Angelon

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ANGELON® ANGELON

Composition:

Active substances:

1 tablet contains adenosine-5’-triphosphate-histidinate-magnesium(II) tripotassium salt octahydrate (calculated as substance free of sodium chloride and water) 20 mg, containing a total amount of adenine nucleotides 12.6 mg;

Excipients: powdered sugar; lactose monohydrate; magnesium stearate; colloidal anhydrous silicon dioxide.

Medicinal form. Tablets.

Main physicochemical properties: 20 mg tablets, white in color, with a flat surface, beveled edge, and a score line.

Pharmacotherapeutic group.

Cardiological preparations. ATC code C01EB10.

Pharmacological properties.

Pharmacodynamics.

ANGELON**®** is a medicinal product of a new class of substances — multiligand coordination compounds with macroergic phosphates. Its molecule consists of adenosine-5'-triphosphate (ATP), the amino acid histidine, and magnesium and potassium salts. It produces a characteristic pharmacological effect that is not inherent in any individual chemical component (ATP, histidine, K+, Mg++).

ANGELON**®** affects metabolic processes in the myocardium, normalizes energy metabolism, membrane ion-transport system activity, membrane lipid composition parameters, and the activity of membrane-bound enzymes. It improves the myocardial antioxidant defense system, exerts anti-ischemic and membrane-stabilizing effects, and provides an antiarrhythmic effect in supraventricular tachycardia.

The medicinal product has an energy-sparing effect due to inhibition of the enzyme 5'-nucleotidase, which regulates the rate of hydrolysis of energy substrates. ANGELON**®** prevents structural and functional damage to cardiomyocyte plasma membranes by maintaining the quantitative and qualitative composition of membrane lipids through inhibition of membrane-bound phospholipase activity. ANGELON**®** suppresses the intensity of lipid peroxidation (LPO) processes, thereby reducing the accumulation in membranes of hydrolysis and peroxidation products of fatty acid phospholipids, such as lysophospholipids, which possess pronounced detergent properties and can induce disturbances in the contractile and rhythmic activity of the heart during ischemia. In experimental myocardial ischemia, the drug increases the activity of Na+-K+-ATPase and Ca2+, Mg2+-ATPase, as well as the membrane calcium-binding potential. ANGELON**®** improves indices of central and peripheral hemodynamics and coronary blood flow, normalizes myocardial contractility, and thereby enhances physical performance. Under ischemic conditions, the drug reduces myocardial oxygen consumption, activates cardiac functional status, increases cardiac output, thus reducing the frequency of angina attacks and dyspnea during physical exertion.

ANGELON**®** restores normal sinus rhythm in patients with paroxysmal supraventricular tachycardia associated with atrial fibrillation and flutter, and also reduces the activity of ectopic rhythm foci (atrial and ventricular extrasystoles).

ANGELON**®** normalizes tissue concentrations of potassium and magnesium and reduces uric acid concentration.

Pharmacokinetics.

After administration into the body, the medicinal product ANGELON**®** slowly degrades, forming adenosine.

Clinical characteristics.

Indications.

Use as part of combination therapy for:

• ischemic heart disease, stable and unstable angina pectoris, exertional angina, and angina with documented vasospasm;
• previous myocardial infarction, post-infarction myocardial syndrome (diffuse and focal cardiosclerosis), ischemic cardiomyopathy;
• cardiac arrhythmias;
• neurocirculatory asthenia, cardiogenic neurosis;
• cardiomyopathies;
• myocarditis;
• fatigue syndrome.

Contraindications.

• Hypersensitivity to the drug or its components;
• acute myocardial infarction;
• cardiogenic shock and other types of shock;
• obstructive diseases of the bronchopulmonary system;
• severe forms of bronchial asthma;
• sinoatrial block;
• second- and third-degree atrioventricular block;
• hyperkalemia, hypermagnesemia;
• hemorrhagic stroke.

Interaction with other medicinal products and other forms of interaction.

ANGELON**®** must not be used concomitantly with cardiac glycosides due to increased risk of atrioventricular block.

Concomitant use with potassium-sparing diuretics, potassium supplements, and angiotensin-converting enzyme (ACE) inhibitors may increase the risk of hyperkalemia; with magnesium-containing preparations — hypermagnesemia.

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

Dipyridamole enhances the therapeutic effect of ANGELON, whereas xanthinol nicotinate, caffeine, theophylline, and aminophylline reduce it.

Special precautions for use.

Use with caution in cases of pronounced arterial hypotension, concomitant use with cardiac glycosides (due to increased risk of atrioventricular block), and in patients predisposed to bronchospasm.

During prolonged use, monitor blood potassium and magnesium levels.

The medicinal product contains powdered sugar and lactose; therefore, it should be used with caution in patients with diabetes mellitus. The drug is contraindicated in patients with hereditary intolerance to glucose-galactose or sucrose-isomaltose. Consumption of products containing caffeine (coffee, tea) should be limited.

Use during pregnancy or breastfeeding.

There are no clinical data on the safety and efficacy of the medicinal product during pregnancy; therefore, its use in pregnant women is contraindicated+.

Breastfeeding should be discontinued during treatment.

Ability to influence reaction speed when driving or operating machinery.

If dizziness or decreased arterial pressure occurs during treatment, patients should refrain from driving or operating machinery.

Dosage and Administration

ANGELON**®** tablets should be taken sublingually and held under the tongue until completely dissolved. The single dose is 10*–40 mg, 3–4 times daily, regardless of food intake.

In acute cardiac conditions (angina attack, arrhythmia), ANGELON**®** tablets should be administered at a dose of 10*–80 mg until improvement of symptoms. The maximum daily dose is 160 mg.

The duration of treatment is determined by a physician and averages 20–30 days. If necessary, the course may be repeated after 10–15 days.

* Use the medicinal product at the appropriate dosage strength.

Children

Not recommended for use in children.

Overdose

Symptoms: bradycardia, atrioventricular block, arterial hypotension, and syncope associated with a sudden drop in arterial pressure may occur.
Treatment: discontinue the drug and initiate symptomatic therapy. In case of bradycardia, administer atropine sulfate.

Adverse reactions.

Of the skin and subcutaneous tissue: skin rashes, itching, facial hyperemia, Quincke's edema.

Of the respiratory system: bronchospasm.

Of the cardiovascular system: decreased blood pressure, tachycardia, atrioventricular block.

Of the gastrointestinal tract: nausea, epigastric discomfort, increased gastrointestinal motility.

Of the urinary system: increased diuresis.

Of the nervous system: headache, dizziness.

Of the vascular system: sensation of warmth.

Of 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 expiry date stated on the packaging.

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; 3 or 4 blisters per carton.

Availability category. Over-the-counter.

Manufacturer: LLC "Pharmaceutical Company "PharCoS".

Manufacturer's address:
360, Sviato-Pokrovska Street,
Hostomel settlement, Irpin city,
Kyiv region, 08290, Ukraine.

Marketing Authorization Holder:

LLC Pharmaceutical Company "PharCoS".

Address of the Marketing Authorization Holder:

50-A Zodchykh Street, Kyiv, 03162, Ukraine.