Silybum marianum fruits

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MARIAN THISTLE FRUITS (SYLIBIMARIANIFRUCTUS)

Composition:

Active substance: crushed fruits of milk thistle (Silybi marianae fructus);

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

Pharmaceutical form. Fruits.

Main physico-chemical properties: fragments of fruits of various shapes passing through a 3 mm sieve, light to dark brown or black in color. The raw material should not have a rancid odor.

Pharmacotherapeutic group. Drugs used in liver and biliary tract disorders. ATC Code A05BA.

Pharmacological properties.

Pharmacodynamics. Biologically active substances contained in the fruits of Silybum marianum (the flavonoid silymarin and its main isomer silibin) determine the hepatoprotective, choleretic, cholagogue, and membrane-stabilizing effects of the drug, namely: they normalize metabolic processes in the liver, increase the resistance of hepatocytes to adverse environmental factors, promote faster recovery 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 the recommended doses. Should not be used for the treatment of acute conditions.

Interaction with other medicinal products and other forms of interaction. Interaction with other drugs is unknown.

Instructions for use.

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

Ability to affect reaction speed when driving or operating machinery. No effect.

Method of administration and dosage.

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

Children.

The efficacy and safety of the medicinal product in children have not been established; therefore, "Silybi fructus" is 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, in a place inaccessible to children.

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

Availability. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's location and address of business activity.

4 Skladska Street, Zaporizhzhia, Ukraine, 69050.

Marketing authorization holder. JSC Pharmaceutical Factory "Viola".

Address of the marketing authorization holder.

75 Amosova Akademika Street, Zaporizhzhia, Ukraine, 69063.