Product Information:

MASACOL 800mg Tablets contain Mesalazine (5-Aminosalicylic Acid, 5-ASA) 800mg, a targeted anti-inflammatory agent used in the management of inflammatory bowel disease (IBD). Mesalazine acts locally in the colon by inhibiting prostaglandin and leukotriene production, reducing mucosal inflammation without significant systemic immunosuppression.

This higher-strength formulation is designed for convenient dosing, often allowing once- or twice-daily administration due to extended-release or pH-dependent release technology that delivers the drug directly to the site of inflammation in the ileum and colon.

Uses of (MASACOL 800MG TABLETS):

1. Induction and maintenance of remission in ulcerative colitis (mild to moderate)
2. Treatment of Crohn’s disease with colonic involvement
3. Management of proctosigmoiditis and left-sided colitis
4. Long-term prevention of IBD relapse

Key Benefits of (MASACOL 800MG TABLETS):

1. High-strength dose reduces pill burden (e.g., 2–3 tablets/day vs. 6+ with 400mg)
2. Local action in the colon minimizes systemic side effects
3. Effective for both acute flare control and long-term maintenance
4. Improved adherence due to simplified dosing schedule

How To Use (MASACOL 800MG TABLETS):

1. Take with or after food to minimize gastrointestinal irritation.
2. Swallow whole with water—do not crush, chew, or break (to preserve enteric or extended-release coating).
3. Typical adult dosage:
4. Induction of remission: 2.4g/day (e.g., 1 tablet three times daily or 2 tablets twice daily)
5. Maintenance therapy: 1.6g–2.4g/day (e.g., 1–2 tablets twice daily)
6. Continue treatment during remission to prevent relapse.

When Not to Use (MASACOL 800MG TABLETS):

Do not use if you have:

1. Hypersensitivity to mesalazine, salicylates (e.g., aspirin), or any excipients
2. Severe renal impairment (CrCl <30 mL/min)
3. Active peptic ulcer disease
4. History of mesalazine-induced myocarditis, pericarditis, or blood dyscrasias

Side Effects of (MASACOL 800MG TABLETS):

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

Rare: Fever, hair loss, elevated liver enzymes, fatigue.

Serious (rare but require immediate attention):

1. Acute pancreatitis (severe upper abdominal pain radiating to back)
2. Hepatotoxicity (jaundice, dark urine, right upper quadrant pain)
3. Renal impairment (reduced urine output, edema, elevated creatinine)
4. Blood disorders (unexplained bruising, sore throat, pallor—signs of agranulocytosis)
5. Discontinue and seek emergency care if these occur.

Dosage: (MASACOL 800MG TABLETS):

1. Ulcerative Colitis (Induction): 2.4g/day in 2–3 divided doses (e.g., 800mg TDS or 1.6g BD)
2. Maintenance: 1.6g–2.4g/day (e.g., 800mg twice daily)
3. Elderly or mild renal impairment: Start at lower dose; monitor kidney function regularly

Who It’s For (MASACOL 800MG TABLETS):

Adults and adolescents with mild to moderate ulcerative colitis or Crohn’s colitis who require effective, convenient, and well-tolerated long-term therapy.

Warnings & Precautions:

1. Perform baseline and periodic renal function tests (risk of interstitial nephritis)
2. Discontinue if fever, rash, or flu-like symptoms develop (possible hypersensitivity syndrome)
3. Avoid in patients with salicylate allergy (cross-reactivity risk)
4. May cause harmless orange-yellow discoloration of urine

Drug Interactions:

1. Azathioprine or 6-mercaptopurine: ↑ Risk of myelosuppression
2. NSAIDs: ↑ Risk of renal toxicity
3. Warfarin: Mesalazine may potentiate anticoagulant effect—monitor INR
4. Always inform your doctor about all medications and supplements.

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 on the blister pack. Available by prescription in Pakistan.