| Product Name: | Alendronate Sodium Tablets USP |
| Brand Name: | Generic |
| Strength: | 5mg, 10mg, 35mg, 70mg |
| Dosage Form: | Tablets (Film-coated) |
| 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: | Antiosteoporotic |
| Indication: | Alendronate is also used to treat osteoporosis in men and women who are taking corticosteroids. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Alendronate Sodium Tablets USP 5mg
B) Alendronate Sodium Tablets USP 10mg
C) Alendronate Sodium Tablets USP 35mg
D Alendronate Sodium Tablets USP 70mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- A) Alendronate Sodium Tablets USP 5mg
Each uncoated tablet contains:
Sodium Alendronate USP
Equivalent to Alendronic Acid………5mg
Excipients……………………………………..q.s. - B) Alendronate Sodium Tablets USP 10mg
Each uncoated tablet contains:
Sodium Alendronate USP
Equivalent to Alendronic Acid………5mg
Excipients……………………………………..q.s. - C) Alendronate Sodium Tablets USP 35mg
Each uncoated tablet contains:
Sodium Alendronate USP
Equivalent to Alendronic Acid………35mg
Excipients……………………………………..q.s. - D) Alendronate Sodium Tablets USP 70mg
Each uncoated tablet contains:
Sodium Alendronate USP
Equivalent to Alendronic Acid………70mg
Excipients……………………………………..q.s.
THERAPEUTIC INDICATIONS:
Alendronate is used to prevent and treat certain types of bone loss (osteoporosis) in adults. Osteoporosis causes bones to become thinner and break more easily.
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].
Dispense in tight container.
Dosage: As directed by the Physician
Attach dispensing label as per end country.