Hofficin^® Evalar (Tablets) Instructions for Use

Marketing Authorization Holder

Evalar, CJSC (Russia)

Contact Information

EVALAR CJSC (Russia)

ATC Code

A05AX (Other drugs for the treatment of biliary tract diseases)

Active Substance

Cynara (BAN adopted for use in the United Kingdom)

Dosage Form

Hofficin® Evalar

Film-coated tablets, 200 mg: 40, 60, or 180 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from reddish-brown to brown in color, round, biconvex; on the cross-section, the core is from grayish-brown to brown with lighter and darker inclusions.

* The dry extract of Cynara scolymus leaves is obtained from fresh Cynara scolymus L. leaves, family Asteraceae; the ratio of the starting plant material to the obtained extract is (15-35:1), extractant purified water.

Excipients: microcrystalline cellulose, povidone K17, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate.

Shell composition: hypromellose (hydroxypropyl methylcellulose), polyethylene glycol 4000, iron oxide red, titanium dioxide, iron oxide black.

20 pcs. – blister packs (2) – cardboard cartons.
20 pcs. – blister packs (3) – cardboard cartons.
20 pcs. – blister packs (9) – cardboard cartons.

Clinical-Pharmacological Group

Herbal preparation with choleretic and diuretic effect

Pharmacotherapeutic Group

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

Pharmacological Action

The pharmacological effect of the drug is due to the complex of biologically active substances contained in the leaves of Cynara scolymus.

Cynarin in combination with phenolic acids has a choleretic, as well as a hepatoprotective effect. Ascorbic acid, carotene, vitamins B₁ and B₂, and inulin contribute to the normalization of metabolic processes.

The drug also has a diuretic effect and enhances the excretion of urea.

Pharmacokinetics

Not applicable.

Indications

For adults and children from 6 years of age in complex therapy:

• Biliary dyskinesia of the hypokinetic type;
• Chronic non-calculous cholecystitis;
• Chronic hepatitis;
• Liver cirrhosis;
• Chronic nephritis;
• Chronic renal failure.

ICD codes

Dosage Regimen

Orally, before meals.

Adults 2-3 tablets 3 times/day.

Children over 6 years are recommended to take 1-2 tablets (depending on age) 3 times/day.

The drug is contraindicated for use in children under 6 years of age (see section “Contraindications”).

The course of treatment is 2-3 weeks.

Repeated courses of treatment are possible in consultation with a doctor.

Adverse Reactions

Allergic reactions are possible.

With prolonged use of the drug in high doses, diarrhea may develop.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients included in the drug;
• Cholelithiasis;
• Obstruction (occlusion) of the biliary tract;
• Acute diseases of the liver, kidneys, biliary and urinary tracts;
• Severe hepatocellular insufficiency;
• Children under 6 years of age.

Use in Pregnancy and Lactation

Pregnancy

Use of the drug during pregnancy is possible only as prescribed and under the supervision of a physician.

Breastfeeding period

Use of the drug during breastfeeding is possible only as prescribed and under the supervision of a physician.

Fertility

No data available.

Use in Hepatic Impairment

Contraindicated in cholelithiasis, obstruction (occlusion) of the biliary tract, acute diseases of the liver and biliary tract, severe hepatocellular insufficiency.

Use in Renal Impairment

Contraindicated in acute diseases of the kidneys and urinary tract.

Pediatric Use

Contraindicated for use in children under 6 years of age.

Special Precautions

The patient should be informed that if symptoms of the disease persist or the condition worsens during the use of the drug for 2 weeks, the attending physician should be informed.

In case of severe prolonged diarrhea or abdominal pain, the drug should be discontinued.

Effect on ability to drive vehicles and machinery

The use of the drug does not affect the ability to perform potentially hazardous activities requiring increased concentration and speed of psychomotor reactions (driving vehicles, working with moving mechanisms, work of a dispatcher and operator).

Overdose

To date, no cases of overdose have been reported.

Drug Interactions

Interactions with other medicinal products are currently unknown.

Storage Conditions

The drug should be stored in the original packaging (carton) at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

Over-the-Counter

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.