Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
GALANTAMINE HYDROBROMIDE
Clonmel Healthcare Ltd
GALANTAMINE HYDROBROMIDE
8 Milligram
Prolonged Release Capsules
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
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. GALANTAX XL 8MG PROLONGED-RELEASE CAPSULES, HARD GALANTAX XL 16MG PROLONGED-RELEASE CAPSULES, HARD GALANTAX XL 24MG PROLONGED-RELEASE CAPSULES, HARD Galantamine PACKAGE LEAFLET: INFORMATION FOR THE USER WHAT IS IN THIS LEAFLET: 1. What Galantax XL is and what it is used for 2. What you need to know before you take Galantax XL 3. How to take Galantax XL 4. Possible side effects 5. How to store Galantax XL 6. Contents of the pack and other information 1. WHAT GALANTAX XL IS AND WHAT IT IS USED FOR Galantax XL is an antidementia medicine used to treat the symp- toms of mild to moderately severe dementia of the Alzheimer type, a disease that alters brain function. The symptoms of Alzheimer’s disease include increasing memory loss, confusion and behavioural changes. As a result, it becomes more and more difficult to carry out normal daily activities. These symptoms are believed to be due to a lack of acetylcholine, a substance responsible for sending messages between brain cells. Galantax XL increases the amount of acetylcholine in the brain and so could improve the symptoms of the disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GALANTAX XL DO NOT TAKE GALANTAX XL • If you are allergic to galantamine or any of the other ingredients of this medicine (listed in section 6). • If you have severe liver and/or severe kidney disease WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Galantax XL. Galantax XL shoul Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Galantax XL 8mg Prolonged-release Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 8 mg capsule contains 8 mg galantamine (as hydrobromide). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release capsule, hard Opaque white size 2 hard gelatine capsules containing one round biconvex tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Galantax XL is indicated for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer type. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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 Galantax XL should be reassessed on a regular basis, preferably within three months after start of treatment. Thereafter, the clinical benefit of Galantax XL 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 Galantax XL. Discontinuation of Galantax XL 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. In individual patients Lesen Sie das vollständige Dokument