Salofalc, 500 mg 50 pcs.

It has a local anti-inflammatory effect due to inhibition of cyclooxygenase and synthesis of PG and leukotrienes. It inhibits migration, degranulation, phagocytosis of neutrophils as well as immunoglobulin secretion by lymphocytes.

Indications

Nonspecific ulcerative colitis; Crohn’s disease (prevention, treatment of exacerbations).

Pharmacological effect

It has a local anti-inflammatory effect due to inhibition of cyclooxygenase and the synthesis of PG and leukotrienes. Slows down migration, degranulation, phagocytosis of neutrophils, as well as the secretion of immunoglobulins by lymphocytes.

Special instructions

Salofalk is recommended to be used only under the supervision of a physician.

Active ingredient

Mesalazine

Composition

1 tablet contains:

Active substance:

mesalazine500 mg;

Excipients:

sodium carbonate;

MCC;

povidone;

croscarmellose;

glycine;

colloidal silicon dioxide;

calcium stearate;

Shell:

methacrylic acid and methacrylate copolymer 1:1;

talc;

macrogol;

titanium dioxide;

hypromellose;

iron oxide yellow dye (E172, CFR21);

butyl methacrylate.

Contraindications

hypersensitivity to the components of the drug and other salicylic acid derivatives;
blood diseases;
peptic ulcer of the stomach and duodenum;
deficiency of glucose-6-phosphate dehydrogenase;
hemorrhagic diathesis;
severe renal/liver failure;
children’s age (up to 6 years);
phenylketonuria.

With caution: pregnancy (first trimester), mild to moderate renal/liver failure, lung diseases (especially bronchial asthma).

Side Effects

From the gastrointestinal tract: diarrhea, nausea, abdominal pain, flatulence, loss of appetite, vomiting, increased levels of liver enzymes in the blood, hepatitis.

From the central nervous system: headache, depression, dizziness, sleep disturbance, malaise, paresthesia, convulsions, tremor, tinnitus.

Reactions associated with hypersensitivity: skin rash, itching, erythema, fever, bronchospasm, pericarditis and myocarditis, acute pancreatitis, interstitial nephritis, nephrotic syndrome.

Isolated cases of allergic alveolitis and pancolitis have been observed. Under certain conditions, mesalazine and drugs with a similar chemical structure can lead to the development of a syndrome similar to systemic lupus erythematosus syndrome.

Other side effects: rarely – tachycardia, arterial hypertension or hypotension, chest pain, shortness of breath; myalgia, arthralgia. In some cases, proteinuria, hematuria, crystalluria, oliguria, and anuria were observed; anemia, leukopenia, agranulocytosis, thrombocytopenia, hypoprothrombinemia; decreased tear production, alopecia.

Interaction

With simultaneous administration, it is possible to enhance the effect of coumarin anticoagulants, increase the toxicity of methotrexate, reduce the diuretic effect of spironolactone and furosemide, and reduce the effectiveness of probenecid and rifampicin.

Overdose

Symptoms: nausea, vomiting, weakness, drowsiness.

Treatment: symptomatic therapy.

Storage conditions

In a place protected from light, at a temperature not exceeding 25 °C.

Shelf life

3 years

Manufacturer

Losan Pharma GmbH, Germany