Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Galantamine hydrobromide
Dr Reddy's Laboratories (UK) Ltd
N06DA04
Galantamine hydrobromide
24mg
Modified-release capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04110000; GTIN: 05036072005716
WHAT IS IN THIS LEAFLET: 1. What Consion XL is and what it is used for 2. What you need to know before you take Consion XL 3. How to take Consion XL 4. Possible side effects 5. How to store Consion XL 6. Contents of the pack and other information 1. WHAT CONSION XL IS AND WHAT IT IS USED FOR Consion 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 behavioral changes which make it increasingly difficult to carry out normal daily activities. These effects are thought to be caused bya lack of ‘acetylcholine’, a substance responsible for sending messages between brain cells. Consion XL increases the amount of acetylcholine in the brain and treats the signs of the disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CONSION XL DO NOT TAKE CONSION 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 or severe kidney disease WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Consion 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 Consion XL can cause serious skin reactions, heart problems, fits (seizures). You must be aware of these side effects while you are taking Consion XL. See section 4. BEFORE YOU TAKE CONSION XL, your doctor needs to know if you have or have had any of the following: • liver or kidney problems • a heart disorder (such as chest discomfort that is often brought on by physical activity, heart attack, heart failure, slow or uneven heart beat) • changes in ‘electrolyte’ levels (naturally occurring chemicals in the blood, such as potassium) • a peptic (stomach) ulcer • blockage of the stomach or intestines • a disorder of the nervous system (such Pročitajte cijeli dokument
OBJECT 1 CONSION XL 24 MG PROLONGED-RELEASE CAPSULES, HARD Summary of Product Characteristics Updated 05-Apr-2018 | Dr. Reddy's Laboratories (UK) Ltd 1. Name of the medicinal product Consion 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 gelatin capsules containing three round biconvex prolonged-release tablets of 8mg 4. Clinical particulars 4.1 Therapeutic indications Consion 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 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 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 Pročitajte cijeli dokument