Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
RIVASTIGMINE HYDROGEN TARTRATE
McDermott Laboratories Ltd t/a Gerard Laboratories
RIVASTIGMINE HYDROGEN TARTRATE
6 Milligram
Capsules Hard
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
PAGE 1 OF 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RIVASTIGMINE MYLAN 1.5 MG HARD CAPSULES RIVASTIGMINE MYLAN 3 MG HARD CAPSULES RIVASTIGMINE MYLAN 4.5 MG HARD CAPSULES RIVASTIGMINE MYLAN 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 of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Rivastigmine Mylan is and what it is used for 2. What you need to know before you take Rivastigmine Mylan 3. How to take Rivastigmine Mylan 4. Possible side effects 5. How to store Rivastigmine Mylan 6. Contents of the pack and other information 1. WHAT RIVASTIGMINE MYLAN IS AND WHAT IT IS USED FOR The active substance of this medicine 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, Exelon allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rivastigmine Mylan 6 mg capsule, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains rivastigmine hydrogen tartrate equivalent to rivastigmine 6 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard Hard gelatine capsule comprised of an orange body marked “RG 60” in white ink, and a reddish-brown cap marked with “G” in white ink. Containing a white powder. 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 Læs hele dokumentet