VG-5 (Tablets) Instructions for Use

Marketing Authorization Holder

Danapha Pharmaceutical, Joint Stock Company (Vietnam)

ATC Code

A05BA (Drugs for the treatment of liver diseases)

Dosage Form

VG-5

Film-coated tablets: 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets of red-brown color, oval in shape, biconvex; the core is gray-brown in color with lighter inclusions.

Excipients: lactose – 130 mg, colloidal silicon dioxide (aerosil) – 61.6 mg, polyvinylpyrrolidone (povidone) – 6 mg, starch – 110 mg, sodium carboxymethyl starch – 10 mg, magnesium stearate – 6 mg.

Shell composition: hypromellose – 9.33 mg, talc – 9.33 mg, titanium dioxide – 5 mg, macrogol 6000 – 2.8 mg, brown dye (E155) – 0.63 mg.

* – extractant – 90% ethanol

10 pcs. – blisters (3) – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with hepatoprotective and choleretic action

Pharmacotherapeutic Group

Hepatoprotective agent of plant origin

Pharmacological Action

A combined herbal preparation, the pharmacological activity of which is due to the properties of its constituent components.

It has a pronounced hepatoprotective effect, promotes the restoration of the functional and morphological state of hepatocytes, reduces the increased activity of serum enzymes (ALT, AST, gamma-GTP, alkaline phosphatase), and has an antioxidant effect.

In addition, it has a choleretic effect and helps to normalize the composition of bile.

Pharmacokinetics

No data available.

Indications

• Moderate alcoholic steatohepatitis.

ICD codes

Dosage Regimen

Administer the drug orally.

Take two tablets per dose.

Administer twice daily.

Take the tablets 30 minutes before meals.

The standard course of treatment is 6 weeks.

Continue the full prescribed course even if symptoms improve.

Do not exceed the recommended daily dose of four tablets.

A repeated course of treatment is possible only on the recommendation of a physician.

Consult a doctor if no improvement is observed after the initial treatment period.

For patients with diabetes mellitus, note the carbohydrate content is 0.0217 XE per single dose and 0.043 XE per daily dose.

Adverse Reactions

Allergic reactions are possible.

Contraindications

• Tendency to thrombosis;
• Lactase deficiency;
• Lactose intolerance;
• Glucose-galactose malabsorption;
• Pregnancy;
• Lactation period;
• Age under 18 years;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Pediatric Use

Contraindicated in children under 18 years of age.

Special Precautions

Patients suffering from diabetes mellitus should take into account that the carbohydrate content in a single dose of the drug (2 tablets) is 0.0217 XE, and in the daily dose (4 tablets) is 0.043 XE.

Effect on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

No cases of overdose have been reported to date.

Drug Interactions

The drug can be used with antispasmodics and metoclopramide.

Storage Conditions

Store the drug in a dry place, protected from light, at a temperature between 15°C (59°F) and 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

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.