Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
GALANTAMINE HYDROBROMIDE
Shire Pharmaceuticals Limited
N06DA04
GALANTAMINE HYDROBROMIDE
4 Mg/Ml
Oral Solution
Product subject to prescription which may not be renewed (A)
galantamine
Marketed
2000-09-15
Page 1 of 8 Package leaflet: Information for the user REMINYL 4MG/ML ORAL SOLUTION 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 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 Page 2 of 8 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 confusion. SERIOUS SIDE EFFECTS Reminyl can cause serious skin Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT REMINYL 4 mg/ml oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml oral solution contains 4 mg galantamine (as hydrobromide). Excipients with known effect: methyl parahydroxybenzoate and propyl parahydroxybenzoate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution. Clear and colourless oral solution. 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. _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 (8 mg twice a day) and patients should be maintained on 16 mg/day for at least 4 weeks. An increases to the maintenance dose of 24 mg/day (12 mg twice a day) should be considered on an individual basis after appropriate assessment including evaluation of clinical benefit and tolerability. In individual patients not showing an increased response or not tolerating 24 mg/day, a dose reduction to 16 mg/day should be considered. H E A L T H P R O D U C T S R E G U L A T O R Прочитайте повний документ