Silimar^® (Tablets) Instructions for Use

Marketing Authorization Holder

Pharmtsentr Vilar JSC (Russia)

Contact Information

Pharmtsentr Vilar JSC (Russia)

ATC Code

A05BA03 (Silymarin)

Active Substance

Cardui mariae fructus (DAB German Pharmacopoeia)

Dosage Form

Silimar^®

Tablets 100 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Tablets are biconvex or flat-cylindrical in shape, with a bevel, from light brown to brown in color, with inclusions.

	1 tab.
Extract of Silybum marianum fruit	100 mg

Excipients: lactose, potato starch, magnesium stearate.

10 pcs. – non-cell contour packs.
10 pcs. – blister contour packs.
30 pcs. – blister contour packs.
50 pcs. – blister contour packs.
30 pcs. – dark glass jars.
30 pcs. – polystyrene containers.
60 pcs. – polystyrene containers.

Clinical-Pharmacological Group

Hepatoprotective agent

Pharmacotherapeutic Group

Means for the treatment of diseases of the liver and biliary tract; agents for the treatment of liver diseases, lipotropic agents

Pharmacological Action

A hepatoprotective agent of plant origin. It has a hepatoprotective and antitoxic effect.

The therapeutic effect is due to the influence on the metabolism of hepatocytes.

It activates the synthesis of proteins and enzymes in hepatocytes, has a stabilizing effect on the hepatocyte membrane, inhibits the penetration of toxins into liver cells, inhibits dystrophic and potentiates regenerative processes in the liver.

Indications

toxic liver damage;
chronic hepatitis;
liver cirrhosis (as part of complex therapy);
condition after hepatitis;
For prevention in chronic intoxications (including occupational), long-term use of medicines and alcohol.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
B18.1	Chronic viral hepatitis B without delta-agent
B18.2	Chronic viral hepatitis C
K70	Alcoholic liver disease
K71	Toxic liver disease
K73	Chronic hepatitis, not elsewhere classified
K74	Fibrosis and cirrhosis of liver

ICD-11 code	Indication
1E51.0Z	Chronic hepatitis B, unspecified
1E51.1	Chronic viral hepatitis C
4A85.00	Drug hypersensitivity-induced liver disease
DB93	Fibrosis or cirrhosis of liver
DB94.Z	Alcoholic liver disease, unspecified
DB95.Z	Drug-induced or toxic liver disease, unspecified
DB97.2	Chronic hepatitis, not elsewhere classified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer orally to adults.

Take 1 to 2 tablets three times daily.

Ingest each dose 30 minutes before meals.

The standard course of treatment is 25 to 30 days.

For chronic conditions or severe toxic liver damage, repeat the course if necessary.

Initiate a repeat course after an interval of 1 to 3 months, based on clinical assessment.

For long-term preventive use against occupational or medicinal intoxications, follow the same dosage under medical supervision.

Do not administer to children under 12 years of age.

Discontinue use and seek medical advice if allergic reactions or a laxative effect occur.

Adverse Reactions

Possible allergic reactions.

In some cases laxative effect.

Contraindications

Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

It is not recommended to prescribe the drug during pregnancy and lactation (breastfeeding).

Special Precautions

Use in pediatrics

It is not recommended to prescribe the drug to children under 12 years of age.

Overdose

Data on overdose of Silimar^® are not provided.

Drug Interactions

Data on drug interactions of Silimar^® are not provided.

Storage Conditions

The drug should be stored out of the reach of children, in a dry, light-protected place.

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is available without a prescription.

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.

Medical Disclaimer