Salofalc, 500 mg 100 pcs

An anti-inflammatory intestinal agent. It has local anti-inflammatory effect caused by inhibition of neutrophil lipooxygenase and synthesis of prostaglandins and leukotrienes. It inhibits migration, degranulation, phagocytosis of neutrophils and secretion of immunoglobulins by lymphocytes.

It has 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. Effects on the content of prostaglandins in the intestinal mucosa have also been shown.

In oral administration mesalazine has predominantly local effects in the intestinal mucosa and submucosa, acting on the intestinal lumen side.

It is therefore 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 gastric juice tolerance of the Salofolk granules and the pH-dependent (due to the Eudragit L coating) and delayed (due to the matrix structure of the granules) release of mesalazine help ensure that the active ingredient is released at the desired location.

Indications

Active ingredient

Composition

1 tablet contains:

Active substance:

mesalazine 500 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

Special Instructions

Contraindications

With caution: pregnancy (1st trimester), mild to moderate renal/liver failure, 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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