국가: 뉴질랜드
언어: 영어
출처: Medsafe (Medicines Safety Authority)
Donepezil hydrochloride 10mg
Ipca Pharma (NZ) Pty Limited
Donepezil hydrochloride 10 mg
10 mg
Film coated tablet
Active: Donepezil hydrochloride 10mg Excipient: Hyprolose Hypromellose Iron oxide yellow Lactose Macrogol 6000 Maize starch Microcrystalline cellulose Purified talc Purified water Sodium stearyl fumarate Titanium dioxide
Prescription
Hetero Drugs Limited
Donepezil hydrochloride is indicated for the treatment of mild, moderate and severe Alzheimer's disease.
Package - Contents - Shelf Life: Blister pack, PVDC/PVC/Al - 84 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVDC/PVC/Al - 90 tablets - 36 months from date of manufacture stored at or below 30°C
2013-08-21
NEW ZEALAND DATA SHEET – DONEPEZIL IPCA 1 PRODUCT NAME Donepezil IPCA 5mg, 10 mg, film coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablets contains 5mg donepezil hydrochloride Each tablet contains 10 mg donepezil hydrochloride Excipient(s) with known effect Contains Lactose For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Donepezil 10 mg Tablets are yellow colored, circular, biconvex, film coated tablets embossed with ‘C’ on one side and ‘6’ on the other side. Donepezil 5 mg Tablets are white to off-white, circular, biconvex, film coated tablets embossed with ‘C’ on one side and ‘7’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Donepezil is indicated for the treatment of mild, moderate and severe Alzheimer’s disease. Donepezil is indicated for the treatment of vascular dementia (dementia associated with cerebrovascular disease. 4.2 DOSE AND METHOD OF ADMINISTRATION _ADULTS/ELDERLY _ Treatment should be initiated and supervised by a doctor experienced in the diagnosis and treatment of Alzheimer’s Dementia. Individual response to donepezil cannot be predicted. Treatment should be continued for as long as a therapeutic benefit for the patient exists. Discontinuation of therapy should be considered where there is no longer evidence of a therapeutic effect, which should be assessed by periodic evaluations by the physician using input from the patient and caregiver. The use of donepezil in patients with other types of dementia or other types of memory impairment (e.g., age-related cognitive decline), has not been established. The dosages of donepezil shown to be effective in controlled clinical trials are 5 mg and 10 mg administered once daily. Although there is no statistically significant evidence that a greater treatment effect is obtained from the use of the 10 mg dose, there is a suggestion, based on analysis of group data that some additional benefits may accrue to some patients from the use of the higher dose. Treatment is ini 전체 문서 읽기