Instructions for use of Biloddi tablets 200 mg No. 50
Composition
active ingredient: hymecromon;
1 tablet contains 200 mg of hymecromone;
excipients: potato starch, gelatin, sodium lauryl sulfate, magnesium stearate.
Dosage form
Pills.
Main physicochemical properties: tablets of white or white with a yellow tint, round, flat on both sides, engraved with “Ch” on one side.
Pharmacotherapeutic group
Drugs for the treatment of liver and biliary tract diseases. Other drugs for the treatment of biliary tract diseases. Hymecromon. ATX code A05AX02.
Pharmacological properties
Pharmacodynamics
Hymecromon is a coumarin derivative. Hymecromon has an antispasmodic effect on the smooth muscles of the bile ducts and the sphincter of Oddi, increases bile secretion and accelerates its excretion through the bile ducts. This reduces bile stasis and related disorders, and also prevents cholesterol deposition and the formation of gallstones.
Pharmacokinetics
After oral administration, hymecromone is well absorbed from the digestive tract. The maximum concentration of hymecromone in the blood plasma is reached after 2–3 hours. The half-life is approximately 1 hour. Hymecromone binds to blood plasma proteins. The average volume of distribution is 20.8 ± 11.4 l. Hymecromone is excreted in the urine as metabolites: glucuronide - approximately 93% of the administered dose, sulfonate - 1.4% and unchanged hymecromone - 0.3%.
There are no data on the penetration of hymecromone into breast milk and its penetration through the placenta.
Indication
Use Bilodynia as an adjunct therapy in the symptomatic treatment of spasms and dyskinesia of the bile ducts, and dyspeptic disorders.
Conditions after operations on the gallbladder and biliary tract.
Decreased appetite, nausea, constipation (against the background of bile hyposecretion).
Contraindication
Hypersensitivity to hymecromone or to any other component of the drug;
biliary obstruction;
acute hepatic and/or renal failure;
ulcerative colitis and Crohn's disease.
Interaction with other medicinal products and other types of interactions
Morphine weakens the effect of hymecromone. With the simultaneous use of hymecromone and metoclopramide, the effectiveness of both drugs is reduced.
Application features
The drug should be discontinued if any symptoms of hepatic and/or renal failure occur.
Bilody contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially sodium-free.
Use during pregnancy or breastfeeding.
Pregnancy
There is no data on the safety of using hymecromone during pregnancy, so Biloddi should not be used during pregnancy.
Breastfeeding period
It is not known whether hymecromone is excreted in human milk, therefore a risk to breast-fed infants cannot be excluded. A decision should be made whether to discontinue breast-feeding, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.
The ability to influence the reaction speed when driving vehicles or other mechanisms.
There is no data on the effect of hymecromone on the ability to drive vehicles or other mechanisms.
Method of administration and doses
Dosage
Adults: 200 to 400 mg (1–2 tablets) half an hour before meals 3 times a day for two weeks.
It is not recommended to divide the tablet.
Method of application
Oral.
Children.
Due to the lack of experience with the use of the drug Bilodynia in children, it should not be prescribed to patients under the age of 18.
Overdose
There are no data on overdose of hymecromone.
Adverse reactions
Bilodynia is usually well tolerated.
Adverse reactions are classified by frequency as follows: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10000, < 1/1000); very rare (<1/10000); frequency unknown (cannot be estimated from the available data).
Gastrointestinal tract
Rare: diarrhea, feeling of fullness or pressure in the abdominal cavity.
On the part of the immune system
Rare: hypersensitivity reactions.
Skin and subcutaneous tissue disorders
Rare: rash or other skin allergic reactions.
Reporting of suspected adverse reactions
Reporting adverse reactions after registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of a medicinal product to the State Expert Center of the Ministry of Health of Ukraine at the link: https://aisf.dec.gov.ua/.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
10 tablets in a blister, 5 blisters in a pack.
Vacation category
Without a prescription.
Producer
Adamed Pharma S.A. / Adamed Pharma SA
Location of the manufacturer and address of its place of business.
ul. Marszalka Jozefa Pilsudskiego 5, 95-200 Pabianice, Poland.
