PACKAGE LEAFLET: INFORMATION FOR THE USER 1. WHAT TOPIRAMATE IS AND WHAT IT IS USED FOR

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR THE USER TOPIRAMATE 25 MG, 50 MG, 100 MG, 200 MG FILM-COATED TABLETS (Topiramate) Read all of this leaflet carefully before you start taking this medicine. - Keep this leaflet. You may need to read it again. - If you have further questions, ask your doctor or your pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, - even if their symptoms are the same as yours. - If you notice any side effects not mentioned in this leaflet or if you experience one of the listed side effects as serious, please inform your doctor or pharmacist. In this leaflet: 1. What Topiramate is and what it is used for 2. Before you take Topiramate 3. How to take Topiramate 4. Possible side effects 5. How to store Topiramate 6. Further information 1. WHAT TOPIRAMATE IS AND WHAT IT IS USED FOR Topiramate belongs to a group of medicines called anticonvulsants or antiepileptic drugs. Topiramate can be used to treat various types of epilepsy in adults and children aged 12 years and older and to prevent frequently recurring migraine headaches in adults. Topiramate can be taken either on its own or in combination with other medicines used to treat epilepsy. 2. BEFORE YOU TAKE TOPIRAMATE Do not take Topiramate - if you are hypersensitive (allergic) to topiramate or any of the other ingredients of the medicinal product. - for the prevention of migraine headaches if you are pregnant or of child bearing age and you are not using an effective method of contraception Take special care with Topiramate - if you suffer from kidney or liver disease (your doctor may need to lower your topiramate dose) - if you or any member of your family suffer from kidney stones. Topiramate may increase your chances of suffering from kidney stones. If you suffer from pain in the kidneys or lower back see your doctor immediately. Fatty and low carbonate diets and medicines that increase the risk of kidney stone formation should be avoided (please check with your pharmacist).

2 - if you begin to lose weight. You should contact your doctor to discuss what you should do. - if during treatment your eyes become painful or your vision blurred tell your doctor immediately. The symptoms may be caused by increased pressure in the eye (glaucoma) caused by topiramate. - if you or any member of your family has suffered from depression. Topiramate can cause mood disturbances and depression. Your doctor will discuss appropriate treatments with you Tell your doctor if you have regular kidney dialysis. Your doctor may want to increase your topiramate dose on your dialysis days. It is important to drink plenty of fluids whilst on topiramate to reduce the chances of suffering from kidney stones. Topiramate can reduce the ability of your body to sweat, especially in children taking this medicine causing body temperature to rise during exerciseor when in warm environments. Drinking plenty of fluids before and during exercise or when in warm environments may reduce the risk of heat-related side-effects like headaches and feeling sick. Topiramate may reduce serum bicarbonate levels in the blood causing a condition known as metabolic acidosis. This may occur at any time while you are taking topiramate, including early in your treatment. The risk of suffering from metabolic acidosis is greater if you suffer from kidney disease, severe respiratory disorders, epileptic seizures lasting more than 30 minutes (status epilepticus) or diarrhoea or if you have had recent surgery. If you have a high fat or protein diet or are taking certain other medicines you may also be at risk from metabolic acidosis. Long term metabolic acidosis increases the risk of kidney stone formation and in children it may reduce growth rates and cause rickets. Your doctor may want to reduce your dose or gradually stop your topiramate treatment. Tell your doctor immediately if you or your child suffers from suicidal thoughts. Taking other medicines: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription. Topiramate may alter the effectiveness of other medicines and other medicines may alter the effectiveness of topiramate when they are taken together. It is especially important to tell your doctor if you are taking any of the following: - Phenytoin or carbamazepine (for epilepsy) because your doctor may need to change the doses of these antiepilieptic medicines or your dose of topiramate - Digoxin (for heart disease) because your doctor may need to change your digoxin dose

3 - Diltiazem (for high blood pressure and chest pain caused by angina) because your doctor may need to change your topiramate dose - Hormonal contraceptives because their effectiveness may be reduced while you are on topiramate. You should tell your doctor of any change in your menstrual bleeding pattern - Metformin, glibenclamide or pioglitazone (for diabetes) because your doctor will want to monitor your diabetes - Lithium (for manic depression) as your doctor may need to change your lithium dose - Hydrochlorothiazide (HCTZ) (water tablets) because your doctor may need to reduce your topiramate dose Taking Topiramate with food and drink: Topiramate can be taken with or without a meal with a sufficient quantity of liquid. Taking Topiramate and alcohol together may increase the effects of Topiramate on your central nervous system. Therefore you should avoid taking TOPIRAMATE and alcohol together. Pregnancy and breast-feeding Topiramate may damage the developing foetus. However, untreated epilepsy and serious seizures caused by suddenly stopping your medication might cause more damage. Therefore, topiramate should only be taken during pregnancy, if in the opinion of your doctor, the potential benefits outweigh the potential risks to the foetus. Topiramate Film-coated Tablets must not be taken to prevent migraine attacks during pregnancy or if you are a woman of child bearing age and you are not using effective contraception. Topiramate is excreted in human breast milk. Therefore, topiramate should not be taken during breast feeding or breast feeding should be stopped. You should contact your doctor for advice on what is appropriate for you. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines: Topiramate may influence your ability to drive as it may cause drowsiness, dizziness and other symptoms that might affect your ability to concentrate. You should exercise caution when driving or using machines until you are sure of how topiramate affects you. Important information about some of the ingredients of Topiramate: Topiramate 200 mg Film-coated Tablets contain the colourants Sunset Yellow (E110) and Allura Red (E129), which may cause allergic reactions. If you have been told that you have an allergy to these food colourants, contact your doctor before taking this medicinal product.

4 3. HOW TO TAKE TOPIRAMATE Always take Topiramate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. Your doctor will start with a low dose and slowly increase the dose until you are on the amount needed to control your epilepsy or migraine headaches. Always check that you have enough tablets and do not run out. Dosage if you are only taking topiramate to treat your epilepsy (for adults and adolescents aged 12 years and older): Your doctor will start you on 25 mg for 7 days to be taken nightly. Your doctor may increase your daily dose with mg every 7 or 14 days until your epilepsy is under control. Your doctor will tell you how much to take. The usual dose for adults or children aged 12 years and older is 50 mg twice daily but your doctor may tell you to use a higher or lower dose. The maximum recommended daily dose is 400 mg. Dosage if you are taking topiramate and other antiepileptic drugs to treat your epilepsy (for adults and adolescents aged 12 years and older): Your doctor will start you on mg for 7 days to be taken nightly. Your doctor may increase your daily dose with mg every 7 or 14 days until your epilepsy is under control. Your doctor will tell you how much to take. The usual dose for adults or children aged 12 years and older is 100 to 200 mg twice daily but your doctor may tell you to use a higher or lower dose. The maximum recommended daily dose is 800 mg. Dosage if you are taking topiramate to prevent migraine headaches: Your doctor will start you 25 mg for 7 days to be taken nightly. Your doctor may increase your daily dose with 25 mg every 7 days. The usual dose for adults is 50 mg twice daily but your doctor may tell you to use a lower dose. Patients with Kidney Problems: If you suffer from kidney disease your doctor will start you on half the usual dose. If your dose needs to be increased this will be done slowly to reduce the chance of you suffering from unwanted side-effects. Patients with Liver Problems: If you suffer from liver disease tell your doctor. Your doctor will tell you how much to take and how often to take it.

5 Patients on Kidney Dialysis: You must tell your doctor if you are undergoing kidney dialysis treatment as your dose may need to be increased on your dialysis days. Children under 12 years: There is limited information on the use of topiramate in children younger than 12 years of age. Therefore do not give topiramate to children younger than 12 years of age unless you have discussed this with your doctor. Method of Administration: Try to take the tablets at the same time every day. Part of your total daily dose should be taken in the morning and the remainder in the evening. Swallow the tablets whole with plenty of water. Do not chew or break the tablets. If you take more Topiramate than you should Contact your doctor or nearest casualty department immediately. Take the container and any remaining tablets with you. Signs and symptoms of topiramate overdose include: drowsiness, speech disturbances, blurred vision, double vision, inability to concentrate, tiredness and a lack of energy, lack of responsiveness, low blood pressure, abdominal pain, headache, agitation, dizziness, abnormal coordination, depression and seizures and changes in blood tests. If you forget to take Topiramate If you miss a dose take it as soon as you remember unless it is nearly time for your next dose. In which case, do not take the missed dose simply carry on as normal. Do not take a double dose to make up for forgotten individual doses. If you stop taking Topiramate Your medicine has been prescribed to help control your epilepsy or the recurrence of migraine headaches. Do not suddenly stop taking this medicine without talking to your doctor first. If you have to stop taking topiramate your doctor will gradually reduce your dose to reduce the chance of you suffering an epileptic fit or migraine attack. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, topiramate can cause side effects, although not everyone gets them. The frequencies are defined as: Very common (more than 1 out of 10 persons) Common (more than 1 out of 100 persons but less than 1 out of 10 persons)

6 Uncommon (more than 1 out of 1,000 persons but less than 1 out of 100 persons) Rare (more than 1 out of 10,000 persons but less than 1 out of 1,000 persons) Very common side effects include: headaches, feeling sick, dizziness, exhaustion, tiredness, nervousness, weight loss and anorexia, changes in thinking including difficulty in concentrating, slow thinking, confusion and forgetfulness, drowsiness, sleepiness and speech disorders depression, anxiety, uncoordinated movements, tingling, loss of appetite and vision disorders including blurred vision and double vision. Common side effects include: pain in bones, allergic reactions, trouble sleeping, changes in the blood (including blood acidity, a decrease in red and white blood cells, a decrease in platelets), nosebleeds, bruising of the skin, feelings of apathy or euphoria, mood swings, weakness, agitation, reduced sex drive, changes in taste, kidney stones (that may cause blood in the urine or pain in the lower back or genital area), incontinence, constipation, abdominal pain, hair loss, tremors and co-ordination problems including problems walking normally, changes in personality and aggressive behaviour, cognitive problems including changes in thinking or awareness, involuntary eye movements and menstrual disturbances. Uncommon side effects include: hallucinations, personality disorders, thoughts or attempts of committing suicide, difficulty breathing, diarrhoea, being sick, suffering from a dry mouth, inflammation of the skin, itchiness, inability to move properly, loss of responsiveness and reduced sweating (mostly in children) mainly during exercise or in particularly warm conditions. If someone becomes flushed or overheated, they should relax in a cool place and drink plenty of water. Rare side effects include: difficulty seeing including eye pain and shortsightedness (glaucoma and acute myopia), changes in liver function which may rarely result in hepatitis or liver failure. If you feel unwell with one of these side effects, contact your doctor immediately. There have been isolated reports of the occurrence of skin rashes, blisters on the skin and sore mouth/eyes. If you have a high temperature or feel unwell with one of these side effects, contact your doctor immediately. If any of the side effects gets serious, or you notice any side effects not listed in this leaflet please tell your doctor or pharmacist. 5. HOW TO STORE TOPIRAMATE Keep out of reach and sight of children. Do not use Topiramate after the expiry date which is stated on the blister and the carton. The expiry date refers to the last day of that month. Store in the original package in order to protect from light and moisture. Do not use topiramate if you notice discolouration of the tablets. 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.

7 6. FURTHER INFORMATION What Topiramate Film-coated Tablets contain The active substance is topiramate. Each film-coated tablet contains 25 mg, 50 mg, 100 mg or 200 mg topiramate per tablet. The other ingredients are: Tablet core: microcrystalline cellulose, povidone K29-32, silica colloidal anhydrous, sodium starch glycolate (type A), magnesium stearate. Film-coat: titanium dioxide (E171), Hypromellose (E464), macrogol 400, polysorbate 80 (E433)(25 mg only), iron oxide yellow (E172)(50/100 mg only), allura red aluminium lake (E129), sunset yellow aluminium lake (E110) and indigo carmine aluminium lake (E132)(200 mg only). What Topiramate Film-coated tablets look like and contents of the pack Your medicine comes in the form of a film-coated tablet that should look like the following: 25 mg: White, round, biconvex, film-coated tablet marked with G on one side and TO over 25 on the other. 50 mg: Yellow, round, biconvex, film-coated tablet marked with G on one side and TO over 50 on the other. 100 mg: Yellow, round, biconvex, film-coated tablet marked with G on one side and TO over 100 on the other. 200 mg: Red, round, biconvex, film-coated tablet marked with G on one side and TO over 200 on the other. The medicinal product is available in aluminium foil blisters in pack sizes of 10, 15, 20, 28, 30, 50, 60, 90, 100, 200 film-coated tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder To be completed nationally. Manufacturer To be completed nationally. This medicinal product is authorised in the Member States of the EEA under the following names: Austria Belgium Czech Republic Topiramat Arcana Topiramate Mylan

8 Denmark Finland Germany Greece Italy Norway Poland Slovak Republic Slovenia Sweden The Netherlands United Kingdom Topiramat dura 25 mg, 50 mg, 100 mg, 200 mg Filmtabletten Topiramate / Generics Topiramato Mylan Generics Jactigen Topiramaat Mylan Topiramate This leaflet was last approved in June 2008