Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Galantamine hydrobromide
Aspire Pharma Ltd
N06DA04
Galantamine hydrobromide
24mg
Modified-release capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04110000; GTIN: 5060209730622
Package leaflet: Information for the user GATALIN XL 8MG PROLONGED-RELEASE CAPSULES, HARD GATALIN XL 16MG PROLONGED-RELEASE CAPSULES, HARD GATALIN XL 24MG PROLONGED-RELEASE CAPSULES, HARD galantamine WHAT IS IN THIS LEAFLET: 1. What Gatalin XL is and what it is used for 2. What you need to know before you take Gatalin XL 3. How to take Gatalin XL 4. Possible side effects 5. How to store Gatalin XL 6. Contents of the pack and other information 1. WHAT GATALIN XL IS AND WHAT IT IS USED FOR Gatalin XL 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. Galantamine increases the amount of acetylcholine in the brain and treats the signs of the disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GATALIN XL DO NOT TAKE GATALIN XL • 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 Gatalin XL. This medicine is only used in Alzheimer’s disease, and is not recommended for other types of memory loss or confusion. SERIOUS SIDE EFFECTS Galantamine can cause serious skin reactions, heart problems and fits (seizures). You must be aware of these side effects while you are taking Gatalin XL. See ‘Look out for serious side effects’ in section 4. BEFORE YOU TAKE GATALIN XL, your doctor needs to know if you have, or have had, any of the following: • liver or kidney problems • a heart condition (such as chest discomfort that is often brought on by physical activity, a heart attack, Les hele dokumentet
OBJECT 1 GATALIN XL 24MG PROLONGED RELEASE CAPSULES, HARD Summary of Product Characteristics Updated 16-Dec-2016 | Aspire Pharma Ltd 1. Name of the medicinal product Gatalin XL 24 mg prolonged release capsules, hard 2. Qualitative and quantitative composition Each 24 mg capsule contains 24 mg galantamine (as hydrobromide). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Prolonged release capsule, hard 24mg: Opaque orange size 2 hard gelatine capsules containing three round biconvex tablets 4. Clinical particulars 4.1 Therapeutic indications Gatalin XL 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 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 to 16 mg/day shou Les hele dokumentet