Description
Release form
Capsules 140 mg. 10 capsules in a blister made of a film of PVC-aluminum foil. 2, 3 or 6 blisters in a cardboard box along with instructions for use.
Packing
30 pcs.
Pharmacological action
Pharmacotherapeutic group: hepatoprotective agent.
ATX code: A05BA03.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamics
Milk thistle dry extract standardized on the content of silymarin.
Therapeutic effect of silymarin:
Detoxification. The antitoxic effect of silymarin was revealed during studies on various models of liver damage, for example, pale toadstool toxin phalloidin and alpha-amanitine, lanthanides, carbon tetrachloride, galactosamine, thioacetamide and hepatotoxic FV3 virus.
Cytoprotective. Silymarin inhibits the penetration into the cell of certain hepatotoxic substances (venom of a pale toadstool).
Antioxidant. Due to the ability of silymarin to bind free radicals, it has antioxidant activity. The pathophysiological process of lipid peroxidation, which is responsible for the destruction of cell membranes, is interrupted or prevented. Silymarin acts not only as an antioxidant – reducing the degree of generation of free radicals, but also as a means of stimulating the regeneration of the glutathione system, one of the most important protective systems of the liver.
Regenerative. Membrane stabilizing. Silymarin stimulates the synthesis of proteins and phospholipids. Cell membranes are stabilized. Own proteins and phospholipids restore damaged hepatocyte structures. The recovery ability is improved and the regeneration of liver cells is accelerated. In intact cells, this effect is not observed.
Hypocholesterolemic. Silymarin normalizes hyperlipidemia, reduces plasma cholesterol and low density lipoproteins (LDL).
Antifibrotic. Silymarin inhibits collagenase and elastase in the liver, helping to reduce the degree of fibrosis.
Anti-inflammatory. A key feature of silymarin / silibinin is its ability to block the 5-lipoxygenase pathway and inhibit leukotriene formation.
Pharmacokinetics
The main component of silymarin is silibinin. When ingested, silibinin quickly dissolves and enters the intestine, then through the portal vein system 85% of it enters the liver and is selectively distributed in hepatocytes, where it is metabolized by conjugation. Up to 80% of the active substance during the first passage through the liver is excreted with bile in combination with glucuronides and sulfates. Due to deconjugation in the intestine up to 40% of silibinin excreted in the bile, it is reabsorbed and enters into enterohepatic circulation, the elimination period is 6.3 hours. The bioavailability of Legalon® 140 is 85%.
When taking milk thistle extract fruit in therapeutic doses (140 mg of silymarin 3 times a day), the level of silibinin in the bile is the same after taking repeated doses and after taking a single dose. The results showed that silibinin does not cumulate in the body.
After repeated use of silymarin inside of 140 mg 3 times a day, a stable level of excretion with bile is achieved.
Indications
In the complex treatment of chronic inflammatory liver diseases, liver cirrhosis and toxic liver lesions (caused by liver toxic substances).
Contraindications
Hypersensitivity to the components of the drug (fruits of the milk thistle and / or other complex plants, or to any of the excipients).
Children under 12 years of age (for this dosage form).
Caution: No specific requirements.
Use during pregnancy and lactation
B no direct or indirect toxic effects on reproductive function have been identified in studies. As a preventative measure, it is advisable to avoid the use of the drug during pregnancy and during breastfeeding.
Special instructions
The drug does not affect the ability to drive vehicles or engage in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
Composition
One capsule contains: Active ingredient: milk thistle fruit extract dry (36-44: 1) – 173.0-186.7 mg, equivalent to 140 mg of silymarin (DNPH), equivalent to 108.2 mg of silymarin (HPLC / Germ.F.) calculated on silibinin.
Excipients: polysorbate 80, povidone, mannitol, sodium carboxymethyl starch (type A), magnesium stearate.
The shell is a hard gelatin capsule, size “1”, which includes: gelatin, iron oxide red (E172), titanium dioxide (E171), sodium lauryl sulfate, black iron oxide (E172).
Dosage and administration of
Inside, after meals, drinking plenty of fluids. 1 capsule 3 times a day. Maintenance dose – 1 capsule 2 times a day.
The duration of therapy is determined by the doctor.
Side effects
The frequency of side effects is defined as follows:
Very often:> 1/10
Frequently: <1/10> 1/100
Infrequently: <1/100> 1/1000
Rarely: <1/1000 > 1/10000
Very rare: <1/10000. Disorders of the immune system: Very rarely – hypersensitivity reactions, rash. Disorders of the respiratory tract: Very rarely – shortness of breath. Disorders of the gastrointestinal tract: Rarely, gastrointestinal upset, soft stool. Drug Interactions Not studied. Overdose No cases of overdose have been reported. It is possible to increase the side effect of the drug. Treatment: symptomatic therapy should be performed with an overdose. Storage conditions In a dark place at a temperature not exceeding 30 C. Keep out of the reach and sight of children. Shelf life 5 years. Terms and conditions without prescription Dosage form capsules Possible product names LEGAL 0,14 N30 CAPS Legal 140 capsules 140mg N30 LEGAL 140 CAPS. No. 30 Legalon 140 capsules 140 mg, 30 pcs. LEGAL 140MG. No. 30 CAPS. Madaus, Germany
