Country: Israel
Language: English
Source: Ministry of Health
RIVASTIGMINE AS HYDROGEN TARTRATE
DEXCEL LTD, ISRAEL
N06DA03
HARD CAPSULE
RIVASTIGMINE AS HYDROGEN TARTRATE 6 MG
PER OS
Required
GENEPHARM S.A., GREECE
RIVASTIGMINE
Treatment of patients with mild to moderately severe dementia of the Alzheimer type, also termed probable alzheimer's disease or alzheimer's disease.Symptomatic treatment of mild to moderately severe alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementiaassociated with Parkinson's disease.
2019-09-30
PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine can be sold with a physician’s prescription only RIVASTIGMINE DEXCEL 1.5, 3, 4.5, 6 MG, CAPSULES Each capsule contains Rivastigmine (as hydrogen tartrate) 1.5, 3, 4.5 or 6 mg respectively. Inactive ingredients and allergens in the medicine - see section 6 "Additional information". READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, ask the doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if you think that their illness is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? For the treatment of patients with mild to moderately severe dementia of the Alzheimer’s type, also called Alzheimer’s disease. For the symptomatic treatment of mild to moderately severe Alzheimer’s dementia. For the symptomatic treatment of mild to moderately severe dementia associated with Parkinson’s disease. Rivastigmine belongs to a group of substances called cholinesterase inhibitors. In patients with dementia of Alzheimer’s disease or Parkinson’s disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, RIVASTIGMINE DEXCEL allows levels of acetylcholine to be increased in the brain, and helps to reduce the symptoms of Alzheimer’s disease and dementia associated with Parkinson’s disease. RIVASTIGMINE DEXCEL is intended for the treatment of adult patients with mild to moderately severe Alzheimer’s dementia , a progressive brain disorder that gradually affects memory, intellectual ability and behavior. The capsules can also be used to treat dementia in adult patients with Parkin Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Rivastigmine Dexcel 1.5 mg, hard capsules Rivastigmine Dexcel 3 mg, hard capsules Rivastigmine Dexcel 4.5 mg, hard capsules Rivastigmine Dexcel 6 mg, hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Rivastigmine Dexcel 1.5 mg Each capsule contains rivastigmine (as hydrogen tartrate) 1.5 mg. Rivastigmine Dexcel 3 mg Each capsule contains rivastigmine (as hydrogen tartrate) 3 mg. Rivastigmine Dexcel 4.5 mg Each capsule contains rivastigmine (as hydrogen tartrate) 4.5 mg. Rivastigmine Dexcel 6 mg Each capsule contains rivastigmine (as hydrogen tartrate) 6 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsules Rivastigmine Dexcel 1.5 mg Yellow hard gelatin capsules imprinted with "RIVA 1.5mg" in black on the body, containing white to off white granular powder. Rivastigmine Dexcel 3 mg Light orange hard gelatin capsules imprinted with "RIVA 3mg" in black on the body, containing white to off white granular powder. Rivastigmine Dexcel 4.5 mg Caramel hard gelatin capsules imprinted with "RIVA 4.5mg" in black on the body, containing white to off white granular powder. Rivastigmine Dexcel 6 mg Light orange/caramel hard gelatin capsules imprinted with "RIVA 6mg" in black on the body, containing white to off white granular powder 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Treatment of patients with mild to moderately severe dementia of the Alzheimer type, also termed probable Alzheimer's disease or Alzheimer's disease. Symptomatic treatment of mild to moderately severe Alzheimer's dementia. Symptomatic treatment of mild to moderately severe dementia associated with Parkinson's disease. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology Rivastigmine should be administered twice a day, with morning and evening meals. The capsules should be swallowed whole. _ _ _Initial dose _ 1.5 mg twice a day. _ _ _Dose titration _ The starting dose is 1.5 mg twice a day. If this dose is well tolerated after a minimum o Read the complete document