Angelon®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ANGELON® ANGELON

Composition:

Active substances:

1 tablet contains adenosine-5’-triphosphate histidine-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: menthol; sugar powder; lactose monohydrate; magnesium stearate; colloidal anhydrous silicon dioxide.

Pharmaceutical form. Menthol-flavored tablets.

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

Pharmacotherapeutic group.

Cardiological preparations. ATC code C01EB10.

Pharmacological Properties.

Pharmacodynamics.

ANGELON® is a medicinal agent of a new class of substances — hetero-ligand coordination compounds with macroergic phosphates, whose molecule consists of adenosine-5'-triphosphate (ATP), the amino acid histidine, and magnesium and potassium salts, producing a characteristic pharmacological effect that is not inherent to any individual chemical component (ATP, histidine, K+, Mg++).

ANGELON® affects metabolic processes in the myocardium, normalizes energy metabolism, the activity of cellular membrane ion-transport systems, 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 antiarrhythmic action in supraventricular tachycardia.

The medicinal agent produces an energy-sparing effect by inhibiting the activity 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 lipid composition of membranes, inhibiting the activity of membrane-bound phospholipases. ANGELON® suppresses the intensity of lipid peroxidation (LPO) processes, thereby reducing the accumulation in membranes of hydrolysis and peroxidation products of phospholipid fatty acids, 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 calcium-binding potential of the membrane. ANGELON® improves parameters of central and peripheral hemodynamics and coronary circulation, normalizes myocardial contractility, thereby enhancing physical performance. Under ischemic conditions, the drug reduces myocardial oxygen consumption, activates cardiac functional status, increases cardiac output, thus contributing to a reduction in 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 agent ANGELON® slowly degrades, forming adenosine.

Clinical characteristics.

Indications.

• To be used in complex therapy for:
• ischemic heart disease, stable and unstable angina, exertional angina, and angina with documented coronary 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 interactions.

ANGELON® must not be used concurrently with cardiac glycosides due to increased risk of developing 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-adrenergic blockers, 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 developing 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 using the drug during pregnancy; therefore, its use in pregnant women is contraindicated.

Breastfeeding should be discontinued during treatment.

Ability to influence reaction rate when driving or operating machinery.

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

Dosage and Administration.

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

In acute cardiac conditions (angina attack, arrhythmia), ANGELON® tablets should be taken in doses of 10*–80 mg until the patient's condition improves. The maximum daily dose is 160 mg.

The duration of treatment is determined by a physician; on average, it lasts 20–30 days. If necessary, the course may be repeated after 10–15 days.

* Use the medicinal product in the appropriate dosage.

Children.

Do not use in children.

Overdose.

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

Adverse reactions.

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

From the respiratory system: bronchospasm.

From the cardiovascular system: decreased arterial pressure, tachycardia, atrioventricular block, coronary artery spasm, which may lead to myocardial infarction.

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

From the urinary system: increased diuresis.

From the nervous system: headache, dizziness.

From the vascular system: sensation of warmth.

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 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 in a blister; 3 or 4 blisters per carton.

Prescription status. Over-the-counter.

Manufacturer.

LLC "Pharmaceutical Company "FARCO""

Manufacturer's address and place of business.

360, Sviato-Pokrovska St., smt. Hostomel, Irpin, Kyiv region, Ukraine, 08290.

Marketing Authorization Holder.

LLC Pharmaceutical Company "FARCO".

Address of the Marketing Authorization Holder.

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