DOMILIUM ODT

INSTRUCTIONS for medical use of the medicinal product ANGEOLON^®

ANGEOLON^®

Composition:

active substances:

1 tablet contains adenozine-5'-triphosphatoglycinato-magnesium(II) trikalium salt octahydrate (in terms of the substance that does not contain sodium chloride and water) 20 mg with a content of adenine nucleotides 12.6 mg;

excipients: menthol; sugar powder; lactose, monohydrate; magnesium stearate; colloidal silicon dioxide anhydrous.

Pharmaceutical form.

Menthol-flavored tablets.

Main physical and chemical properties:

tablets of 20 mg of white color with a flat surface, facet and notch.

Pharmacotherapeutic group.

Cardiological preparations. ATX code C01E B10.

Pharmacological properties.

Pharmacodynamics.

ANGEOLON^®is a medicinal product of a new class of substances - poly ligand coordination compounds with macroergic phosphates, the molecule of which consists of adenosine-5'-triphosphate (ATP), the amino acid histidine, salts of magnesium and potassium, and has a characteristic pharmacological effect that is not inherent in any individual chemical component (ATP, histidine, K⁺, Mg⁺⁺).

ANGEOLON^®affects metabolic processes in the myocardium, normalizes energy metabolism, the activity of ion transport systems of cell membranes, indicators of lipid composition of membranes, the activity of membrane-bound enzymes, improves the antioxidant protection system of the myocardium, has anti-ischemic, membrane-stabilizing, anti-arrhythmic effect in supraventricular tachycardia.

The medicinal product has an energy-saving effect due to the inhibition of the activity of the enzyme 5'-nucleotidase, which is responsible for the rate of hydrolysis of energy substrates. ANGEOLON^®prevents structural and functional damage to the plasma membranes of cardiomyocytes, ensuring the preservation of the quantitative and qualitative composition of membrane lipids, inhibiting the activity of membrane-bound phospholipases. ANGEOLON^®inhibits the intensity of lipid peroxidation processes (LPO), thereby reducing the accumulation in membranes of products of hydrolysis and peroxidation of phospholipid fatty acids, lysophospholipids, which have pronounced detergent properties and the ability to cause disturbances of contractile and rhythmic activity of the heart during ischemia. In the case of experimental myocardial ischemia, the medicinal product increases the activity of Na⁺-K⁺-ATPase and Ca²⁺, Mg²⁺-ATPase and the calcium-binding potential of the membrane. ANGEOLON^®improves indicators of central and peripheral hemodynamics, coronary blood flow, normalizes myocardial contractility, which increases indicators of physical performance. Under conditions of ischemia, the medicinal product reduces myocardial oxygen consumption, activates the functional state of the heart, increases cardiac output, which contributes to a decrease in the frequency of angina attacks and shortness of breath during physical exertion.

ANGEOLON^®restores normal sinus rhythm in patients with paroxysmal supraventricular tachycardia with atrial fibrillation and flutter, as well as reduces the activity of ectopic rhythm sources (atrial and ventricular extrasystoles).

ANGEOLON^®normalizes the concentration of potassium and magnesium in tissues, reduces the concentration of uric acid.

Pharmacokinetics.

When administered, the medicinal product ANGEOLON^®slowly decomposes with the formation of adenosine.

Clinical characteristics.

Indications.

• To be used in complex therapy:
• ischemic heart disease, stable and unstable angina, exertional angina and angina with registered spasm of vessels;
• previously transferred myocardial infarction, post-infarction myocardial syndrome (diffuse and focal cardiosclerosis), ischemic cardiomyopathy;
• heart rhythm disorders;
• neurocirculatory asthenia, cardiogenic neurosis;
• cardiomyopathies;
• myocarditis;
• fatigue syndrome.

Contraindications.

• Increased sensitivity to the medicinal product and its components;
• acute myocardial infarction;
• cardiogenic and other types of shock;
• obstructive diseases of the bronchopulmonary system;
• severe forms of bronchial asthma;
• sinoatrial block;
• atrioventricular block II-III degree;
• hyperkalemia, hypermagnesemia;
• hemorrhagic stroke.

Interaction with other medicinal products and other types of interactions.

ANGEOLON^®should not be used simultaneously with cardiac glycosides due to the increased risk of atrioventricular block.

When taken simultaneously with potassium-sparing diuretics, potassium preparations, and angiotensin-converting enzyme inhibitors (ACE), the risk of hyperkalemia, with magnesium preparations - hypermagnesemia, increases.

ANGEOLON^®may enhance the antianginal effect of alpha- and beta-adrenoblockers, calcium channel blockers, nitrates.

Dipyridamole enhances the therapeutic effect of ANGEOLON, while xanthinol nicotinate, caffeine, theophylline, aminophylline reduce it.

Features of application.

To be used with caution in case of pronounced arterial hypotension, simultaneously with cardiac glycosides (due to the increased risk of atrioventricular block), with a tendency to bronchospasm.

During prolonged use, it is necessary to monitor the level of potassium and magnesium in the blood.

The medicinal product contains sugar powder and lactose, so patients with diabetes should use it with caution. Patients with hereditary intolerance to glucose-galactose, sucrose-isomaltose should not use the medicinal product. Limit the consumption of products containing caffeine (coffee, tea).

Use during pregnancy or breastfeeding.

Clinical data on the safety and efficacy of the medicinal product during pregnancy are absent, so its use in pregnant women is contraindicated.

Breastfeeding should be stopped during treatment.

Ability to affect the speed of reaction when driving vehicles or working with other mechanisms.

If during treatment, dizziness, decreased blood pressure are observed, one should refrain from driving vehicles and working with other mechanisms.

Method of application and doses.

ANGEOLON^®tablets should be taken sublingually and kept until completely dissolved. Single dose - 10*-40 mg 3-4 times a day, regardless of food intake.

In acute cardiac conditions (angina attack, arrhythmia), ANGEOLON^®tablets should be taken at 10*-80 mg until the condition improves. The maximum daily dose is 160 mg.

The treatment period is determined by the doctor, on average it is 20-30 days. If necessary, the course can be repeated after 10-15 days.

* The medicinal product should be used in the corresponding dosage.

Children.

Not to be used in children.

Overdose.

Symptoms: possible development of bradycardia, atrioventricular block, arterial hypotension, syncopal state, associated with a sudden decrease in blood pressure. Treatment: discontinue the medicinal product and start symptomatic therapy. In case of bradycardia, administer atropine sulfate.

Adverse reactions.

From the skin and subcutaneous tissue: skin rashes, itching, hyperemia of the face, Quincke's edema.

From the respiratory system: bronchospasm.

From the cardiovascular system: decreased blood pressure, tachycardia, atrioventricular block, coronary arteriospasm, which can lead to myocardial infarction.

From the gastrointestinal tract: nausea, feeling of discomfort in the epigastric region, increased motility of the digestive tract.

From the urinary system: increased diuresis.

From the nervous system: headache, dizziness.

From the vessels: feeling of heat.

From the immune system: allergic reactions, including skin rashes, itching, Quincke's edema.

Shelf life.

3 years.

The medicinal product should not be used after the expiration date indicated on the package.

Storage conditions.

Store in the original package at a temperature not exceeding 25 °C.

Store in a place inaccessible to children.

Packaging.

10 tablets in a blister pack; 3 or 4 blister packs in a box.

Release category.

Without a prescription.

Manufacturer.

LLC "Pharmaceutical company "FarCoS".

Location of the manufacturer and its address.

08290, Ukraine, Kyiv region, Irpin city, Gostomel settlement, Svyato-Pokrovskaya street, 360.

Applicant.

LLC Pharmaceutical company "FarCoS).

Location of the applicant.

Ukraine, 03162, Kyiv, Zodchikh street, 50-A.