Leflunomide 10mg Tab

Product Details
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Name Of Product(Genric Name) :

Leflunomide 10mg Tab

Product Description :

LEFLUNOMIDE 10 mg TABLETS

1. COMPOSITION

Each film-coated tablet contains:

  • Leflunomide — 10 mg

  • Pharmaceutical excipients — q.s.

2. PHARMACEUTICAL FORM

Film-Coated Tablet.

3. THERAPEUTIC CLASS

Disease-Modifying Antirheumatic Drug (DMARD) / Immunomodulatory Agent.

4. INDICATIONS

  • Treatment of active rheumatoid arthritis in adults.

  • May be used to reduce signs and symptoms and to improve physical function in patients with active rheumatoid arthritis.

  • Treatment should be initiated and monitored by a physician experienced in the management of rheumatic diseases.

5. CONTRAINDICATIONS

  • Hypersensitivity to Leflunomide or any component of the formulation.

  • Pregnancy or women of childbearing potential who are not using reliable contraception.

  • Severe hepatic impairment.

  • Significant impairment of bone marrow function or severe anaemia, leukopenia, neutropenia or thrombocytopenia unrelated to rheumatoid arthritis.

  • Severe immunodeficiency.

  • Severe infections.

  • Moderate to severe renal impairment.

  • Concomitant treatment with other hepatotoxic or immunosuppressive DMARDs requires specialist supervision.

6. DRUG INTERACTIONS

Leflunomide may interact with:

  • Hepatotoxic medicines — may increase the risk of liver injury.

  • Other immunosuppressive or DMARD therapies — may increase the risk of adverse effects.

  • Warfarin — monitoring of anticoagulant effect may be required.

  • Rifampicin — may increase exposure to the active metabolite.

  • Certain oral contraceptives — exposure to some contraceptive hormones may increase.

  • Cholestyramine or activated charcoal — significantly reduces leflunomide metabolite concentrations and is used during accelerated elimination when clinically indicated.

7. ADMINISTRATION

Take 10 mg once daily, or as directed by a physician.

  • Swallow the tablet whole with sufficient water.

  • Treatment requires regular monitoring of liver function and blood cell counts.

  • Do not discontinue treatment without medical advice.

  • Pregnancy must be avoided during treatment and until adequate drug elimination has been confirmed.

  • Women of childbearing potential should use reliable contraception as advised by their physician.

8. STORAGE

Store below 25°C, protected from moisture, heat and direct sunlight.
Keep the tablets in the original package.
Keep out of reach of children.
Do not use after the expiry date.


Market : international export

Private Label : Available

Registration Support : Available

Regulatory documents : Available on request


TABLETS