Silybum marianum fruits

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT MARIANE THISTLE FRUITS (SILYBI MARIANI FRUCTUS)

Composition:

Active substance: crushed milk thistle fruits;

One pack contains 50 g, 100 g, or 200 g of crushed milk thistle fruits.

Dosage form. Fruits.

Main physico-chemical properties: fragments of fruits of various shapes passing through a sieve with 3 mm apertures; light to dark brown or black in color. Specific, weak odor inherent to raw material, without foreign odors, free from moldy smell. Taste slightly bitter, specific, without foreign aftertastes.

Pharmacotherapeutic group. Agents used in liver and biliary tract disorders. ATC Code A05B A.

Pharmacological properties.

Pharmacodynamics. Biologically active substances contained in the fruits of Silybum marianum (flavonoid silymarin and its main isomer silibin) determine the hepatoprotective, choleretic, cholagogue, and membrane-stabilizing effects of the medicinal product, namely: they normalize metabolic processes in the liver, increase the resistance of hepatocytes to the effects of adverse environmental factors, promote faster restoration of liver parenchyma and its physiological functions, and also enhance bile formation and excretion, as well as secretory and motor functions of the gastrointestinal tract.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

As part of complex therapy for chronic hepatitis, chronic cholecystitis, hepatic steatosis, and toxic liver damage.

Contraindications.

Hypersensitivity to the drug.

Special precautions.

The drug should be used according to physician's recommendations and in recommended doses. Do not use for the treatment of acute conditions.

Interaction with other medicinal products and other forms of interactions.

Interaction with other drugs is unknown.

Instructions for use.

Use during pregnancy or breastfeeding.

The drug is recommended for use during pregnancy or breastfeeding only if clearly needed and under medical supervision.

Effect on the ability to drive or operate machinery. No effect.

Method of administration and dosage.

Pour 1 cup of boiling water over 1 teaspoon of fruits, let stand for 10–20 minutes, then strain. Take warm, in small sips, 1 cup 3 times daily: in the morning on an empty stomach, at noon 30 minutes before meals, and in the evening before bedtime.

The duration of treatment is determined by a physician depending on the nature and course of the disease.

Children. The efficacy and safety of using this medicinal product in children have not been established; therefore, milk thistle fruits are not recommended for this age group of patients.

Overdose. Not observed.

Side effects.

The drug is usually well tolerated by patients, but diarrhea, increased diuresis, and allergic reactions are possible.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 50 g, 100 g, or 200 g per package with an inner pouch.

Availability category. Over-the-counter.

Manufacturer. JSC "FITOPHARM".

Manufacturer's address and place of business.

7, Sibirtseva St., Bakhmut, Donetsk region, 84500, Ukraine.

Marketing authorization holder. JSC "FITOPHARM".

Address of the marketing authorization holder.

18, 3rd floor, 7, Verkhovnoyi Rady Ave., Kyiv, 02100, Ukraine.