Pharmacy No. 84. Delivery of medicines to your home and office.

The pharmacy is closed on Sundays and holidays.

Medicines

my basket

Apteka84.kz is an online pharmacy that offers its customers medicines, medicinal and decorative cosmetics, dietary supplements, vitamins, baby food, intimate products for adults, medical equipment and thousands of other medical and cosmetic products at low prices. All data presented on the Apteka84.kz website is for informational purposes only and is not a substitute for professional medical care. Apteka84.kz strongly recommends that you carefully read the instructions for use contained in each package of medicines and other products. If you currently have any symptoms of the disease, you should seek help from a doctor. You should always tell your doctor or pharmacist about all the medicines you take. If you feel you need further help, please consult your local pharmacist or contact our GP online or by telephone.

Salofalk suppositories (Salofalk)

INSTRUCTIONS (information for specialists) on the medical use of the drug SALOFALK®

INN: Mesalazine

General characteristics White to grayish torpedo-shaped suppositories, uniform in consistency and with an intact smooth surface.

Composition of the drug Each suppository contains the active substance: mesalazine (5-aminosalicylic acid) auxiliary substances: solid fat, cetyl alcohol, sodium docusate.

Dosage form Rectal suppositories

Pharmacotherapeutic group: anti-inflammatory intestinal agents, aminosalicylic acid and similar active ingredients ATC code: A07EC02

Pharmacological properties Pharmacodynamics The mechanism of anti-inflammatory action is unknown. In vitro studies have demonstrated that inhibition of the enzyme lipoxygenase may play a role. An effect on prostaglandin concentrations in the intestinal mucosa has also been demonstrated. Mesalazine (5-aminosalicylic acid/5-ASA) may also act as a radical scavenger of reactive oxygen species. When administered rectally into the intestinal lumen, mesalazine has a significant local effect on the intestinal mucosa and submucosal layers. Pharmacokinetics General properties of mesalazine: Absorption Mesalazine is absorbed most effectively in the proximal parts of the intestine and least effectively in the distal parts of the intestine. Biotransformation Mesalazine undergoes first-pass metabolism with the formation of inactive N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA) both in the intestinal mucosa and in the liver. Acetylation appears to be independent of the patient's acetylation phenotype. Some mesalazine is also acetylated by colonic bacteria. Plasma protein binding is 43% for mesalazine and 78% for N-Ac-5-ASA. Excretion/excretion Mesalazine and its metabolite N-Ac-5-ASA are excreted in feces (most of them), 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 along with bile ( smaller part). It is excreted by the kidneys mainly in the form of N-Ac-5-ASA. Approximately 1% of an oral dose of mesalazine is excreted in breast milk, mainly as N-Ac-5-ASA. Specific features of the drug Salofalk® rectal suppositories 500 mg: Distribution Scintigraphic studies conducted using the drug Salofalk® rectal suppositories, labeled with a technetium isotope, demonstrated that the peak distribution of the drug occurs 2-3 hours after administration of the drug due to disintegration under the influence of body temperature. First of all, the drug penetrates the rectum and rectosigmoid colon. The drug Salofalk® rectal suppositories 500 mg is particularly suitable for the treatment of proctitis (ulcerative colitis of the rectum) due to the data presented on the distribution of the drug. Absorption The maximum concentration of 5-aminosalicylic acid in the blood plasma after using a single dose, as well as after using multiple doses (within several weeks of taking the drug Salofalk® rectal suppositories 500 mg 3 times a day) is in the range of 0.1–1.0 mcg /ml, and the concentration of the main metabolite N-Ac-5-ASA is 0.3–1.6 μg/ml. The period for achieving the maximum concentration of 5-ASA is partially realized during the first hour after use of the drug. Excretion After using a single dose of the drug Salofalk® rectal suppositories 500 mg, approximately 11% of the drug (within 72 hours) is excreted in the urine, and after repeated use (within several weeks of using the drug Salofalk® rectal suppositories 500 mg 3 times a day) - 13 % of the dose of 5-ASA is excreted in the urine. Approximately 10% of the drug is excreted in the bile. Data from Preclinical Safety Studies Preclinical data from standard pharmacological safety, genotoxicity, carcinogenicity (in rats) and reproductive toxicity studies did not indicate any particular hazard to humans. In toxicity studies, nephrotoxicity (medullary necrosis of the kidney and damage to the epithelium of the proximal convoluted tubule or the entire nephron) was observed with repeated oral administration of high doses of mesalazine. The clinical significance of the findings is unclear.

Indications for use Treatment of acute attacks of ulcerative colitis limited to the rectum.

Method of administration and dosage Adults and elderly people: 1 suppository of the drug Salofalk® rectal suppositories 500 mg three times a day (which corresponds to 1500 mg of mesalazine daily) is administered rectally.

As soon as remission has occurred, use for prophylactic purposes should be reduced to 1 suppository of Salofalk® rectal suppositories 250 mg three times a day (for example, Salofalk® rectal suppositories 250 mg).

Children and adolescents: There is little experience with the use of Salofalk® rectal suppositories 500 mg in children and limited literature on the effectiveness of the drug in children. General instructions for dosing the drug: When using the drug Salofalk®, rectal suppositories three times a day, they should be administered rectally in the morning, in the middle of the day and before bedtime. Treatment with Salofalk® rectal suppositories should be carried out regularly and according to the instructions, since the effect is achieved when these conditions are met. The duration of treatment is determined by the attending physician.

Side effects The following side effects have been reported in connection with the use of mesalazine: Organ system/organ/category Frequency according to the medical dictionary of regulatory activities Rare (≥1/10,000, <1/1,000) Very rare (<1/10,000 ) Disorders of the circulatory and lymphatic systems Changes in the blood count (aplastic anemia, agranulocytosis, pancytopenia, neutropenia, leukopenia, thrombocytopenia) Disorders of the nervous system Headaches, dizziness Peripheral neuropathies Disorders of the cardiovascular system Myocarditis, pericarditis Respiratory disorders tract and mediastinum Allergic or fibrotic pulmonary reactions (including dyspnea, cough, bronchospasm, alveolitis, pulmonary eosinophilia, pulmonary infiltration, pneumonitis) Gastrointestinal disorders Abdominal pain, diarrhea, bloating, nausea and vomiting Acute pancreatitis kidneys Kidney dysfunction, including acute and chronic interstitial nephritis and renal failure Skin and subcutaneous tissue disorders Photosensitivity (increased sensitivity of the skin to light) Alopecia (hair loss) Musculoskeletal and connective tissue disorders Myalgia, arthralgia Side effects immune system Hypersensitivity reactions, such as allergic exanthema, drug fever, drug-induced lupus erythematosus syndrome, pancolitis Disorders of the liver and biliary tract Changes in the functional parameters of the liver (increased levels of transaminases and cholestasis parameters), hepatitis, cholestatic hepatitis Disorders of the reproductive system Oligospermia ( reversible)

Photosensitivity (increased sensitivity of the skin to light) More severe reactions have been reported in patients with underlying skin conditions such as atopic dermatitis and atopic eczema.

Contraindications - known hypersensitivity to salicylic acid and its derivatives or to any of the excipients included in the drug; - severe liver and/or kidney dysfunction.

Overdose There is very limited information on mesalazine overdose (for example, when ingesting high doses for suicidal purposes), which does not indicate nephro- or hepatotoxicity of the drug. No specific antidote is known. Treatment is symptomatic and supportive.

Precautions At the discretion of the physician, a blood test (blood test with differential leukocyte count), determination of indicators of the functional state of the liver (levels of ALT or AST enzymes, plasma creatinine levels) and a urine test (test strips) should be performed before starting treatment and during treatment. . It is recommended to conduct these studies 14 days after the start of treatment and then 2-3 times with an interval of 4 weeks. If the results obtained are normal, then it is sufficient to carry out these tests every three months. If additional manifestations of the disease appear, additional studies should be performed immediately. Use with caution when treating patients with reduced liver function. Salofalk® rectal suppositories should not be used in the treatment of patients with reduced renal function. If a decrease in renal function occurs during treatment, mesalazine-related nephrotoxicity should be considered. Careful monitoring of patients with respiratory system disorders, especially asthma, is necessary when prescribing Salofalk® rectal suppositories. Patients with known hypersensitivity to drugs containing sulfasalazine should only be treated under close medical supervision. If symptoms of acute intolerance appear, such as cramps, acute abdominal pain, fever, severe headaches and skin rash, treatment with Salofalk® rectal suppositories should be discontinued immediately. Cetyl alcohol, which is part of the drug Salofalk® rectal suppositories, can cause local skin irritation (for example, contact dermatitis).

Period of pregnancy and lactation At the moment, there is insufficient data on the use of the drug Salofalk® rectal suppositories for pregnant women. However, no adverse effects from the use of mesalazine on pregnancy or the health of the fetus and newborn were observed. No other epidemiological information is available at this time. There is one case of renal failure in a newborn born to a woman who received high doses of mesalazine for a long time during pregnancy (2-4 g per day orally). Animal studies of the oral route of mesalazine have demonstrated no direct or indirect adverse effects on gestation, embryo/fetal development, parturition or postnatal development. Salofalk® rectal suppositories should be prescribed during pregnancy only if the expected benefit outweighs the potential risk. N-acetyl-5-aminosalicylic acid and small amounts of mesalazine are secreted into breast milk. To date, experience with the use of mesalazine during breastfeeding is very limited. The development of hypersensitivity reactions in infants, such as diarrhea, cannot be excluded. Thus, the drug Salofalk® rectal suppositories should be prescribed during breastfeeding only if the expected benefit outweighs the potential risk. If the baby develops diarrhea, breastfeeding should be stopped.

Effect on the ability to drive a car and operate complex equipment There was no effect on the ability to drive a car or operate complex equipment. The use of the drug Salofalk® rectal suppositories either has no effect or has an insignificant effect on the ability to drive a car and operate complex equipment.

Interaction with other medicinal products No specific interaction studies have been conducted. The possibility of increasing the suppressive effect of azathioprine, 6-mercaptopurine or thioguanine on the bone marrow should be taken into account during treatment with simultaneous use of the drug Salofalk® rectal suppositories. There is weak evidence that mesalazine may reduce the effect of the anticoagulant warfarin.

Storage conditions and expiration date Store in a place protected from light at a temperature not exceeding 25 oC. Keep out of the reach of children. Shelf life: 3 years. Do not use after expiration date.

Dispensing conditions Prescription

Packaging Rectal suppositories 500 mg, 250 mg: 5 suppositories in a blister laminated with PVC/low-density polyethylene; 2 blisters along with instructions for use in a cardboard pack.

Applicant/manufacturer Dr. Falk Pharma GmbH Leinenweberstr. 5 79108 Freiburg Germany

Representative in the Republic of Belarus Representative office of Alpen Pharma AG JSC in the Republic of Belarus 220053, Minsk, st. Parkhomenko 3, office 1-B Tel/fax: (+375 17) 3350644