| Product Name: | Diacerein Capsules 50mg |
| Brand Name: | Generics |
| Strength: | 50mg |
| 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: | Anti-inflammatory agent |
| Indication: | Diacerein is a medicine used to treat joint diseases such as osteoarthritis (swelling and pain in the joints). Following an EU-wide review of diacerein, its use has been restricted in order to minimize the risks of severe diarrhoea and liver problems. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Diacerein Capsules 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Diacerein Capsules 50mg
Each hard gelatin capsule contains:
Diacerein USP……………50mg
Excipients……………….q.s.
Approved colours used in capsule shells.
THERAPEUTIC INDICATIONS:
Diacerein is a medicine used to treat joint diseases such as osteoarthritis (swelling and pain in the joints). Following an EU-wide review of diacerein, its use has been restricted in order to minimize the risks of severe diarrhoea and liver problems.
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]. Protect from light and moisture.
Dispense in tight, light-resistant container.
Dosage: As directed by the Physician.