A. Febuxostat Tablet 40mg
B. Febuxostat Tablet 80mg
C. Febuxostat Tablet 120mg
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a. Febuxostat Tablet 40mg
Each film-coated tablet contains:
Febuxostat…………………….40mg
Excipients………………………q.s.
Color: Ponceau 4R
b. Febuxostat Tablet 80mg
Each film-coated tablet contains:
Febuxostat…………………….80mg
Excipients………………………q.s.
Color: Quinoline Yellow
c. Febuxostat Tablet 120mg
Each film-coated tablet contains:
Febuxostat…………………….120mg
Excipients………………………q.s.
Color: FD&C Yellow 6
Each film-coated tablet contains:
Febuxostat…………………….40mg
Excipients………………………q.s.
Color: Ponceau 4R
b. Febuxostat Tablet 80mg
Each film-coated tablet contains:
Febuxostat…………………….80mg
Excipients………………………q.s.
Color: Quinoline Yellow
c. Febuxostat Tablet 120mg
Each film-coated tablet contains:
Febuxostat…………………….120mg
Excipients………………………q.s.
Color: FD&C Yellow 6
THERAPEUTIC INDICATIONS:
Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat is indicated in adults.
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.
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: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.
Febuxostat Tablet 40mg Technical Specification:
| Product Name: | Febuxostat Tablet |
| Brand Name: | Generics |
| Strength: | 40mg, 80mg, 120mg |
| Dosage Form: | Tablet (Film-coated) |
| Route of Administration: | Via oral Route |
| Packing: | 30s, 90s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antigout Drugs, Antihyperuricemic agents. |
| Indication: | Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat is indicated in adults. |
| Storage: | Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect it from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Febuxostat Tablet 40mg
- Febuxostat Tablet 80mg
- Febuxostat Tablet 120mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Febuxostat Tablet 40mg
Each film-coated tablet contains:
Febuxostat…………………….40mg
Excipients………………………q.s.
Colour: Ponceau 4R - Febuxostat Tablet 80mg
Each film-coated tablet contains:
Febuxostat…………………….80mg
Excipients………………………q.s.
Colour: Quinoline Yellow - Febuxostat Tablet 120mg
Each film-coated tablet contains:
Febuxostat…………………….120mg
Excipients………………………q.s.
Colour: FD&C Yellow 6
THERAPEUTIC INDICATIONS:
Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat is indicated in adults.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep the 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: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect it from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.
