Product Information:

MASACOL 400mg Tablets contain Mesalazine (5-Aminosalicylic Acid, 5-ASA) 400mg, an anti-inflammatory drug specifically targeted to the gastrointestinal tract. Mesalazine works by inhibiting prostaglandin and leukotriene synthesis, reducing inflammation in the colon without significant systemic immunosuppression.

This formulation is typically enteric-coated or pH-dependent, ensuring release in the ileum and colon—where it acts topically on inflamed mucosa.

Uses of (MASACOL 400MG TABLETS):

1. Induction and maintenance of remission in ulcerative colitis (mild to moderate)
2. Treatment of Crohn’s disease (particularly colonic involvement)
3. Management of proctitis and proctosigmoiditis
4. Prevention of relapse in quiescent inflammatory bowel disease (IBD)

Key Benefits of (MASACOL 400MG TABLETS):

1. Local anti-inflammatory action with minimal systemic absorption
2. Effective for both acute flare-ups and long-term maintenance
3. Lower risk of serious side effects compared to corticosteroids or immunosuppressants
4. Once- or twice-daily dosing (depending on formulation)

How To Use (MASACOL 400MG TABLETS):

1. Take with or after food to reduce gastric irritation.
2. Swallow whole with water—do not crush, chew, or break (to preserve enteric coating).
3. Typical adult dose:
4. Induction: 1.2–2.4g/day in 2–3 divided doses
5. Maintenance: 800mg–1.6g/day
6. Continue therapy even during remission to prevent relapse.

When Not to Use (MASACOL 400MG TABLETS):

Do not use if you have:

1. Hypersensitivity to salicylates (e.g., aspirin) or mesalazine
2. Severe renal impairment
3. Active gastric or duodenal ulcers
4. History of mesalazine-induced myocarditis or pericarditis

Side Effects of (MASACOL 400MG TABLETS):

Common: Headache, nausea, abdominal pain, diarrhea, flatulence.

Rare: Rash, fever, hair loss, elevated liver enzymes.

Serious (rare but require monitoring):

1. Acute pancreatitis (severe upper abdominal pain radiating to back)
2. Hepatotoxicity (jaundice, dark urine, fatigue)
3. Renal impairment (reduced urine output, swelling)
4. Blood dyscrasias (unexplained bruising, sore throat, pallor)
5. Discontinue and seek immediate medical help if these occur.

Dosage: (MASACOL 400MG TABLETS):

1. Ulcerative Colitis (Induction): 2–3 tablets (800–1200mg) 2–3 times daily (total 1.6–2.4g/day)
2. Maintenance: 1–2 tablets twice daily (800–1600mg/day)
3. Elderly or renal impairment: Use lowest effective dose; monitor kidney function

Who It’s For (MASACOL 400MG TABLETS):

Adults and adolescents with mild to moderate ulcerative colitis or Crohn’s colitis requiring long-term anti-inflammatory therapy with a favorable safety profile.

Warnings & Precautions:

1. Monitor renal function before and during treatment (mesalazine can cause interstitial nephritis)
2. Discontinue if unexplained fever, rash, or flu-like symptoms occur (may indicate hypersensitivity)
3. Avoid in patients with salicylate allergy (cross-reactivity possible)
4. May temporarily discolor urine yellow-orange (harmless)

Drug Interactions:

1. Azathioprine/6-MP: ↑ Risk of blood dyscrasias
2. NSAIDs: ↑ Risk of renal toxicity
3. Warfarin: Mesalazine may enhance anticoagulant effect (monitor INR)
4. Always inform your doctor about all medications.

Additional Information:

Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children. Do not use after the expiration date. Available by prescription in Pakistan.