Country: Малезија
Језик: Енглески
Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLONAZEPAM
DUOPHARMA (M) SDN. BHD.
CLONAZEPAM
100 Tablets
DUOPHARMA (M) SDN. BHD.
_Consumer Medication Information Leaflet (RIMUP) _ 1 RIVOPAM TABLET Clonazepam (0.5mg/2mg) WHAT IS IN THE LEAFLET? 1. What RIVOPAM is used for 2. How RIVOPAM works 3. Before you use RIVOPAM 4. How to use RIVOPAM 5. While you are using it 6. Side effects 7. Storage and Disposal of RIVOPAM 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT RIVOPAM IS USED FOR Rivopam is used to treat epilepsy in infants, children and adults. It lowers the number of fits (seizures) that you have. Ask your doctor if you have any questions about why Rivopam Tablet has been prescribed for you. HOW RIVOPAM WORKS Rivopam contains a medicine called clonazepam. This belongs to a group of medicines called ‘benzodiazepines’. BEFORE YOU USE RIVOPAM - _When you must not use it_ Do not take Rivopam if you are allergic to: medicines containing clonazepam or other benzodiazepines any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include skin rash, itching or hives; swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing; wheezing or shortness of breath. Do not take Rivopam if you have: respiratory depression (decreased rate of breathing) lung disease an addiction to alcohol. 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 use it_ Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives. Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether Rivopam is safe to use during pregnancy. Therefore, if there is a need to take Rivopam during pregnancy, your doctor will discuss the risks and benefits with you. Tell your doctor if you are breastfeeding or plan to breastfeed. Rivopam is not recommended for use during breastfeeding as it passes into the breast milk. Tel Прочитајте комплетан документ
Page 1 of 2 [REVISION DATE: 28.08.2023] [DUOPHARMA (M) SDN BHD] RIVOPAM TABLET DESCRIPTION: RIVOPAM TABLET 0.5 MG : A white 7 mm round tablet with marking 'd' and a 'flower'. RIVOPAM TABLET 2MG : A white 7 mm round tablet with marking 'DUO 861' on the scored side and 'd' on another side. COMPOSITION: RIVOPAM TABLET 0.5 MG : Each tablet contains Clonazepam 0.5 mg. RIVOPAM TABLET 2 MG : Each tablet contains Clonazepam 2 mg. PHARMACODYNAMICS: The active substance of clonazepam is a benzodiazepine derivative, closely related to nitrazepam and diazepam, exhibiting marked anticonvulsant properties in animals. Clonazepam prevents generalisation of convulsive activity. In the majority of cases, clonazepam improves both focal seizures and primarily generalised attacks. PHARMACOKINETICS: Clonazepam is nearly completely absorbed after oral administration with peak serum levels being reached between 2 and 3 hours. The volume of distribution is 2-3 litres/kg. Clonazepam is metabolised by the liver and pathways include hydroxylation and reduction of the nitro group. INDICATION: The majority of clinical forms of epileptic disease in infants and children, especially typical or atypical petit mal epilepsies, tonic-clonic seizures generalised from the onset or secondarily, status epileptics in all its clinical forms. Clonazepam has also demonstrated efficacy in both major and minor seizures in adults including grand mal, petit mal, (classical and atypical forms) and in psychomotor, myoclonic, focal and tonic and atonic seizures. RECOMMENDED DOSAGE: ORAL TREATMENT: Dosage of clonazepam is essentially individual and depends in the first instance on the age of the patient. It will be determined in each patient according to clinical response and tolerance. In order to minimise initial adverse reaction it is essential to commence with low doses and increase the daily dose progressively until a maintenance dose suited to the individual patient has been reached. Some degree of tolerance may be observed to both the adverse and therapeutic Прочитајте комплетан документ