Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
GALANTAMINE HYDROBROMIDE
Shire Pharmaceuticals Ireland Limited
N06DA; N06DA04
GALANTAMINE HYDROBROMIDE
8 milligram(s)
Capsule, hard
Product subject to prescription which may not be renewed (A)
Anticholinesterases; galantamine
Marketed
2004-11-19
1 PACKAGE LEAFLET: INFORMATION FOR THE USER REMINYL XL 8 MG PROLONGED-RELEASE CAPSULES, HARD REMINYL XL 16 MG PROLONGED-RELEASE CAPSULES, HARD REMINYL XL 24 MG PROLONGED-RELEASE CAPSULES, HARD galantamine 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Reminyl XL is and what it is used for 2. What you need to know before you take Reminyl XL 3. How to take Reminyl XL 4. Possible side effects 5. How to store Reminyl XL 6. Contents of the pack and other information 1. WHAT REMINYL XL IS AND WHAT IT IS USED FOR Reminyl XL contains the active substance ‘galantamine’ an antidementia medicine. It is used in adults to treat the symptoms of mild to moderately severe Alzheimer’s disease, a type of dementia that alters brain function. Alzheimer’s disease causes increasing memory loss, confusion and behavioural changes which make it increasingly difficult to carry out normal daily activities. These effects are thought to be caused by a lack of ‘acetylcholine’, a substance responsible for sending messages between brain cells. Reminyl increases the amount of acetylcholine in the brain and treats the signs of the disease. The capsules are made in a ‘prolonged-release’ form. This means that they release the medicine slowly. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE REMINYL XL DO NOT TAKE REMINYL XL if you are allergic to galantamine or to any of the other ingredients of this medicine (listed in section 6) if you have severe liver or severe kidney disease WARNINGS AND PRECAUTIONS T Lue koko asiakirja
Health Products Regulatory Authority 19 March 2021 CRN00C5M5 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT REMINYL XL 8 mg prolonged-release capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 8 mg capsule contains 8 mg galantamine (as hydrobromide). Excipients with known effect 8 mg capsules: sucrose 59 mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Prolonged-release capsule, hard White opaque, size 4 hard capsules with the inscription “G8”, containing white to off-white pellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reminyl XL is indicated for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer type. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults/Elderly_ _Before start of treatment_ The diagnosis of probable Alzheimer type of dementia should be adequately confirmed according to current clinical guidelines (see section 4.4). _Starting dose_ The recommended starting dose is 8 mg/day for 4 weeks. _Maintenance dose_ The tolerance and dosing of galantamine should be reassessed on a regular basis, preferably within 3 months after start of treatment. Thereafter, the clinical benefit of galantamine and the patient’s tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines. Maintenance treatment can be continued for as long as therapeutic benefit is favourable and the patient tolerates treatment with galantamine. Discontinuation of galantamine should be considered when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment. The initial maintenance dose is 16 mg/day and patients should be maintained on 16 mg/day for at least 4 weeks. An increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment including evaluation of clinical benefit and tolerability. Health Products Regulatory Authority 19 March 2021 CRN00C5M5 Page 2 of 11 In individual pat Lue koko asiakirja