Biloddi

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BILDDI (BILODDI)

Composition:

active substance: cimetron;

1 tablet contains 200 mg of cimetron;

excipients: potato starch, gelatin, sodium lauryl sulfate, magnesium stearate.

Pharmaceutical form. Tablets.

Main physico-chemical characteristics: white or white with yellowish tint tablets, round, flat on both sides, with "Ch" engraved on one side.

Pharmacotherapeutic group. Agents for the treatment of liver and biliary tract disorders. Other agents for the treatment of biliary tract disorders. Cimetron. ATC code A05AX02.

Pharmacological properties.

Pharmacodynamics.

Hymecromone is a derivative of coumarin. Hymecromone has a spasmolytic effect on the smooth musculature 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 associated disorders, and also prevents cholesterol deposition and gallstone formation in the gallbladder.

Pharmacokinetics.

After oral administration, hymecromone is well absorbed from the gastrointestinal tract. Maximum plasma concentration of hymecromone is reached within 2–3 hours. The elimination half-life is approximately 1 hour. Hymecromone binds to plasma proteins. The mean 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%.

Data on the penetration of hymecromone into breast milk and its placental transfer are lacking.

Clinical characteristics.

Indications.

Biloddі should be used as an adjunctive therapy in the symptomatic treatment of spasms and biliary duct dyskinesia, dyspeptic disorders.

Conditions following surgery on the gallbladder and biliary tract.

Decreased appetite, nausea, constipation (against a background of hyposecretion of bile).

Contraindications.

• Hypersensitivity to gimécromone or to any other component of the medicinal product;
• biliary tract obstruction;
• acute hepatic and/or renal failure;
• ulcerative colitis and Crohn's disease.

Interaction with other medicinal products and other forms of interactions.

Morphine reduces the effect of gimécromone. When gimécromone and metoclopramide are used concomitantly, the efficacy of both medicinal products is reduced.

Special precautions for use.

The medicinal product should be discontinued if any symptoms of hepatic and/or renal insufficiency occur.

Biloddi contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is practically sodium-free.

Use during pregnancy or breastfeeding.

Pregnancy

There are no data on the safety of using gimectron during pregnancy; therefore, Biloddi should not be used during pregnancy.

Breastfeeding period

It is unknown whether gimectron passes into breast milk, therefore a risk to breastfed infants cannot be excluded. The necessity of discontinuing breastfeeding should be considered, weighing the benefits of breastfeeding for the child against the therapeutic benefits for the mother.

Ability to influence reaction rate when driving vehicles or operating machinery.

There are no data on the effect of gimectron on the ability to drive vehicles or operate machinery.

Dosage and Administration

Dosage

Adults: 200 to 400 mg (1–2 tablets) taken half an hour before meals, three times daily for two weeks.

The tablet should not be divided.

Administration method

Oral.

Children

Due to lack of experience with the use of the medicinal product Biloddі in children, it should not be administered to patients under 18 years of age.

Overdose

Data regarding gimecrinone overdose are not available.

Adverse reactions

Bilodd is generally 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 not known (cannot be estimated from the available data).

Gastrointestinal disorders

Rare: diarrhoea, feeling of fullness or pressure in the stomach or abdominal cavity.

Immune system disorders

Rare: hypersensitivity reactions.

Skin and subcutaneous tissue disorders

Rare: rash or other skin allergic reactions.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after the medicinal product is authorized is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, should report any suspected adverse reactions and lack of efficacy to the State Expert Centre of the Ministry of Health of Ukraine via the following link: https://aisf.dec.gov.ua/.

Shelf life

3 years.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging

10 tablets per blister, 5 blisters per carton.

Availability

Over-the-counter (without prescription).

Manufacturer

Adamed Pharma S.A.

Manufacturer's address and place of business

ul. Marszalka Jozefa Pilsudskiego 5, 95-200 Pabianice, Poland / ul. Marszalka Jozefa Pilsudskiego 5, 95-200 Pabianice, Poland.