Odecromone^® (Tablets) Instructions for Use

Marketing Authorization Holder

Pharmfirma Sotex, CJSC (Russia)

Manufactured By

Interpharma, LLC (Russia)

Or

Rapharma, JSC (Russia)

Contact Information

PharmFirma Sotex CJSC (Russia)

ATC Code

A05AX02 (Hymecromone)

Active Substance

Hymecromone (Rec.INN registered by WHO)

Dosage Form

Odecromone®

Tablets 200 mg: 20, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets from almost white to white, round, flat-cylindrical, with a bevel on both sides and a score on one side.

Excipients: corn starch pregelatinized, gelatin, magnesium stearate, sodium lauryl sulfate.

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.

Clinical-Pharmacological Group

Drug with choleretic and spasmolytic action

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

Choleretic drug. Hymecromone is a coumarin derivative.

It increases the formation and secretion of bile and accelerates its excretion through the biliary tract.

It has a selective antispasmodic effect on the bile ducts and the sphincter of Oddi (does not reduce gastrointestinal motility and blood pressure).

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

Pharmacokinetics

Absorption

When taken orally, it is easily absorbed from the digestive tract, weakly binds to plasma proteins.

C_max in blood serum is reached in 2-3 hours.

Distribution

Weakly binds to plasma proteins.

Metabolism

Hymecromone is metabolized mainly in the liver to glucuronide and sulfate metabolites.

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 passage through the placenta.

Indications

For adults, adolescents and children aged 7 years and older

• 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

Orally, 30 minutes before meals.

Adults from 18 years old – 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

The frequency of adverse reactions is given in accordance with the WHO classification: very common (≥1/10), common (≥1/100 but < 1/10), uncommon (≥1/1000 but < 1/100), rare (≥1/10000 but < 1/1000), very rare (<1/10000) and frequency unknown (cannot be estimated from the available data).

Immune system disorders: frequency unknown – allergic reactions.

Nervous system disorders: frequency unknown – headache.

Gastrointestinal disorders: frequency unknown — diarrhea, flatulence, abdominal pain, ulceration of the gastrointestinal mucosa.

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after drug registration to ensure continuous monitoring of the benefit-risk ratio of the drug. Healthcare professionals are recommended to report any suspected adverse drug reactions through the national adverse reaction reporting systems of the member states of the Eurasian Economic Union.

Contraindications

• Hypersensitivity to hymecromone or any of the excipients included in the drug;
• Obstruction of the biliary tract;
• Renal/hepatic failure;
• Ulcerative colitis and Crohn’s disease;
• Gastric and duodenal ulcer;
• Hemophilia;
• Children under 7 years of age.

Use in Pregnancy and Lactation

Pregnancy

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

Prescription of the drug Odecromone^® to pregnant women is permissible only in cases where the potential benefit to the mother outweighs the potential risk to the fetus and child.

Breastfeeding period

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

Prescription of the drug Odecromone^® during breastfeeding is permissible only in cases where the potential benefit to the mother outweighs the potential risk to the fetus and 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.

Influence 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

To date, no cases of overdose have been reported.

Drug Interactions

Morphine weakens the effect of hymecromone.

When taken concomitantly with metoclopramide, the effect of both drugs is weakened.

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 Odecromone^®.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

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.