| Product Name: | Memantine Hydrochloride Tablet USP |
| Brand Name: | Generics |
| Strength: | 7mg, 14mg, 21mg, 28mg |
| 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: | Memantine Hydrochloride Tablets are indicated for the treatment of moderate to severe dementia of Alzheimer’s type. |
| 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:
- Memantine Hydrochloride Tablet USP 7mg
- Memantine Hydrochloride Tablet USP 14mg
- Memantine Hydrochloride Tablet USP 21mg
- Memantine Hydrochloride Tablet USP 28mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Memantine Hydrochloride Tablet USP 7mg
Each film-coated tablet contains:
Memantine Hydrochloride USP…………….7mg
Excipients………………………………………Q.s.
Color: Quinoline Yellow - Memantine Hydrochloride Tablet USP 14mg
Each film-coated tablet contains:
Memantine Hydrochloride USP…………….14mg
Excipients………………………………………Q.s.
Color: D&C Red 33 - Memantine Hydrochloride Tablet USP 21mg
Each film-coated tablet contains:
Memantine Hydrochloride USP…………….21mg
Excipients………………………………………Q.s.
Color: Carmoisine Lake - Memantine Hydrochloride Tablet USP 28mg
Each film-coated tablet contains:
Memantine Hydrochloride USP…………….28mg
Excipients………………………………………Q.s.
Color: Carmoisine Lake
THERAPEUTIC INDICATIONS:
Memantine Hydrochloride Tablets are indicated for the treatment of moderate to severe dementia of Alzheimer’s type. Memantine Hydrochloride Tablets are indicated for the treatment of moderate to severe dementia of Alzheimer’s type.
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.