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:

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

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

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 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.