Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
RIVASTIGMINE
MEDISPEC (M) SDN.BHD
RIVASTIGMINE
30pieces Pieces
DaeHwa Pharmaceutical Co.Ltd
RIVAMENSA PATCH 5 RIVAMENSA PATCH 10 Rivastigmine (9mg, 18mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _RIVAMENSA Patch _ is used for 2. How _RIVAMENSA Patch _ works 3. Before you use _RIVAMENSA Patch_ 4. How to use _RIVAMENSA Patch_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _RIVAMENSA_ _ _ _Patch_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _RIVAMENSA PATCH _IS USED FOR Treatment of patients with mild to moderately severe dementia of the Alzheimer type and severe dementia of the Alzheimer's type. Treatment of patients with mild to moderately severe dementia associated with Parkinson's disease. HOW _RIVAMENSA PATCH _WORKS Rivastigmine improves the function of nerve cells in the brain. It works by preventing the breakdown of a chemical called acetylcholine. People with dementia usually have lower levels of this chemical, which is important for the processes of memory, thinking, and reasoning. BEFORE YOU USE _RIVAMENSA PATCH_ - _When you must not use it _ - if you are allergic to rivastigmine or any of the other ingredients of this medicine. - if you have ever had an allergic reaction to a similar type of medicine (carbamate derivatives). - if you have a skin reaction spreading beyond the patch size, if there is a more intense local reaction (such as blisters, increasing skin inflammation, swelling) and if it does not improve within 48 hours after removal of the transdermal patch. If this applies to you, tell your doctor and do not apply RIVAMENSA Patch. - _Pregnancy and breast-feeding _ If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. RIVAMENSA should not be used during pregnancy unless clearly necessary. You should not breast-feed during treatment with RIVAMENSA Patch. - _Before you start to use it _ Talk to your doctor before using RIVAMENSA: - if you have, or have ever had, Read the complete document
PROPOSED PACKAGE INSERT PRODUCT NAME RIVAMENSA PATCH 10 RIVAMENSA PATCH 5 NAME AND STRENGTH OF ACTIVE INGREDIENT(S) RIVAMENSA PATCH 10 : 18mg as Rivastigmine RIVAMENSA PATCH 5 : 9mg as Rivastigmine PRODUCT DESCRIPTION Appearance of Rivamensa patch is as follows per each dose. Rivamensa patch 5 (9mg as rivastigmine) : Transdermal patch of semi-transparent square shape with rounded corners in patch size of 5cm 2 . Rivamensa patch 10 (18mg as rivastigmine) : Transdermal patch of semi-transparent square shape with rounded corners in patch size of 10cm 2 . PHARMACODYNAMICS _Mechanism of Action:_ Pathological changes in dementia eg, Alzheimer's disease involve cholinergic neuronal pathways that project from the basal forebrain to the cerebral cortex and hippocampus. These pathways are known to be involved in attention, learning and memory, and other cognitive processes. Rivastigmine, a brain-selective acetyl- and butyryl-cholinesterase inhibitor of the carbamate type, is thought to facilitate cholinergic neurotransmission by slowing the degradation of acetylcholine released by functionally intact cholinergic neurons. Data from animal studies indicate that rivastigmine selectively increases the availability of acetylcholine in the cortex and hippocampus. Thus, Rivastigmine may have an ameliorative effect on cholinergic-mediated cognitive deficits associated with Alzheimer's disease and with Parkinson's disease. In addition, there is some evidence that cholinesterase inhibition could slow the formation of amyloidogenic β-amyloid-precursor protein (APP) fragments, and thus of amyloid plaques, which are one of the main pathological features of Alzheimer's disease. PHARMACOKINETICS _Absorption_: Absorption of rivastigmine from Rivastigmine patches is slow. After the first dose, detectable plasma concentrations are observed after a lag time of 0.5-1 hr. Concentrations then rise slowly and typically after 8 hrs reach levels close to maximum, although maximum values (Cmax) are often reached at later times (10-16 hrs). After t Read the complete document