Salofalk tablets p / o 500mg, No. 50

• NNC,

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

Inside, 400-800 mg are used 3 times / day for 8-12 weeks.

Active ingredient: mesalazine (5-ASA) - 500mg

Excipients: sodium carbonate, glycine, povidone, microcrystalline cellulose, sodium croscarmellose, colloidal silicon dioxide, calcium stearate, hypromellose, methacrylic acid and methacrylate copolymer (1: 1), talc, titanium dioxide, iron dye yellow oxide, macrogolate, butyl.

• Blood diseases

• severe liver and / or kidney dysfunction,

• peptic ulcer of the stomach or duodenum in the acute phase,

• blood clotting disorders,

• children under 2 years old,

• hypersensitivity to salicylates.

Tablets, enteric film-coated tablets from light yellow to yellow-brown color, oval, biconvex.

Clinical and pharmacological group: An anti-inflammatory drug used to treat Crohn's disease and NUC

Pharmaco-therapeutic group: Antimicrobial and anti-inflammatory intestinal agent

pharmachologic effect

Anti-inflammatory agent with a predominant localization of action in the intestine. Mesalazine (5-aminosalicylic acid) inhibits the activity of neutrophil lipoxygenase and the synthesis of arachidonic acid metabolites (prostaglandins and leukotrienes), which are inflammatory mediators. Inhibits migration, degranulation, phagocytosis of neutrophils, as well as the secretion of immunoglobulins by lymphocytes. Mesalazine has antioxidant properties by binding to free oxygen radicals.

Pharmacokinetics

After oral administration, mesalazine is slowly released from the dosage form in the distal small intestine and in the large intestine. Plasma protein binding is 43%. It is metabolized in the intestinal mucosa and in the liver to form N-acetyl-5-ASA. T1 / 2 is 0.5-2 hours. Mesalazine is excreted in the urine, mainly in the acetylated form.

Indications

• NNC,

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

Dosage regimen

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

Inside, 400-800 mg are used 3 times / day for 8-12 weeks.

Side effect

From the digestive system: diarrhea, nausea, vomiting, heartburn, abdominal pain, loss of appetite, dry mouth, stomatitis, increased activity of liver enzymes.

From the nervous system: headache, depression, dizziness, sleep disturbances, paresthesias, tremors, tinnitus.

Allergic reactions: skin rash, itching, erythema.

From the side of the cardiovascular system: palpitations, tachycardia, arterial hypertension or hypotension, chest pain, shortness of breath.

From the urinary system: proteinuria, hematuria, crystalluria, oliguria, anuria.

From the hematopoietic system: anemia, leukopenia, agranulocytosis, thrombocytopenia; hypoprothrombinemia.

Others: alopecia, a decrease in the production of lacrimal fluid.

Contraindications for use

• Blood diseases

• severe liver and / or kidney dysfunction,

• peptic ulcer of the stomach or duodenum in the acute phase,

• blood clotting disorders,

• children under 2 years old,

• hypersensitivity to salicylates.

Application during pregnancy and lactation

In the first trimester of pregnancy, use is possible only on strict indications. If the individual course of the disease allows, then in the last 2-4 weeks of pregnancy, mesalazine should be discontinued.

If necessary, use during lactation should decide on the termination of breastfeeding, due to the lack of sufficient clinical experience with the use of mesalazine in this category of patients.

Application for violations of liver function

Contraindicated in severe liver dysfunction.

Use with caution in liver diseases.

Application for impaired renal function

Contraindicated in severe renal impairment.

Use with caution in kidney disease.

Application in children

Contraindicated in children under 2 years of age. Use in children under 2 years of age is possible only if the intended benefit of therapy outweighs the potential risk to the child.

special instructions

Use with caution in diseases of the liver and kidneys, deficiency of glucose-6-phosphate dehydrogenase, allergic diseases and predisposition to them. Before starting treatment, and then monthly during the first 3 months of treatment, monitoring of the picture of peripheral blood, liver function, as well as determination of the concentration of urea and creatinine in the blood should be carried out. Patients who are 'slow acetylators' are at increased risk of side effects.

Use in children under 2 years of age is possible only if the intended benefit of therapy outweighs the potential risk to the child.

Drug interactions

With the simultaneous use of mesalazine with azathioprine, mercaptopurine, the toxicity of azathioprine and mercaptopurine increases; with warfarin - a case of decreasing the effectiveness of warfarin has been described.