Legalon 140, 140mg capsules, 60pcs

Product description

Pharmacotherapeutic group: hepatoprotective agent. ATX code: A 05 VA 03.

Composition

One capsule contains:

Active ingredient:

milk thistle Spotted Fruit Extract Dry (36-44: 1) – 173.0-186.7 mg, equivalent to 140 mg silymarin (DNPH), equivalent to 108.2 mg silymarin (HPLC/Germ. F. ) based on silibinin.

Excipients: polysorbate 80, povidone, mannitol, sodium carboxymethyl starch (type A), magnesium stearate.

The shell is a solid gelatin capsule, size “1”, which includes: gelatin, iron oxide red dye (E 172), titanium dioxide (E 171), sodium lauryl sulfate, iron oxide black dye (E 172).

Pharmacological action

Milk thistle spotted fruit dry extract is standardized for silymarin content.

Therapeutic effect of silymarin:  

Detoxification equipment. The antitoxic effect of silymarin was revealed in studies on various models of liver damage, for example, the pale toadstool toxin phalloidin and alpha-amanitin, lanthanides, carbon tetrachloride, galactosamine, thioacetamide and the heptotoxic FV3 virus.

Cytoprotective. Silymarin inhibits the penetration of certain hepatotoxic substances (pale toadstool venom) into the cell.

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 free radical generation, 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 agent. Silymarin stimulates the synthesis of proteins and phospholipids. Cell membranes are stabilized. Its own proteins and phospholipids restore damaged structures of the hepatocyte. It improves the regenerative ability and accelerates the regeneration of liver cells. This effect is not observed in intact cells.

Hypocholesterolemic. Silymarin normalizes hyperlipidemia, reduces the level of cholesterol and low-density lipoproteins (LDL) in the blood plasma.

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 have an inhibitory effect on leukotriene formation.

Pharmacokinetics

The main component of silymarin is silibinin. When taken orally, silibinin quickly dissolves and enters the intestines, then 85% of it enters the liver through the portal vein system and is selectively distributed in hepatocytes, where it is metabolized by conjugation. Up to 80% of the Active ingredient during the first passage through the liver is excreted in bile in combination with glucuronides and sulfates. Due to deconjugation in the intestine, up to 40% of silibinin released with bile is reabsorbed and enters the enterohepatic circulation, the elimination period is 6.3 hours. Bioavailability of the drug  Legalon ® 140 is 85%.

When taking milk thistle fruit extract 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 accumulate in the body.

After multiple oral use of silymarin 140 mg 3 times a day, a stable level of bile excretion is achieved.

Indications

In the complex therapy of chronic inflammatory liver diseases, cirrhosis of the liver and toxic liver damage (caused by substances toxic to the liver).

Use during pregnancy and lactation

In the course of studies, no direct or indirect toxic effects on reproductive function were detected. As a preventive measure, it is advisable to avoid using the drug during pregnancy and during breastfeeding.

Contraindications

Hypersensitivity to the components of the drug (milk thistle fruits and/or other compound plants, or to any of the excipients). Children under 12 years of age (for this dosage form).

Side effects

The frequency of side effects is defined as follows:

• Very Common: > 1/10;>
• Common: <1/10 > 1/100;<1/10 >
• Infrequently: <1/100 > 1/1000;<1/100 >
• Rare: <1/1000> 1/10000;<1/1000>
• Very rare:

Immune system disorders: Very rarely – hypersensitivity reactions, rash. Respiratory tract disorders: Very rarely – shortness of breath. Disorders of the gastrointestinal tract: Rarely – gastrointestinal disorders, soft stools.

How to take, course of use and dosage

Inside, after eating, with a sufficient amount of liquid.

Take 1 capsule 3 times a day. Maintenance dose-1 capsule 2 times a day.

The duration of therapy is determined by the doctor.

Overdose

No overdose cases have been reported. It is possible to increase the side effect of the drug. Treatment: in case of overdose, symptomatic therapy should be performed.

Description

Capsule appearance: solid gelatin capsules, size “1”, brown body and lid. Appearance of the capsule contents: yellow powder.

Special instructions

With caution, there are no special requirements. THE EFFECT OF THE DRUG ON THE ABILITY TO DRIVE VEHICLES, mechanisms, and the drug does not affect the ability to drive vehicles or engage in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions

In a place protected from light, at a temperature not exceeding 30 ° C. Keep out of reach of children.

Shelf

life is 5 years. Do not use after the expiration date indicated on the package.

Active ingredient

Milk Thistle Spotted Fruit Extract

Dosage form

Capsules