Country: Միացյալ Թագավորություն
language: անգլերեն
source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Rivastigmine hydrogen tartrate
Consilient Health Ltd
N06DA03
Rivastigmine hydrogen tartrate
4.5mg
Capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04110000; GTIN: 3838989600662
PACKAGE LEAFLET: INFORMATION FOR THE USER NIMVASTID 1.5 MG HARD CAPSULES NIMVASTID 3 MG HARD CAPSULES NIMVASTID 4.5 MG HARD CAPSULES NIMVASTID 6 MG HARD CAPSULES Rivastigmine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Nimvastid is and what it is used for 2. What you need to know before you take Nimvastid 3. How to take Nimvastid 4. Possible side effects 5. How to store Nimvastid 6. Contents of the pack and other information 1. WHAT NIMVASTID IS AND WHAT IT IS USED FOR The active substance of Nimvastid is rivastigmine. Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In patients with Alzheimer’s dementia or dementia due to 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, Nimvastid allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer’s disease and dementia associated with Parkinson’s disease. Nimvastid is used 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 behaviour. The capsules and oral solution can also be used for the treatment of dementia in adult patients with Parkinson’s di read_full_document
OBJECT 1 NIMVASTID 4.5 MG HARD CAPSULES Summary of Product Characteristics Updated 20-May-2016 | Consilient Health Ltd 1. Name of the medicinal product Nimvastid 4.5 mg hard capsules 2. Qualitative and quantitative composition Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 4.5 mg rivastigmine. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Hard capsule. White to almost white powder in a capsule with brownish red cap and brownish red body. 4. Clinical particulars 4.1 Therapeutic indications Symptomatic treatment of mild to moderately severe Alzheimer's dementia. Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease. 4.2 Posology and method of administration Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia or dementia associated with Parkinson's disease. Diagnosis should be made according to current guidelines. Therapy with rivastigmine should only be started if a caregiver is available who will regularly monitor intake of the medicinal product by the patient. 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 of two weeks of treatment, the dose may be increased to 3 mg twice a day. Subsequent increases to 4.5 mg and then 6 mg twice a day should also be based on good tolerability of the current dose and may be considered after a minimum of two weeks of treatment at that dose level. If adverse reactions (e.g. nausea, vomiting, abdominal pain or loss of appetite), weight decrease or worsening of extrapyramidal symptoms (e.g. tremor) in patients with dementia associated with Parkinson's disease are observed during treatment, these may respond to omitting one or more doses. If adverse reactions persist, the daily dose should be read_full_document