देश: न्यूज़ीलैंड
भाषा: अंग्रेज़ी
स्रोत: Medsafe (Medicines Safety Authority)
Donepezil hydrochloride 10mg
REX Medical Ltd
Donepezil hydrochloride 10 mg
10 mg
Film coated tablet
Active: Donepezil hydrochloride 10mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry yellow 04F52201 Purified water Starch
Blister pack, PVC/PE/PVDC/AI, 10 tablets per blister strip, Sample pack, 30 tablets
Prescription
Prescription
Cipla Ltd
Donepezil tablets are indicated for the treatment of mild, moderate and severe Alzheimer's disease.
Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC/AI, 10 tablets per blister strip, Sample pack - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVDC/AI, 10 tablets per blister strip - 90 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVDC/AI, 10 tablets per blister strip - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVDC/AI, 10 tablets per blister strip - 250 tablets - 36 months from date of manufacture stored at or below 25°C
2006-06-30
1 NEW ZEALAND DATASHEET 1 PRODUCT NAME Donepezil 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Donepezil hydrochloride 5mg and 10mg tablets. 3 PHARMACEUTICAL FORM Donepezil film-coated tablets for oral administration are supplied containing 5 mg donepezil hydrochloride, equivalent to 4.56 mg donepezil free base, or 10 mg donepezil hydrochloride, equivalent to 9.12 mg donepezil free base. Donepezil 5mg tablets are white, circular, biconvex film-coated tablets, embossed ‘DPZ’ on one side and ‘5’ on the other side. The tablet diameter is approximately 7.1 mm. Donepezil 10mg tablets are yellow, circular, biconvex film-coated tablets, embossed ‘DPZ’ on one side and ‘10’ on the other side. The tablet diameter is approximately 9.1 mm. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Donepezil tablets are indicated for the treatment of mild, moderate and severe Alzheimer's disease. Donepezil tablets are indicated for the treatment of vascular dementia (dementia associated with cerebrovascular disease). 4.2 Dose and method of administration ADULTS/ELDERLY It is recommended that the diagnosis and treatment of Alzheimer’s disease should be initiated and supervised by a doctor with appropriate experience in Alzheimer’s disease. Individual patient response to donepezil therapy cannot be predicted. Where a therapeutic benefit for the patient exists, then treatment should be continued. Where there is no longer evidence of a therapeutic effect, discontinuation of therapy should be considered. The physician should periodically assess the therapeutic effect using input from the patient and caregiver. Donepezil usage in patients with other types of memory impairment (e.g. age-related cognitive decline) or other types of dementia has not been established. 5mg and 10mg dosages of donepezil hydrochloride administered once daily in controlled clinical trials have been shown to be effective. With the 10mg dose per day there is no statistically significant evidence that a greater treatment effect is obtained from this पूरा दस्तावेज़ पढ़ें