| Product Name: | Rabeprazole Sodium+Levosulpiride Sustain Release Capsule |
| Brand Name: | Generics |
| Strength: | 20mg+75mg |
| 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: | LEVOSULPIRIDE+RABEPRAZOLE belongs to a group of medicines called gastrointestinal agents used to treat gastro-esophageal reflux disease (GERD), acidity, heartburn, Zollinger-Ellison syndrome, Helicobacter pylori infection, irritable bowel syndrome, indigestion, duodenal and gastric ulcers. |
| Storage: | Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Rabeprazole Sodium+Levosulpiride Sustain Release Capsule (20mg+75mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Rabeprazole Sodium+Levosulpiride Sustain Release Capsule (20mg+75mg)
Each hard gelatin capsule contains:
Rabeprazole Sodium I.P………20 mg.
(As enteric coated pellets)
Levosulpiride………………………75 mg.
(As Sustained release pellets)
Excipients…………………………….q.s.
Approved colours used in capsule shell & pellets
Dosage: As directed by the Physician.
THERAPEUTIC INDICATIONS:
LEVOSULPIRIDE+RABEPRAZOLE belongs to a group of medicines called gastrointestinal agents used to treat gastro-esophageal reflux disease (GERD), acidity, heartburn, Zollinger-Ellison syndrome, Helicobacter pylori infection, irritable bowel syndrome, indigestion, duodenal and gastric ulcers.
CAUTION & SCHEDULE:
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 a cool & dry place, protect from light & moisture.
Below 30 Protect from light
Keep the medicines out of reach of children
Capsule should be swallowed as whole and not to be chewed, opened or crushed.
Dosage: As directed by the Physician.