Essliver Forte^® (Capsules) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Nabros Pharma, Pvt. Ltd. (India)

Packaging and Quality Control Release

NABROS PHARMA, Pvt. Ltd. (India)

Or

NIZHPHARM, JSC (Russia)

Contact Information

NIZHPHARM group of companies (Russia)

ATC Code

A05C (Drugs for the treatment of biliary tract diseases and lipotropic agents in combination)

Dosage Form

Essliver Forte®

Capsules: 30, 50, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, with a red body and a brown cap; the capsule contents are a powder from pinkish-yellow to orange in color, the presence of particles in the form of a compacted powder mass from yellowish-white to brown in color is allowed, with a specific odor.

* in the form of a 50% semi-finished product: α-Tocopherol acetate, gelatin.

Excipients : sodium methylparahydroxybenzoate – 0.4 mg, sodium propylparahydroxybenzoate – 0.2 mg, disodium edetate – 0.1 mg, butylated hydroxytoluene – 1 mg, magnesium aluminosilicate monohydrate (aluminum magnesium silicate hydrate) – 5 mg, talc – up to 400 mg.

Composition of the hard gelatin capsule sodium lauryl sulfate (sodium dodecyl sulfate), titanium dioxide, colorant azorubine (colorant carmoisine), colorant sunset yellow FCF, colorant brilliant blue FCF, colorant quinoline yellow, colorant ponceau 4R, sodium methylparahydroxybenzoate, sodium propylparahydroxybenzoate, water, gelatin.

10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.

Clinical-Pharmacological Group

Hepatoprotective agent

Pharmacotherapeutic Group

Hepatoprotective agent

Pharmacological Action

Hepatoprotector. The action is due to the properties of the components that make up the drug.

Essential phospholipids are complex substances that are diglyceride esters of phosphatidic and unsaturated fatty acids (mainly oleic and linoleic). They are an important structural element of cell membranes and the membranes of hepatocyte organelles. Phospholipids regulate membrane permeability and the activity of membrane-bound enzymes, ensuring normal processes of oxidative phosphorylation.

The drug normalizes the biosynthesis of phospholipids and general lipid metabolism in cases of hepatocyte damage of various etiologies.

It restores hepatocyte membranes through structural regeneration and by competitively inhibiting oxidative processes: by integrating into biomembranes, unsaturated fatty acids are able to take on toxic effects instead of membrane lipids.

It promotes the regeneration of liver cells and stabilizes the physicochemical properties of bile.

Thiamine (vitamin B₁) as a coenzyme is involved in carbohydrate metabolism.

Riboflavin (vitamin B₂) is the most important catalyst for cellular respiration processes.

Pyridoxine (vitamin B₆) as a coenzyme is involved in the metabolism of amino acids and proteins.

Cyanocobalamin (vitamin B₁₂) together with folic acid is involved in the synthesis of nucleotides.

Nicotinamide (vitamin PP) is involved in the processes of tissue respiration, fat and carbohydrate metabolism.

Tocopherol (vitamin E) has antioxidant properties, providing protection for unsaturated fatty acids in membranes from lipid peroxidation.

Pharmacokinetics

Data on the pharmacokinetics of the drug Essliver^® Forte have not been provided.

Indications

• Lipid metabolism disorders of various origins;
• Fatty liver dystrophy of various etiologies;
• Liver cirrhosis;
• Alcoholic and narcotic liver damage;
• Drug-induced liver damage;
• Radiation-induced liver damage;
• Psoriasis (as part of combination therapy).

ICD codes

Dosage Regimen

The drug is prescribed as 2 caps. 2-3 times/day. The duration of treatment is at least 3 months. If necessary, longer use of the drug or repeated courses of treatment are possible after consultation with a doctor.

For psoriasis, the drug is used as an auxiliary therapy agent, 2 caps. 3 times/day for 2 weeks.

The drug should be taken with meals; capsules should be swallowed whole with a sufficient amount of water.

Adverse Reactions

From the digestive system rarely – a feeling of discomfort in the epigastric region.

Other allergic reactions.

The drug is usually well tolerated.

Contraindications

• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Essliver^® Forte should be used with caution during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Use is possible according to indications.

Pediatric Use

Use with caution in children under 12 years of age.

Special Precautions

Use in pediatrics

Use with caution in children under 12 years of age.

Overdose

Data on overdose of the drug Essliver^® Forte have not been provided.

Drug Interactions

Data on the drug interactions of Essliver^® Forte have not been provided.

Storage Conditions

The drug should be stored out of the reach of children, in a dry place at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.