Topiramate Accord Healthcare 25Mg, 50Mg, 100Mg and 200Mg Film-Coated Tablets (Topiramate)
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Package leaflet: Information for the user Topiramate Accord Healthcare 25mg, 50mg, 100mg and 200mg Film-coated Tablets (Topiramate) Read all of this leaflet carefully before you start Topiramate tablets with food, drink and alcohol taking this medicine because it contains important You can take Topiramate tablets with or without food. To information for you. prevent kidney stones whilst being treated with Topiramate • Keep this leaflet. You may need to read it again. tablets, drink plenty of fluids during the day. You should • If you have any further questions, ask your doctor or avoid drinking alcohol when taking Topiramate tablets. pharmacist. Pregnancy and breast-feeding • This medicine has been prescribed for you only. Do Pregnancy not pass it on to others. It may harm them, even if Migraine prevention: their signs of illness are the same as yours. Topiramate tablets can harm an unborn baby. You must • If you get any side effects, talk to your doctor or not take Topiramate tablets if you are pregnant. You must pharmacist. This includes any possible side effects not not take Topiramate tablets for migraine prevention if you listed in this leaflet. See section 4. are a woman of childbearing potential unless you are using • The full name of this medicine is Topiramate Accord effective contraception. Talk to your doctor about the best Healthcare 25mg, 50mg, 100mg and 200mg kind of contraception and whether Topiramate tablets Film-coated Tablets but within the leaflet it will be are suitable for you. Before the start of treatment with referred to as Topiramate tablets. Topiramate tablets, a pregnancy test should be performed. Treatment of epilepsy: If you are a woman of childbearing potential you should What is in this leaflet: talk to your doctor about other possible treatments instead 1 What Topiramate tablets are and what they of Topiramate tablets. If the decision is made to take are used for Topiramate tablets, you should use effective contraception. 2 What you need to know before you take Talk to your doctor about the best kind of contraception to use while you are taking Topiramate tablets. Before the Topiramate tablets start of treatment with Topiramate tablets a pregnancy test 3 How to take Topiramate tablets should be performed. 4 Possible side effects 5 How to store Topiramate tablets Talk to your doctor if you wish to become pregnant. As 6 Contents of the pack and other information with other antiepileptic medicines, there is a risk of harm to the unborn child if Topiramate tablets is used during pregnancy. Make sure you are very clear about the risks and the benefits of taking Topiramate tablets for epilepsy 1 What Topiramate tablets are and what they during pregnancy. are used for • If you take Topiramate tablets during pregnancy, your Topiramate belongs to a group of medicines called baby has a higher risk for birth defects, particularly, cleft antiepileptic medicines. It is used: lip (split in the top lip) and cleft palate (split in the roof of • alone to treat seizures in adults and children over age 6 the mouth). Newborn boys may also have a malformation • with other medicines to treat seizures in adults and of the penis (hypospadia). These defects can develop children aged 2 years and above early in pregnancy, even before you know you are • to prevent migraine headaches in adults. pregnant. • If you take Topiramate tablets during pregnancy, your 2 What you need to know before you take baby may be smaller than expected at birth. Talk to Topiramate tablets your doctor if you have questions about this risk during Do not take Topiramate tablets pregnancy. • if you are allergic to topiramate or any of the other • There may be other medicines to treat your condition ingredients of this medicine (listed in section 6). that have a lower risk of birth defects. • for migraine prevention do not take if you are pregnant • Tell your doctor straight away if you become pregnant or if you are a woman of childbearing potential unless you while taking Topiramate tablets. You and your doctor are using effective contraception (see ‘Pregnancy and should decide if you will continue to take Topiramate breast-feeding’ for further information). You should talk to tablets while you are pregnant. your doctor about the best kind of contraception to use while you are taking Topiramate tablets. Breast-feeding The active substance in Topiramate tablets (topiramate) Warnings and precautions passes into human milk. Effects have been seen in Talk to your doctor or pharmacist before taking breastfed babies of treated mothers, including diarrhoea, Topiramate tablets if you feeling sleepy, feeling irritable, and poor weight gain. • have, or have a family history of kidney stones or too Therefore, your doctor will discuss with you whether you much calcium in the urine abstain from breast-feeding or whether to abstain from • have other kidney problems, or are having kidney treatment with Topiramate tablets. Your doctor will take dialysis into account the importance of the medicine to the mother and the risk for the baby. • have a history of blood and body fluid abnormality (metabolic acidosis) Mothers who breastfeed while taking Topiramate tablets • have liver problems must tell the doctor as soon as possible if the baby • have eye problems, especially glaucoma experiences anything unusual. • have a growth problem • are on a high fat diet (ketogenic diet) Driving and using machines • are taking Topiramate tablets to treat epilepsy and you Dizziness, tiredness and vision problems may occur whilst are pregnant or a woman of childbearing potential taking Topiramate tablets. Do not drive or use any tools or (see section ‘Pregnancy and breast-feeding’ for further machines without talking to your doctor first. information). Topiramate tablets contain lecithin (soya oil) If you are not sure if any of the above applies to you, talk to Topiramate 50mg, 100mg and 200mg tablets contain your doctor or pharmacist before lecithin (soya oil). If you are allergic to peanuts or soya, do using Topiramate tablets. not use this medicinal product. It is important that you do not stop taking your medicine This medicine contains less than 1 mmol sodium without first consulting your doctor. (23mg) per film-coated tablet, that is to say essentially ‘sodium-free’. You should also talk to your doctor before taking any other medicine containing topiramate that is given to you as an 3 How to take Topiramate tablets alternative to Topiramate tablets. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not You may experience weight loss while taking Topiramate sure. tablets. Therefore, your weight should be checked regularly Your doctor will usually start you on a low dose and slowly when using this medicine. If you are losing too much increase your dose until the best dose is found. weight or if a child using this medicine is not gaining enough weight, you should consult your doctor. The recommended dose is If you take Topiramate tablets only for epilepsy You should drink plenty of fluids while taking Topiramate • Adults – starting dose of 25mg at night. The dose will tablets, especially prior to and during activities such as be slowly increased to a maintenance dose, usually 100- exercise or being exposed to warm temperatures, as this 200mg a day in 2 divided doses. Maximum dose of 500mg may reduce the risk of heat-related side effects. a day in 2 divided doses. • Children over 6 years of age – starting dose of 0.5-1mg A small number of people being treated with anti-epileptic per kg of body weight at night increasing slowly to a medicines such as Topiramate tablets have had thoughts maintenance dose, usually 100mg a day. of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor. If you take Topiramate tablets with another epilepsy medicine Topiramate tablets may in rare cases cause high levels of • Adults – starting dose of 25-50mg at night. The dose will ammonia in the blood (seen in blood tests) which can lead be slowly increased to a maintenance dose, usually 200- to a change in brain function, especially if you are also 400mg a day in 2 divided doses. taking a medicine called valproic acid or sodium valproate. Since this may be a severe condition, tell your doctor • Children over 2 years of age – starting dose of 1-3mg immediately if the following symptoms occur (see also per kg of body weight at night increasing slowly to a section 4 ‘Possible side effects’): maintenance dose, usually 5-9mg per kg of body weight a day in 2 divided doses. • difficulty thinking, remembering information, or solving problems Prevention of migraines • being less alert or aware • Adults – starting dose of 25mg at night. The dose will be • feeling very sleepy with low energy slowly increased to a maintenance dose of 100mg a day At higher doses of Topiramate tablets, the risk of in 2 divided doses. developing these symptoms may increase. • Children – Not recommended for use in children. Other medicines and Topiramate tablets Swallow whole. Do not chew. Take with or without food. Tell your doctor or pharmacist if you are taking, have To prevent kidney stones while taking Topiramate tablets, recently taken or might take any other medicines. drink plenty of fluids during the day. Topiramate and certain other medicines can affect each other. Sometimes the dose of some of your other If you take more Topiramate tablets than you medicines or Topiramate tablets will have to be adjusted. should Especially, tell your doctor or pharmacist if you are taking: See a doctor right away.