Mesalazine Prolonged Release Tablets IP 500mg Technical Specification:

Product Name:Mesalazine Prolonged Release Tablets IP 500mg
Brand Name:Meslataj
Strength:(500mg), (1200mg)
Dosage Form:Tablets(uncoated)
Route of Administration:Via Oral Route
Packing:10s, 15s, 50s, 100s
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Anti-Ulcer
Indication: Mesalazine is used to treat ulcerative colitis and Crohn’s disease and other types of inflammatory bowel disease. It belongs to a group of medicines called aminosalicylates. These help to reduce redness and swelling (inflammation) and can help with healing. Some people take Mesalazine together with steroids.
Storage:Store between 20°C to 25°C. Excursions are permitted from 15°C to 30°C. Keep in a cool & Dry Place. Protect from Light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Mesalazine Prolonged Release Tablets IP 500mg
    Each un-coated prolonged-release tablet contains:
    Mesalazine IP …………………500mg
    Excipients…………………………q.s.
    Colour: Red oxide of iron & Titanium dioxide IP
  • Mesalazine Prolonged Release Tablets IP 1200mg
    Each un-coated prolonged-release tablet contains:
    Mesalazine IP …………………1200mg
    Excipients…………………………q.s.
    Colour: Red oxide of iron & Titanium dioxide IP

THERAPEUTIC INDICATIONS:

Mesalazine is used to treat ulcerative colitis and Crohn’s disease and other types of inflammatory bowel disease. It belongs to a group of medicines called aminosalicylates. These help to reduce redness and swelling (inflammation) and can help with healing. Some people take Mesalazine together with steroids.

CAUTION & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
TABLET SHOULD BE SWALLOWED WHOLE & DO NOT CHEW OR CRUSHED.

SCHEDULE: SCHEDULE H PRESCRIPTION DRUG: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

STORAGE: Store between 20°C to 25°C. Excursions are permitted from 15°C to 30°C. Keep in a cool & Dry place. Protect from Light and moisture.

Dosage: As directed by a physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Mesalazine Prolonged Release Tablets IP 500mg
B. Mesalazine Prolonged Release Tablets IP 1200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Mesalazine Prolonged Release Tablets IP 500mg
Each un-coated prolonged release tablet contains:
Mesalazine IP …………………500mg
Excipients…………………………q.s.
Colour: Red oxide of iron & Titanium dioxide IP


B. Mesalazine Prolonged Release Tablets IP 1200mg
Each un-coated prolonged release tablet contains:
Mesalazine IP …………………1200mg
Excipients…………………………q.s.
Colour: Red oxide of iron & Titanium dioxide IP

THERAPEUTIC INDICATIONS:

Mesalazine is used to treat ulcerative colitis and Crohn's disease and other types of inflammatory bowel disease. It belongs to a group of medicines called amino salicylates. These help to reduce redness and swelling (inflammation) and can help with healing. Some people take Mesalazine together with steroids.

CAUTION & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
TABLET SHOULD BE SWALLOWED WHOLE & DO NOT CHEW OR CRUSHED.

SCHEDULE: SCHEDULE H PRESCRIPTION DRUG: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

STORAGE: Store between 20°C to 25°C. Excursions are permitted from 15°C to 30°C. Keep in a cool & Dry place. Protect from Light and moisture.
DOSAGE: As directed by physician.