| Product Name: | Loperamide Hydrochloride Capsules USP |
| Brand Name: | Generic |
| Strength: | 2mg |
| Dosage Form: | Capsules (Hard gelatin) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Gastroenterological, Anti-diarrhoeal |
| Indication: | Loperamide is a medicine to treat diarrhoea (runny poo). It can help with short-term diarrhoea or irritable bowel syndrome (IBS). |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Loperamide Hydrochloride Capsules USP 2mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Loperamide Hydrochloride Capsules USP 2mg
Each hard gelatin Capsule Capsules contains:
Loperamide Hydrochloride USP………………….2mg
Excipients…………………………………………………..q.s
Approved colours used in capsule shells.
THERAPEUTIC INDICATIONS:
Loperamide is a medication used to decrease the frequency of diarrhea. It is often used for this purpose in inflammatory bowel disease and short bowel syndrome. It is not recommended for those with blood in the stool, mucus in the stool, or fevers. Loperamide is also used for recurring or longer lasting diarrhoea from bowel conditions such as Crohn’s disease, ulcerative colitis and short bowel syndrome.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician.