Holicron (Tablets) Instructions for Use

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Contact Information

OZON LLC (Russia)

ATC Code

A05AX02 (Hymecromone)

Active Substance

Hymecromone (Rec.INN registered by WHO)

Dosage Form

Holicron

Tablets 200 mg: 10, 14, 20, 21, 28, 30, 35, 40, 42, 49, 50, 56, 60, 63, 70, 80, 84, 90, 100, 112, 120, 140, 150, 168, 180, 196, 210, 224, 240, 252, 270, 280, or 300 pcs.

Dosage Form, Packaging, and Composition

Tablets round, biconvex, from white to white with a yellowish tint.

Excipients: corn starch – 45 mg, gelatin – 3 mg, sodium lauryl sulfate – 1 mg, magnesium stearate – 1 mg.

7 pcs. – blister packs (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
10 pcs. – blister packs (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
28 pcs. – blister packs (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.
30 pcs. – blister packs (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) – cardboard packs.

Clinical-Pharmacological Group

Drug with choleretic and spasmolytic action

Pharmacotherapeutic Group

Drugs for the treatment of liver and biliary tract diseases; drugs for the treatment of gallbladder diseases; other drugs for the treatment of biliary tract diseases

Pharmacological Action

Choleretic drug. Hymecromone is a coumarin derivative.

It increases bile formation and accelerates its excretion through the biliary tract. It has a selective spasmolytic effect on the bile ducts and the sphincter of Oddi (does not reduce gastrointestinal motility and blood pressure).

It reduces bile stasis in the gallbladder, prevents cholesterol crystallization and thus the formation of gallstones.

Pharmacokinetics

Absorption and Distribution

When taken orally, it is easily absorbed from the digestive tract and weakly binds to plasma proteins. C_max in blood serum is reached in 2-3 hours.

Metabolism and Excretion

T_1/2 is about 1 hour. Hymecromone is excreted by the kidneys (about 93% as glucuronate, 1.4% as sulfonate, 0.3% unchanged). There are no data on the excretion of hymecromone in breast milk and on its passage through the placenta.

Indications

• biliary dyskinesia and sphincter of Oddi dyskinesia of the hyperkinetic type;
• non-calculous chronic cholecystitis, cholangitis, cholelithiasis;
• condition after surgical interventions on the gallbladder and biliary tract;
• decreased appetite, nausea, constipation, vomiting (against the background of bile hyposecretion).

ICD codes

Dosage Regimen

It is prescribed orally, 30 minutes before meals.

Adults – 200-400 mg (1-2 tablets) 3 times/day. The daily dose is 1200 mg.

Children from 7 years old – 200 mg (1 tablet) 1-3 times/day. The daily dose is 600 mg.

The course of treatment is 2-3 weeks.

In case of a missed dose, the drug should be taken as soon as possible, or if it is almost time for the next dose, the missed dose should not be taken. A double dose should not be taken at once.

If improvement does not occur after treatment, or symptoms worsen, or new symptoms appear, it is necessary to consult a doctor. The drug should be used only according to the indications, method of application, and doses specified in the instructions.

Adverse Reactions

Possible allergic reactions, headache.

From the digestive system diarrhea, flatulence, abdominal pain, ulceration of the gastrointestinal mucosa are possible.

If side effects mentioned in the instructions are noted or they worsen, or any other side effects not mentioned in the instructions are noticed, a doctor should be informed.

Contraindications

• obstruction of the biliary tract;
• renal failure;
• hepatic failure;
• ulcerative colitis, Crohn’s disease;
• gastric and duodenal ulcer;
• hemophilia;
• children under 7 years of age;
• hypersensitivity to the active substance or any other component of the drug;

Use in Pregnancy and Lactation

There are no data on the safety of hymecromone use during pregnancy and the period of breastfeeding.

Prescription of hymecromone to pregnant women and during breastfeeding is permissible only in cases where the potential benefit to the mother outweighs the potential risk to the fetus or child.

Use in Hepatic Impairment

Contraindicated in hepatic failure.

Use in Renal Impairment

Contraindicated in renal failure.

Pediatric Use

Contraindicated in children under 7 years of age.

Special Precautions

Does not impair the secretory function of the digestive glands and processes of intestinal absorption.

In case of symptoms of hepatic and/or renal failure, it is necessary to stop taking the drug and consult a doctor.

Effect on the ability to drive vehicles, mechanisms

The drug does not affect the ability to perform potentially hazardous activities that require increased concentration and speed of psychomotor reactions (including driving vehicles, working with moving mechanisms).

Overdose

To date, no cases of overdose have been reported.

Drug Interactions

Morphine weakens the effect of hymecromone.

When taken concomitantly with metoclopramide, the effects of both drugs are weakened.

It enhances the effects of indirect anticoagulants.

If the patient is taking the above or other drugs (including over-the-counter), a doctor should be consulted before using the drug.

Storage Conditions

The drug should be stored at a temperature not exceeding 25°C (77°F) in the original packaging (carton). 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 without a 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.