Donepezil Hydrochloride SR Tablet 11.5mg Technical Specification:
| Product Name: | Donepezil Hydrochloride Sustained Release Tablet 11.5mg |
| Brand Name: | Generics |
| Strength: | (11.5mg), (23mg) |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via oral Route |
| Packing: | 10s, 30s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Anti-Alzheimer’s |
| Indication: | Donepezil is a medicine that helps with some types of dementia. It does not cure dementia. However, it treats some of the symptoms of Alzheimer’s disease, Parkinson’s disease, or dementia with Lewy bodies. It can also help with “mixed dementia”. |
| Storage: | Protect from moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Donepezil Hydrochloride SR Tablet 11.5mg
- Donepezil Hydrochloride SR Tablet 23mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Donepezil Hydrochloride SR Tablet 11.5mg
Each Film coated sustained release tablet contains:
Donepezil Hydrochloride IP…………………………….11.5mg
Excipients…………………………………………………. q.s.
Colours: Ferric oxide red USP NF
- Donepezil Hydrochloride SR Tablet 23mg
Each Film coated sustained release tablet contains:
Donepezil Hydrochloride IP…………………………….23mg
Excipients…………………………………………………. q.s.
Colours: Ferric oxide red NF
THERAPEUTIC INDICATIONS:
Donepezil is a medicine that helps with some types of dementia. It does not cure dementia. However, it treats some of the symptoms of Alzheimer’s disease, Parkinson’s disease or dementia with Lewy bodies. It can also help with “mixed dementia”.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: To be sold by retail on the prescription of a Neurologist only.
STORAGE & DOSAGE:
Storage: Protect from moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Neurologist.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Donepezil Hydrochloride SR Tablet 11.5mg
B. Donepezil Hydrochloride SR Tablet 23mg
B. Donepezil Hydrochloride SR Tablet 23mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Donepezil Hydrochloride SR Tablet 11.5mg
Each Film coated sustained release tablet contains:
Donepezil Hydrochloride IP…………………………….11.5mg
Excipients…………………………………………………. q.s.
Colours: Ferric oxide red USP NF
b) Donepezil Hydrochloride SR Tablet 23mg
Each Film coated sustained release tablet contains:
Donepezil Hydrochloride IP…………………………….23mg
Excipients…………………………………………………. q.s.
Colours: Ferric oxide red NF
Each Film coated sustained release tablet contains:
Donepezil Hydrochloride IP…………………………….11.5mg
Excipients…………………………………………………. q.s.
Colours: Ferric oxide red USP NF
b) Donepezil Hydrochloride SR Tablet 23mg
Each Film coated sustained release tablet contains:
Donepezil Hydrochloride IP…………………………….23mg
Excipients…………………………………………………. q.s.
Colours: Ferric oxide red NF
THERAPEUTIC INDICATIONS:
Donepezil is a medicine that helps with some types of dementia. It does not cure dementia. However, it treats some of the symptoms of Alzheimer's disease, Parkinson's disease or dementia with Lewy bodies. It can also help with "mixed dementia”.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: To be sold by retail on the prescription of a Neurologist only.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: To be sold by retail on the prescription of a Neurologist only.
STORAGE & DOSAGE:
Storage: Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Neurologist.
Dosage: As directed by the Neurologist.










