Sibectan^® (Tablets) Instructions for Use

Marketing Authorization Holder

Pharmtsentr Vilar JSC (Russia)

Contact Information

PHARMCENTR VILAR JSC (Russia)

ATC Code

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

Dosage Form

Sibectan®

Tablets: 10, 20, 30, or 40 pcs.

Dosage Form, Packaging, and Composition

Tablets are round, biconvex, ranging from grayish-green to dark gray or grayish-brown in color with inclusions.

Excipients: lactose (milk sugar), potato starch grade “extra”, colloidal silicon dioxide (aerosil A-380), calcium stearate, croscarmellose sodium.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
15 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.

* – containing a sum of flavonoids and phenolic acids calculated as luteolin and absolutely dry substance 55%
** – containing a sum of flavolignans calculated as silybin and absolutely dry substance 65%
*** – containing a sum of flavonoids calculated as rutin and absolutely dry substance 8%
**** – containing phenolic compounds calculated as rutin and absolutely dry substance 5%

Clinical-Pharmacological Group

Herbal preparation with hepatoprotective and choleretic action

Pharmacotherapeutic Group

Means for the treatment of diseases of the liver and biliary tract; agents for the treatment of liver diseases, lipotropic agents

Pharmacological Action

Herbal hepatoprotector. It has hepatoprotective, membrane-stabilizing, antioxidant, and choleretic effects.

Indications

As a hepatoprotective agent for

• Chronic persistent hepatitis;
• Chronic cholecystitis;
• Hypomotor dyskinesia of the gallbladder.

As part of complex therapy for

• Liver cirrhosis;
• Fatty liver dystrophy of alcoholic origin.

ICD codes

Dosage Regimen

Administer the drug to adults orally.

Take 2 tablets 4 times daily.

Adhere to a total daily dosage of 8 tablets.

Take each dose 20-40 minutes before meals.

Follow the standard treatment course of 20-25 days.

If clinically required, extend the therapy for an additional 10-15 days.

Do not exceed the recommended dosage or duration of treatment without medical supervision.

Swallow the tablets whole with a sufficient amount of water.

Adverse Reactions

Possible: allergic reactions.

Contraindications

• Cholelithiasis;
• Pregnancy;
• Lactation period;
• Children under 18 years of age;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Can be used according to indications.

Pediatric Use

The drug is not recommended for children under 12 years of age.

Overdose

To date, no cases of overdose of the drug Sibectan^® have been identified.

Drug Interactions

Drug interaction of Sibectan^® has not been described.

Storage Conditions

The drug should be stored in a dry, light-protected place, out of the reach of children, 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.