Active substanceMesalazineMesalazine
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  • Dosage form: & nbspRectal suspension.
    Composition:30 g of suspension (1 enema) contain 2 g of mesalazine.
    Excipients:
    Xanthan gum, carbomer, sodium ethylamine acetate, sodium benzoate, potassium disulphite, potassium acetate, purified water, nitrogen gas.
    Description:Homogeneous suspension from light gray to brown,free from foreign inclusions.
    Pharmacotherapeutic group:Antimicrobial and anti-inflammatory intestinal.
    ATX: & nbsp

    A.07.E.C.02   Mesalazine

    A.07.E.C   Aminosalicylic acid and its analogues

    Pharmacodynamics:Has anti-inflammatory effect. It 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 breaks free oxygen radicals.
    The release of mesalazine occurs in the rectum and colon. In the intestinal mucosa and in the liver mesalazine is metabolized in N-acetyl-5-ASA.
    Indications:Nonspecific ulcerative colitis in the phase of exacerbation (with the involvement of the rectum and the left parts of the colon).
    Contraindications:Pronounced impairment of liver and / or kidney function; peptic ulcer of stomach and duodenum; hemorrhagic diathesis (with a tendency to bleeding); children's age up to 2 years; increased sensitivity to salicylic acid and its derivative.
    Carefully:Caution is prescribed for Salofalk patients with impaired renal excretion, impaired breathing (especially for patients with bronchial asthma),at deficiency of glucose-6-phosphate dehydrogenase (a slight risk of hemolysis at the recommended dosage) in patients with hypersensitivity to sulfasalazine.
    Pregnancy and lactation:In the first trimester of pregnancy, the prescription of the drug is only possible on strict indications. If the course of the disease allows, then in the last 2-4 weeks of pregnancy the drug should be discontinued.
    If it is necessary to prescribe Salofalka during lactation, the question of stopping breastfeeding should be resolved.
    Before the planned pregnancy, it is recommended, if possible, to stop Salofalkom treatment or to apply the drug in reduced doses.
    Dosing and Administration:The contents of one reservoir are injected rectally once a day before bedtime (it is recommended to clean the intestine).
    The daily dose is 30-50 mg / kg body weight. The maximum daily dose is 3 g.
    To prevent relapses, oral intake of Salofalk in the form of tablets in a dose of 15-30 mg / kg of body weight per day is recommended. The daily dose should be divided into 2 divided doses.
    Side effects:Side effects from the gastrointestinal tract: diarrhea, nausea, abdominal pain, flatulence, loss of appetite, vomiting, increased levels of hepatic enzymes in the blood, hepatitis.
    Side effects from the central nervous system: headache, depression, dizziness, sleep disorders, malaise, paresthesia, convulsions, tremors, tinnitus.
    Reactions associated with hypersensitivity: skin rash, itching, erythema, fever, bronchospasm, pericarditis and myocarditis, acute pancreatitis, interstitial nephritis, nephrotic syndrome. There were individual cases of allergic alveolitis and pancolitis. Under certain conditions mesalazine and drugs having a similar chemical structure can lead to the development of a syndrome similar to the systemic lupus erythematosus syndrome.
    Other side effects: rarely - tachycardia, hypertension or hypotension, chest pain, dyspnea; myalgia, arthralgia. In some cases, proteinuria, hematuria, crystalluria, oliguria, anuria were observed; anemia, leukopenia, agranulocytosis, thrombocytopenia, hypoprothrombinemia; reduction of lacrimal fluid production, alopecia.
    Taking into account the chemical structure of the active ingredient, it is impossible to exclude the possibility of increasing the level of methemoglobin.
    If acute signs of intolerance arise, treatment should be stopped immediately.
    Overdose:Cases of an overdose have not been revealed. In case of an overdose, symptomatic treatment is performed.
    Interaction: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 diuritichesky effect of furosemide and spironolactone.
    Form release / dosage:Rectal suspension 2g / 30 ml.
    Packaging:For 30 ml in white, round compressible vials of dense polyethylene, closed with a lubricated tip of the rectal applicator and a protective cap. The bottle is placed in a contoured package of heat-sealable PVC film and paper laminated with an aluminum coating.
    7 bottles of polyethylene, placed in a circuit pack each, along with instructions for use in a cardboard box.
    Storage conditions:In the dark place at a temperature of no higher than 25 ° C.Keep out of the reach of children.
    Shelf life:2 years. Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:П N013074 / 03
    Date of registration:07.12.2007 / 29.06.2015
    Expiration Date:Unlimited
    The owner of the registration certificate: Dr. Falk Farma GmbH Dr. Falk Farma GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspDOCTOR FALK PHARMA GmbH DOCTOR FALK PHARMA GmbH Germany
    Information update date: & nbsp2016-09-22
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