Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
GALANTAMINE HYDROBROMIDE
Pharmathen S.A.
GALANTAMINE HYDROBROMIDE
8 Milligram
Prolonged Release Capsules
Product subject to prescription which may not be renewed (A)
Withdrawn
2014-05-30
1 PACKAGE LEAFLET: INFORMATION FOR THE USER MITHEGAN XL 8MG PROLONGED-RELEASE CAPSULES, HARD MITHEGAN XL 16MG PROLONGED-RELEASE CAPSULES, HARD MITHEGAN XL 24MG 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 Mithegan XL is and what it is used for 2. What you need to know before you take Mithegan XL 3. How to take Mithegan XL 4. Possible side effects 5. How to store Mithegan XL 6. Contents of the pack and other information 1. WHAT MITHEGAN XL IS AND WHAT IT IS USED FOR Mithegan XL is an antidementia medicine used to treat the symptoms 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 behavioral 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. Mithegan 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 MITHEGAN XL DO NOT TAKE MITHEGAN XL • If Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mithegan XL 8mg Prolonged-release Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 8 mg prolonged-release 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 prolonged-release tablet of 8 mg 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mithegan XL is indicated for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer type. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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). Posology 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 three 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 bene Прочетете целия документ