A) Diclofenac Sodium/Misoprostol Tablets 50mg/200mcg
B) Diclofenac Sodium/Misoprostol Tablets 75mg/200mcg
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Diclofenac Sodium/Misoprostol Tablets 50mg/200mcg
Each film-coated tablet contains:
Diclofenac Sodium USP
(enteric coated)..……………….50mg
Misoprostol USP……………….200mcg
Excipients……………………..q.s.
Colour: Sunset Yellow
B) Diclofenac Sodium/Misoprostol Tablets 75mg/200mcg
Each film-coated tablet contains:
Diclofenac Sodium USP
(enteric coated)..……………….75mg
Misoprostol USP……………….200mcg
Excipients……………………..q.s.
Colour: Titanium Dioxide USP
Each film-coated tablet contains:
Diclofenac Sodium USP
(enteric coated)..……………….50mg
Misoprostol USP……………….200mcg
Excipients……………………..q.s.
Colour: Sunset Yellow
B) Diclofenac Sodium/Misoprostol Tablets 75mg/200mcg
Each film-coated tablet contains:
Diclofenac Sodium USP
(enteric coated)..……………….75mg
Misoprostol USP……………….200mcg
Excipients……………………..q.s.
Colour: Titanium Dioxide USP
THERAPEUTIC INDICATIONS:
Diclofenac is used to reduce pain, swelling, and joint stiffness from arthritis. Diclofenac is known as a nonsteroidal anti-inflammatory drug (NSAID). Misoprostol protects the stomach from diclofenac's irritating effects. This combination medication is used to treat arthritis in people at high risk of getting stomach/intestinal ulcers and complications from the ulcers (such as bleeding).
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT SPIT, CHEW OR CRUSH.
Patients must be advised of the abortifacient property and warned not to give the drug to others.
WARNING: It is dangerous to take this medication except in accordance with medical advice.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT SPIT, CHEW OR CRUSH.
Patients must be advised of the abortifacient property and warned not to give the drug to others.
WARNING: It is dangerous to take this medication except in accordance with medical advice.
STORAGE & DOSAGE:
Storage: Store at 25°C (77°F) excusion permitted to 15°C to 30°C (59°F to 86°F)[see USP Controlled Room Temperature]. Protect from Light and Moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Diclofenac Sodium/Misoprostol Tablets 75mg/200mcg Technical Specification:
| Product Name: | Diclofenac Sodium/Misoprostol Tablets |
| Brand Name: | Generic |
| Strength: | 50mg/200mcg, 75mg/200mcg |
| 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: | Analgesic, Anti-inflammatory, Antipyretic, NSAID |
| Indication: | Diclofenac is used to reduce pain, swelling, and joint stiffness from arthritis. Diclofenac is known as a nonsteroidal anti-inflammatory drug (NSAID). Misoprostol protects the stomach from diclofenac’s irritating effects. |
| Storage: | Store at 25°C (77°F) excusion permitted to 15°C to 30°C (59°F to 86°F)[see USP Controlled Room Temperature]. Protect from Light and Moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Diclofenac Sodium/Misoprostol Tablets 50mg/200mcg
- Diclofenac Sodium/Misoprostol Tablets 75mg/200mcg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Diclofenac Sodium/Misoprostol Tablets 50mg/200mcg
Each film-coated tablet contains:
Diclofenac Sodium USP
(enteric coated)..……………….50mg
Misoprostol USP……………….200mcg
Excipients……………………..q.s.
Colour: Sunset Yellow - Diclofenac Sodium/Misoprostol Tablets 75mg/200mcg
Each film-coated tablet contains:
Diclofenac Sodium USP
(enteric coated)..……………….75mg
Misoprostol USP……………….200mcg
Excipients……………………..q.s.
Colour: Titanium Dioxide USP
THERAPEUTIC INDICATIONS:
Diclofenac is used to reduce pain, swelling, and joint stiffness from arthritis. Diclofenac is known as a nonsteroidal anti-inflammatory drug (NSAID). Misoprostol protects the stomach from diclofenac’s irritating effects. This combination medication is used to treat arthritis in people at high risk of getting stomach/intestinal ulcers and complications from the ulcers (such as bleeding).
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT spit, CHEW OR CRUSH.
Patients must be advised of the abortifacient property and warned not to give the drug to others.
Warning: It is dangerous to take this medication except in accordance with medical advice.
STORAGE & DOSAGE:
Storage: Store at 25°C (77°F) excusion permitted to 15°C to 30°C (59°F to 86°F)[see USP Controlled Room Temperature]. Protect from Light and Moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
