Pays: Chypre
Langue: grec
Source: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
DONEPEZIL HYDROCHLORIDE
DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629
N06DA02
DONEPEZIL
5MG
FILM COATED TABLETS
DONEPEZIL HYDROCHLORIDE (8000001576) 5MG
ORAL USE
Εθνική Διαδικασία
DONEPEZIL
Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 10 TABS IN BLISTER(S) (320010701) 10 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 14 TABS IN BLISTER(S) (320010702) 14 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 20 TABS IN BLISTER(S) (320010703) 20 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 TABS IN BLISTER(S) (320010704) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 30 TABS IN BLISTER(S) (320010705) 30 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται
SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Zildon 5 mg Film-coated tablets Zildon 10 mg Film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION For 5 mg strength: Each tablet contains 5 mg donepezil hydrochloride. Excipient(s) with known effect: 75.5 mg lactose monohydrate /film-coated tablet For 10 mg strength: Each tablet contains 10 mg donepezil hydrochloride. Excipient(s) with known effect: 151.0 mg lactose monohydrate /film-coated tablet For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets For strength 5 mg: White film-coated biconvex, unscored tablets with bevelled edges. For strength 10 mg: Yellow film-coated biconvex, unscored tablets with bevelled edges. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ZILDON tablets are indicated for the symptomatic treatment of mild to moderately severe Alzheimer's dementia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults/Elderly: Treatment is initiated at 5 mg/day (once-a-day dosing). ZILDON should be taken orally, in the evening, just prior to retiring. The 5 mg/day dose should be maintained for at least one month in order to allow the earliest clinical responses to treatment to be assessed and to allow steady-state concentrations of donepezil hydrochloride to be achieved. Following a one-month clinical assessment of treatment at 5 mg/day, the dose of ZILDON can be increased to 10 mg/day (once-a-day dosing). The maximum recommended daily dose is 10 mg. Doses greater than 10 mg/day have not been studied in clinical trials. Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia. Diagnosis should be made according to accepted guidelines (e.g. DSM IV, ICD 10). Therapy with donepezil should only be started if a caregiver is available who will regularly monitor drug intake for the patient. Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists. Therefore, the clinical benefit of do Lire le document complet