Naturcarsevt (Capsules, Dragee) Instructions for Use

ATC Code

A05BA03 (Silymarin)

Active Substance

Silibinin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Hepatoprotective agent

Pharmacotherapeutic Group

Hepatoprotective agent of plant origin

Pharmacological Action

Hepatoprotective agent of plant origin. Contains a dry extract of milk thistle fruit (Silybum marianum (L.) Gaertn.) – equivalent to silymarin, which is a sum of flavolignans: silibinin (silibin), isosilibinin, silidianin, and silicristin.

It has hepatoprotective and antitoxic action. The therapeutic effect is due to its influence on the metabolism of hepatocytes.

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

Pharmacokinetics

When taken orally, absorption from the gastrointestinal tract is low and slow (half-absorption period – 2.2 hours), it is metabolized in the liver by conjugation, T_1/2 – 6 hours.

It is excreted mainly with bile in the form of glucuronides and sulfates. Does not accumulate in the body.

After repeated oral administration of 140 mg 3 times/day, a stable level of excretion with bile is achieved. Enterohepatic circulation takes place.

Silymarin is excreted from the body mainly with bile and, to a lesser extent, by the kidneys.

Indications

Toxic liver damage, chronic hepatitis, liver cirrhosis (as part of complex therapy), after hepatitis.

As a prophylactic agent for chronic intoxications (including occupational), long-term use of medications and alcohol.

ICD codes

Dosage Regimen

Take orally with a sufficient amount of water.

For adults and adolescents over 12 years, the standard dose is one capsule or dragee (equivalent to 140 mg silymarin) three times daily.

Adhere strictly to the individual dosage and treatment duration prescribed by your physician, based on the clinical situation.

For chronic liver conditions, including hepatitis and cirrhosis, administer as part of long-term therapy.

Conduct repeated treatment courses after intervals of one to three months for chronic diseases.

For prophylactic use against chronic intoxications, follow the prescribed dosage, typically one dragee twice or three times daily.

Do not exceed the maximum daily dose unless directed by a physician.

Swallow the capsule or dragee whole; do not chew or crush.

Adverse Reactions

Rarely laxative effect, allergic reactions.

Contraindications

Hypersensitivity to silibinin; children under 12 years of age; pregnancy, breastfeeding period.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Pediatric Use

Contraindicated for use in children under 12 years of age.

Drug Interactions

With the combined use of silymarin with oral contraceptives and drugs used for hormone replacement therapy (HRT), a reduction in the effects of the latter is possible.

With the combined use, silymarin may enhance the effects of drugs such as diazepam, alprazolam, ketoconazole, lovastatin, vinblastine due to its suppressive effect on the cytochrome P450 isoenzyme system.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.