Marsalaz 500 mg 30 tablets

Description

Marsalaz is an anti-inflammatory medication indicated for the treatment and maintenance of remission in ulcerative colitis.

Indications for Use

Treatment of the acute phase of mild to moderate ulcerative colitis

Maintenance of remission in ulcerative colitis

Dosage and Method of Administration

Adults:

Acute phase: 1.5–4 g mesalazine per day, in single or divided doses

Maintenance: 1.5–3 g mesalazine per day, in single or divided doses

Evaluate efficacy after 8 weeks of treatment.

Elderly: Use with caution; only in patients with normal renal function.

Children under 18 years: Safety and efficacy not established. Do not use in children under 5.

Method: Oral administration. Take whole tablets with fluid before meals.

Contraindications

Hypersensitivity to mesalazine, salicylates, or excipients

Severe liver or kidney impairment

Hemorrhagic diathesis

Precautions

Monitor liver and kidney function before and during treatment

Ensure adequate fluid intake (risk of kidney stones)

Discontinue if intolerance or hypersensitivity occurs

Use caution in patients with asthma, ulcers, or heart sensitivity (e.g., myocarditis)

Avoid with lactulose-type laxatives

Risk of severe skin reactions (SJS, TEN, DRESS)

Red-brown urine may occur with bleach exposure

Pregnancy and Breastfeeding

Use only if benefits outweigh risks.

Pregnancy: Crosses placenta; limited data do not suggest major risk, but associations with low birth weight and preterm birth reported

Breastfeeding: Excreted in breast milk; discontinue if infant develops diarrhea

Side Effects

Blood/lymphatic: Leukopenia, thrombocytopenia, aplastic anemia

Immune: Allergic reactions, lupus-like syndrome

Nervous system: Headache, dizziness, peripheral neuropathy

Cardiac: Myocarditis, pericarditis

Respiratory: Allergic lung reactions

GI: Nausea, diarrhea, vomiting, pancreatitis, colitis worsening

Hepatic: Elevated liver enzymes, hepatitis

Skin: Rash, photosensitivity, SJS, TEN, DRESS

Musculoskeletal: Myalgia, arthralgia

Renal: Interstitial nephritis, nephrotic syndrome, renal failure, kidney stones

Reproductive: Reversible oligospermia

Storage Conditions

Store below 30°C in a dry place.

Packaging

Carton box containing blister strips, total 30 tablets and insert leaflet.