ZENTAN 12MG FILM COATED TABLETS

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

GALANTAMINE HYDROBROMIDE

Διαθέσιμο από:

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

Φαρμακολογική κατηγορία (ATC):

N06DA04

INN (Διεθνής Όνομα):

GALANTAMINE

Δοσολογία:

12MG

Φαρμακοτεχνική μορφή:

FILM COATED TABLETS

Σύνθεση:

GALANTAMINE HYDROBROMIDE (0001953044) 15.379MG

Οδός χορήγησης:

ORAL USE

Τρόπος διάθεσης:

Εθνική Διαδικασία

Θεραπευτική περιοχή:

GALANTAMINE

Περίληψη προϊόντος:

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

Αρχείο Π.Χ.Π.

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