Ropren^® (Drops) Instructions for Use

Marketing Authorization Holder

Solagift, LLC (Russia)

Manufactured By

Pharmaceutical Factory Of St. Petersburg, PJSC (Russia)

Contact Information

SOLAGRAN SAN LLC (Russia)

ATC Code

A05BA (Drugs for the treatment of liver diseases)

Dosage Form

Ropren®

Oral drops: 4 g or 8 g bottle with dropper caps

Dosage Form, Packaging, and Composition

Oral drops transparent, oily, from yellow to yellowish-orange in color.

Excipients : refined deodorized sunflower oil (up to 100 g).

4 g – dark glass bottles (1) complete with a dropper cap – cardboard packs.
8 g – dark glass bottles (1) complete with a dropper cap – cardboard packs.

Clinical-Pharmacological Group

Hepatoprotective agent of plant origin

Pharmacotherapeutic Group

Hepatoprotective agent of plant origin

Pharmacological Action

The drug is of plant origin. It has a hepatoprotective and hypolipidemic effect. It normalizes the processes of oxidative phosphorylation at the level of cellular metabolism. It promotes the restoration of hepatocyte membranes through the competitive inhibition of peroxide processes.

In the liver, it is converted into dolichol, which is involved in the glycosylation of membrane proteins and the formation of glycoproteins. It normalizes the detoxification function of the liver.

Pharmacokinetics

Data not provided.

Indications

• Fatty liver dystrophy of various etiologies;
• Hepatitis;
• Liver cirrhosis (in complex therapy);
• Toxic liver lesions (alcoholic, narcotic, drug-induced).

ICD codes

Dosage Regimen

Administer the drug orally during meals.

Use the standard dosage of 3 drops three times daily.

Adhere to a treatment course of 3 months.

For severe liver conditions, such as active cirrhosis or significant toxic damage, the dosage may be increased to 5 drops three times daily based on physician assessment.

Initiate therapy only after a confirmed diagnosis.

Use the supplied dropper cap for accurate measurement.

Count drops directly into a spoon or mix with a small amount of cold or warm water.

Do not use hot liquids.

Shake the bottle gently before each use if contents have separated.

Do not interrupt the prescribed course without consulting your physician.

The therapeutic effect is cumulative and develops with continuous use.

Store the bottle upright at the prescribed temperature to maintain stability.

Adverse Reactions

Possible allergic reactions.

Contraindications

• Pregnancy (studies have not been conducted);
• Lactation period (studies have not been conducted);
• Childhood (studies have not been conducted);
• Hypersensitivity to the drug components.

Use in Pregnancy and Lactation

Due to the fact that safety studies on the use of the drug during pregnancy and lactation have not been conducted, Ropren^® should not be prescribed to pregnant and breastfeeding women.

Pediatric Use

Contraindicated in childhood.

Overdose

With a significant overdose (4 ml per dose), a mild laxative effect was noted.

Drug Interactions

Drug interaction of Ropren^® has not been identified.

Storage Conditions

The drug should be stored in a dry place, protected from light, out of the reach of children, at a temperature not exceeding 10°C (50°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is dispensed by prescription.

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.