Salofalk, enteric soluble prolonged-acting granules 500mg 50pcs

Composition

Active ingredient:

mesalazine (5-aminosalicylic acid) 500 mg;

Auxiliary substances:

MCC;

hypromellose;

colloidal anhydrous silicon dioxide;

Eudragite NE 40D (40% dispersion of a copolymer of methyl methacrylate and ethyl acrylate (2: 1) and 2% Nonoxynol-9) in terms of dry matter;

magnesium stearate;

dry matter 33% simethicone emulsion (consists of 92% simethicone 7.7% methylcellulose,0.3% sorbic acid).

Pharmacological action

The drug Salofalk has a local anti-inflammatory effect. The effect of the drug is due to the inhibition of neutrophilic lipoxygenase and the synthesis of prostaglandins and leukotrienes.

Mesalazine 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 of prostaglandins in the intestinal mucosa is also shown.

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 moderate and mild ulcerative colitis;
• maintenance of remission and or long-term therapy of ulcerative colitis.

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

• blood disease;
• ulcer disease of stomach and duodenal ulcers;
• haemorrhagic diathesis (a tendency to hemorrhage);
• severe renal insufficiency;
• severe liver failure;
• deficiency of glucose-6-phosphate dehydrogenase;
• phenylketonuria (for granules);
• children’s age up to 3 years (for tablets);
• children up to age 6 years (for granules);
• hypersensitivity to the components of the drug salofalk worth us and other derivatives of salicylic acid.

With caution, Salofalk should be prescribed for mild to moderate renal/hepatic insufficiency, lung diseases (especially bronchial asthma), and pregnancy (I trimester).

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

Inside. Salofalk pellets should not be chewed. The prescribed dose of Salofalk granules should be taken in the morning, at lunchtime and in the evening, or the entire dose once in the morning. Salofalk pellets should be placed on the tongue and swallowed without chewing, washed down with plenty of liquid.

For the treatment of exacerbation of ulcerative colitis

, Depending on the clinical need in each individual case,1 sachet of 500-1000 mg of mesalazine 3 times a day or 3 sachets 1 time a day (corresponds to 1.5-3.0 g of mesalazine per day).

To maintain remission of ulcerative colitis

500 mg of mesalazine 3 times a day or 3 sachets 1 time a day (corresponds to 1.5 g of mesalazine per day).

Children under 6 years of age

Salofalk in granules should not be prescribed to children under 6 years of age, since the experience of using the drug in patients of this age group is very limited.

Children over 6 years of age and teenagers

In case of exacerbation of the disease, depending on its severity, mesalazine is prescribed at a dose of 30-50 mg / kg / day with a distribution of the daily dose in 3 doses or in 1 reception. To maintain remission, mesalazine is prescribed at a dose of 15-30 mg / kg / day, while the daily dose can be divided into 2 doses. Children with a body weight of up to 40 kg are usually recommended to be prescribed half the adult dose, children with a body weight of more than 40 kg-the adult dose.

Both in the treatment of exacerbations of the inflammatory process, and with prolonged use in order to maintain remission, granules should be taken regularly and consistently, which allows achieving the required therapeutic effect. Exacerbation of ulcerative colitis usually subsides after 8-12 weeks, after which the dose of mesalazine in most patients can be reduced to 1.5 g per day.

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

Granules coated with an enteric coating of prolonged action

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

4 years

Active ingredient

Mesalazine

Conditions of release from pharmacies

By prescription

Dosage form

granules