Salofalk rectal foam 1g/application, 14pcs

Composition

1 application contains:

Active ingredient:

mesalazine 1 g;

Auxiliary substances:

propylene glycol-3.4364 g;

sodium disulfite-0.05 g;

polysorbate 60-0.0364 g;

disodium edetate-0.0136 g;

cetostearyl alcohol-00091 g;

propellant (propane 7%, / isobutane 88%/butane 5% under pressure 2.5 bar) – 0.176 g

Pharmacological action

Salofalk is an anti-inflammatory.

Pharmacodynamics

It has a local anti-inflammatory effect due to the inhibition of cyclooxygenase and the synthesis of PG and leukotrienes. It slows down the migration, degranulation, phagocytosis of neutrophils, as well as the secretion of immunoglobulins by lymphocytes. It has an antioxidant effect (due to its ability to bind to free oxygen radicals and destroy them).

Mesalazine can also trap radicals formed from reactive oxygen species. The results obtained in vitro studies indicate a possible role of lipoxygenase inhibition.

The effect on the content is also shown PG in the intestinal mucosa. When taken orally, mesalazine has a predominantly local effect in the intestinal mucosa and submucosal layer, acting from the intestinal lumen.

Therefore, it is important that mesalazine is available to the area of inflammation. The ratio of systemic bioavailability to mesalazine plasma concentrations is not significant in terms of therapeutic efficacy, but rather serves as a factor affecting safety.

Ensuring the release of the Active ingredient in the right place helps that Salofalk granules are resistant to gastric juice and are characterized by pH-dependent (due to the coating in the form of Eudrajit L) and delayed (due to the matrix structure of the granules) release of mesalazine.

Indications

Exacerbation of distal forms of ulcerative colitis of moderate and mild severity; maintenance of remission of distal forms of ulcerative colitis (long-term therapy).

Use during pregnancy and lactation

If you are pregnant, suspect pregnancy, plan pregnancy, or breast-feed, you should consult your doctor. The drug should not be used in the last 4 weeks of pregnancy.

Salofalk can be used during pregnancy only in cases where the potential benefit of its use for the mother exceeds the possible risk to the fetus.

When breastfeeding, rectal forms of the drug should not be used — the Active ingredient and its metabolites can enter breast milk. If it is necessary to prescribe Salofalk during lactation, the question of stopping breastfeeding should be decided.

Contraindications

• hypersensitivity to the components of the drug and other derivatives of salicylic acid;
• blood diseases;
• peptic ulcer of the stomach and duodenum;
• glucose-6-phosphate dehydrogenase deficiency;
• hemorrhagic diathesis;
• severe renal / hepatic insufficiency;
• children (up to 6 years);
• phenylketonuria.

With caution:  pregnancy (first trimester), mild to moderate renal/hepatic insufficiency, and lung diseases (especially bronchial asthma).

Side effects

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

From the central nervous system:  headache, depression, dizziness, sleep disturbance, malaise, paresthesia, convulsions, tremor, tinnitus.

Hypersensitivity reactions:  skin rash, pruritus, erythema, fever, bronchospasm, pericarditis and myocarditis, acute pancreatitis, interstitial nephritis, nephrotic syndrome.

There were isolated cases of allergic alveolitis and pancolitis. 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, arterial hypertension or hypotension, pain behind the sternum, shortness of breath; myalgia, arthralgia. In some cases, proteinuria, hematuria, crystalluria, oliguria, anuria; anemia, leukopenia, agranulocytosis, thrombocytopenia, hypoprothrombinemia; decreased production of tear fluid, alopecia were observed.

Interaction

Concomitant use may increase the effect of coumarin anticoagulants, increase the toxicity of methotrexate, reduce the diuretic effect of spironolactone and furosemide, and reduce the effectiveness of probenecid and rifampicin.

Increases the hypoglycemic effect of oral antidiabetic agents-sulfonylureas.

How to take, course of use and dosage

If the doctor does not prescribe otherwise, in adults and children over 12 years of age, the drug is usually used 1 time a day before bedtime (1 dose corresponds to 2 applications/taps). If it is difficult to keep such a volume of foam in the intestine, the drug should be administered in two stages: 1 time at night, and 1 more time-at night or early in the morning (after defecation).

To achieve the best result, it is recommended to administer the drug after bowel movement (defecation).

At the time of use, Salofalk rectal foam should be at room temperature (20-25 °C).

If you are admitted to the hospital or consult with other doctors, you should inform them about the use of this drug.

The therapeutic effect is achieved with regular use of the drug Salofalk rectal foam.

The duration of the course of treatment is selected by the doctor individually.

As a rule, exacerbation of mild forms of ulcerative colitis can be stopped within 4-6 weeks. After this period, it is recommended to visit the attending physician to decide whether to prescribe an oral form of mesalazine for maintenance therapy.

Overdose

Symptoms:  nausea, vomiting, weakness, drowsiness.

Treatment:  symptomatic therapy.

Special instructions

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

Before starting treatment, during therapy (14 days after its start and then every 4 weeks), as well as after the end of therapy (every 3 months), blood and urine tests should be performed.

To monitor kidney function, it is recommended to determine the level of urea and creatinine in the blood serum, study the urine sediment.

Form of production

Rectal foam

Storage conditions

In a dark place, at a temperature not exceeding 25 °C.

Shelf life

3 years

Active ingredient

Mesalazine

Conditions of release from pharmacies

Prescription