Mesalazol
Overview
Mesalazol
Rectal suppositories, 250 mg / 500 mg / 1000 mg
COMPOSITION
Each suppository contains the active substance mesalazine 250 mg, 500 mg or 1000 mg, depending on the strength.
Excipients: semi-synthetic solid glycerides. In addition, the 500 mg suppositories contain cetyl alcohol and sodium docusate.
WHAT IT IS USED FOR
An intestinal anti-inflammatory medicine for the treatment of mild to moderate acute episodes and for the prevention of relapses of ulcerative colitis limited to the rectum (ulcerative proctitis).
HOW IT WORKS
Mesalazine acts locally on the inflamed lining of the rectum, reducing inflammation. When given rectally, it works directly at the affected area.
HOW TO USE
Administered rectally. The dose is set by your doctor according to the severity of the disease and the strength of the suppositories.
acute episode – 250 mg: 2 suppositories 3 times a day (morning, midday and evening);
acute episode – 500 mg: 1 suppository 3 times a day (morning, midday and evening);
acute episode – 1000 mg: 1 suppository once a day, in the evening;
prevention of relapses – 250 mg: 1 suppository 3 times a day (morning, midday and evening).
Treatment should not be stopped suddenly. Ensure an adequate fluid intake during treatment.
WHEN IT SHOULD NOT BE USED
hypersensitivity to mesalazine, salicylates or to any of the excipients;
severe hepatic or renal failure.
Important to know
Your doctor may order blood and urine tests before and during treatment to monitor kidney and liver function and blood counts. Mesalazol must not be used in case of kidney impairment.
Use with caution in patients with bronchial asthma and in those who have reacted to sulfasalazine-containing medicines. Stop treatment and consult a doctor if cramps or acute abdominal pain, fever, severe headache, vision disturbances, tinnitus or skin rash occur. Read the package leaflet carefully before use.
Possible side effects
Rare: abdominal pain, diarrhoea, flatulence, nausea, vomiting, constipation, headache, dizziness, photosensitivity reactions.
Very rare or frequency not known: changes in blood cell counts, allergic reactions, damage to the kidneys (including stone formation), liver, heart or lungs, neuropathy, muscle and joint pain.
If side effects occur, stop using the product and consult a doctor or pharmacist.
STORAGE
Store below 25 °C. Do not freeze. Keep out of the reach of children. Shelf life: 36 months.
QUESTIONS AND CONTACTS
For questions about the medicine, please consult your doctor or pharmacist. Manufacturer: FARMAPRIM SRL, 5 Crinilor str., Porumbeni village, Criuleni district, Republic of Moldova, MD-4829. Pharmacovigilance: safety@farmaprim.md.
Brief information prepared on the basis of the approved Summary of Product Characteristics. It does not replace consultation with a doctor or pharmacist and does not contain all information about the medicine. Always read the package leaflet.