Salofalc, rectal 250 mg 10 pcs

Mesalazine

Indications

Distal forms of nonspecific ulcerative colitis (prevention, treatment of exacerbations).

Pharmacological effect

Pharmacotherapeutic group: Antimicrobial and anti-inflammatory intestinal agent.

ATX code A07EC02

PHARMACOLOGICAL PROPERTIES

Has an anti-inflammatory effect. Inhibits the synthesis of arachidonic acid metabolites (prostaglandins), the activity of neutrophil lipoxygenase, inhibits the migration, degranulation and phagocytosis of neutrophils, the secretion of immunoglobulins by lymphocytes; binds and destroys oxygen free radicals.

Pharmacokinetics

Release of mesalazine occurs in the rectum and colon. It is already metabolized in the intestinal mucosa and in the liver into N-acetyl-5-ASA, so the concentration in plasma is relatively low (after a single dose – 0.5 -1.5 mcg/ml). Binds to plasma proteins by 43% (metabolite – by 75 – 83%). 0.1% of the dose penetrates into mother’s milk (in the form of a metabolite).

Active ingredient

Mesalazine

Composition

Each suppository contains

Active substance: 250 mg mesalazine

Excipients: solid fat.

Pregnancy

In the first trimester of pregnancy, the drug can be prescribed only according to strict indications. If the course of the disease allows, then in the last 2-4 weeks of pregnancy the use of the drug should be discontinued.

If necessary, the use of Salofalk during lactation should resolve the issue of stopping breastfeeding.

Before a planned pregnancy, it is recommended, if possible, to stop treatment with Salofalk or use the drug in reduced doses.

Contraindications

Severe dysfunction of the liver and/or kidneys; peptic ulcer of the stomach and duodenum in the acute phase; hemorrhagic diathesis (with a tendency to bleeding); children under 2 years of age; hypersensitivity to salicylic acid and its derivatives.

WITH CAUTION

Salofalk is prescribed with caution to patients with impaired renal excretory function, deficiency of glucose-6-phosphate dehydrogenase, impaired respiratory function (especially patients with bronchial asthma), and patients with hypersensitivity to sulfasalazine.

Side Effects

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

Side effects from the central nervous system: headache, depression, dizziness, sleep disturbances, 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, weakness, chest pain, shortness of breath; myalgia, arthralgia. In some cases,

proteinuria, hematuria, crystalluria, oliguria, anuria; anemia, leukopenia, agranulocytosis, thrombocytopenia, hypoprothrombinemia; decreased tear production, alopecia. Taking into account the chemical structure of the active ingredient, the possibility of an increase in methemoglobin levels cannot be ruled out.

If acute signs of intolerance occur, treatment should be stopped immediately.

Interaction

Salofalk increases the effect of anticoagulants, enhances the hypoglycemic effect of sulfonylurea derivatives, increases the toxicity of methotrexate, enhances the damaging effect of glucocorticoids on the gastric mucosa, reduces the tuberculostatic effect of rifampicin, the uricosuric effect of probenecid and sulfinpyrazone, the diuretic effect of spironolactone and furosemide.

Overdose

No cases of overdose have been identified. In case of overdose, symptomatic treatment is carried out.

Storage conditions

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

Keep out of the reach of children.

Shelf life

3 years. Do not use after expiration date.

Manufacturer

Dr Falk, Germany