Odeston Forte tablets 400mg, No. 50

• Dyskinesia of the biliary tract and the sphincter of Oddi,

• Acalculous chronic cholecystitis,

• Cholangitis,

• Dysfunction of the bile ducts in patients with uncomplicated cholelithiasis,

• Condition after surgery on the gallbladder and biliary tract.

• Decreased appetite, nausea, constipation, vomiting (against the background of bile hyposecretion).

Inside, 30 minutes before meals; adults - 400 mg 3 times a day. The daily dose is 1200 mg.

The course of treatment is 2 weeks.

Take the whole tablet.

If a dose is missed, the drug should be taken as soon as possible, or if the time for the next dose is approaching, do not take the missed dose. Do not take a double dose at once.

Active ingredient: gimecromone - 400.00 mg;

Excipients: potato starch - 90.00 mg, gelatin - 6.00 mg; sodium lauryl sulfate - 2.00 mg; magnesium stearate - 2.00 mg.

• Hypersensitivity to gimecromone or any excipient of the drug;

• Obstruction of the biliary tract;

• Renal / hepatic impairment

• Peptic ulcer and 12 duodenal ulcer;

• Hemophilia;

• Ulcerative colitis, Crohn's disease;

• Children under 18 years of age (for a given dosage).

Carefully

The drug should be discontinued if symptoms of renal / hepatic impairment appear.

Trade name of the drug:

Odeston Forte

International non-proprietary name:

hymecromone.

Dosage form:

pills.

Composition

Active ingredient: gimecromone - 400.00 mg;

Excipients: potato starch - 90.00 mg, gelatin - 6.00 mg; sodium lauryl sulfate - 2.00 mg; magnesium stearate - 2.00 mg.

Description

Oblong biconvex tablets from white to almost white, without engraving.

Pharmacotherapeutic group

Choleretic agent.

ATX code:

A05AX02.

Pharmacological properties

Pharmacodynamics

Mechanism of action

Gimecromone is a coumarin derivative. Choleretic drug. Increases the formation and secretion of bile. It has a selective antispasmodic effect on the bile ducts and the sphincter of Oddi (does not reduce the peristalsis of the gastrointestinal tract (GIT)) and blood pressure (BP). Reduces stagnation of bile, prevents the crystallization of cholesterol and thus the development of gallstones.

Pharmacokinetics

Suction

When taken orally, it is easily absorbed from the digestive tract. The maximum concentration in the blood serum is reached after 2-3 hours. The half-life is about 1 hour.

Distribution

In blood plasma, it binds to plasma proteins. The volume of distribution is 20.8 ± 11.4 liters. There are no data on the excretion of gimecromone in breast milk.

Metabolism

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

Withdrawal

Gimecromone is excreted by the kidneys (about 93% in the form of glucuronide, 1.4% - in the form of sulfate, 0.3% - unchanged).

Indications for use

• Dyskinesia of the biliary tract and the sphincter of Oddi,

• Acalculous chronic cholecystitis,

• Cholangitis,

• Dysfunction of the bile ducts in patients with uncomplicated cholelithiasis,

• Condition after surgery on the gallbladder and biliary tract.

• Decreased appetite, nausea, constipation, vomiting (against the background of bile hyposecretion).

Contraindications

• Hypersensitivity to gimecromone or any excipient of the drug;

• Obstruction of the biliary tract;

• Renal / hepatic impairment

• Peptic ulcer and 12 duodenal ulcer;

• Hemophilia;

• Ulcerative colitis, Crohn's disease;

• Children under 18 years of age (for a given dosage).

Carefully

The drug should be discontinued if symptoms of renal / hepatic impairment appear.

Use during pregnancy and breastfeeding, fertility.

Pregnancy use

There are insufficient data on the use of hymecromone in pregnant women. There are no data on the effect of gimecromone on the fetus when using the drug during pregnancy. As a precautionary measure, it is recommended to avoid the use of Odeston Forte during pregnancy.

Application during breastfeeding

There are no data on the excretion of gimecromone in breast milk.

However, the risk to newborns and infants cannot be excluded. If necessary, the use of the drug should decide on the termination of breastfeeding.

Fertility

In preclinical studies, no effect on fertility was observed.

Method of administration and dosage

Inside, 30 minutes before meals; adults - 400 mg 3 times a day. The daily dose is 1200 mg.

The course of treatment is 2 weeks.

Take the whole tablet.

If a dose is missed, the drug should be taken as soon as possible, or if the time for the next dose is approaching, do not take the missed dose. Do not take a double dose at once.

Side effect

The drug Odeston Forte is usually well tolerated.

The adverse reactions presented below are listed by body system and in accordance with the frequency of occurrence. The frequency of occurrence is determined as follows: very often (? 1/10), often (? 1/100 and <1/10), infrequently (? 1/1000 and <1/100), rarely (? 1/10 000 and <1/1000), very rare (<1/10000, including isolated cases), unknown (cannot be estimated from the available data).

Frequency of occurrence of adverse reactions

Digestive system disorders
Rare: diarrhea, flatulence, fullness or pressure in the stomach.
Unknown: abdominal pain, ulceration of the gastrointestinal mucosa.

Immune system disorders
Rare: allergic reactions.

Nervous system disorders
Unknown: headache.

Skin and subcutaneous tissue disorders
Rare: skin rash and other allergic skin reactions.

Overdose

There are no data regarding cases of overdose of gimecromone.

Interaction with other medicinal products

Morphine weakens the action of hymecromone. When taken together with metoclopramide, the effect of both drugs is weakened. Enhances the effects of indirect anticoagulants.

special instructions

The drug should not be used if symptoms of renal or hepatic failure develop.

Special precautions for the destruction of unused medicinal product

Medicines should not be disposed of via wastewater or household waste containers.

Ask your pharmacist how to dispose of unused medicine.

These activities will help protect the environment.

Influence on the ability to drive vehicles, mechanisms

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

Release form

Tablets, 400 mg.

10 tablets in a PVC / Al blister. 3 or 5 blisters together with instructions for use in a cardboard box.

Shelf life

2 years.

Do not use after the expiration date printed on the package.

Storage conditions

Store at a temperature not exceeding 25 ? C.

Keep out of the reach of children.

Vacation conditions

Without recipe.