Mesacol tablets p / o 400mg, No. 50

• Nonspecific ulcerative colitis,

• Crohn's disease (prevention and treatment of exacerbations).

Inside.

With an exacerbation of the disease, 1-2 tablets (400-800 mg) 3 times a day for 8-12 weeks.

For the prevention of exacerbations, 1 tablet (400 mg) is prescribed 3 times a day.

Mesacol tablets should be taken whole after meals with plenty of water.

For children, mesalazine is prescribed in the form of a suspension, suppositories or microclysters.

1 tablet contains as an active substance : mesalazine - 400 mg

Excipients: calcium hydrogen phosphate dihydrate, corn starch, microcrystalline cellulose, hypromellose 2208, povidone K 90, purified talc, colloidal silicon dioxide, sodium carboxymethyl starch (sodium starch glycolate) (type A), methacrylic acid and methyl methacrylate coplate 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).

• 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 impairment,

• childhood.

With caution - hepatic and / or renal failure.

Trade name of the drug: MECAKOL (MESA—ќL)

International non-proprietary name:

Mesalazine

Chemical name: 5-aminosalicylic acid

Dosage form:

enteric-coated tablets.

Composition

1 tablet contains as an active substance : mesalazine - 400 mg

Excipients: calcium hydrogen phosphate dihydrate, corn starch, microcrystalline cellulose, hypromellose 2208, povidone K 90, purified talc, colloidal silicon dioxide, sodium carboxymethyl starch (sodium starch glycolate) (type A), methacrylic acid and methyl methacrylate coplate 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 enteric-coated red-brown tablets.

Pharmacotherapeutic group: antimicrobial and anti-inflammatory intestinal agent

ATX code: A07EC02

Pharmacological action
Pharmacodiamica
Has a local anti-inflammatory effect due to inhibition of the activity of neutrophilic lipoxygenase and the synthesis of prostaglandins and leukotrienes. Inhibits migration, degranulation, phagocytosis of neutrophils, as well as the secretion of immunoglobulins by lymphocytes. It has an antibacterial effect 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 membrane, mesalazine is released mainly in the large intestine (60-79%). In the jejunum, 15-30% of the active substance is released, while only about 10% enters the systemic circulation. Plasma concentration is low. In the body, mesalazine is metabolized to form N-acetyl-5-aminosalicylic acid. The connection with plasma proteins is 43%, and N-acetyl-5-aminosalicylic acid is 73-83%. The drug and its metabolite pass into breast milk. The half-life is 0.5-2 hours, depending on the dose taken, the metabolite is 5-10 hours. Excretion by the kidneys (50%), through the intestines (40%). Cumulates in chronic renal 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 impairment, childhood.

With caution - hepatic and / or renal failure.

Method of administration and dosage

Inside.

With an exacerbation of the disease, 1-2 tablets (400-800 mg) 3 times a day for 8-12 weeks.

For the prevention of exacerbations, 1 tablet (400 mg) is prescribed 3 times a day.

Mesacol tablets should be taken whole after meals with plenty of water.

For children, mesalazine is prescribed in the form of a suspension, suppositories or microclysters.

Side effect
From the digestive system: nausea, vomiting, heartburn, diarrhea, especially when using high doses of the drug (however, diarrhea is not always a consequence of a side effect of the drug, but 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 side of the cardiovascular system: palpitations, tachycardia, arterial hypertension or hypotension, chest pain, shortness of breath. There are separate reports on the development of pericarditis, cardiac conduction disorders.
From the side of the central nervous system: headache, tinnitus, dizziness, polyneuropathy, tremors, convulsions, insomnia, depression, hallucinations.
From the genitourinary system: proteinuria, hematuria, crystalluria, oliguria, anuria, nephrotic syndrome, oligospermia. Some cases of impotence are described.
Co side of the hematopoietic system: eosinophilia, anemia (hemolytic, megablastic, aplastic), leukopenia, agranulocytosis, thrombocytopenia, hypoprothrombinemia.
Allergic reactions: skin rash, itching, erythema, dermatoses, bronchospasm.
Others: weakness, mumps, photosensitivity, lupus-like syndrome, alopecia, decreased production of lacrimal fluid.

Overdose
Symptoms: nausea, vomiting, gastralgia, weakness, drowsiness.
Treatment: gastric lavage, laxative prescription, symptomatic therapy.

Interaction with other drugs
Enhances the hypoglycemic effect of sulfonylurea derivatives, the ulcerogenicity of glucocorticosteroids, the toxicity of methotrexate. Weakens the activity of furosemide, spironolactone, sulfonamides, rifampicin. Strengthens the effect of anticoagulants, increases the effectiveness of uricosuric drugs (tubular secretion blockers). Slows down the absorption of cyanocobapamine.

Application during pregnancy and lactation
Currently, there is no clear information about the safety of Mesacol in pregnant women. Prescribe Mesacol to pregnant women only if the potential benefit to the woman outweighs the potential risk to the fetus. When prescribing Mesacol, a nursing woman should stop breastfeeding.

Special instructions
It should be borne in mind that diarrhea, which may occur during treatment, is not always the result of a side effect of the drug, but may be a manifestation of the underlying disease.
It is advisable to regularly conduct a general blood test (before, during, and also after treatment), and urine (monitoring the excretory function of the kidneys). Patients who are 'slow chelators' are at increased risk of side effects. There may be a yellow-orange staining of urine and lacrimal fluid, staining of soft contact lenses. If you miss a dose, the missed dose should be taken at any time or together with the next dose. If several doses are missed, then, without stopping treatment, you should consult a doctor. If you suspect the development of an acute intolerance syndrome, Mesacol should be canceled. 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 lower the pH.

Release form
Enteric-coated tablets, 400 mg each.
10 tablets in aluminum foil strips. 5 strips together with instructions for use in a cardboard box.

Storage conditions
List B. In a dry, dark place, out of reach of children, at a temperature not exceeding 25 ? C.

Shelf life is
4 years. Do not use after the expiration date printed on the package.

Dispensing from pharmacies: with prescription.