Salofalk, 10 pcs., 500 mg, rectal suppositories

Release form, composition and packaging

Pills

, covered with an enteric film coating from light yellow to yellow-brown, round, biconvex.

• 1 tab. — mesalazine (5-ASA) 250 mg

Excipients: sodium carbonate, glycine, povidone, microcrystalline cellulose, colloidal silicon dioxide, calcium stearate, hypromellose, copolymer of methacrylic acid and methacrylate (1:1), talc, titanium dioxide, yellow iron oxide dye, macrogol, butyl methacrylate.

10 pieces. - blisters (5) - cardboard packs.

10 pieces. - blisters (10) - cardboard packs.

Pills

, covered with an enteric film coating from light yellow to yellow-brown, oval, biconvex.

• 1 tab. — mesalazine (5-ASA) 500 mg

Excipients: sodium carbonate, glycine, povidone, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, calcium stearate, hypromellose, copolymer of methacrylic acid and methacrylate (1:1), talc, titanium dioxide, yellow iron oxide dye, macrogol, butyl methacrylate.

10 pieces. - blisters (5) - cardboard packs.

10 pieces. - blisters (10) - cardboard packs.

Granules

, covered with an enteric coating, long-acting, grayish-white, round, cylindrical or spherical in shape.

• 1 pack — mesalazine (5-ASA) 500 mg

Excipients: microcrystalline cellulose - 200 mg, hypromellose - 18 mg, colloidal anhydrous silicon dioxide - 0.25 mg, Eudrazite NE40D (40% dispersion of copolymer of methyl methacrylate and ethyl acrylate (2:1) and 2% nonoxynol) - 45 mg, magnesium stearate - 7.75 mg, dry matter 33% simethicone emulsion (consists of 92% simethicone, 7.7% methylcellulose, 0.3% sorbic acid) - 0.5 mg.

Composition of the inner shell: hypromellose - 2 mg, copolymer of methacrylic acid and methyl methacrylate (1:1) (eudragit L100) - 75 mg, triethyl citrate - 7.5 mg, talc - 20 mg, magnesium stearate - 5 mg, titanium dioxide - 12.5 mg.

Composition of the outer shell: carmellose sodium - 15 mg, titanium dioxide - 5 mg, aspartame - 1 mg, anhydrous citric acid - 3 mg, vanilla flavor - 2 mg, talc - 5.5 mg, povidone K25 - 5 mg.

930 mg - plastic bags laminated with aluminum foil (50) - cardboard packs.

930 mg - plastic bags laminated with aluminum foil (50) - cardboard packs (2) - cardboard boxes.

Granules

, covered with an enteric coating, long-acting, grayish-white, round, cylindrical or spherical in shape.

• 1 pack — mesalazine (5-ASA) 1 g

Excipients: microcrystalline cellulose - 400 mg, hypromellose - 36 mg, colloidal anhydrous silicon dioxide - 0.5 mg, Eudrazite NE40D (40% dispersion of copolymer of methyl methacrylate and ethacrylate (2:1) and 2% nonoxynol) - 90 mg, magnesium stearate - 15.5 mg, dry matter 33% simethicone emulsion (consists of 92% simethicone, 7.7% methylcellulose, 0.3% sorbic acid) - 1 mg.

Composition of the inner shell: hypromellose - 4 mg, copolymer of methacrylic acid and methyl methacrylate (1:1) (eudragit L100) - 150 mg, triethyl citrate - 15 mg, talc - 40 mg, magnesium stearate - 10 mg, titanium dioxide - 25 mg.

Composition of the outer shell: carmellose sodium - 30 mg, titanium dioxide - 10 mg, aspartame - 2 mg, anhydrous citric acid - 6 mg, vanilla flavor - 4 mg, talc - 11 mg, povidone K25 - 10 mg.

1860 mg - plastic bags laminated with aluminum foil (50) - cardboard packs.

1860 mg - plastic bags laminated with aluminum foil (50) - cardboard packs (2) - cardboard boxes.

Rectal suppositories

from white to cream color, torpedo-shaped, uniform consistency, with an intact, smooth surface.

• 1 sup. — mesalazine (5-ASA) 250 mg

Excipients: solid fat.

5 pieces. - blisters (2) - cardboard packs.

5 pieces. - blisters (6) - cardboard packs.

Rectal suppositories

from white to cream color, torpedo-shaped, uniform consistency, with an intact, smooth surface.

• 1 sup. — mesalazine (5-ASA) 500 mg

Excipients: solid fat, cetyl alcohol, sodium docusate.

5 pieces. - blisters (2) - cardboard packs.

5 pieces. - blisters (6) - cardboard packs.

Rectal suspension

from light gray to brown, free from foreign inclusions.

• 1 fl. — mesalazine (5-ASA) 2 g

Excipients: xanthan gum, carbomer, sodium ethylaminoacetate, sodium benzoate, potassium disulfite, potassium acetate, purified water, nitrogen gas.

30 ml - polyethylene bottles (1) - contour packaging (7) - cardboard packs.

Rectal suspension

from light gray to brown, free from foreign inclusions.

• 1 fl. — mesalazine (5-ASA) 4 g

Excipients: xanthan gum, carbomer, sodium ethylaminoacetate, sodium benzoate, potassium disulfite, potassium acetate, purified water, nitrogen gas.

60 ml - polyethylene bottles (1) - contour packaging (1) - cardboard packs.

SALOFALK

Enteric film-coated tablets

from light yellow to yellow-brown, oval, biconvex.

Excipients: sodium carbonate, glycine, povidone, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, calcium stearate, hypromellose, copolymer of methacrylic acid and methacrylate (1:1), talc, titanium dioxide, yellow iron oxide dye, macrogol, butyl methacrylate.

10 pieces. – blisters (5) – cardboard packs. 10 pieces. – blisters (10) – cardboard packs.

pharmachologic effect

An anti-inflammatory drug with a predominant localization of action in the intestines.

Mesalazine (5-aminosalicylic acid) inhibits the activity of neutrophil lipoxygenase and the synthesis of arachidonic acid metabolites (prostaglandins and leukotrienes), which are mediators of inflammation.

Inhibits migration, degranulation, phagocytosis of neutrophils, as well as the secretion of immunoglobulins by lymphocytes. Mesalazine has antioxidant properties by binding to free oxygen radicals.

Dosage

Orally use 400-800 mg 3 times a day for 8-12 weeks.

From the digestive system:

diarrhea, nausea, vomiting, heartburn, abdominal pain, loss of appetite, dry mouth, stomatitis, increased activity of liver enzymes.

From the nervous system:

headache, depression, dizziness, sleep disturbances, paresthesia, tremor, tinnitus.

Allergic reactions:

skin rash, itching, erythema.

From the cardiovascular system:

palpitations, tachycardia, arterial hypertension or hypotension, chest pain, shortness of breath.

From the urinary system:

proteinuria, hematuria, crystalluria, oliguria, anuria.

From the hematopoietic system:

anemia, leukopenia, agranulocytosis, thrombocytopenia; hypoprothrombinemia.

Other:

alopecia, decreased production of tear fluid.

Pregnancy and lactation

In the first trimester of pregnancy, use is possible only under strict indications. If the individual course of the disease allows, then in the last 2-4 weeks of pregnancy, mesalazine should be discontinued.

If it is necessary to use it during lactation, the issue of stopping breastfeeding should be decided, due to the lack of sufficient clinical experience with the use of mesalazine in this category of patients.

Use in childhood

Contraindicated in children under 2 years of age. Use in children under 2 years of age is possible only if the expected benefit of therapy outweighs the potential risk to the child.

For impaired renal function

Contraindicated in cases of severe renal impairment.

Use with caution for kidney diseases.

Dosage

Pills

The drug is prescribed orally for adults, 500 mg 3 times a day. In severe forms of the disease, the dose can be increased to 3-4 g/day for 8-12 weeks. To prevent relapses, the drug is prescribed at a dose of 500 mg 3 times a day, if necessary, for several years.

Children weighing up to 40 kg are prescribed 1/2 the daily dose for adults - 250 mg 3 times / day (250 mg tablets should be used), children weighing more than 40 kg - 500 mg 3 times / day. To prevent relapses, the drug is prescribed at a dose of 250 mg 3 times a day, if necessary, for several years.

The tablets should be taken whole, without chewing, after meals and washed down with plenty of water. For distal forms of UC, rectal administration of the drug in the form of rectal suppositories or rectal suspension is preferable.

Granules

The dosage regimen for the treatment of exacerbation of ulcerative colitis depends on the clinical need and is individual in each case. Prescribe 1 sachet of 500-1000 mg of mesalazine 3 times a day or 3 sachets 1 time a day (corresponding to 1.5-3.0 g of mesalazine per day). To maintain remission of ulcerative colitis, 500 mg (1 sachet) of mesalazine is prescribed 3 times a day or 3 sachets of 500 mg 1 time/day (corresponding to 1.5 g of mesalazine per day).

For children over 6 years of age and adolescents during exacerbation of the disease, depending on its severity, mesalazine is prescribed at a dose of 30-50 mg/kg body weight/day with the daily dose divided into 3 doses or 1 dose. To maintain remission, mesalazine is prescribed at a dose of 15-30 mg/kg body weight/day, and the daily dose can be divided into 2 doses. Children weighing up to 40 kg are usually recommended to be prescribed half the adult dose, children weighing more than 40 kg - the adult dose.

Salofalk granules cannot 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 granules should be placed on the tongue and swallowed without chewing, with plenty of liquid.

Both when treating an exacerbation of the inflammatory process, and during long-term use to maintain remission, the granules must be taken regularly and consistently, which allows achieving the required therapeutic effect. An 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 / day.

Rectal suppositories

Adults are prescribed 1 suppository of 500 mg or 2 suppositories of 250 mg 3 times a day. In severe forms of the disease, the dose can be doubled. For long-term maintenance treatment and to prevent relapses - 1 suppository 250 mg 3 times a day. Children weighing up to 40 kg are prescribed 1/2 the daily dose for adults - 1 suppository of 250 mg 3 times a day, children weighing more than 40 kg - 1 suppository of 500 mg or 2 suppositories of 250 mg 3 times a day.

Rectal suspension

The contents of one bottle are administered rectally 1 time/day before bedtime (it is recommended to cleanse the intestines first). The daily dose is 30-50 mg/kg body weight. The maximum daily dose is 3 g. To prevent relapses, oral administration of Salofalk in tablet form is recommended at a dose of 15-30 mg/kg body weight/day. The daily dose should be divided into 2 doses.

Reviews and recommendations from doctors and patients

According to the results of clinical studies, Salofalk is well tolerated. Side effects are observed less frequently than when taking placebo (59.4% vs. 63.8%; S. Zakko et al., 2009).

A double randomized dose-finding study proved the effectiveness of the drug. The optimal daily dose is 3.0 g of Salofalk. This group has the best indicators of clinical recovery.

Patients note the rational price-quality ratio of the drug. Salofalk is effective in the treatment of Crohn's disease and the prevention of ulcerative colitis.

Drug interactions

With simultaneous use, Salofalk causes an increase in the effect of indirect anticoagulants (increased risk of gastrointestinal bleeding).

With the simultaneous use of GCS with Salofalk, it is possible that adverse reactions from the gastric mucosa may increase.

With simultaneous use, Salofalk increases the toxicity of methotrexate.

With the simultaneous use of probenecid and sulfinpyrazone with Salofalk, a decrease in the excretion of uric acid is possible.

When used simultaneously, Salofalk reduces the diuretic effect of spironolactone and furosemide.

When used simultaneously with Salofalk, the tuberculostatic effect of rifampicin may be weakened.

With simultaneous use, Salofalk enhances the hypoglycemic effect of sulfonylurea derivatives.

When used simultaneously with lactulose or other drugs that reduce the pH of the intestinal contents, the release of mesalazine from granules may be reduced due to a decrease in pH caused by bacterial metabolism.

In patients receiving concomitant treatment with azathioprine or 6-mercaptopurine, be aware of the possible enhanced myelosuppressive effect of azathioprine and 6-mercaptopurine.

Pregnancy and lactation

In the first trimester of pregnancy, the drug can be prescribed only according to strict indications. If the course of the disease allows, then in the last 2-4 weeks of pregnancy the drug should be stopped. In the second and third trimesters, Salofalk should be used only in cases where the potential benefit of therapy for the mother outweighs the possible risk to the fetus.

Salofalk in the form of granules can be used during breastfeeding only in cases where the potential effect of its use for the mother outweighs the possible risk of adverse effects for the child. If a breastfed newborn develops diarrhea, breastfeeding should be stopped.

If it is necessary to prescribe Salfalk in tablet form during lactation, breastfeeding should be stopped. Before a planned pregnancy, it is recommended, if possible, to stop treatment with Salofalk or use the drug in reduced doses.

Analogues of the drug according to ATC codes:

MESACOL PENTASA SALOFALK SAMEZIL

Before using SALOFALK you should consult your doctor. These instructions for use are for informational purposes only. For more complete information, please refer to the manufacturer's instructions.

Side effects

Reactions associated with hypersensitivity: skin rash, itching, erythema, fever, bronchospasm, pericarditis, myocarditis, acute pancreatitis, interstitial nephritis, nephrotic syndrome. Isolated cases of allergic alveolitis and pancolitis have been observed. Under certain conditions, mesalazine and drugs with a similar chemical structure can lead to the development of a syndrome similar to systemic lupus erythematosus syndrome.

• From the digestive system: loss of appetite; rarely (1/10,000) - diarrhea, nausea, abdominal pain, flatulence, vomiting; very rarely (
• From the nervous system: rarely (1/10,000) - headache, dizziness; very rarely (convulsions, tremors, tinnitus.
• From the cardiovascular system: possible - tachycardia, arterial hypertension or hypotension; very rarely (
• From the musculoskeletal system: very rarely (
• From the hematopoietic system: in some cases - anemia, leukopenia, agranulocytosis, thrombocytopenia.
• From the blood coagulation system: in some cases - hypoprothrombinemia.
• From the urinary system: in some cases - proteinuria, hematuria, crystalluria, oliguria, anuria.
• Other: in some cases - a decrease in the production of tear fluid; very rarely (fever, sore throat, reversible decrease in sperm motility.

Taking into account the chemical structure of the active substance, the possibility of an increase in methemoglobin levels cannot be excluded. If acute signs of intolerance occur, treatment should be stopped immediately.

Indications

Pills:

• nonspecific ulcerative colitis (UC);
• Crohn's disease (prevention, treatment of exacerbations).

Granules:

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

For rectal suppositories:

• distal forms of nonspecific ulcerative colitis (prevention and treatment of exacerbations).

For rectal suspension:

• nonspecific ulcerative colitis in the acute phase (involving the rectum and left colon).

Contraindications

• blood diseases;
• peptic ulcer of the stomach and duodenum;
• hemorrhagic diathesis (with a tendency to bleeding);
• severe renal failure;
• severe liver failure;
• deficiency of glucose-6-phosphate dehydrogenase;
• phenylketonuria (for granules);
• children under 3 years of age (for tablets);
• children under 6 years of age (for granules);
• hypersensitivity to the components of the drug and other salicylic acid derivatives.

Salofalk should be prescribed with caution in case of mild to moderate renal/liver failure, lung diseases (especially bronchial asthma), and in the first trimester of pregnancy.

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special instructions

Before starting treatment, during, and after treatment, a general blood and urine test is necessary. Before starting treatment and during its implementation, it is necessary to determine parameters of the functional state of the liver (such as ALT or AST activity) and monitor urine tests (using immersion test strips). Monitoring is usually recommended 14 days after the start of treatment, then 2-3 more times with an interval of 4 weeks. If test results are normal, follow-up studies should be performed every 3 months. If additional symptoms occur, follow-up studies should be performed immediately.

Use with caution in patients with impaired liver function. The use of Salofalk is not recommended for patients with severe renal impairment. If renal dysfunction develops during treatment, the nephrotoxic effect of mesalazine should be considered. During treatment, renal function should be monitored.

When prescribing Salofalk to patients with lung diseases, in particular bronchial asthma, it is necessary to exercise careful monitoring during treatment. Patients with a history of indications of adverse reactions when prescribed drugs containing sulfasalazine are subject to careful monitoring during the initial period of treatment with Salofalk. If, during treatment with Salofalk, acute intolerance reactions occur, such as cramps, acute abdominal pain, fever, severe headache and rash, use of the drug must be stopped immediately.

Patients who are “slow acetylators” have an increased risk of developing side effects. There may be a yellow-orange coloration of urine and tears, and staining of soft contact lenses. If several doses are missed, the patient should consult a doctor without stopping treatment.

When prescribing the drug to patients suffering from phenylketonuria, it should be remembered that Salofalk granules contain aspartame in doses equivalent to the following amount of phenylalanine: 0.56 mg (Salofalk granules 500 mg), 1.12 mg (Salofalk granules 1 g).

Use in pediatrics

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

Impact on the ability to drive vehicles and operate machinery

Care should be taken when driving a vehicle and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reaction.

Salofalk suspension - instructions, composition, dosage, side effects of use

Salofalk suspension

Salofalk suspension (Suspensio Salofalk)

General characteristics:

international and chemical names: mesalazine;

basic physicochemical properties: homogeneous suspension, which has a color from very light brown to brown, without foreign parts;

Composition of 1 enema (60 g suspension) includes 4 g mesalazine (5-aminosalicylic acid);

other components: sodium benzoate, potassium metabisulfite, disodium edetate, carbomer 934 R [carbopol 974 R], potassium acetate, xanthan gum, purified water.

Release form of the medicine. Rectal suspension.

Pharmacotherapeutic group . An anti-inflammatory drug that is used for intestinal diseases. ATS code A 07 EC 02.

Action of the medicine.

The mechanism of anti-inflammatory action is not known. Results from in vitro studies suggest that lipoxygenase inhibition may have a role.

The effect of mesalazine on the concentration of prostaglandins in the intestinal mucosa has also been demonstrated. Mesalazine (5-aminosalicylic acid/5-ASA) may also act as a reactive oxygen radical scavenger.

Mesalazine, when administered rectally, acts predominantly locally on the intestinal mucosa and submucosal tissue.

Pharmacokinetics.

General properties of mesalazine

Absorption

Absorption of mesalazine is highest in the proximal part of the intestine and lowest in the distal part.

Biotransformation

Mesalazine is metabolized both presystemically in the intestinal mucosa and in the liver into the pharmacologically inactive N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA). It is obvious that acetylation does not depend on the phenotype of the patient's acetylation apparatus. A certain amount of acetylation also occurs due to the action of bacteria in the large intestine. The binding of mesalazine and N-Ac-5-ASA to proteins is 43% and 78%, respectively.

Elimination/excretion

Mesalazine and its metabolite N-Ac-5-ASA are excreted in feces (the main part), through the kidneys (varies between 20 and 50% depending on the method of use, dosage form and route of release of mesalazine, respectively) and with bile (minor part). Renal excretion occurs predominantly in the form of N-Ac-5-ASA. About 1% of the total administered oral dose of mesalazine is excreted into breast milk, mainly in the form of N-Ac-5-ASA.

Specific aspects for Salofalk enemas 4 g/60 ml

Distribution

Intrascopic examination in patients with mild or moderate ulcerative colitis showed that the enema fluid at the beginning of treatment and during remission after 12 weeks is distributed mainly in the rectum and sigmoid colon and the smaller colon in the colon.

Absorption and excretion:

In a study on patients with ulcerative colitis in remission, peak plasma concentrations of 0.92 μg/ml 5-ASA and 1.62 μg/ml N-Ac-5-ASA were reached after approximately 11-12 hours under constant conditions . The elimination rate was approximately 13% (after 45 hours), with the majority (about 85%) in the form of the metabolite N-Ac-5-ASA.

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Plasma concentrations under constant conditions of 5-ASA and N-Ac-5-ASA in children with chronic inflammatory bowel diseases during treatment with Salofalk enemas 4 g/60 ml were 0.5 - 2.8 mcg/ml and 0.9 - 4 .1 µg/ml respectively.

Indications for use.

Acute attacks of ulcerative colitis.

Method of use and dose.

Adults

The dosage schedule below is usually used

For patients with symptoms of acute inflammation, the contents of one enema bottle (60 g of suspension) are injected into the intestines as an enema once a day, before bedtime.

Children over 6 years old and teenagers

Salofalk enemas in a dosage of 4 g/60 ml.

The required enema dosages should be selected based on the severity and severity of the disease of the large intestine and the body weight of the child or adolescent.

It is generally recommended to use half the adult dose for body weights up to 40 kg and the full normal dose for adults for body weights over 40 kg.

Children weighing more than 40 kg can also be prescribed half the dose (2 g/30 ml) of the Salofalk enema 4 g/60 ml or the full dose of Salofalk 4 g/60 ml, depending on the degree of inflammation.

To use half the dose when administering the suspension, the enema must be pressed only halfway. She can be held in this position thanks to the valve that is located at the top of the enema. The other half of the enema bottle that remains can be used later in the day.

The best results are achieved when the intestines are emptied before using the Salofalk enema.

The desired therapeutic result can be achieved only with regular and constant use of Salofalk enemas.

The duration of treatment is determined by the doctor individually depending on the course of the disease.

Acute attacks of ulcerative colitis regress, usually after 8–12 weeks, after which Salofalk enemas 4 g/60 ml are usually not used.

Side effect.

To assess adverse events, the following information regarding their frequency is used:

Very common:

those that are observed in more than 1 patient that is being treated, from 10

Frequent:

those that are observed in more than 1 patient that is being treated, from 100

Uncommon:

those that are observed in more than 1 patient being treated, per 1,000

Liquid:

those that are observed in more than 1 patient being treated, from 10,000

Very liquid:

those observed in 1 case out of 10,000 patients treated, or few, including isolated cases

Side effects related to the gastrointestinal tract (liquid):

abdominal pain, diarrhea, flatulence, nausea and vomiting.

Side effects related to the central nervous system (liquid):

headache, dizziness.

Kidney related side effects (very mild):

impaired renal function, including acute chronic intestinal nephritis and renal failure.

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Hypersensitivity reactions (very mild):

allergic rash, drug fever, bronchospasm, pericarditis, myocarditis, acute pancreatitis, allergic alveolitis, lupus erythematosus syndrome, pancolitis.

Musculoskeletal disorders (very mild):

myalgia and arthralgia.

Disorders of the circulatory and lymphatic systems (very fluid):

changes in blood composition (aplastic anemia, agranulocytosis, pancytopenia, neutropenia, leukopenia, thrombocytopenia).

Liver and gallbladder disorders (very mild):

changes in liver function parameters (increased transaminase activity and bile stagnation parameters), hepatitis, cholestatic hepatitis.

Disorders of the skin and its appendages (very liquid):

alopecia.

Contraindications.

Salofalk enemas cannot be used:

- for the presence of hypersensitivity to salicylic acid, its derivatives, potassium metabisulfite or any of the other ingredients;

- with severe impairment of liver or kidney function;

- with existing stomach or duodenal ulcers;

- patients with hemorrhagic diathesis;

- in children under 6 years of age.

Exceeding the permissible dose of the drug (overdose).

To date, no cases of intoxication or specific antidotes have been reported.

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

Features of use.

It is necessary to do blood tests (form elements; liver function parameters such as ALT or AST; serum creatinine) and urine (test strips, sediment) during and after treatment. It is recommended that tests be done approximately 14 days after the start of treatment and then 2–3 more times at intervals of 4 weeks.

If the results of laboratory tests are within normal limits, routine checks can be carried out 4 times per hour, but if other additional symptoms appear, tests must be done urgently.

Particular attention should be paid to liver dysfunction.

Salofalk enemas are not recommended for use by patients with impaired renal function. If renal function deteriorates during treatment, mesalazine-induced renal toxicity should be taken into account.

Patients with pulmonary diseases, including patients with asthma, should be under the supervision of a physician during the course of treatment with Salofalk enemas.

Patients who have adverse reactions to drugs that contain sulfasalazine should be monitored from the very beginning of the treatment course using Salofalk enemas. In case of acute symptoms of intolerance, such as cramps, acute abdominal pain, fever, severe headache and rash, drug therapy should be stopped immediately.

Due to the fact that Salofalk enemas 4 g/60 ml contain potassium metabisulfite, they can provoke allergic reactions with symptoms of anaphylaxis and bronchoconstriction (bronchospasm) in sensitive patients, including those with a history of asthma or allergies.

Due to the fact that the drug contains sodium benzoate, hypersensitivity reactions may occur in patients prone to them in the form of irritation of the skin, eyes and mucous membranes.

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Salofalk enemas should not be administered to children under 6 years of age.

Pregnancy and lactation

There is insufficient data on the use of Salofalk enemas for the treatment of pregnant women, however, information on use in a limited number of pregnant women indicates the absence of undesirable effects of mesalazine on the course of pregnancy or on the health of the fetus and (or) newborn. To date, no other epidemiological information that is relevant to the drug is known. In an isolated case, renal failure in the newborn was reported after prolonged use during pregnancy of mesalamine at a high dose (2-4 g orally).

Salofalk enemas should be used during pregnancy only when the expected benefit of use outweighs the possible risk.

N-acetyl-5-aminosalicylic acid and, to a lesser extent, mesalazine are excreted into breast milk. To date, there is only limited experience of use for the treatment of women during lactation. Hypersensitivity reactions such as diarrhea cannot be excluded. Therefore, Salofalk enemas should be used during breastfeeding only when the expected benefit of use outweighs the possible risk. If a nursing infant develops diarrhea, breastfeeding should be stopped.

Impact on the ability to drive a car and operate machinery

No effect on the ability to drive a car or operate machinery was observed.

Interaction with other drugs . No specific interaction studies have been conducted.

Interactions may occur during treatment with Salofalk 4 g/60 ml enemas while using the following medications simultaneously. Most of these possible interactions are based on theoretical considerations:

— Coumarin-type anticoagulants:

possible potentiation of the anticoagulant effect (increased risk of intestinal bleeding);

- Glucocorticoids: possible increase in adverse gastric effects;

— Sulfonylureas: possible increased sugar-lowering effects in the blood;

- Methotrexate: the toxic effect of methotrexate may increase;

— Probenecid / sulfinpyrazone: the uricosuric effect may be weakened;

- Spironolactone / furosemide: a decrease in the diuretic effect is possible;

— Rifampicin: the tuberculostatic effect may be weakened.

In patients taking azathioprine or 6-mercaptopurine concomitantly, the myelosuppressive effect of azathioprine or 6-mercaptopurine may be enhanced.

Features of conditions, shelf life and sales. . Keep out of reach of children at room temperature (not higher than 25°C), in sealed blisters. Protect from light.

Shelf life – 2 years. The shelf life of opened and half-used enema is 2 days. Opened and half-used enema should be stored at room temperature (not higher than 25°C). The drug should not be used after the expiration date indicated on its packaging.

Sources of information: rsml.med.by, mednet.by, drugs.com, webmd.com.