ZILDON 10MG FILM COATED TABLETS

Country: Cyprus

Language: Greek

Source: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Active ingredient:

DONEPEZIL HYDROCHLORIDE

Available from:

DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629

ATC code:

N06DA02

INN (International Name):

DONEPEZIL

Dosage:

10MG

Pharmaceutical form:

FILM COATED TABLETS

Composition:

DONEPEZIL HYDROCHLORIDE (8000001576) 10MG

Administration route:

ORAL USE

Prescription type:

Εθνική Διαδικασία

Therapeutic area:

DONEPEZIL

Product summary:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 10 TABS IN BLISTER(S) (320010801) 10 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 14 TABS IN BLISTER(S) (320010802) 14 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 20 TABS IN BLISTER(S) (320010803) 20 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 TABS IN BLISTER(S) (320010804) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 30 TABS IN BLISTER(S) (320010805) 30 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Summary of Product characteristics

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