Nazione: Cipro
Lingua: greco
Fonte: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
GALANTAMINE HYDROBROMIDE
DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629
N06DA04
GALANTAMINE
12MG
FILM COATED TABLETS
GALANTAMINE HYDROBROMIDE (0001953044) 15.379MG
ORAL USE
Εθνική Διαδικασία
GALANTAMINE
Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 7 TABS IN BLISTER(S) (300002101) 7 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 10 TABS IN BLISTER(S) (300002102) 10 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 TABS IN BLISTER(S) (300002103) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 30 TABS IN BLISTER(S) (300002104) 30 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται
1. NAME OF THE MEDICINAL PRODUCT Zentan 4 mg Film-coated tablets Zentan 8 mg Film-coated tablets Zentan 12 mg Film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION For 4mg strength: Each tablet contains 4 mg galantamine as galantamine hydrobromide. Excipient(s) with known effect: Each tablet contains lactose monohydrate. For 8mg strength: Each tablet contains 8 mg galantamine as galantamine hydrobromide. Excipient(s) with known effect: Each tablet contains lactose monohydrate. For 12mg strength: Each tablet contains 12 mg galantamine as galantamine hydrobromide. Excipient(s) with known effect: Each tablet contains lactose monohydrate and FD & C yellow # 6 / sunset yellow FCF Aluminium Lake (E110). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets For 4mg strength: Off-white, circular, biconvex film-coated tablets For 8mg strength: Pink coloured, circular, biconvex film-coated tablets, scored on one side, plain on the other side. For 12mg strength: Orange-brown coloured, circular, biconvex film-coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zentan is indicated for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer type. 1 SUMMARY OF PRODUCT CHARACTERISTICS 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 four 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 tolerat Leggi il documento completo