| Product Name: | Donepezil Hydrochloride Tablets USP |
| Brand Name: | Generics |
| Strength: | 5mg, 10mg |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via oral Route |
| Packing: | 30s, 90s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anti-Alzheimer’s |
| Indication: | Donepezil hydrochloride tablets and USP are indicated for the treatment of dementia of Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease. |
| Storage: | Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect it from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Donepezil Hydrochloride Tablets USP 5mg
- Donepezil Hydrochloride Tablets USP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Donepezil Hydrochloride Tablets USP 5mg
Each coated Film-coated tablet contains:
Donepezil Hydrochloride USP……………………………5mg
Excipients…………………………………………………….…. q.s.
Colours: Quinoline Yellow - Donepezil Hydrochloride Tablets USP 10mg
Each coated Film-coated tablet contains:
Donepezil Hydrochloride USP……………………………10mg
Excipients…………………………………………………….…. q.s.
Colours: Carmoisine Lake
THERAPEUTIC INDICATIONS:
Donepezil hydrochloride tablets, USP are indicated for the treatment of dementia of Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect it from moisture.
Dosage: As directed by the Physician.