País: Armênia
Língua: inglês
Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
galantamine (galantamine hydrobromide)
Pharmaten International S.A. Industrial Park Sapes
galantamine (galantamine hydrobromide)
8mg
capsules prolonged-release, hard
Prescription
PACKAGE LEAFLET: INFORMATION FOR THE USER GALANTAMINE PHARMATHEN 8MG PROLONGED-RELEASE CAPSULES, HARD GALANTAMINE PHARMATHEN 16MG PROLONGED-RELEASE CAPSULES, HARD Galantamine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Galantamine Pharmathen is and what it is used for 2. Before you take Galantamine Pharmathen 3. How to take Galantamine Pharmathen 4. Possible side effects 5. How to store Galantamine Pharmathen 6. Further information 1. WHAT GALANTAMINE PHARMATHEN IS AND WHAT IT IS USED FOR Galantamine Pharmathen 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. Galantamine Pharmathen increases the amount of acetylcholine in the brain and so could improve the symptoms of the disease. 2. BEFORE YOU TAKE GALANTAMINE PHARMA- THEN DO NOT TAKE GALANTAMINE PHARMATHEN • If you are allergic (hypersensitive) to galantamine or to any of the other ingredients listed in section 6 of this leaflet • If you have severe liver and/or severe kidney disease. TAKE SPECIAL CARE WITH GALANTAMINE PHARMATHEN Galantamine Pharmathen should be used in Alzheimer’s disease and not other forms of memory loss or confusion. Medicines are not always suitable for every Leia o documento completo
1 1. NAME OF THE MEDICINAL PRODUCT Galantamine Pharmathen 8 mg prolonged release capsules, hard Galantamine Pharmathen 16 mg prolonged release capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 8 mg capsule contains 8 mg galantamine (as hydrobromide). Each 16 mg capsule contains 16 mg galantamine (as hydrobromide). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged release capsule, hard 8mg: Opaque white size 2 hard gelatine capsules containing one round biconvex tablet 16mg: Opaque, flesh size 2 hard gelatine capsules containing two round biconvex tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Galantamine Pharmathen is indicated for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer type. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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 2 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 no Leia o documento completo