Name Silibor. Active ingredient: 1 tablet contains silymarin (in the form of a dry extract of milk thistle fruit (24-27:1, extractant – acetone 95%)) 35 mg; excipients: potato starch; sodium starch glycolate (type A); calcium stearate; lactose, monohydrate; hypromellose; titanium dioxide (E 171); sunset yellow FCF (E 110). Basic physical and chemical properties Film-coated tablets, from orange to brownish-orange in color, with a biconvex surface. Marbling and inclusions are allowed on the surface of the tablets. Pharmacotherapeutic group Drugs used in liver diseases, lipotropic substances. Silymarin. ATX code A05B A03. Pharmacological properties Pharmacodynamics. The drug contains the active component of silymarin, obtained from the fruits of the milk thistle plant. Silymarin is a mixture of four isomers of flavonolignans: silibinin, isosilybinin, silydianin and silicristin. The drug has a hepatoprotective and antitoxic effect. The drug inhibits the penetration of toxins into the liver cells (shown on the poison of the pale toadstool), and also causes physico-chemical stabilization of the cell membrane of hepatocytes, limits or prevents the loss of soluble components (including transaminases) of liver cells. The antioxidant effect of the drug is due to the interaction of silibinin with free radicals in the liver and their transformation into less toxic compounds. Thus, the process of lipid peroxidation is interrupted and no further destruction of cellular structures occurs; toxins are neutralized physiologically. Silymarin stimulates the synthesis of proteins (structural and functional) and phospholipids in affected liver cells (normalizing lipid metabolism), stabilizes their cell membranes, binds free radicals (antioxidant action), thus protecting liver cells from harmful effects and contributing to their recovery. The clinical effect of the drug is manifested in the improvement of the general condition of patients with liver diseases, the reduction of subjective complaints (such as weakness, a feeling of heaviness in the right hypochondrium, loss of appetite, itching, vomiting). Laboratory indicators improve: the activity of transaminases, gamma-glutamyl transferase, alkaline phosphatase and the level of bilirubin in the blood plasma decrease. Pharmacokinetics. After oral administration, silymarin is slowly absorbed from the digestive tract. It undergoes enterohepatic circulation. Does not accumulate. It is intensively distributed in the body. As a result of studies with 14C-labeled silibinin, the highest concentrations of the substance are found in the liver and a very small amount – in the kidneys, lungs, heart and other organs. Silymarin is metabolized in the liver by conjugation. In bile, metabolites such as glucuronides and sulfates have been identified. The half-life of silymarin is 6 hours. It is excreted mainly in the bile (about 80%) in the form of glucuronides and sulfates and slightly (about 5%) in the urine. Indications Symptomatic treatment of chronic toxic liver damage; for maintenance treatment in patients with chronic inflammatory liver disease or cirrhosis. Contraindications Hypersensitivity to the components of the drug. Acute poisoning of various etiologies. Children’s age up to 12 years. Interaction with other drugs and other forms of interaction With the simultaneous use of silymarin and oral contraceptives and drugs used in estrogen replacement therapy, the effectiveness of the latter may decrease. Silymarin can enhance the effects of drugs such as diazepam, alprazolam, ketoconazole, lovastatin, vinblastine, antiallergic drugs (fexofenadine), anticoagulants (clopidogrel, warfarin), atorvastatin by inhibiting the cytochrome P450 system. PrecautionsTreatment with this drug is not a substitute for diet or avoidance of hepatotoxic substances that cause liver damage (eg, alcohol). Due to the possible estrogen-like effect of silymarin, it should be used with caution in patients with hormonal disorders (endometriosis, uterine fibroids, breast, ovarian and uterine carcinoma, prostate carcinoma). In these cases, it is necessary to consult the patient with a doctor. Due to the lactose content, the drug should not be taken by patients with rare congenital galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. If jaundice develops, it is necessary to consult a doctor to correct therapy. The dye Sunset Yellow FCF (E 110) contained in the preparation may cause allergic reactions and is not recommended for use in children. Use during pregnancy or lactation There are no data on the safety and efficacy of the drug during pregnancy or lactation, so it should not be prescribed during this period. The ability to influence the reaction rate when driving vehicles or operating other mechanisms The drug does not affect the ability to drive vehicles or work with other mechanisms. Patients with existing vestibular disorders should use the drug with caution when driving vehicles or using other mechanisms. Dosing and Administration Tablets are taken orally, without chewing, with a sufficient amount of water. Unless otherwise indicated, adults and children over 12 years of age are recommended to take 4 tablets 3 times a day, which corresponds to 420 mg of silymarin per day. The duration of the course of treatment is determined by the doctor individually, depending on the nature and characteristics of the course of the disease. Children There are no sufficient data on the use of the drug in children, so it should be used in children under the age of 12 years. Overdose There are no reports of cases of overdose. Treatment: in case of an overdose of the drug (taken at a dose that is several times higher than the therapeutic one), one should induce vomiting, wash the stomach, take activated charcoal and, if necessary, apply symptomatic treatment prescribed by a doctor. Adverse reactions Usually the drug is well tolerated. Rarely, in some cases and with individual hypersensitivity, the following side effects can be observed: from the digestive system: nausea, dyspepsia, diarrhea, vomiting, heartburn; on the part of the skin and skin appendages: in rare cases, skin allergic reactions are possible – itching, rash, urticaria, increased alopecia; others: it is very rare to observe an increase in existing vestibular disorders, increased diuresis, shortness of breath. Side effects that pass and disappear after stopping the drug without taking special measures. Shelf life 2 years. Do not use after the expiration date. Storage conditionsStore in the original packaging at a temperature not exceeding 25°C. Keep out of the reach of children. Packing Film-coated tablets, 35 mg No. 25 (25×1), No. 20 (20×1), No. 30 (10×3), No. 80 (10×8) in blisters made of PVC film and aluminum foil, placed together with a leaflet in a cardboard box. Holiday category Without a prescription. Buy Silibor 35 tablets p/o 35mg No. 10×3 The price of Silibor 35 tablets p/o 35mg No. 10×3
INN | MILK THISTLE FRUIT EXTRACT |
---|---|
The code | 18 267 |
Barcode | 4 820 044 116 385 |
Dosage | 35mg |
Active substance | Silibinin |
Manufacturer | Pharmaceutical company Health LLC, Ukraine |
Importer | LLC PKF "Yassa", Vitebsk, 21009, Vitebsk, Lazo st., 5-99; UE "MedPharmInvest", Minsk, Republic of Belarus, Minsk region, Minsk district, Papernyansky village, 50/1-1 district, Dubovlyany village |
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