Salofalc, 250 mg 50 pcs.

Salofalc – anti-inflammatory.

Pharmacodynamics

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 and secretion of immunoglobulins by lymphocytes. It has an antioxidant effect (due to the ability to bind with free oxygen radicals and destroy them). Mesalazine can also trap radicals formed from reactive oxygen compounds.

The results obtained in in vitro studies indicate a possible role of lipooxygenase inhibition. The effect on the GH content in the intestinal mucosa has also been shown. When administered orally, mesalazine has predominantly a local effect in the intestinal mucosa and submucosa layer, acting on the intestinal lumen side. Therefore, it is important that mesalazine is accessible to the area of inflammation.

The ratio of systemic bioavailability to plasma concentration of mesalazine is not significant in terms of therapeutic efficacy, but rather serves as a factor influencing safety.

The fact that Salofalc granules are resistant to gastric juice and are characterized by pH-dependent (due to Eudragit L coating) and delayed (due to matrix structure of the granules) release of mesalazine helps to ensure the release of the active substance in the right place.

Indications

Non-specific ulcerative colitis; Crohn’s disease (prevention, treatment of exacerbations).

Active ingredient

Composition

1 tablet contains:

The active ingredient:

mesalazine250 mg;

Associates:

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.

How to take, the dosage

The drug is used strictly on prescription.

Overly, whole, without chewing, after a meal, with plenty of water.

Adults: 500 mg (2 tablets of 250 mg or 1 tablet of 500 mg) 3 times a day. In severe forms of the disease the dose can be increased to 3-4 g/day for 8-12 weeks.

To prevent recurrences, the drug is prescribed 500 mg (2 tablets of 250 mg or 1 tablet of 500 mg) 3 times a day, if necessary, for several years.

In children. For body weight up to 40 kg half the daily dose for adults (1 tablet of 250 mg 3 times a day), over 40 kg the daily dose for adults (2 tablets of 250 mg or 1 tablet of 500 mg) 3 times a day is prescribed.

To prevent relapses, the drug is prescribed 250 mg 3 times daily, if necessary for several years.

In distal forms of nonspecific ulcerative colitis it is preferable to administer the drug rectally in the form of suppositories or enemas.

Interaction

In concomitant administration the effect of coumarin anticoagulants may be enhanced, methotrexate toxicity may be increased, the diuretic effect of spironolactone and furosemide may be reduced, the effectiveness of probenecid and rifampicin may be reduced.

It enhances hypoglycemic effect of oral antidiabetic agents – sulfonylurea derivatives.

Special Instructions

Salofalc is recommended to be used only under the supervision of a doctor.

Blood and urine tests should be performed before treatment, during therapy (14 days after the start of therapy and then every 4 weeks), and after the end of therapy (every 3 months).

In order to control kidney function it is recommended to determine serum urea and creatinine levels, urine sediment examination.

Contraindications

With caution: pregnancy (1st trimester), renal/liver failure of mild and moderate severity, lung diseases (especially bronchial asthma).

Side effects

Gastrointestinal disorders: diarrhea, nausea, abdominal pain, flatulence, loss of appetite, vomiting, increased level of liver enzymes in blood, hepatitis.

CNS disorders: headache, depression, dizziness, sleep disturbance, malaise, paresthesias, seizures, tremors, tinnitus.

Reactions associated with hypersensitivity: skin rash, itching, erythema, fever, bronchospasm, pericarditis and myocarditis, acute pancreatitis, interstitial nephritis, nephrotic syndrome. Individual cases of allergic alveolitis and pancolitis have been observed. Under certain conditions, mesalazine and drugs with a similar chemical structure may lead to the development of a syndrome similar to that of systemic lupus erythematosus.

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

Overdose

Symptoms: nausea, vomiting, weakness, drowsiness.

Treatment: symptomatic therapy.

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