Esomeprazole Gastro-resistant Tablets 40mg Technical Specification:

Product Name:Esomeprazole Gastro-resistant Tablets 40mg
Brand Name:Generic
Strength:20mg, 40mg
Dosage Form:Tablets (Gastro-resistant)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-Ulcer, Antacid, Gastroenterological
Indication: Esomeprazole Gastro-resistant tablets are indicated in adults for:
-Gastroesophageal Reflux Disease (GERD)
-Treatment of erosive reflux esophagitis.
-Long-term management of patients with healed esophagitis to prevent relapse.
-Symptomatic treatment of gastroesophageal reflux disease.
Storage:Store below 30°C. Protect from Light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Esomeprazole Gastro-resistant Tablets 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Esomeprazole Gastro-resistant Tablets 40mg
    Each enteric coated tablet contains:
    Esomeprazole Magnesium Trihydrate BP
    Equivalent to Esomeprazole………….40mg
    Excipients………………………………………q.s.
    Colours: Red oxide of iron

THERAPEUTIC INDICATIONS:

Esomeprazole Gastro-resistant tablets are indicated in adults for:

  • Gastroesophageal Reflux Disease (GERD)
  • Treatment of erosive reflux esophagitis.
  • Long-term management of patients with healed esophagitis to prevent relapse.
  • Symptomatic treatment of gastroesophageal reflux disease.

CAUTION & WARNING:

CAUTION:  SWALLOW WHOLE DO NOT CHEW OR CRUSH

Take whole tablet with water.

Preserve in tight container.

Read enclosed leaflet before use.

WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage: Store below 30°C. Protect from Light and moisture.

Dosage: The recommended dose is one Esomeprazole 40mg gastro-resistant tablet once a day for 4 weeks.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Esomeprazole Gastro-resistant Tablets 20mg
B. Esomeprazole Gastro-resistant Tablets 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Esomeprazole Gastro-resistant Tablets 20mg
Each enteric coated tablet contains:
Esomeprazole Magnesium Trihydrate BP
Equivalent to Esomeprazole………….20mg
Excipients………………………………………q.s.
Colours: Quinazoline green ss

B. Esomeprazole Gastro-resistant Tablets 40mg
Each enteric coated tablet contains:
Esomeprazole Magnesium Trihydrate BP
Equivalent to Esomeprazole………….40mg
Excipients………………………………………q.s.
Colours: Red oxide of iron


THERAPEUTIC INDICATIONS:

Esomeprazole Gastro-resistant tablets are indicated in adults for:
• Gastroesophageal Reflux Disease (GERD)
• Treatment of erosive reflux esophagitis.
• Long-term management of patients with healed esophagitis to prevent relapse.
• Symptomatic treatment of gastroesophageal reflux disease.

CAUTION & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Take whole tablet with water.
Preserve in tight container.
Read enclosed leaflet before use.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

Storage: Store below 30°C.
Protect from Light and moisture.
Dosage: The recommended dose is one Esomeprazole 40mg gastro-resistant tablet once a day for 4 weeks.