LIV.52®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT LIV.52®

Composition:

Active substances: 1 tablet contains powders: of Capparis spinosa roots – 65 mg; of Cichorium intybus seeds – 65 mg; of Solanum nigrum – 32 mg; of Cassia occidentalis – 16 mg; of Terminalia arjuna bark – 32 mg; of Tamarix gallica – 16 mg; of Achillea millefolium seeds – 16 mg; of iron oxide (Mandur bhasma) – 33 mg; which are processed with aqueous extract from: Eclipta alba, Phyllanthus amarus, Boerhaavia diffusa roots, Tinospora cordifolia stems, Raphanus sativus root vegetables, Emblica officinalis fruits, Plumbago zeylanica rhizomes, Embelia ribes seeds, Terminalia chebula fruits, Fumaria officinalis tubers.

Excipients: magnesium stearate, microcrystalline cellulose, sodium croscarmellose, sodium carboxymethylcellulose, colloidal anhydrous silicon dioxide.

Pharmaceutical form. Tablets.

Main physico-chemical properties: round, biconvex tablets of greenish-gray color with light and dark specks.

Pharmacotherapeutic group.

Agents used in liver and biliary tract disorders.

ATC code A05.

Pharmacological properties.

A combined herbal hepatoprotective agent. Protects liver parenchyma from the effects of toxic agents. The hepatoprotective action of the drug is due to the antioxidant and membrane-stabilizing properties of its components. The drug increases the levels of endogenous tocopherols in hepatocytes and the level of cytochrome P450. Liv.52® stimulates biosynthesis of proteins and phospholipids. Promotes regeneration of hepatocytes, reduces degenerative, fatty, and fibrotic changes, and enhances intracellular metabolism.

The medicinal product regulates blood plasma protein levels and normalizes the albumin/globulin ratio. Ensures normalization of plasma transaminases, cholesterol, and triglyceride levels, thereby reducing manifestations of dyslipidemia. Decreases bilirubin and alkaline phosphatase levels. Enhances the liver's ability to store glycogen.

Improves colloidal properties of bile, prevents formation of gallstones. Enhances contractile function of the gallbladder. Improves digestion and nutrient absorption. Stimulates hematopoiesis.

In alcoholic liver damage, the drug reduces blood and urinary ethanol levels; increases acetaldehyde dehydrogenase activity, thereby promoting reduction of acetaldehyde levels; prevents acetaldehyde binding to cellular proteins and accelerates its elimination.

Clinical characteristics.

Indications.

Complex treatment and prevention of chronic diffuse liver diseases, alcoholic liver damage, and radioactive or chemotherapeutic liver injuries. As a means to enhance body resistance during hepatotoxic damage, and to accelerate recovery during the convalescence period after severe illnesses or surgeries. Cholecystoangiocholelitis and biliary tract dyskinesia.

Contraindications.

Hypersensitivity to the components of the drug or to other plants of the Asteraceae (Compositae) family. Gallstone disease. Acute inflammatory diseases of the stomach and intestines. Increased blood coagulation, tendency to thrombosis.

Interaction with other medicinal products and other forms of interaction.

When used concomitantly with Liv.52® and ibuprofen, the level of the latter in the body decreases due to delayed absorption. Concomitant use with tetracycline or doxycycline reduces the bioavailability of these antibiotics.

Special precautions for use.

There have been reports of the development of epidermal necrolysis in patients with chronic and acute infectious hepatitis who were taking Liv.52®.

In acute infectious hepatitis, the drug should be used with caution and only as prescribed by a physician.

Use during pregnancy or breastfeeding.

Contraindicated.

Ability to affect reaction rate when driving or operating machinery.

Has no effect.

Dosage and Administration.

Liv.52® tablets are taken orally.

For adults and children aged 14 years and older: 2 tablets three times a day.

For children aged 6 to 14 years: 1 tablet three times a day.

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

In alcoholic liver damage, adults are prescribed 2 tablets three times a day for 1 month, followed by 1 tablet three times a day for 6–12 months.

Children.

The efficacy and safety of the drug in children under 6 years of age have not been established; therefore, it is contraindicated in this age group.

Overdose.

Cases of overdose have not been reported. Dizziness or increased intensity of adverse reactions may occur. There is no specific antidote. Treatment is symptomatic.

Adverse reactions.

Skin and subcutaneous tissue disorders: hyperemia, rash, pruritus, skin edema, severe skin reactions, including toxic epidermal necrolysis.

Gastrointestinal disorders: dyspeptic symptoms, nausea, diarrhea.

Hypersensitivity reactions may occur during the use of the medicinal product.

Shelf life . 3 years.

Storage conditions.

Store at a temperature not exceeding 30 °C in the original packaging.

Keep out of reach of children.

Packaging.

100 tablets in a plastic bottle; 1 bottle in a cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer.

Himalaya Wellness Company.

Manufacturer's address.

Makali, Bangalore–562 162, India.