GENERIC NAME OF THE MEDICINAL PRODUCT:
B. Esomeprazole Gastro-resistant Tablets 40mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
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:
• 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:
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:
Protect from Light and moisture.
Dosage: The recommended dose is one Esomeprazole 40mg gastro-resistant tablet once a day for 4 weeks.
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.