Legalon140 (capsules of 140 mg N60) to restore liver function dry extract from the fruits of milk thistle

Composition

active substance: dry extract from the fruits of milk thistle (Silybum marianum);

1 capsule contains 173–186.7 mg of dry extract from the fruits of milk thistle (Silybum marianum) [36-44:1], which corresponds to 140 mg of silymarin (DNPH) or 108.2 mg of silymarin (HPLC/DAB) in terms of silibinin (solvent - ethyl acetate);

auxiliary substances: microcrystalline cellulose, corn starch, sodium starch glycolate (type A), sodium lauryl sulfate, magnesium stearate, iron oxide red E 172, iron oxide black E 172, titanium dioxide E 171, gelatin.

Medicinal form

Capsules.

Main physical and chemical properties: hard gelatin capsule size 1. Brown cap without marking, brown body without marking. The contents of the capsule are a homogeneous, pressed powder of a brownish-yellow color.

Pharmacotherapeutic group

Means used for the treatment of liver diseases. Hepatotropic drugs.

ATX code А05В А03.

Pharmacological properties

Pharmacodynamics.

The ability of silymarin to bind free radicals provides its antioxidant activity. Thus, the pathophysiological process of lipid peroxidation, which is responsible for the destruction of cell membranes, is interrupted or prevented. In damaged hepatocytes, silymarin stimulates protein synthesis and normalizes phospholipid metabolism, as a result of which silymarin stabilizes cell membranes and limits or prevents the loss of soluble components (in particular, transaminases) of liver cells. Silymarin inhibits the penetration of some hepatotoxic substances (poisons of pale toadstool) into the cell. Silymarin enhances protein synthesis by specifically stimulating RNA polymerase A, an enzyme found in the nucleus. This leads to the increased formation of ribosomal RNA, and therefore to the stimulation of the synthesis of structural and functional proteins (enzymes). As a result, the regenerative capacity is improved and the regeneration of liver cells is accelerated.

Pharmacokinetics.

Absorption is low and slow (the half-life is 2.2 hours), it is metabolized in the liver by conjugation, the half-life is 6.3 hours. It is excreted mainly with bile in the form of glucuronides and sulfates. Does not accumulate in the body. Intestinal-hepatic circulation is noted.

Indication

Toxic liver damage: for the supportive treatment of patients with chronic inflammatory liver diseases or liver cirrhosis.

Contraindication

Hypersensitivity to the fruits of milk thistle, to other components of the drug or to any of the excipients; acute poisonings of various etiologies.

Interaction with other medicinal products and other types of interaction

With the simultaneous use of silymarin in maximally large doses and oral contraceptives or drugs used in estrogen replacement therapy, a decrease in the effectiveness of the latter is possible. By inhibiting the cytochrome P450 system, silymarin thereby enhances the effect of some drugs, namely: anti-allergic drugs (fexofenadine); hypocholesterolemic drugs (lovastatin); anticoagulants (clopidogrel, warfarin); antipsychotic drugs (alprozolam, diazepam, lorazepam); antifungal drugs (ketoconazole); certain drugs for the treatment of cancer (vinblastine).

Features of use

Treatment with the drug for liver diseases will be more effective if you follow a diet and abstain from alcohol.

Because of the possible estrogenic effect of silymarin in maximally large doses, it should be used with caution in patients with hormonal disorders (endometriosis, uterine fibroids, carcinoma of the breast, ovaries and uterus, carcinoma of the prostate gland). In these cases, consultation with a doctor is required.

If signs of jaundice appear (the skin turns from light yellow to dark yellow, yellowing of the whites of the eyes), you should consult a doctor.

Use during pregnancy or breastfeeding.

There are no data on the effectiveness and safety of the drug during pregnancy or breastfeeding, so it should not be prescribed during this period.

The ability to influence the speed of reaction when driving vehicles or other mechanisms.

It was not noted. If the patient has any vestibular disorders while taking the drug, one should refrain from driving vehicles or working with other mechanisms.

Method of application and dosage

Adults and children over 12 years old should take 1 capsule 3 times a day.

Capsules should be swallowed whole, without chewing, with a sufficient amount of liquid.

The course of treatment is determined by the doctor individually, depending on the nature and course of the disease.

Children. There are insufficient data on the use of this drug in children, so it should not be used in children under 12 years of age.

Overdose

Signs and symptoms of intoxication were not observed. The side effects described below may increase.

The specific antidote is unknown. Symptomatic measures are recommended.

Side effects

Criteria for assessing the frequency of the development of an adverse reaction to a medicinal product:

Very often: ≥ 1/10

Often: ≥ 1/100 – < 1/10

Uncommon: ≥ 1/1000 – < 1/100

Rarely: ≥ 1/10000 – < 1/1000

Very rarely: < 1/10000

Unknown: it is impossible to estimate the frequency of cases

The drug is well tolerated. Rarely, in individual cases and with individual hypersensitivity, the following side effects can be observed:

from the digestive tract: nausea, vomiting, dyspepsia, heartburn, mild diarrhea;

from the respiratory system: shortness of breath;

from the urinary system: increased diuresis;

from the side of the skin and skin appendages: increased alopecia, in rare cases possible hypersensitivity reactions, including skin rashes, itching;

others: it is very rare to observe an increase in existing vestibular disorders.

Adverse reactions are temporary and disappear after stopping the drug without the use of special measures.

Expiration date 5 years

Storage conditions

Store at a temperature not higher than 30 °C in a place inaccessible to children.

Packaging

10 capsules in a blister; 2 or 3 or 6 blisters in a cardboard box.

Leave category

Without a prescription.

Features of application

Adults are allowed

Children - from 12 years old

Pregnant women are prohibited

Nursing mothers are prohibited

People with allergies - with caution

Diabetics are allowed

Drivers - take with caution