GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Leflunomide Tablets 10mg
B. Leflunomide Tablets 20mg
B. Leflunomide Tablets 20mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Leflunomide Tablets 10mg
Each film-coated tablet contains:
Leflunomide 10mg
Excipients q.s
Color: Sunset yellow FCF
B. Leflunomide Tablets 20mg
Each film-coated tablet contains:
Leflunomide 20mg
Excipients q.s
Color: Lake tartrazine
Each film-coated tablet contains:
Leflunomide 10mg
Excipients q.s
Color: Sunset yellow FCF
B. Leflunomide Tablets 20mg
Each film-coated tablet contains:
Leflunomide 20mg
Excipients q.s
Color: Lake tartrazine
THERAPEUTIC INDICATIONS:
Leflunomide is used alone or in combination with other medications to treat rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function). Leflunomide is in a class of medications called disease-modifying antirheumatic drugs (DMARDs).
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Dispense in a tight, light-resistant container.
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.
Dispense in a tight, light-resistant container.
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). Store in dry place protected from light and moisture.
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end county.
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end county.
Leflunomide Tablets 10mg Technical Specification:
| Product Name: | Leflunomide Tablets USP |
| Brand Name: | Generic |
| Strength: | (10mg), (20mg) |
| 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: | Antirheumatic |
| Indication: | Leflunomide is used alone or in combination with other medications to treat rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function). Leflunomide is in a class of medications called disease-modifying antirheumatic drugs (DMARDs). |
| Storage: | Store at 20° to 25°C (68° to 77°F). Store in dry place protected from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Leflunomide Tablets 10mg
- Leflunomide Tablets 20mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Leflunomide Tablets 10mg
Each film-coated tablet contains:
Leflunomide………………..10mg
Excipients……………………q.s
Color: Sunset yellow FCF - Leflunomide Tablets 20mg
Each film-coated tablet contains:
Leflunomide………………..20mg
Excipients……………………q.s
Color: Lake tartrazine
THERAPEUTIC INDICATIONS:
Leflunomide is used alone or in combination with other medications to treat rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function). Leflunomide is in a class of medications called disease-modifying antirheumatic drugs (DMARDs).
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
dispense in a tight, light-resistant container.
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). Store in dry place protected from light and moisture.
Store in dry place protected from light and moisture.
Dosage:
As directed by the Physician
Attach dispensing label as per end county.
