Instructions for Legalon 140 capsules 140 mg No. 60
Composition
active ingredient: dry extract from milk thistle fruits (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);
excipients: microcrystalline cellulose, corn starch, sodium starch glycolate (type A), sodium lauryl sulfate, magnesium stearate, red iron oxide E 172, black iron oxide E 172, titanium dioxide E 171, gelatin.
Dosage form
Capsules.
Main physicochemical properties: hard gelatin capsule size 1. Brown cap without marking, brown body without marking. Capsule contents – homogeneous, compressed powder of brownish-yellow color.
Pharmacotherapeutic group
Drugs used to treat liver diseases. Hepatotropic drugs.
ATX code A05B A03.
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 (poison of the milk thistle). Silymarin enhances protein synthesis by specifically stimulating RNA polymerase A, an enzyme located in the nucleus. This leads to increased formation of ribosomal RNAs, and therefore, to stimulation of the synthesis of structural and functional proteins (enzymes). As a result, the regenerative capacity of liver cells improves and regeneration is accelerated.
Pharmacokinetics.
Absorption is low and slow (half-life is 2.2 hours), metabolized in the liver by conjugation, half-life is 6.3 hours. Excreted mainly with bile in the form of glucuronides and sulfates. Does not accumulate in the body. Enterohepatic circulation is noted.
Indication
Toxic liver lesions: for supportive treatment of patients with chronic inflammatory liver diseases or cirrhosis.
Contraindication
Hypersensitivity to milk thistle fruits, to other components of the drug or to any of the excipients; acute poisoning of various etiologies.
Interaction with other medicinal products and other types of interactions
With the simultaneous use of silymarin in the highest possible doses and oral contraceptives or drugs used in estrogen replacement therapy, the effectiveness of the latter may decrease. By inhibiting the cytochrome P450 system, silymarin thereby enhances the effect of some drugs, namely: antiallergic drugs (fexofenadine); hypocholesterolemic drugs (lovastatin); anticoagulants (clopidogrel, warfarin); antipsychotic drugs (alprozolam, diazepam, lorazepam); antifungal drugs (ketoconazole); some drugs for the treatment of cancer (vinblastine).
Application features
Treatment with the drug for liver diseases will be more effective if you follow a diet and avoid alcohol.
Due to the possible estrogen-like effect of silymarin in the highest possible 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 (skin turning from light yellow to dark yellow, yellowing of the whites of the eyes), you should consult a doctor.
Use during pregnancy or breastfeeding
There is no data on the efficacy and safety of the drug during pregnancy or breastfeeding, so it should not be prescribed during this period.
Ability to influence reaction speed when driving vehicles or other mechanisms
None noted. If the patient experiences any vestibular disorders while taking the drug, they should refrain from driving or operating other mechanisms.
Method of administration and doses
Adults and children over 12 years of age should take 1 capsule 3 times a day. The capsules should be swallowed whole, without chewing, with sufficient liquid. The course of treatment is determined by the doctor individually, depending on the nature and course of the disease.
Children: There is insufficient data on the use of this drug in children, so it should not be used in children under 12 years of age.
Overdose
No signs and symptoms of intoxication were observed. The adverse reactions described below may be aggravated.
No specific antidote is known. Symptomatic measures are recommended.
Side effects
Criteria for assessing the frequency of adverse drug reactions:
| Very often: | ≥ 1/10 |
| Often: | ≥ 1/100 – < 1/10 |
| Infrequently: | ≥ 1/1000 – < 1/100 |
| Rarely: | ≥ 1/10000 – < 1/1000 |
| Very rare: | < 1/10000 |
| Unknown: | the frequency of cases cannot be estimated |
The drug is well tolerated. Rarely, in isolated cases and with individual hypersensitivity, the following side effects may be observed:
from the digestive tract: nausea, vomiting, dyspepsia, heartburn, mild diarrhea;
Respiratory system: shortness of breath;
From the urinary system: increased diuresis;
Skin and skin appendages: increased alopecia, in rare cases hypersensitivity reactions are possible, including skin rashes, itching;
Others: very rarely, an exacerbation of existing vestibular disorders can be observed.
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 exceeding 30 °C out of the reach of children.
Packaging
10 capsules in a blister; 2 or 3 or 6 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
MADAUS GmbH/MADAUS GmbH.
Address
Benzstrasse 1, 61352 Bad Homburg, Germany.
Applicant
MEDA Pharma GmbH & Co. KG/MEDA Pharma GmbH & Co. KG.
