Vinboron

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VINBORON® (vINBORON®)

Composition:

Active substance: vinboron;

One tablet contains 20 mg or 40 mg of vinboron (as vinboron hydrochloride, calculated as 100% and dry substance);

Excipients: microcrystalline cellulose, crospovidone, colloidal anhydrous silicon dioxide, magnesium stearate;

Film-coating: polyethylene glycol, sodium saccharin, talc, hypromellose, titanium dioxide (E 171).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: film-coated tablets of white or white with a yellowish tint. A cross-section reveals a core surrounded by a coating layer.

Pharmacotherapeutic group.

Agents used in functional disorders of the gastrointestinal tract.

ATC code A03AX.

Pharmacological properties.

Pharmacodynamics.

Vinboron® is a synthetic agent with local anesthetic and pronounced spasmolytic effects. It reduces tone and motility of smooth muscles, eliminating or preventing spasms of smooth muscles of internal organs, including those of the gastrointestinal tract.

Vinboron® dilates coronary and cerebral vessels, improving coronary and cerebral blood flow. Under the influence of the drug, tissue uptake of glucose and oxygen by the brain is enhanced. In addition to its spasmolytic effect on cerebral and cardiac vessels, with prolonged use Vinboron® exerts an anti-atherosclerotic effect due to reduction in free cholesterol and β-lipoproteins in blood serum. The drug improves microcirculation and increases volumetric velocity of coronary blood flow, creating an oxygen reserve in the myocardium. An important feature of Vinboron® is its antiplatelet (antithrombotic) activity and improvement of blood rheological parameters under conditions of hypercoagulability. Vinboron® also exhibits a mild thrombolytic effect. The antiarrhythmic action of Vinboron® is combined with the ability to increase myocardial resistance to development of arrhythmias and fibrillations. In patients with initial hypertension, Vinboron® may normalize arterial pressure. The drug has a mild bronchodilatory effect and immunostimulatory activity, which becomes more pronounced with long-term use.

Pharmacokinetics.

Vinboron® is rapidly absorbed in the gastrointestinal tract, distributed throughout all organs and tissues, and accumulates predominantly in bronchi and abdominal organs. The drug is metabolized in the liver via the cytochrome P450 system; metabolites are excreted both with bile and urine. Maximum plasma concentration (Cmax) is reached within 40 minutes after oral administration. The elimination half-life (T1/2) is 157 minutes. Pharmacotherapeutic effect begins to develop within 30–40 minutes and lasts 4–6 hours. The drug readily penetrates histohematologic and blood-brain barriers.

Clinical characteristics.

Indications.

As a spasmolytic agent in the treatment of gastrointestinal disorders:

• dysfunction of the gallbladder and the sphincter of Oddi:
  • hyperkinetic (hypermotor) gallbladder dyskinesia;
  • hypertonic dystonia of the sphincter of Oddi.
• Irritable bowel syndrome with constipation.

As part of complex therapy for cerebral circulation disorders.

Contraindications.

• Hypersensitivity to the active substance or to other components of the drug;
• severe renal or hepatic impairment;
• chronic nephritis with edema and impaired renal nitrogen excretion;
• uncontrolled arterial hypotension;
• diabetes mellitus;
• bleeding gastric or duodenal ulcers;
• hypokinetic dyskinesia of the biliary tract;
• conditions associated with impaired venous blood outflow from cerebral vessels.

Interaction with other medicinal products and other forms of interaction.

When used concomitantly, the drug may enhance the effects of spasmolytics, antianginal, antihypertensive, and antiplatelet agents.

Special precautions for use.

Treatment with Vinboron® should be initiated under blood pressure monitoring. If a significant decrease in arterial pressure occurs, administration of the drug must be discontinued.

The drug should be prescribed with caution in acute myocardial infarction and in patients with pronounced atherosclerosis of coronary and cerebral vessels.

This medicinal product contains less than 1 mmol (23 mg)/dose of sodium, i.e. it is practically sodium-free.

Use during pregnancy or breastfeeding.

The use of this medicinal product during pregnancy is contraindicated.

If treatment with Vinboron® is necessary, breastfeeding should be discontinued.

Ability to affect reaction speed when driving or operating machinery.

During treatment with Vinboron®, driving and operating vehicles or other potentially hazardous machinery is contraindicated.

Dosage and Administration.

The drug should be administered to adults in a dose of 20–40 mg 3–4 times daily, regardless of food intake. The maximum daily dose is 160 mg. The treatment course usually lasts 4–6 weeks.

Children.

The drug is not recommended for use in pediatric practice.

Overdose.

There have been no reported cases of Vinboron® overdose to date. However, in cases of increased individual sensitivity, skin rashes and decreased arterial pressure (AP) are possible. Treatment: symptomatic. In the event of arterial hypotension, discontinue the drug and administer sympathomimetics.

Side effects

• Nervous system: headache, dizziness, general weakness.
• Cardiovascular system: arterial hypotension.
• Gastrointestinal tract: decreased appetite.
• Allergic reactions, including skin rash.

If any of the above side effects occur, the dose should be reduced or the drug temporarily discontinued.

Reporting suspected side effects

Reporting of suspected adverse reactions after registration of the medicinal product is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all cases of suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions.

In the original packaging at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging.

10 tablets per blister, 1 or 4 blisters per carton.

Prescription status.

Prescription only.

Manufacturer.

Public Joint-Stock Company "Scientific and Production Center "Borshchagovskiy Chemical and Pharmaceutical Plant".

Manufacturer's address and location of operations.

17 Myru Street, Kyiv, 03134, Ukraine.