Topiramate Sandoz 100mg Tablets 60

  Information General Information TOPIRAMATE SANDOZ®topiramate tablets--------------------------------------------------------------------------------Consumer Medicine InformationWHAT IS IN THIS LEAFLETThis leaflet answers some common questions about Topiramate Sandoz. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.All medicines have risks and benefits. Your doctor has weighed the risk of you taking Topiramate Sandoz against the benefits it is expected to have for you.If you have any concerns about taking this medicine, ask your doctor or pharmacist.Keep this leaflet with the medicine. You may need to read it again.WHAT TOPIRAMATE SANDOZ IS USED FORTopiramate Sandoz is used to treat various types of epilepsy in adults and children over 2 years of age, and to prevent migraines in adults.Topiramate Sandoz contains the active ingredient topiramate.Topiramate belongs to a group of medicines called anti-convulsants. It prevents seizures and migraines by acting on the nerves and chemicals in the brain.Your doctor may prescribe Topiramate Sandoz on its own, or in addition to another medicine for controlling your seizures or migraines.Ask your doctor if you have any questions about why this medicine has been prescribed for you.Your doctor may have prescribed it for another reason.BEFORE YOU TAKE TOPIRAMATE SANDOZWhen you must not take itDo not take this medicine if you have an allergy to:the active ingredient topiramate or to any of the other ingredients listed at the end of this leaflet under Product Descriptionany other similar medicines.Some of the symptoms of an allergic reaction may include:shortness of breathwheezing or difficulty breathingswelling of the face, lips, tongue or other parts of the bodyrash, itching or hives on the skin.Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.If you are not sure whether you should start taking this medicine, talk to your doctor.Before you start to take itTell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.Tell your doctor if you have or have ever had any of the following medical conditions:a personality disorder or mental illnesskidney stones, kidney disease or a family history of kidney stonesliver diseaseeye problem or high pressure in the eye.Tell your doctor if you are pregnant or plan to become pregnant. Topiramate Sandoz has caused harm to the developing foetus in animal studies. Its safety has not been verified in pregnant humans. However, it is very important to control your fits while you are pregnant. If it is necessary for you to take this medicine, your doctor can help you decide whether or not to take it during pregnancy.Tell your doctor if you are breastfeeding or wish to breastfeed. Topiramate Sandoz may appear in breast milk and it is not recommended to breastfeed while taking this medicine.If you have not told your doctor about any of the above, tell him/her before you start taking Topiramate Sandoz.Taking other medicinesTell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.Some medicines and Topiramate Sandoz may interfere with each other. These include:other medicines for epilepsy, such as phenytoin or carbamazepinedigoxin (used to treat heart disease)oral contraceptives (the pill)metformin, pioglitazone, glibenclamide (used to treat diabetes)acetazolamide (used to treat glaucoma)lithium, risperidone (used to treat bipolar disorder and schizophrenia)hydrochlorothiazide (used to treat swelling or high blood pressure)propranololvalproic aciddiltiazem (used to treat hypertension and prevent angina)venlafaxine (used to treat depression)any medicine which slows your reactions. This may include medicines to help you sleep or relieve pain, antidepressants, tranquillisers or antihistamines which can make you drowsy.These medicines may be affected by Topiramate Sandoz, or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.HOW TO TAKE TOPIRAMATE SANDOZFollow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.If you do not understand the instructions, ask your doctor or pharmacist for help.How much to takeThe doses shown below are the usual recommended doses. However, your doctor may tell you to take higher or lower doses. Your doctor will start with a low dose and slowly increase the dose to the lowest amount needed to control your epilepsy.At the start of treatment Topiramate Sandoz may be taken once a day, preferably at night. After the dose is increased, it is taken twice a day.You should continue taking Topiramate Sandoz until your doctor tells you to stop. Before stopping, it is recommended that the dose be reduced gradually.Adults Epilepsy - Treatment starts at a low dose of 25mg to 50mg per day. The dose is then gradually increased by 25mg to 100mg over weekly periods or longer, until the most suitable dose is reached.Migraine - Treatment starts at a low dose of 25mg nightly for one week. The dose is then increased over weekly periods or longer by 25mg/day, until the most suitable dose is reached.Children (2 years and over) - epilepsy only - Treatment starts at 25mg or less per day, depending on the body weight. This dose is then gradually increased over weekly periods or longer, until the most suitable dose is reached.Ask your doctor or pharmacist if you are unsure of the correct dose for you. They will tell you exactly how much to take.Follow the instructions they give you. If you take the wrong dose, Topiramate Sandoz may not work as well and your problem may not improve.How to take itYou can take the tablets with or without food. Always swallow the tablets whole with plenty of water.If you forget to take itTake your dose as soon as you remember, and continue to take it as you would normally.If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.Do not take a double dose to make up for the dose you missed. This may increase the chance of you getting an unwanted side effect.If you are not sure what to do, ask your doctor or pharmacist.If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.If you take too much (overdose)Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Topiramate Sandoz. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.If you take too much Topiramate Sandoz, you may experience headache, dizziness, lightheadedness, drowsiness, convulsions, speech disturbances, double or blurred vision, difficulty with thinking, abnormal coordination, stomach pain, depression, agitation, faster breathing or you may lose consciousness.WHILE YOU ARE TAKING TOPIRAMATE SANDOZThings you must doAlways follow your doctor’s instructions carefully.Tell your doctor if you become pregnant while taking Topiramate Sandoz.If you are about to start taking a new medicine, tell your doctor and pharmacist that you are taking Topiramate Sandoz.Drink plenty of water. Topiramate Sandoz has been known to cause kidney stones and drinking water may help prevent this.Things you must not doDo not stop taking Topiramate Sandoz without your doctor’s permission.Do not take Topiramate Sandoz to treat any other complaints unless your doctor says so.Do not give your medicine to anyone else, even if their symptoms seem similar to yours.Do not drink alcohol.Do not drive or operate machinery until you know how the medicine affects you.Things to be careful ofEffects on thoughts and behaviourMedicines used to treat epilepsy can increase the risk of suicidal thoughts and behaviour. If you experience feelings of deep sadness and unworthiness (depression) or a worsening of these feelings, any unusual changes in your mood or the emergence of suicidal thoughts, behaviour or thoughts of self harm, you should report this to your doctor immediately.Effects on driving and operating machineryTopiramate Sandoz may cause drowsiness, dizziness or other symptoms which could affect your ability to drive or operate machinery. It may also cause visual disturbances and/or blurred vision. Make sure you know how you are affected by this medicine before you drive or use machinery.Particular care is recommended when you first start taking Topiramate Sandoz or if the amount of Topiramate Sandoz or any other medicine you are taking is increased or decreased.Effects of food and alcoholTopiramate Sandoz can be taken with or without food.Do not drink alcohol while taking Topiramate Sandoz. Alcohol may increase the risk of unwanted side effects, such as drowsiness.SIDE EFFECTSTell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Topiramate Sandoz. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.Do not be alarmed by the following lists of side effects. You may not experience any of them.Ask your doctor or pharmacist to answer any questions you may have.Tell your doctor or pharmacist if you notice any of the following and they worry you:unusual tiredness, drowsiness, weakness, dizzinessdecrease in appetite or weight lossitchy skin or skin rashinability to sleepheadachetingling and numbness of hands and feetnose bleednausea, diarrhoea, constipationtaste disturbance or loss of taste.Tell your doctor as soon as possible if you notice any of the following as you may need medical attention:nervousness or feeling anxiousdisturbance in attentiondifficulty with memory or memory impairmentslowing of thought processesabnormal behaviourbalance disorderco-ordination problemsexpressive language disorderunusual hair loss or thinningabnormal frequent urinationdecreased feeling or sensitivity, especially in the skinfever or high temperatureunusual weaknessdifficulty in speaking.Tell your doctor immediately if you have:kidney stonespain when passing urinesudden changes in your eyesight (e.g. blurred or loss of vision) or rapid uncontrollable movements of the eyes.These are serious side effects that may require urgent medical attention. Serious side effects are rare.Tell your doctor or pharmacist if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people.AFTER TAKING TOPIRAMATE SANDOZStorageKeep your medicine in the original container until you need to take it.If you take it out of its original container it may not keep well.Keep your medicine in a cool dry place where the temperature stays below 30°C.Do not store Topiramate Sandoz or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.DisposalIf your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.PRODUCT DESCRIPTIONWhat it looks likeTopiramate Sandoz tablets are available in bottles of 60 tablets:25mg tablets are white, round shaped, film-coated tablets, plain on both sides.50mg tablets are yellow, round shaped, film-coated tablets, plain on both sides.100mg tablets are white, round shaped, film-coated tablets, plain on both sides.200mg tablets are yellow, round shaped, film-coated tablets, plain on both sides.IngredientsActive Ingredient:Each Topiramate Sandoz 25mg tablet contains 25mg topiramate.Each Topiramate Sandoz 50mg tablet contains 50mg topiramate.Each Topiramate Sandoz 100mg tablet contains 100mg topiramate.Each Topiramate Sandoz 200mg tablet contains 200mg topiramate.Inactive Ingredients:lactosepregelatinised maize starchmicrocrystalline cellulosesodium starch glycollatemagnesium stearatetitanium dioxidehypromellosemacrogol 400polysorbate 80iron oxide yellow (50mg and 200mg tablets only).SupplierTopiramate Sandoz is supplied in Australia by:Sandoz Pty LtdABN 60 075 449 553Level 4, 100 Harris StPyrmont NSW 2009Tel: 1800 634 500 1800 634 500This leaflet was prepared in August 2009.Australian Register NumbersTopiramate Sandoz 25mg tablets: AUST R 135762Topiramate Sandoz 50mg tablets: AUST R 135779Topiramate Sandoz 100mg tablets: AUST R 135794Topiramate Sandoz 200mg tablets: AUST R 135810Published by MIMS/myDr October 2009Consumers should be aware that the information provided by the Consumer Medicines Information (“CMI”) search (“CMI Search”) is for information purposes only and consumers should continue to obtain professional advice from a qualified healthcare professional regarding any condition for which they have searched for CMI. CMI is supplied by the relevant pharmaceutical company for each consumer medical product. All copyright and responsibility for CMI is that of the relevant pharmaceutical company. UBM Medica Australia uses its best endeavours to ensure that at the time of publishing, as indicated on the publishing date for each resource (e.g. “Published by MIMS/myDr January 2007”), the CMI provided was complete to the best of UBM Medica Australia’s knowledge. The CMI and the CMI Search are not intended to be used by consumers to diagnose, treat, cure or prevent any disease or for any therapeutic purpose. UBM Medica Australia, its servants and agents shall not be responsible for the continued currency of the CMI, or for any errors, omissions or inaccuracies in the CMI and/or the CMI Search whether arising from negligence or otherwise or from any other consequence arising there from Miscellaneous Drug Interactions Warnings Common Uses Ingredients Directions Indications