Valeocor-Q10^® (Tablets) Instructions for Use

Marketing Authorization Holder

Pharmasoft Npc, LLC (Russia)

Manufactured By

ZiO-Health CJSC (Russia)

ATC Code

C01EB09 (Ubidecarenone)

Active Substance

Ubidecarenone (Rec.INN registered by WHO)

Dosage Form

Valeocor-Q10®

Chewable tablets 50 mg: 10, 20, 30, 40 or 50 pcs.

Dosage Form, Packaging, and Composition

Chewable tablets orange in color with a small amount of white specks, round, smooth, with a bevel and a score line.

Excipients: macrogol 6000 – 500.1 mg, isomalt – 80.7 mg, carmellose sodium – 35 mg, ascorbic acid – 30 mg, sodium stearyl fumarate – 3.5 mg, aspartame – 0.7 mg.

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.

Clinical-Pharmacological Group

Drug improving myocardial metabolism

Pharmacotherapeutic Group

Cardiotonic agent of non-glycoside structure

Pharmacological Action

Cardiotonic drug of non-glycoside structure. Ubidecarenone is a natural substance that is a vitamin-like coenzyme.

Ubidecarenone (coenzyme Q10, ubiquinone) is an endogenous substrate involved in electron transfer in the transport chain of redox processes, in the energy metabolism process, and in the oxidative phosphorylation reaction in the mitochondrial respiratory chain of cells.

It participates in cellular respiration processes, increasing ATP synthesis. It has a clinically significant antioxidant effect.

Ubidecarenone protects cell membrane lipids from peroxidation and reduces the area of myocardial damage under conditions of ischemia and reperfusion.

Ubidecarenone prevents the prolongation of the QT interval and improves exercise tolerance.

Due to endogenous synthesis, 100% of the body’s requirement for coenzyme Q10 is met only up to the age of 20.

The content of coenzyme Q10 decreases in elderly patients, as well as in various diseases, in both adults and children.

Pharmacokinetics

No clinical pharmacokinetic studies of the drug have been conducted.

Absorption

Experimental studies in animals have shown that after oral administration, the drug is rapidly absorbed, T_max in plasma is reached 1 hour after administration. The bioavailability of the drug is 20%.

Elimination

T_1/2 is 2 hours. The drug is excreted in the urine unchanged and in the form of metabolites.

Indications

• In the complex therapy of coronary artery disease (including myocardial infarction – the period of restorative therapy), chronic heart failure, arterial hypertension;
• For the prevention and replenishment of coenzyme Q10 deficiency;
• To improve adaptation to increased physical exertion in athletes.

ICD codes

Dosage Regimen

As part of complex therapy for the treatment of coronary artery disease and chronic heart failure, it is used in a dose of 150 mg (3 tablets)/day in 3 divided doses. The tablets should be chewed.

As part of complex therapy for arterial hypertension, to replenish coenzyme Q10 deficiency and to improve adaptation to increased physical exertion in athletes, it is used in a dose of 50-100 mg (1-2 tablets)/day. The tablets should be chewed.

The duration of the course of taking the drug is 1-3 months.

Adverse Reactions

From the digestive system, dyspeptic phenomena are possible (heartburn, epigastric pain, nausea, vomiting, diarrhea).

From the cardiovascular system, a decrease in blood pressure and tachycardia are possible.

Allergic reactions are possible: skin redness, skin itching, swelling of the nasal mucosa, allergic conjunctivitis.

Contraindications

• Severe arterial hypotension (BP less than 90/60 mm Hg);
• Severe bradycardia (heart rate less than 50 beats/min);
• Acute glomerulonephritis;
• Peptic ulcer of the stomach and duodenum in the acute phase;
• Pregnancy;
• Lactation period (breastfeeding);
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The drug is not recommended for use during pregnancy and lactation (breastfeeding), as strictly controlled clinical studies on the safety of the drug in pregnant and lactating women have not been conducted.

Use in Renal Impairment

Contraindicated in acute glomerulonephritis.

Geriatric Use

Use is possible according to the dosing regimen.

Special Precautions

The drug should be used with caution in arterial hypotension.

Effect on the ability to drive vehicles and mechanisms

There are no data on the adverse effect of the drug on the ability to drive vehicles and mechanisms.

Overdose

Cases of overdose of the drug Valeocor-Q10^® are not known.

Drug Interactions

Valeocor-Q10^® potentiates the pharmacological effects of cardiotonic, antihypertensive, and antianginal agents.

Concomitant use of lipid-lowering drugs (HMG-CoA reductase inhibitors, fibrates), beta-blockers (atenolol, metoprolol, propranolol), warfarin, tricyclic antidepressants may lead to a decrease in the plasma concentration of ubidecarenone.

Storage Conditions

The drug should be stored out of the reach of children, in a dry, light-protected place at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years. Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.