국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Galantamine hydrobromide
Fontus Health Ltd
N06DA04
Galantamine hydrobromide
24mg
Modified-release capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04110000; GTIN: 5060421930169
1 PACKAGE LEAFLET: INFORMATION FOR THE USER LUVENTA XL 8 MG PROLONGED-RELEASE CAPSULES, HARD LUVENTA XL 16 MG PROLONGED-RELEASE CAPSULES, HARD LUVENTA 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 Luventa XL is and what it is used for 2. What you need to know before you take Luventa XL 3. How to take Luventa XL 4. Possible side effects 5. How to store Luventa XL 6. Contents of the pack and other information 1. WHAT LUVENTA XL IS AND WHAT IT IS USED FOR Luventa 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. Luventa 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 LUVENTA XL DO NOT TAKE LUVENTA 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 Luventa XL. Luventa XL should be used in Alzheimer’s disease and not other forms 전체 문서 읽기
OBJECT 1 LUVENTA XL 24MG PROLONGED RELEASE CAPSULES, HARD Summary of Product Characteristics Updated 27-Jul-2016 | Fontus Health Ltd 1. Name of the medicinal product Luventa XL 24 mg prolonged-release capsules, hard 2. Qualitative and quantitative composition Each 24 mg prolonged-release capsule contains 24 mg galantamine (as hydrobromide). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Prolonged release capsule, hard Opaque orange size 2 hard gelatine capsules containing three round biconvex prolonged-release tablets of 8 mg 4. Clinical particulars 4.1 Therapeutic indications Luventa 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 benefit and tolerability. In individual patients not showing an increased response or not tolerating 24 mg/day, a dose reduction 전체 문서 읽기