Country: Իսրայել
language: անգլերեն
source: Ministry of Health
DONEPEZIL HYDROCHLORIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
N06DA02
TABLETS
DONEPEZIL HYDROCHLORIDE 10 MG
PER OS
Required
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
DONEPEZIL
DONEPEZIL
For the treatment of mild to moderately severe Alzheimer's dementia
2014-12-31
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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 read_full_document