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Instructions for use SALOFALK® tablets

General properties of mesalazine

Suction

Mesalazine is absorbed most efficiently in the proximal intestine and least efficiently in the distal intestine.

Distribution

Plasma protein binding of mesalazine and N-Ac-5-ASA is 43% and 78%, respectively. Approximately 1% of an oral dose of mesalazine is excreted in breast milk, mainly as N-Ac-5-ASA.

Metabolism

Mesalazine undergoes first-pass metabolism to form inactive N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA), both in the intestinal mucosa and in the liver. The pattern of acetylation is independent of the patient's acetylation phenotype. Part of mesalazine is also acetylated due to the action of bacterial microflora of the large intestine.

Removal

Mesalazine and its metabolite N-Ac-5-ASA are excreted in excrement (most of it), kidneys (the amount varies from 20% to 50% depending on the route of administration, dosage form and mechanism of release of the active substance) and bile (minor part) . It is excreted by the kidneys mainly in the form of N-Ac-5-ASA.

Specific features of the drug Salofalk® in the form of tablets 250 mg

Distribution

A combined pharmacoscintigraphic/pharmacokinetic study demonstrated that when taken with food (breakfast test), enteric film-coated tablets dissolve in approximately 3-4 hours in the ileum. The average time for evacuation of gastric contents was approximately 3 hours. After approximately 7 hours, the tablets reached the colon. In a subsequent study in volunteers, the evacuation time from the duodenum to the ileum was approximately 3 hours, with the highest concentration of 5-ASA in the intestinal lumen observed 7-8 hours after co-administration of the tablets with a test breakfast. Approximately 75% of the mesalazine dose reaches the large intestine unmetabolized.

Suction

The release of mesalazine from Salofalk® 250 mg enteric film-coated tablets begins after a lag phase of approximately 3-4 hours. The highest plasma concentration is achieved after approximately 5 hours (in the ileum) and with the administration of mesalazine at a dose of 500 mg 3 times/day (3×2 tablets. Salofalk® 250 mg) under the condition of steady-state equilibrium is 2.1±1.7 µg/ml for mesalazine and 2.8±1.7 µg/ml for its metabolite, N-A4-5-ACK.

Removal

During long-term treatment with Salofalk® 250 mg enteric film-coated tablets at a daily dose of 500 mg mesalazine 3 times a day (assuming steady state), the total rate of renal excretion of mesalazine and N-A4-5-ACK was approximately 55% (value obtained within 24 hours after the last dose). The proportion of unmetabolized mesalazine was approximately 5%. T1/2 is 0.7-2.4 hours (on average 1.4±0.6 hours) when using mesalazine at a dose of 500 mg 3 times a day.

Specific features of the drug Salofalk® in the form of tablets 500 mg

Distribution

A combined pharmacoscintigraphic/pharmacokinetic study demonstrated that when taken with food (breakfast test), enteric film-coated tablets dissolve in approximately 3-4 hours in the ileum. After approximately 4-5 hours, the tablets reach the colon. The total transit time in the large intestine is about 17 hours.

Suction

The release of mesalazine from Salofalk® 500 mg enteric film-coated tablets begins after a lag phase of approximately 3-4 hours. The highest plasma concentration is achieved after approximately 5 hours (in the ileum) and with the administration of mesalazine at a dose of 500 mg 3 times/day, subject to steady state equilibrium, is 3±1.6 µg/ml for mesalazine and 3.4±1.6 µg/ml for its metabolite, N-Ac-5-ASA.

Removal

The total rate of renal excretion of mesalazine and N-Ac-5-ASA within 24 hours with repeated doses (1 tablet 500 mg 3 times a day for 2 days; and 1 tablet on the third control day) was approximately 60% ( value obtained within 24 hours after the last dose). The proportion of unmetabolized mesalazine was approximately 10%.

Salofalk

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 administered 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 tablets po enteric soluble 500 mg No. 10x5

Name

Salofalk tablet, coated intestinal p/o 500 mg per bl. in pack No. 10x5

Main active ingredient

Mesalazine

Release form

Pills

Compound

The active substance of Salofalk, 500 mg tablets is mesalazine. One Salofalk tablet contains 500 mg of mesalazine (5-aminosalicylic acid); excipients: anhydrous sodium carbonate, glycine, povidone (K 25), microcrystalline cellulose, anhydrous colloidal silicon dioxide, calcium stearate, croscarmellose sodium, hypromellose, methacrylic acid methyl methacrylate copolymer (1:1) (Eudragit L 100), macrogol 6000, talc , titanium dioxide (E171), yellow iron oxide (E172), basic butyl methacrylate copolymer (Eudragit E).

Description

Salofalk, tablets 500 mg are enteric film-coated tablets, unpolished with a smooth surface, without cracks, from oil-yellow to ocher color.

Dosage

500 mg

Indications for use

Salofalk, 500 mg tablets contains the active substance - mesalazine (5-aminosalicylic acid) - an anti-inflammatory drug used to treat inflammatory bowel diseases. Salofalk, 500 mg tablets are prescribed for: • treatment of acute attacks and prevention of relapses of inflammatory disease of the large intestine, known in medicine as ulcerative colitis; • treatment of acute attacks of chronic inflammatory bowel disease, known as Crohn's disease.

Contraindications

Do not take Salofalk 500 mg tablets if: - you are allergic (hypersensitivity) to salicylic acid, salicylates such as Aspirin or other ingredients of Salofalk 500 mg tablets; - you have severe liver or kidney disease; - you have a stomach or duodenal ulcer; - You bleed easily or your doctor has told you that you have problems with blood clotting. You should start taking Salofalk, 500 mg tablets with caution if: - you have ever had problems with your lungs, especially if you suffer from asthma; - you were allergic to sulfasalazine, a substance related to mesalazine; - you have liver problems; — you have problems with your kidneys. Tell your doctor if you have any of the conditions described above.

Use during pregnancy and lactation

Before using any medicine, you should consult your doctor. You should take Salofalk 500 mg tablets during pregnancy only if it has been recommended to you by your doctor. If you are breastfeeding, you should only take Salofalk 500 mg tablets if your doctor has prescribed it.

Directions for use and doses

Salofalk 500 mg tablets should be taken as prescribed by your doctor. Salofalk, 500 mg tablets are intended for oral administration. Take the tablets in the morning, midday and evening 1 hour before meals. Do not chew the tablets and take them with plenty of water. Dosage Adults Unless your doctor has prescribed a different regimen for you, the following general recommendations should be followed: Crohn's disease Ulcerative colitis Treatment of exacerbations Treatment of exacerbations Relapse prevention / long-term Mesalazine (active substance) 1.5 g - 4.5 g 1.5 g - 3 .0 g 1.5 g Salofalk, tablets 500 mg from 1 tablet x 3 times a day to 3 tablets x 3 times a day from 1 tablet X 3 times a day to 2 tablets x 3 times a day 1 tablet X 3 times per day Children over 6 years of age and adolescents Please consult your doctor for a recommendation regarding the correct dosage of Salofalk, 500 mg tablets for your child. The dose depends on the severity of your child's condition and his body weight. Typically, the following recommendations apply: children weighing up to 40 kg are prescribed half the adult dose, and children weighing more than 40 kg are prescribed the normal adult dose. Due to the high dosage of Salofalk, 500 mg tablets for children are not convenient for use. Typically, Salofalk is used for children, 250 mg tablets according to the following recommendations: Crohn's disease Ulcerative colitis Treatment of exacerbations Treatment of exacerbations Relapse prevention / long-term treatment Mesalazine (active substance) 0.75 g - 2.25 g 0.75 g - 1.5 g 0.75 g Salofalk, tablets 250 mg from 1 tablet x 3 times a day to 3 tablets x 3 times a day from 1 tablet x 3 times a day to 2 tablets x 3 times a day 1 tablet 3 times a day Duration Treatment How long you will take Salofalk, 500 mg tablets depends on your condition. Your doctor must decide how long you should take this drug. Taking Salofalk, 500 mg tablets, should be regular and systematic, both during exacerbation of inflammation and during long-term treatment, since only in this case can the desired therapeutic effect be achieved. If you feel that the effect of taking the pills is too strong or, on the contrary, too weak, please consult your doctor. In rare cases, in patients who underwent intestinal resection or surgical intervention on the intestine in the ileocecal (ileocecal) region, accompanied by removal of the colon valve, excretion of undissolved Salofalk tablets in the stool was observed, which was caused by too short a transit time. If you notice this effect, please notify your doctor.

Side effect

Like all medicines, Salofalk 500 mg tablets may cause side effects and may not be suitable for all patients. All medications can cause allergic reactions, although serious allergic reactions are very rare. If, after taking the medicine, you notice any of these symptoms, immediately inform your doctor: - allergic skin rash; - fever; - labored breathing. If you experience any of the following serious side effects, stop taking the drug and call your doctor immediately: If you feel very unwell with fever and/or sore throat and mouth, call your doctor right away. Symptoms may be caused by a low number of white blood cells (agranulocytosis). This may increase the chance of a serious infection. You will have a blood test to check if your white blood cell count may be low. Important The following side effects have also been reported: Rare side effects (occurring in less than 1 in 1000 patients): Abdominal pain, diarrhea, flatulence, nausea and vomiting, headache, dizziness. Very rare side effects (occurring in less than 1 in 10,000 patients): - changes in kidney function, sometimes accompanied by swelling of the extremities or pain in the side; - chest pain, difficulty breathing or swelling of the limbs due to heart problems; - severe abdominal pain as a result of acute inflammation of the pancreas; - severe difficulty breathing as a result of allergic inflammation of the lung tissue; - severe diarrhea and abdominal pain as a result of allergic inflammation of the intestines; - skin rash or inflammation; - pain in muscles and joints; - fever, sore throat, malaise, as a result of changes in the blood formula; - bile spillage or abdominal pain as a result of problems with the liver and gall bladder; - hair loss and baldness; - numbness and tingling in the arms and legs (peripheral neuropathy); - reversible decrease in sperm production. If any of the side effects begin to bother you seriously, or you notice any side effects not listed in this leaflet, please contact your doctor.

Overdose

If you take more Salofalk tablets at one time than you should, simply continue taking them as prescribed and do not reduce the next dose. If you have any doubts, contact your doctor so he can decide what to do.

Interaction with other drugs

Please tell your doctor if you are taking or have recently taken any of the medicines containing the following substances, as the effectiveness of these medicines may change when interacting with Salofalk 500 mg tablets: - Certain medicines that reduce blood clotting (medicines for thrombosis and blood thinning); - Glucocorticoids (certain steroidal anti-inflammatory drugs such as prednisolone); - Sulfonylurea derivatives (substances used to control blood sugar levels, such as glibenclamide); - Methotrexate (a drug used to treat leukemia or immune system disorders); — Probenecid/sulfinpyrazone (a drug used to treat gout); — Spironolactone/furosemide (drugs used to treat heart disease); — Rifampicin (a drug used to treat tuberculosis); - Medicines containing azathioprine or 6-mercaptopurine (used to treat diseases of the immune system). Please also tell your doctor if you are taking or have recently taken any other medications, including over-the-counter medications.

Precautionary measures

Salofalk, tablets 500 mg should be used under medical supervision. During treatment, your doctor will regularly monitor your blood and urine levels. Children under 6 years old. Data on the use of this drug in children under 6 years of age are limited, and therefore this drug is not recommended for use in this age group.

Storage conditions

Store in a place protected from light at a temperature not exceeding 25°C. Keep out of the reach of children.