Eslidine^® (Capsules) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Nizhpharm JSC (Russia)

Or

Chemopharm, LLC (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

Eslidine®

Capsules: 30 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size 0, with a light brown body and a brown cap; the capsule contents are a yellow-brown or brown homogeneous mass from ointment-like to a denser consistency with a characteristic odor.

Excipients: soybean oil.

Capsule shell composition: titanium dioxide, iron oxide black, iron oxide red, iron oxide yellow, purified water, gelatin.

10 pcs. – blister packs (2, 3, 4, 5, 6, 9, 10) – cardboard packs.
15 pcs. – blister packs (2, 3, 4, 5, 6, 9, 10) – cardboard packs.

Clinical-Pharmacological Group

Hepatoprotective agent

Pharmacotherapeutic Group

Hepatoprotective agent

Pharmacological Action

A combined drug that has a hepatoprotective effect and normalizes all types of metabolism ( lipid, protein, carbohydrate).

Methionine, one of the active components of the drug, is an essential amino acid that is a source of mobile methyl groups. Methionine is necessary for the synthesis of choline. An increase in choline content contributes to an increase in the synthesis of endogenous (internal) phospholipids and a decrease in the deposition of neutral fat in the liver. Methionine is also necessary for the detoxification of xenobiotics. In atherosclerosis, it reduces the concentration of cholesterol and increases the concentration of blood phospholipids.

Essential phospholipids are essential factors for the development and functioning of liver cells. The main fraction of essential phospholipids in the drug is represented by phosphatidylcholine (73%), which is the main component of biological membranes. Entering the body, phosphatidylcholine restores the integrity of the membranes of affected liver cells and activates phospholipid-dependent enzymes located in the membrane, thereby normalizing permeability and enhancing the detoxification and excretory potential of liver cells.

Methionine and essential phospholipids enhance each other’s action, being a source of endogenous and exogenous phospholipids, respectively, improve the functional state of liver cells and have a hepatoprotective effect.

Methionine is also involved in the metabolism of sulfur-containing amino acids, in the synthesis of epinephrine, creatinine and other biologically active compounds, transforms the action of hormones, vitamins (B₁₂, ascorbic, folic acids), enzymes, proteins, and participates in transmethylation, deamination, and decarboxylation reactions.

Eslidine^® restores liver function, increases its detoxification capacity, and also normalizes lipid, carbohydrate and protein metabolism in the body.

Pharmacokinetics

Data on the pharmacokinetics of the drug Eslidine^® are not provided.

Indications

The drug is used in gastroenterology, dermatology, neurology, cardiology.

• Fatty liver dystrophy of various etiologies;
• Acute and chronic hepatitis (except viral);
• Liver cirrhosis;
• Toxic liver damage (alcoholic, narcotic, drug-induced);
• Impaired hepatocyte function (as a complication of other diseases);
• Pre- and postoperative treatment for operations in the hepatobiliary area;
• Psoriasis (as part of complex therapy);
• Cerebral atherosclerosis (as part of complex therapy);
• Coronary artery atherosclerosis (as part of complex therapy);
• Diabetes mellitus (as part of complex therapy);
• Exhaustion, dystrophy.

ICD codes

Dosage Regimen

The drug is taken orally, with meals. Capsules should be swallowed whole with a sufficient amount of water.

For liver diseases, coronary artery and cerebral atherosclerosis, diabetes mellitus, dystrophy and exhaustion, 2 capsules 3 times/day are prescribed. The recommended course of treatment is 3 months, the minimum course is 1 month.

For psoriasis – 2 capsules 3 times/day. The recommended course of treatment is 2 weeks.

For children over 7 years of age with liver diseases, diabetes mellitus, fatty liver dystrophy – 2 capsules 3 times/day for 1-3 months.

For psoriasis in children over 7 years of age – 2 capsules 3 times/day for 2 weeks.

For children from 3 to 7 years of age, 1 capsule 3 times/day is prescribed for 1-3 months.

Adverse Reactions

Possible allergic reactions.

Contraindications

• Severe hepatic insufficiency, hepatic encephalopathy;
• Viral hepatitis;
• Children under 3 years of age;
• Hypersensitivity to the components of the drug.

With caution, the drug should be used during pregnancy, in children aged 3 to 7 years, in renal insufficiency (due to the risk of increasing hyperazotemia).

Use in Pregnancy and Lactation

Studies confirming the safety of Eslidine^® for the fetus and safety for the child during breastfeeding have not been conducted.

Use of the drug during pregnancy and lactation is possible only as prescribed by a doctor in cases where the intended benefit to the mother outweighs the possible risk to the fetus and child.

Use in Hepatic Impairment

Contraindicated in severe hepatic insufficiency, hepatic encephalopathy, viral hepatitis.

Use in Renal Impairment

With caution, the drug should be used in renal insufficiency (due to the risk of increasing hyperazotemia).

Pediatric Use

Contraindication: children under 3 years of age. With caution, the drug should be used in children aged 3 to 7 years.

Overdose

With accidental exceeding of the daily dose several times, a decrease in blood pressure, increased heart rate, and disorientation are possible.

Treatment: symptomatic therapy is carried out.

Drug Interactions

Drug interactions of the drug Eslidine^® have not been described.

Storage Conditions

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

Shelf Life

The shelf life is 2 years. Do not use the drug after the expiration date printed on the package.

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.