Esomeprazole Magnesium Trihydrate and Itopride HCl Capsules 40mg+150mg Technical Specification:
| Product Name: | Esomeprazole Magnesium Trihydrate and Itopride HCl Capsules 40mg+150mg |
| Brand Name: | Generic |
| Strength: | (40mg+150mg) |
| Dosage Form: | Capsule (Hard-gelatine) |
| Route of Administration: | Via oral Route |
| Packing: | 10s, 30s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Anti-Ulcer |
| Indication: | ESOMEPRAZOLE+ITOPRIDE is a combination medicine used to treat acidity, gastroesophageal reflux disease (GERD), stomach ulcers (peptic ulcers, gastric ulcers due to H pylori), heartburn symptoms, and Zollinger Ellison syndrome. |
| Storage: | Store in cool, dry place. below 25˚C. Protect from Light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Esomeprazole Magnesium Trihydrate and Itopride HCl Capsules 40mg+150mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Esomeprazole Magnesium Trihydrate and Itopride HCl Capsules 40mg+150mg
Each Hard gelatin capsule contains:
Esomeprazole Magnesium Trihydrate IP
Equivalent to Esomeprazole ………………40mg
(As enteric coated pellets)
Itopride Hydrochloride…………………….150mg
(As sustained-release pellets)
Excipients…………………………q.s.
Colours: Titanium Dioxide IP
Approved colour used in empty capsule shells.
THERAPEUTIC INDICATIONS:
ESOMEPRAZOLE+ITOPRIDE is a combination medicine used to treat acidity, gastroesophageal reflux disease (GERD), stomach ulcers (peptic ulcers, gastric ulcers due to H pylori), heartburn symptoms and Zollinger Ellison syndrome.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Storage: Store in cool, dry place. below 25˚C. Protect from Light and moisture.
Dosage: As directed by the Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Esomeprazole Magnesium Trihydrate and Itopride HCl Capsules 40mg+150mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Esomeprazole Magnesium Trihydrate and Itopride HCl Capsules 40mg+150mg
Each Hard gelatin capsule contains:
Esomeprazole Magnesium Trihydrate IP
Equivalent to Esomeprazole ………………40mg
(As enteric coated pellets)
Itopride Hydrochloride…………………….150mg
(As sustained release pellets)
Excipients…………………………q.s.
Colours: Titanium Dioxide IP
Approved colour used in empty capsule shells.
Each Hard gelatin capsule contains:
Esomeprazole Magnesium Trihydrate IP
Equivalent to Esomeprazole ………………40mg
(As enteric coated pellets)
Itopride Hydrochloride…………………….150mg
(As sustained release pellets)
Excipients…………………………q.s.
Colours: Titanium Dioxide IP
Approved colour used in empty capsule shells.
THERAPEUTIC INDICATIONS:
ESOMEPRAZOLE+ITOPRIDE is a combination medicine used to treat acidity, gastro-esophageal reflux disease (GERD), stomach ulcers (peptic ulcers, gastric ulcers due to H pylori), heartburn symptoms and Zollinger Ellison syndrome.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Storage: Store in cool, dry place. below 25˚C. Protect from Light and moisture.
Dosage: As directed by the Physician.
Dosage: As directed by the Physician.
