Memantine Hydrochloride Tablets USP 5mg
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Memantine Hydrochloride Tablets USP 5mg Technical Specification:

Product Name:Memantine Hydrochloride Tablets USP 5mg
Brand Name:Generics
Strength:(5mg), (10mg), (20mg)
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 the 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 from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Memantine Hydrochloride Tablets USP 5mg
    Each film-coated tablet contains:
    Memantine Hydrochloride USP…………….5mg
    Excipients………………………………………Q.s.
    Colours: Tartrazine and Titanium Dioxide IP
  • Memantine Hydrochloride Tablets USP 10mg
    Each film-coated tablet contains:
    Memantine Hydrochloride USP…………….10mg
    Excipients………………………………………Q.s.
    Colours: Ferrosoferric Oxide USP-NF, Titanium Dioxide IP
  • Memantine Hydrochloride Tablets USP 20mg
    Each film-coated tablet contains:
    Memantine Hydrochloride USP…………….20mg
    Excipients………………………………………Q.s.
    Colours: 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 from moisture.

Dosage:  As directed by the Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Memantine Hydrochloride Tablets USP 5mg
B. Memantine Hydrochloride Tablets USP 10mg
C. Memantine Hydrochloride Tablets USP 20mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Memantine Hydrochloride Tablets USP 5mg
Each film coated tablet contains:
Memantine Hydrochloride USP…………….5mg
Excipients……………………………………...Q.s.
Colours: Tartrazine and Titanium Dioxide IP

b) Memantine Hydrochloride Tablets USP 10mg
Each film coated tablet contains:
Memantine Hydrochloride USP…………….10mg
Excipients……………………………………...Q.s.
Colours: Ferrosoferric Oxide USP-NF, Titanium Dioxide IP

c) Memantine Hydrochloride Tablets USP 20mg
Each film coated tablet contains:
Memantine Hydrochloride USP…………….20mg
Excipients……………………………………...Q.s.
Colours: Carmoisine Lake

THERAPEUTIC INDICATIONS:

Memantine Hydrochloride Tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Memantine Hydrochloride Tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer's type.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP 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 from moisture.

Dosage: As directed by the Physician.