Legalon^® 70 (Capsules) Instructions for Use

Marketing Authorization Holder

Meda Pharma, GmbH & Co. KG (Germany)

Manufactured By

Madaus GmbH (Germany)

ATC Code

A05BA03 (Silymarin)

Active Substance

Cardui mariae fructus (DAB German Pharmacopoeia)

Dosage Form

Legalon® 70

Capsules 70 mg: 20, 30, or 60 pcs.

Dosage Form, Packaging, and Composition

Capsules are hard gelatin, size “2”, with a brown body and cap; the appearance of the capsule contents is a yellow powder.

Excipients: polysorbate 80, povidone K25, mannitol, sodium carboxymethyl starch (type A), magnesium stearate.

Capsule shell composition: gelatin, iron oxide red dye (E172), titanium dioxide (E171), sodium lauryl sulfate, iron oxide black dye (E172).

10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.

Clinical-Pharmacological Group

Hepatoprotective agent

Pharmacotherapeutic Group

Hepatoprotective agent

Pharmacological Action

Herbal remedy. The main effect is hepatoprotective. Flavolignans, including silybin, dehydrosilybin, isosilybin, silymarin, dehydrosilymarin, silychristin, and taxifolin (2.8-3.8%), stabilize lysosomal and cell membranes, preventing the release of enzymes from cells.

They interact with free radicals and inhibit lipid peroxidation processes. Due to their antioxidant action, they hinder the penetration of various toxins (including chlorinated hydrocarbons, alpha-amanitin from the death cap mushroom, nitrosamines) into liver cells.

Silybin, silymarin, and their derivatives stimulate specific RNA polymerase A, resulting in the activation of protein and phospholipid synthesis in hepatocytes, and the acceleration of regeneration and detoxification processes in the liver.

The normalization of metabolic processes is facilitated by the tocopherols, macro- (potassium, magnesium) and microelements (copper, selenium) contained in the fruit.

The fatty oil of the fruit (20-34%) contains a large amount of unsaturated fatty acids (including linoleic acid – 50-62%), which have redox properties, promote cholesterol oxidation, and together with beta-sitosterol, prevent atherosclerosis.

Mucilage polysaccharides (5%) have an enveloping and gastroprotective effect. The nitrogen-containing compound betaine improves the process of digestion and bile formation in the liver. Silybum marianum fruit has a lactogenic effect.

Indications

Conditions after viral and toxic hepatitis, liver injuries, abdominal surgeries; chronic hepatitis, hepatocholecystitis, biliary dyskinesia, pancreatitis, liver cirrhosis; toxic liver damage (including that caused by the use of aminoglycosides, tetracycline, immunosuppressants, NSAIDs, anti-tuberculosis drugs, barbiturates, tranquilizers; organic solvents; mushroom poisoning, heavy metal salts, halogenated hydrocarbons; in alcohol intoxication); hyperlipidemia, prevention of atherosclerosis.

ICD codes

Dosage Regimen

Take orally with a sufficient amount of water.

For adults and adolescents over 12 years, the standard dose is one 70 mg capsule taken three times daily.

Administer the capsules at regular intervals, preferably during or immediately after meals to improve tolerability.

For the treatment of severe liver conditions, such as toxic liver damage or cirrhosis, the dosage may be increased based on medical supervision.

In cases of acute intoxication, including mushroom poisoning, initiate treatment as soon as possible under direct medical guidance.

The standard course of treatment typically lasts for a minimum of several weeks; continue therapy until liver parameters normalize.

For long-term management of chronic conditions, the duration of use is determined by the treating physician.

Do not exceed the recommended daily dose of 210 mg (three capsules) unless specifically instructed by a doctor.

If a dose is missed, take it as soon as remembered; if it is near the time for the next dose, skip the missed dose and resume the regular schedule.

Adverse Reactions

Rarely laxative effect.

Contraindications

Hypersensitivity to Silybum marianum.

Special Precautions

There is a report of antagonistic interaction of silymarin with yohimbine and phentolamine.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.