ASENTA 5

Држава: Израел

Језик: Енглески

Извор: Ministry of Health

Активни састојак:

DONEPEZIL HYDROCHLORIDE

Доступно од:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

АТЦ код:

N06DA02

Фармацеутски облик:

TABLETS

Састав:

DONEPEZIL HYDROCHLORIDE 5 MG

Пут администрације:

PER OS

Тип рецептора:

Required

Произведен од:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

Терапеутска група:

DONEPEZIL

Терапеутска област:

DONEPEZIL

Терапеутске индикације:

For the treatment of mild to moderately severe Alzheimer's dementia

Датум одобрења:

2014-12-31

Информативни летак

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Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Asenta 5 mg film coated tablets
Asenta 10 mg film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg donepezil hydrochloride
Excipients with known effect:
Each 5 mg tablet contains 84 mg lactose
monohydrate
Each film-coated tablet contains 10 mg donepezil hydrochloride
Excipients with known effect: Each 10 mg tablet contains 168 mg
lactose
monohydrate
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Asenta 5 mg film coated tablets are white round, film coated tablets
with '5'
embossed on one side
Asenta 10 mg film coated tablets are yellow round, film coated tablets
with '10'
embossed on one side
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Asenta film coated tablets are indicated for the treatment of mild to
moderately
severe Alzheimer's dementia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults/ Elderly people _
_ _
Treatment is initiated at 5 mg/day (once-a-day dosing). 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 Asenta 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
donepezil should be
reassessed on a