Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Sodium valproate
Sanofi-Aventis Australia Pty Ltd
Medicine Registered
EPILIM ® _Sodium Valproate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Epilim. 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 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 a medicine used to for the treatment of epilepsy in adults and children. 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, however, may have prescribed Epilim for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT 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 IT_ DO NOT TAKE IT 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. Les hele dokumentet
Epilim Oral PI CCDSv14 PIv8 2 Oct 12 Page 1 PRODUCT INFORMATION EPILIM ® NAME OF THE MEDICINE NON-PROPRIETARY NAME Sodium valproate CHEMICAL NAME Sodium di-n-propylacetic acid CHEMICAL STRUCTURE CAS REGISTRY NUMBER 1069-66-5 DESCRIPTION _Active_: Sodium valproate. Sodium valproate is a white, odourless, crystalline powder with a saline taste. It is highly soluble in water and alcohol. Its molecular weight is 166. It is quite dissimilar to other established anticonvulsants such as barbiturates, hydantoins, succinamides, oxazolidinediones and acetylureas in that it has no nitrogen or aromatic moiety. _Inactive_: Crushable: includes maize starch, kaolin, silicon dioxide and magnesium stearate. Enteric-Coated: includes povidone, purified talc, magnesium stearate, calcium silicate, anhydrous citric acid, macrogol 6000, hypromellose, polyvinyl acetate phthalate, diethyl phthalate, stearic acid, amaranth aluminium lake, indigo carmine aluminium lake, titanium dioxide. Sugar-Free Liquid: includes hydroxyethylcellulose, saccharin sodium, sorbitol solution (70%) (non-crystallising), anhydrous citric acid, brilliant scarlet 4R, purified water, flavour imitation cherry 17.40.0740, sodium methyl hydroxybenzoate and sodium propyl hydroxybenzoate. Syrup: includes sucrose, sorbitol, saccharin sodium, brilliant scarlet 4R, purified water, flavour imitation cherry 17.40.0740, sodium methyl hydroxybenzoate and sodium propyl hydroxybenzoate. PHARMACOLOGY CLASS: Anticonvulsant, antipsychotic. CH 3 CH 2 CH 2 CHCOONa CH 3 CH 2 CH 2 Epilim Oral PI CCDSv14 PIv8 2 Oct 12 Page 2 SITE AND MODE OF ACTION: The mode of action of Epilim has not been fully established. Its anticonvulsant effect is attributed to the blockade of voltage dependent Na + chan Les hele dokumentet