Risedronate Sodium Tablets IP 35mg
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Risedronate Sodium Tablets IP 35mg Technical Specification:

Product Name: Risedronate Sodium Tablets IP 35mg
Brand Name: Generic
Strength: (5mg), (30mg), (35mg), (150mg)
Dosage Form: Tablets (Film-coated)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet
Regulatory Documents: COA, MOA, Stability Studies, GMP
Therapeutic use: Antiosteoporotic
Indication: Risedronate is for use when you have a high risk of bone fracture due to osteoporosis.
Storage: Protect from light and Moisture, Store at a temperature not exceeding 30°C.

GENERIC NAME OF THE MEDICINAL PRODUCT:

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Risedronate Sodium Tablets IP 5mg
    Each film-coated tablet contains:
    Risedronate Sodium Hemi-Pentahydrate IP
    Equivalent to Risedronate Sodium…………5mg
    Excipients……………………………………………….q.s.
    Colour: Caramel
  • Risedronate Sodium Tablets IP 30mg
    Each film-coated tablet contains:
    Risedronate Sodium Hemi-Pentahydrate IP
    Equivalent to Risedronate Sodium…………30mg
    Excipients……………………………………………….q.s.
    Colour: Sunset Yellow FCF
  • Risedronate Sodium Tablets IP 35mg
    Each film-coated tablet contains:
    Risedronate Sodium Hemi-Pentahydrate IP
    Equivalent to Risedronate Sodium…………35mg
    Excipients……………………………………………….q.s.
    Colour: Titanium dioxide IP
  • Risedronate Sodium Tablets IP 150mg
    Each film-coated tablet contains:
    Risedronate Sodium Hemi-Pentahydrate IP
    Equivalent to Risedronate Sodium…………150mg
    Excipients……………………………………………….q.s.
    Colour: Tartrazine yellow

THERAPEUTIC INDICATIONS:

Risedronate is used by adults to treat a disease that weakens bones (Paget’s disease). This medication helps to reduce bone pain and may prevent long-term complications from this disease. Risedronate works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). It belongs to a class of medications called bisphosphonates.

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 Endocrinologist/Rheumatologist/gynaecologist/Orthopedics surgeon only.

STORAGE & DOSAGE:

Storage: Protect from light and Moisture, Store at a temperature not exceeding 30°C.

Dosage: One tablet same day every week.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Risedronate Sodium Tablets IP 5mg
B) Risedronate Sodium Tablets IP 30mg
C) Risedronate Sodium Tablets IP 35mg
D) Risedronate Sodium Tablets IP 150mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Risedronate Sodium Tablets IP 5mg
Each film coated tablet contains:
Risedronate Sodium Hemi-Pentahydrate IP
Equivalent to Risedronate Sodium…………5mg
Excipients……………………………………………….q.s.
Colour: Caramel

B) Risedronate Sodium Tablets IP 30mg
Each film coated tablet contains:
Risedronate Sodium Hemi-Pentahydrate IP
Equivalent to Risedronate Sodium…………30mg
Excipients……………………………………………….q.s.
Colour: Sunset Yellow FCF

C) Risedronate Sodium Tablets IP 35mg
Each film coated tablet contains:
Risedronate Sodium Hemi-Pentahydrate IP
Equivalent to Risedronate Sodium…………35mg
Excipients……………………………………………….q.s.
Colour: Titanium dioxide

D) Risedronate Sodium Tablets IP 150mg
Each film coated tablet contains:
Risedronate Sodium Hemi-Pentahydrate IP
Equivalent to Risedronate Sodium…………150mg
Excipients……………………………………………….q.s.
Colour: Tartrazine yellow

THERAPEUTIC INDICATIONS:

Risedronate is used by adults to treat a disease that weakens bones (Paget's disease). This medication helps to reduce bone pain and may prevent long-term complications from this disease. Risedronate works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). It belongs to a class of medications called bisphosphonates.

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 Endocrinologist/Rheumatologist/Gynecologists/Orthopedics surgeon only.

STORAGE & DOSAGE:

Storage: Protect from light and Moisture, Store at a temperature not exceeding 30°C.
Dosage: One tablet same day every week.