Salofalk candles 500mg №30

Dosage form

Rectal suppositories

Composition

1 rectal suppository contains: mesalazine 500 mg.
Excipients: solid fat, cetyl alcohol, docut sodium. DESCRIPTION Torpedo-shaped suppositories ranging from white to cream-colored, of uniform consistency and intact smooth surface.

Packing

In the blister 5 suppositories. In a carton pack 6 blisters.

Mechanism of action

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

Indications and usage

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

Contraindications

- The expressed abnormalities of the liver and / or kidneys.
- Peptic ulcer and 12 duodenal ulcer in the acute phase.
- Hemorrhagic diathesis (with a tendency to bleed).
- Children's age up to 2 years.
- Hypersensitivity to salicylic acid and its derivatives.

Dosage and administration

Adults - rectal 1 suppository Salofalk 500 mg 3 times a day. In severe forms of the disease, the dose can be doubled.
Children - with a body weight of over 40 kg, the usual dose for adults is prescribed. For the prevention of relapse, oral Salofalk is recommended in the form of pills at a dose of 15-30 mg / kg body weight per day.
The daily dose should be divided into 2 doses.

Adverse reactions

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, paresthesias, convulsions, tremor, tinnitus.
Hypersensitivity Reactions: skin rash, pruritus, erythema, fever, bronchospasm, pericarditis and myocarditis, acute pancreatitis, interstitial nephritis, nephrotic syndrome. Individual cases of allergic alveolitis and pancolitis were observed. Under certain conditions, mesalazine and drugs with a similar chemical structure can lead to the development of a syndrome similar to that of systemic lupus erythematosus.
Other side effects: rarely - tachycardia, hypertension or hypotension, chest pain, shortness of breath; myalgia, arthralgia. In some cases, proteinuria, hematuria, crystalluria, oliguria, anuria, anemia, leukopenia, agranulocytosis, thrombocytopenia, hypoprothrombinemia were observed; decrease in production of tear fluid; alopecia.
Taking into account the chemical structure of the active component, it is impossible to exclude the possibility of increasing the level of methemoglobin.
In the event of acute signs of intolerance, treatment should be stopped immediately.

Drug interactions

Salofalk causes increased anticoagulation action amplification hypoglycemic action of sulfonylurea derivatives, increases the toxicity of Methotrexate, glucocorticoids increases the damaging effect on the gastric mucosa, reduces tuberculostatic effect of rifampicin, uricosuric effect of probenecid and sulfinpyrazone diuretic effects of Furosemide and spironolactone.

Overdosage

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

Store in a dark place at a temperature not exceeding 25 ° C.