Active substanceMesalazineMesalazine
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  • Dosage form: & nbspenteric coated tablets
    Composition:

    1 tablet contains as of the active substance: mesalazine 400 mg

    Excipients: calcium hydrophosphate dihydrate, corn starch, microcrystalline cellulose, hypromellose 2208, povidone K 90, purified talc, silicon dioxide colloid,carboxymethyl starch sodium (sodium starch glycolate) (type A), methacrylic acid and methyl methacrylate copolymer type "C", (eudragit L-100-55), methacrylic acid and methyl methacrylate copolymer type "B", (eudragit S-100), dibutyl phthalate, titanium dioxide, iron oxide red, macrogol 6000 (polyethylene glycol 6000).

    Description:Round, biconvex tablets, covered with enteric-coated shell of red-brown color.
    Pharmacotherapeutic group:Antimicrobial and anti-inflammatory intestinal
    ATX: & nbsp

    A.07.E.C.02   Mesalazine

    A.07.E.C   Aminosalicylic acid and its analogues

    Pharmacodynamics:Has a local anti-inflammatory effect due to inhibition of neutrophil lipoxygenase activity and synthesis of prostaglandins and leukotrienes. It inhibits migration, degranulation, phagocytosis of neutrophils, as well as secretion of immunoglobulins by lymphocytes. It has antibacterial action against some cocci and Escherichia coli (manifested in the large intestine).
    Pharmacokinetics:After taking the drug inside mesalazine begins to be released after 110-170 minutes, after 165-225 minutes the tablets completely dissolve.Due to the presence of a special shell, mesalazine is released mainly in the large intestine (60-79%). In the jejunum, 15-30% of the active substance is released, with only about 10% entering the systemic circulation. The concentration in the plasma is low. In organism mesalazine is metabolized to form N-acetyl-5-aminosalicylic acid. The connection with plasma proteins is 43%, and N-acetyl-5-aminosalicylic acid - 73-83%. The drug and its metabolite penetrate into the mother's milk. Half-life is 0.5-2 hours, depending on the dose taken, metabolite - 5-10 hours. Kidney excretion (50%), through the intestine (40%). Cumulates in chronic kidney failure.
    Indications:Nonspecific ulcerative colitis, Crohn's disease (prevention and treatment of exacerbations).
    Contraindications:Hypersensitivity to salicylates and other components of the drug, blood diseases, peptic ulcer of the stomach and duodenum, deficiency of glucose-6-phosphate dehydrogenase, hemorrhagic diathesis, severe renal / hepatic insufficiency, children's age.
    Carefully:Hepatic and / or renal insufficiency.
    Dosing and Administration:

    Inside.When the disease worsens 1-2 tablets (400-800 mg) 3 times a day for 8-12 weeks. For the prevention of exacerbations appoint 1 tablet (400 mg) 3 times a day. Tablets Mesacol should be taken whole, after eating, washed down with a lot of water.

    Children mesalazine prescribe as a suspension, a candle or microclyster.

    Side effects:

    From the digestive system: nausea, vomiting, heartburn, diarrhea, especially when using high doses of the drug (however, diarrhea is not always a consequence of the side effect of the drug, or it may be a manifestation of the underlying disease); decreased appetite, abdominal pain, dry mouth, stomatitis; increased activity of "hepatic" transaminases in plasma, hepatitis, pancreatitis.

    From the cardiovascular system: palpitation, tachycardia, hypertension or hypotension, chest pain, dyspnoea. There are separate reports on the development of pericarditis, conduction disorders of the heart.

    From the central nervous system: headache, tinnitus, dizziness, polyneuropathy, tremor, convulsions, insomnia, depression, hallucinations.

    From the genitourinary system: proteinuria, hematuria, crystalluria, oliguria, anuria, nephrotic syndrome, oligospermia. Individual cases of impotence are described.

    On the part of the hematopoiesis system: eosinophilia, anemia (hemolytic, megablastic, aplastic), leukopenia, agranulocytosis, thrombocytopenia, hypoprothrombinemia.

    Allergic reactions: skin rash, itching, erythema, dermatosis, bronchospasm.

    Other: weakness, parotitis, photosensitization, lupus-like syndrome, alopecia, a decrease in the production of tear fluid.

    Overdose:

    Symptoms: nausea, vomiting, gastralgia, weakness, drowsiness.

    Treatment: gastric lavage, laxative, symptomatic therapy.

    Interaction:Enhances hypoglycemic effect of sulfonylurea derivatives, ulcerogenicity of glucocorticosteroids, toxicity of methotrexate. It reduces the activity of furosemide, spironolactone, sulfonamides, rifampicin. Strengthens the effect of anticoagulants, increases the effectiveness of uricosuric drugs (tubular secretion blockers). Slows the absorption of cyanocobalamin.
    Special instructions:

    It should be borne in mind that diarrhea, which may occur against the background of treatment, is not always a consequence of the side effect of the drug, and may be a manifestation of the underlying disease.

    It is advisable to conduct a regular blood test (before, during, and after treatment) and urine (control of the excretory function of the kidneys). Patients who are "slow acetals" have an increased risk of developing side effects. It can be observed staining of urine and tear fluid in a yellow-orange color, staining of soft contact lenses. In case of missing the drug, the missed dose should be taken at any time or along with the next dose. If several doses are missed, then, without stopping treatment, you should consult your doctor. If suspected of developing a syndrome of acute intolerance, Mesakol should be abolished. Since at low pH values ​​there is no release of the active substance from the tablet, Mesacol should not be administered simultaneously with drugs that reduce pH.

    Form release / dosage:Tablets, covered with enteric coating, 400 mg each.
    Packaging:For 10 tablets in strips of aluminum foil.5 strips together with instructions for use in a cardboard bundle.
    Storage conditions:List B. In a dry, sheltered from light, out of reach of children at a temperature of no higher than 25 FROM.
    Shelf life:4 years. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N011198
    Date of registration:01.11.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:San Pharmaceutical Industries Co., Ltd.San Pharmaceutical Industries Co., Ltd. India
    Manufacturer: & nbsp
    Information update date: & nbsp03.05.2018
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