Country: Malta
Language: English
Source: Medicines Authority
GALANTAMINE
Janssen-Cilag International NV Turnhoutsewes 30, B-2340 Beerse, Belgium
N06DA04
GALANTAMINE
FILM-COATED TABLET
GALANTAMINE
POM
PSYCHOANALEPTICS
Withdrawn
2006-12-18
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER REMINYL 4 MG FILM-COATED TABLETS REMINYL 8 MG FILM-COATED TABLETS REMINYL 12 MG FILM-COATED TABLETS galantamine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IF 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 is and what it is used for 2. What you need to know before you take Reminyl 3. How to take Reminyl 4. Possible side effects 5. How to store Reminyl 6. Contents of the pack and other information. 1. WHAT REMINYL IS AND WHAT IT IS USED FOR Reminyl 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE REMINYL DO NOT TAKE REMINYL 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 Talk to your doctor or pharmacist before taking Reminyl. This medicine is only used in Alzheimer’s disease, and is not recommended for other types of memory loss or confusi Read the complete document
Page 1 of 12 1. NAME OF THE MEDICINAL PRODUCT REMINYL 4 mg film-coated tablets REMINYL 8 mg film-coated tablets REMINYL 12 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 4 mg tablet contains 4 mg galantamine (as hydrobromide). Each 8 mg tablet contains 8 mg galantamine (as hydrobromide). Each 12 mg tablet contains 12 mg galantamine (as hydrobromide). Excipients with known effect: 4 mg tablet: lactose monohydrate 38.59 mg 8 mg tablet: lactose monohydrate 77.18 mg 12 mg tablet: lactose monohydrate 115.77 mg and orange yellow S aluminium lake (E110) 0.45 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). 4 mg tablet: Off-white, circular, biconvex tablets with the inscription “JANSSEN” on one side and “G4” on the other side; 8 mg tablet: Pink, circular, biconvex tablets with the inscription “JANSSEN” on one side and “G8” on the other side; 12 mg tablet: Orange-brown, circular, biconvex tablets with the inscription “JANSSEN” on one side and “G12” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reminyl 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 (4 mg twice a day) for 4 weeks. Page 2 of 12 _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 gala Read the complete document