Patient Information Leaflet: Rofenac Suppositories

Welcome to your guide on Rofenac Suppositories. This information aims to provide a clear understanding of the medication, its uses, and guidelines for its safe and effective use. Please follow your healthcare provider’s advice and use this information as a supplementary guide.

Composition: What’s Inside?

  • Active Ingredient: Diclofenac Sodium
  • Available in suppositories of 12.5 mg, 25 mg, 50 mg, and 100 mg.

Indications: When to Use Rofenac

Rofenac is recommended for the treatment of various conditions, including:

  1. Rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.
  2. Non-articular rheumatism.
  3. Acute musculoskeletal disorders and back pain.
  4. Painful syndromes of the vertebral column.
  5. Relief of pain in acute trauma and fractures.
  6. Control of pain and inflammation in orthopedic, dental, and other surgeries.
  7. Painful inflammatory conditions in gynecology and primary dysmenorrhea.
  8. Renal colic and biliary colic (Rofenac ampoules are recommended).
  9. Acute attacks of gout.

Dosage Guidelines: Tailored for You

For Adults:

  • Initial daily dose: Usually 100-150 mg.
  • Maintenance: In milder cases or prolonged therapy, 75-100 mg daily.
  • Dosage Form: Generally given in 2-3 divided doses.

For Children (1 year and older):

  • 0.5-2 mg/kg body weight daily, depending on severity.
  • Maximum for juvenile rheumatoid arthritis: 3 mg/kg body weight.
  • Note: Not recommended for children under 12 months.

Contraindications: When to Avoid Rofenac

Avoid Rofenac if you:

  • Are hypersensitive to Diclofenac.
  • Have peptic ulcer or aspirin-induced asthma, acute rhinitis, and urticaria.

Precautions: Use with Caution

  • Severe hepatic function impairment requires caution.
  • Exercise caution in cardiac or renal issues, diuretic use, and post-surgery recovery.
  • Use during pregnancy only if benefits outweigh potential risks.

Special Warnings: Your Safety Matters

  • Cardiovascular Risk:
    • NSAIDs may pose a risk of serious cardiovascular events.
    • Not recommended for coronary artery bypass graft (CABG) surgery.
  • Gastrointestinal Risks:
    • Increased risk of serious gastrointestinal adverse events.
    • Elderly patients are at greater risk.

Side Effects: What to Expect

  • Generally well-tolerated.
  • Common side effects: Gastrointestinal disturbances, headache, dizziness.
  • Rare side effects: Fluid retention, liver function disorders, rash, and pruritis.

Interactions: Stay Informed

  • NSAIDs may interact with diuretics, necessitating potassium level monitoring.
  • Caution when co-administered with Digoxin, Methotrexate, Cyclosporine, or Lithium.

Storage: Keep it Right

  • Store between 15-30°C.

Final Note: Your Health Matters

Remember, Rofenac is a powerful tool for managing various conditions. Always follow your healthcare provider’s instructions, and if in doubt, consult them. Your health is paramount.

[Manufactured by SPIMACO, Al-Qassim Pharmaceutical Plant, Saudi Arabia]