • bleeding or bruising more easily vehicle or operate machines. • tiredness or drowsiness than normal, nose bleeds Trileptal may make you feel sleepy or dizzy, cause blurred vision or • dizziness or spinning sensation • signs of allergy such as swelling double vision, and can make you • headache of the face, lips, eyelids, throat, lose muscle coordination. mouth, tongue or neck • weakness, lack of energy accompanied by difficulty in Be careful driving, operating machinery or doing jobs that

TRILEPTAL® 4 breathing, speaking or (symptoms of a low level of Disposal swallowing sodium in the blood) If your doctor tells you to stop • skin rash, or blistering, fever, and • flu-like symptoms with yellowing taking Trileptal or you find that it pain in the muscle or joints of the skin and/or eyes (signs of has passed the expiry date, ask • severe itching, rash, or hives, hepatitis) your pharmacist what to do with fainting, unconsciousness • irregular vaginal bleeding or any medicine you have left over. • signs of a serious skin reaction, spotting such as painful red areas, severe • thoughts of harming or killing or large blisters, peeling of layers yourself, as a small number of of skin, bleeding in the lips, eyes, people being treated with Product description mouth, nose, nasal passages or antiepileptics have such thoughts genitals. These signs may be or behaviours What it looks like accompanied by fever and chills, The above signs are serious side Trileptal tablets: aching muscles and feeling effects that may require urgent Oval tablets marked with a break line generally unwell medical attention. on both sides, available in packs of • rash, red skin, blistering of the Tell your doctor if you notice 50 and 100 tablets. lips, eyes or moth, skin peeling anything else that is making you Trileptal 150 mg: pale green tablets and accompanied by fever, feel unwell. especially in some Asian coded TD on one side and CG on the populations (e.g. Taiwanese, Some people may have other side other effects not yet known or mentioned Malaysian, and Philippine) and in Trileptal 300 mg: yellow tablets in this leaflet. patients with Chinese ancestry coded TE/TE on one side and CG/ • constant "flu-like" symptoms CG on the other such as chills, fever, sore throat, Trileptal 600 mg: light pink tablets swollen glands, mouth ulcers, After taking Trileptal coded TF/TF on one side and CG/CG aching joints, lack of energy on the other. • fever with swollen glands Storage Trileptal oral suspension: • unusual bleeding or bruising, An off-white to slightly reddish • Keep your medicine in the reddish/purplish patches, or brown liquid supplied with an oral original container until it is time unexplained blotches on the skin dosing syringe and a press-in bottle to take a dose. • red blotchy rash mainly on face adaptor. • Store the medicine in a cool dry which may be accompanied by A 10mL oral dosing syringe is place where the temperature stays fatigue, fever, nausea, loss of supplied with the bottle containing below 30°C. appetite (signs of systemic lupus 250mL of Trileptal oral suspension. erythematosus) • Use the oral suspension within 7 Discolouration of the oral suspension weeks after first opening the • hair loss, weight gain, tiredness, to a slightly reddish brown colour is bottle. After 7 weeks, return any muscle weakness, feeling cold normal and does not affect the unused oral suspension to your (signs of under active thyroid quality of the medicine. pharmacist for safe disposal. gland) • Do not store Trileptal or any Ingredients • fast, unusually slow, or an other medicine in the bathroom or irregular heart beat Trileptal tablets: near a sink. • persistent nausea, vomiting, Contain 150, 300 or 600 mg of • Do not leave it in the car or on severe abdominal pain, loss of oxcarbazepine as the active window sills. appetite, unusual tiredness, ingredient. They also contain: yellowing of the skin and/or eyes, Heat and dampness can destroy some • silica - colloidal anhydrous dark urine or pale bowel motions medicines. • cellulose - microcrystalline (signs of possible or a Keep out of reach of children. serious liver problem) • hypromellose A locked cupboard at least one-and- • tiredness, drowsiness, lack of a-half metres above the ground is a • crospovidone energy, decreased alertness, good place to store medicines. • stearate confusion, nausea, vomiting, • macrogol 8000 (300 mg tablet blurred vision, muscular only) twitching, and increased seizures

TRILEPTAL® 5 • macrogol 4000 (150 and 600 mg Tablets: tablets only) Trileptal 150 mg AUST R 76200 • talc - purified Trileptal 300 mg AUST R 76201 • titanium dioxide Trileptal 600 mg AUST R 76202 • iron oxide yellow (150 and 300 Oral suspension mg tablets only) 60 mg/mL: AUST R 81195 • iron oxide red (150 and 600 mg tablets only) • iron oxide black (150 and 600 mg (tri290620c.doc) based on PI tablets only) (tri290620i.doc) Trileptal tablets do not contain lactose, sucrose, gluten, tartrazine or any other azo dyes. Trileptal oral suspension: Each mL of oral suspension contains 60 mg of oxcarbazepine. The suspension also contains: • purified water • sorbitol (175 mg/mL) • propylene glycol • dispersible cellulose • ascorbic acid (E 300) • yellow-plum-lemon aroma • methyl hydroxybenzoate (E 218) • PEG-8-stearate • sorbic acid (E 200) • saccharin sodium • propyl hydroxybenzoate (E 216). Trileptal oral suspension contains hydroxybenzoates, saccharin, sorbates and sugar alcohols. Ethanol is a component of the flavour.

Sponsor Trileptal is supplied in Australia by: NOVARTIS Pharmaceuticals Australia Pty Limited ABN 18 004 244 160 54 Waterloo Road Macquarie Park NSW 2113 Telephone 1-800-671-203 ® = Registered trademark

This leaflet was prepared in June 2020.

Australian Registration Number.

TRILEPTAL® 6