Salofalk (mesalazine) gastroresistant granules 1.5 g. №35

Description

Salofalk (mesalazine) gastroresistant granules 1.5 g. №35

Composition

active ingredient: mesalazine (5-aminosalicylic acid);

1 sachet (2.79 g granules) contains mesalazine 1.5 g or 1 sachet (5.58 g granules) contains mesalazine 3 g;

excipients: microcrystalline cellulose, hypromelose, anhydrous colloidal silicon dioxide, polyacrylate dispersion, magnesium stearate, simethicone emulsion.

• Coating I: methacrylic acid – methyl methacrylate copolymer (1:1), triethyl citrate, talc, titanium dioxide (E 171), magnesium stearate.
• Coating II: hypromelose, talc.

Finishing coat: sodium carboxymethylcellulose, titanium dioxide (E 171), aspartame (E 951), anhydrous citric acid, sweet vanilla flavor, talc, povidone.

Dosage form

Granules are gastroresistant, prolonged.

Basic physical and chemical properties: rounded particles of elongated or rounded shape, grayish-white color, packed in bags of composite aluminum foil.

Pharmacological group

Anti-inflammatory drugs used to treat bowel diseases.
ATX code A07E C02.

Pharmacological properties

Mesalazine, when taken orally, acts predominantly locally on the intestinal mucosa and on submucosal tissue from the luminal side of the intestine. Therefore, it is important that mesalazine is available in areas of inflammation. Systemic bioavailability and plasma concentrations are thus not essential in determining therapeutic effect, but rather factors in determining the degree of safety. To achieve this effect, Salofalk granules are resistant to gastric juice, and mesalazine is released from them depending on the pH of the medium due to the coating with eudracite L (coating I); prolonged release is provided by the structure of the matrix of granules.

Indications

Treatment of exacerbations and prevention of recurrence of ulcerative colitis (maintenance of ulcerative colitis).

Contraindications

Salofalk in the form of granules should not be used in patients with:

• hypersensitivity to salicylic acid and its derivatives or to any substance that is part of the drug;
• severe impairment of liver or kidney function.

Use during pregnancy or lactation

Data on the use of extended-release salofalk enteric granules in pregnant women are insufficient, however, data on the use of the drug in a limited number of pregnant women indicate that there are no undesirable effects of mesalazine on the course of pregnancy or on the health of the fetus and / or newborn. To date, other epidemiological data regarding the drug are not available. In a single case, after long-term use of mesalazine at a high dose (2-4 g orally) during pregnancy, renal failure was reported in a newborn.

Dosage and administration

Adults and elderly patients

Treatment of exacerbations of ulcerative colitis

Take once a day 1 sachet of Salofalk gastroresistant granules 3 g, 1-2 sachets of Salofalk gastroresistant granules 1.5 g (equivalent to 1.5-3.0 g of mesalazine daily), preferably in the morning, according to individual clinical need.

For the prevention of recurrence of ulcerative colitis (maintenance of remission)

1 sachet of Salofalk gastroresistant granules 1.5 g once a day, which is equivalent to 1.5 g of mesalazine per day.

For patients at increased risk of relapse, the dosage regimen may be changed to 3.0 g mesalazine as a single daily dose, preferably in the morning.

Children under 6

Salofalk gastroresistant granules should not be used in children under 6 years of age due to lack of experience in the use of the drug in this age group.

Children from 6 years old

Depending on the severity of the disease during an exacerbation, mesalazine 30–50 mg/kg body weight should be given once a day, preferably in the morning, or divided into 3 doses. The total dose should not exceed the maximum adult dose.

To prevent relapse (maintenance), 15–30 mg mesalazine/kg body weight/day should be given in divided doses.

Children weighing up to 40 kg are recommended to take half the adult dose, and children weighing more than 40 kg – the usual adult dose.

Salofalk gastroresistant granules should not be chewed. The contents of the bag “Gran-Stix” should be poured onto the tongue and swallowed together with a sufficient amount of liquid, without chewing.

Both in the treatment of exacerbations of inflammation and during long-term treatment, Salofalk gastroresistant granules should be used regularly and continuously to achieve the desired therapeutic effect.

Usually, exacerbations of ulcerative colitis subside within 8-12 weeks; for most patients, the dosage can be reduced to a maintenance dose.

Children

Salofalk gastroresistant granules should not be used in children under 6 years of age due to lack of experience in the use of the drug in this age group. There are limited data on use in children 6-18 years of age.

Overdose

To date, cases of intoxication and specific antidotes have not been reported.

If necessary, intravenous infusion of electrolytes (forced diuresis) should be used.

Side effects:

• Disturbances from the side of the nervous system; headache;
• Gastrointestinal disorders: abdominal pain, diarrhea, dyspepsia, flatulence, nausea, vomiting, acute pancreatitis;
• Research results: Changes in functional liver tests (increased transaminases and cholestasis markers), changes in pancreatic enzymes (increased levels of lipase and amylase), an increased number of eosinophils.