Epilim 200mg Tablet EC 200 (2 x 100)

  Information General Information onsumer Medicine InformationWhat is in this leafletThis leaflet answers some common questions about Epilim, a prescription medicine with the active ingredient sodium valproate.It does not contain all of 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 risks of your taking Epilim against the benefits they expect it will have for you. Please read this leaflet very carefully before you start to take your Epilim, even if you have taken Epilim before. If you have any concerns or questions about taking this medicine, ask your doctor or pharmacist.Keep this leaflet with the medicine. You may need to read it again. What Epilim is used for Epilim is used to control epilepsy. Epilepsy is a condition where you have repeated seizures (fits). There are many different types of seizures, ranging from mild to severe. Epilim belongs to a group of medicines called anticonvulsants. These medicines are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen. Epilim may also be used to control mania, a mental condition with episodes of overactivity, elation or irritability. Epilim may be used alone or in combination with other medicines to treat your condition. Your doctor may have prescribed Epilim for another reason. Ask your doctor if you have any questions about why Epilim has been prescribed for you. There is no evidence that Epilim is addictive. This medicine is available only with a doctor's prescription. Before you take it When you must not take itDo not take Epilim if: You have an allergy to sodium valproate (the active ingredient in Epilim) or any of the ingredients listed at the end of this leaflet.Do not take Epilim if you have or have had any of the following medical conditions: Liver disease (hepatic dysfunction) or severe hepatitis. A family history of hepatitis, especially when caused by medicines. Medicines used in the treatment of epilepsy, including Epilim may have adverse effects on the liver and the kidneys. A urea cycle disorder or a family history of urea cycle disorders. A family history of unexplained infant deaths. Porphyria which is a rare blood disease of blood pigments Known ornithine transcarbamylase deficiency or a family history of ornithine transcarbamylase deficiency. If you are not sure whether you should be taking Epilim, talk to your doctor or pharmacist. Do not take Epilim after the expiry date printed on the pack. Do not take Epilim if the packaging looks torn or shows signs of tampering, or if the tablets do not look quite right. If it has expired or is damaged, return it to your pharmacist for disposal. Before you start to take itTell your doctor or pharmacist if you have allergies to: Any other medicines, especially anticonvulsants Any other substances, such as foods, preservatives or dyesTell your doctor if you drink alcohol. If you have more than 2 drinks per day, you may be putting yourself at risk of a seizure, or fit. If you are a female patient of child-bearing age, make sure that you talk to your doctor about the risks associated with taking Epilim during pregnancy. Tell your doctor or pharmacist if your child is taking any other medicines before you start giving them Epilim, for example, aspirin or any other drugs used to treat epilepsy. Things you must doTell your doctor if you have or have had any medical conditions, especially the following: liver problems (hepatic insufficiency, hepatic damage) kidney problems urea cycle disorders ornithine transcarbamylase (OTC) deficiencyTell your doctor if you are pregnant or intend to become pregnant. Epilim may affect your developing baby if taken in the first trimester of pregnancy, as it is suspected of causing an increased risk of malformations in the exposed fetus. However, do not stop taking Epilim unless your doctor says so as there are risks to the mother and child from uncontrolled epilepsy or uncontrolled mania episodes. Your doctor may want to adapt your treatment and/or prescribe dietary supplements of folate. Tell your doctor if you are breast-feeding or plan to breast-feed. Medicines used in the treatment of epilepsy, including Epilim, pass into the breast milk. Your doctor will discuss the possible risks and benefits of using Epilim during breast-feeding. If you have not told your doctor or pharmacist about any of the above, tell them before you start to take Epilim. Taking other medicinesTell your doctor or pharmacist if you are taking any other medicines, even medicines that you buy without a prescription from your pharmacy, supermarket or health food shop because sometimes even common medicines such as aspirin can have harmful effects if taken with Epilim. Some medicines and Epilim may interfere with each other. These include: Aspirin (and other salicylates) Medicines used to prevent clots (anticoagulants) e.g. warfarin. Other medicines used to treat epilepsy e.g. phenobarbitone, methylphenobarbitone, primidone, phenytoin, carbamazepine, clonazepam, felbamate, lamotrigine, diazepam, lorazepam, oxcarbamazepine and ethosuximide Medicines used to treat depression e.g. monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants. Oral contraceptives. Epilim should have little effect on the oral contraceptive pill, however, you should let your doctor know that you are taking it. Zidovudine (a medicine used to treat viral infections). Neuroleptic agents including clozapine (a medicine used to treat schizophrenia). Mefloquine (a medicine used to treat malaria). Cimetidine (used to treat stomach ulcers). Erythromycin and carbapenem antibiotics such as Invanz and Merram. These medicines and others may be affected by Epilim, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist will advise you. Tell your doctor or pharmacist if your child is taking any other medicines before you start giving them Epilim, for example, aspirin or any other drugs used to treat epilepsy. Children, especially young children, can be more sensitive to some of the side effects of Epilim. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Epilim. How to take it How much to takeOnly your doctor can give you a prescription for Epilim. Your doctor will tell you how much to take, and in what form (liquids or tablets) you should take it. This may depend on your age, your condition and whether or not you are taking any other medicines. Your doctor may recommend that you start with a low dose of Epilim and slowly increase the dose to the lowest amount needed to control your condition. Follow all directions given to you by your doctor carefully. If you do not understand the instructions on the box/bottle, ask your doctor or pharmacist for help. How to take itEpilim tablets may be taken twice a day. Epilim Syrup and Sugar-Free Liquid should be taken 2-3 times a day. The white tablets (100 mg crushable tablets) may be swallowed whole or taken with food or drinks. Do not take the white tablets with "fizzy" water, soda or soft drinks. Swallow the lilac tablets (EC200 and EC500) whole with a glass of water or other liquid. Do not crush or chew the lilac tablets. The lilac tablets have a special coating to stop them dissolving until they have gone through the stomach and into the intestines. Chewing them destroys the coating. When taking Epilim Syrup or Epilim Sugar-Free Liquid shake the bottle well and accurately pour the dose into a medicine measure before taking it. Shaking the bottle and using a medicine measure will make sure you get the correct dose. You can get a medicine measure from your pharmacist. When to take itYour doctor will advise you when to take Epilim. Always follow your doctor's instructions. Take Epilim at about the same time each day. Taking Epilim at the same time each day will have the best effect. It will also help you remember when to take it. If you forget to take itAlways remember to take your prescribed dose otherwise you may find that either your seizures or manic symptoms may return. If you forget a dose, take your next dose as usual. Do not take a double dose to make up for the dose that you missed. This may increase the chance of your getting unwanted side effects. If you are not sure what to do, ask your doctor or pharmacist. How long to take itContinue taking Epilim for as long as your doctor tells you to. Epilim helps control your condition but does not cure it. Therefore you must take your medicine every day, even if you feel well. If you take too much (Overdose) Immediately telephone your doctor or the Poisons Information Centre in Australia (telephone 13 11 26) or the National Poisons Information Centre in New Zealand (telephone 0800 POISON or 0800 764 766), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Epilim. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. If you take too much Epilim you may feel dizzy, drowsy or have cramps in the abdomen. While you are taking it Things you must doTell any other doctors, dentists, pharmacists and health professionals that you are taking Epilim. If you become pregnant while taking Epilim, tell your doctor. Before you have any surgery or emergency treatment, tell your doctor or dentist that you are taking Epilim. Be sure to keep all of your doctors appointments so that your progress can be checked. Your doctor will check your progress and may want to take some tests from time to time. This helps prevent unwanted side effects. Things you must not doDo not give Epilim to anyone else even if their symptoms seem similar to yours or if they have the same condition as you. Do not take Epilim to treat any other complaints unless your doctor tells you to. Do not stop taking Epilim or lower your dose without checking with your doctor. Things to be careful ofBe careful driving or operating machinery until you know how Epilim affects you. Epilim may cause drowsiness or light-headedness in some people, especially at the beginning of treatment. Make sure you know how you react to Epilim before you drive a car, operate machinery, or do anything else that could be dangerous if you are drowsy or light headed. If this occurs do not drive. Children should not ride a bike, climb trees or do anything else that could be dangerous if they are feeling drowsy or sleepy. Epilim may cause drowsiness, dizziness or sleepiness in some people and affect alertness. Diabetics are advised that Epilim Syrup contains 3.6 g/5 mL of sucrose (sugar). Be careful when drinking alcohol while taking Epilim. Combining Epilim and alcohol can make you more sleepy, dizzy or lightheaded. Your doctor may suggest you avoid alcohol while you are treated with Epilim. What do I need to consider about contraception? Unplanned pregnancy may not be desirable in patients receiving medicines for epilepsy or mania. You should use an effective method of contraception and consult your doctor before planning pregnancy; for example, your doctor may want you to start taking folate tablets. Epilim should have little effect on the oral contraceptive pill, however, you should let your doctor know that you are taking it. Side effects All medicines have some unwanted side effects. Sometimes they are serious, but most of the time they are not. Your doctor or pharmacist has weighed the risks of using this medicine against the benefits they expect it will have for you. Do not be alarmed by this list of possible side effects. You may not experience any of them. Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Epilim. Epilim helps most people with epilepsy or mania, but it may have unwanted side effects in a few people. Tell your doctor or pharmacist if you notice any of the following and they worry you: nausea or vomiting abdominal cramps changes in appetite changes in your weight diarrhoea headache tremor unsteadiness when walking, dizziness or light-headedness depression hair loss feeling tired or drowsyThese are the more common side effects of Epilim. Mostly these are mild and short-lived. Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital if you notice any of the following: more frequent or more severe seizures (fits) blood clotting problems spontaneous bruising or bleeding rashes signs of liver problems such as vomiting, loss of appetite, generally feeling unwell, tiredness, yellowing of the skin and/or eyes, dark urine or blood in urine, pain in the abdomen swelling of the feet and legs, weight increase due to fluid build up fainting bizarre behaviour severe upper stomach pain, often with nausea and vomitingThese are serious side effects. You may need urgent medical attention. All of these serious side effects are rare. Tell your doctor if you notice anything else that is making you feel unwell. Other side effects not listed above may also happen in some patients. Some of these side effects can only be found when your doctor does tests from time to time to check your progress. After taking Epilim StorageKeep the tablets in their foil until it is time to take them. If you take the tablets out of the box or the blister pack they will not keep well. Do not store Epilim or any other medicine in the bathroom or near a sink. Keep tablets in a cool dry place below 30 °C. Epilim Syrup and Epilim Sugar-Free Liquid should be kept below 30 °C and away from sunlight. Keep it where children cannot reach it. A locked cupboard at least one and a half metres above ground is a good place to store medicines. DisposalIf your doctor tells you to stop taking your medicine, or the medicine has passed its expiry date, ask your pharmacist what to do with any that are left over. Product description What it looks likeEpilim 100 mg Crushable tablets - White, round, scored tablets, in foil, 100 tablets in a boxEpilim EC200 - Lilac, round, enteric-coated tablets, in foil, 100 tablets in a box. Epilim EC500 - Lilac, round, enteric-coated tablets, in foil, 100 tablets in a box. Epilim Syrup - Red, cherry flavoured syrup, in 300 mL bottle Epilim Liquid Sugar Free - Red, cherry flavoured liquid, in 300 mL bottle IngredientsActive Ingredient: Epilim 100 mg Crushable tablets - 100 mg sodium valproate Epilim EC200 - 200 mg sodium valproate Epilim EC500 - 500 mg sodium valproate Epilim Syrup - 200 mg/5 mL sodium valproate Epilim Liquid Sugar Free - 200 mg/5 mL sodium valproate Inactive Ingredients: Epilim 100 mg Crushable tablets - Maize starch, silicon dioxide, kaolin, magnesium stearate Epilim EC200 - Povidone, talc, magnesium stearate, calcium silicate, citric acid, macrogol, hypromellose, polyvinyl acetate phthalate, diethyl phthalate, stearic acid, amaranth, indigo carmine, titanium dioxide Epilim EC500 - Povidone, talc, magnesium stearate, calcium silicate, citric acid, macrogol, hypromellose, polyvinyl acetate phthalate, diethyl phthalate, stearic acid, amaranth, indigo carmine, titanium dioxide Epilim Syrup - Sucrose, sorbitol, saccharin sodium, sodium methyl hydroxybenzoate, sodium propyl hydroxybenzoate, brilliant scarlet 4R, imitation cherry flavour, water. Epilim Liquid Sugar Free - Sorbitol, saccharin sodium, citric acid, hydroxyethylcellulose, sodium methyl hydroxybenzoate, sodium propyl hydroxybenzoate, brilliant scarlet 4R, imitation cherry flavour, water. ManufacturerSupplied in Australia by: sanofi-aventis australia pty ltd12-24 Talavera RoadMacquarie Park NSW 2113Supplied in New Zealand by: sanofi-aventis new zealand limitedLevel 8, James & Wells Tower56 Cawley StreetEllerslieAucklandTelephone: (09) 580 1810This document was prepared in August 2007. Australian Register Numbers: Epilim 100 mg Crushable tablets - AUST R 15373Epilim EC200 - AUST R 15369Epilim EC500 - AUST R 15370Epilim Syrup - AUST R 15372Epilim Liquid Sugar Free - AUST R 74711® Registered trademark Miscellaneous Drug Interactions Warnings Common Uses Ingredients Directions Indications