Rekardin forte

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT RECARDIN FORTE (RECARDIN FORTE)

Composition:

Active substances: hawthorn tincture, motherwort tincture, valerian tincture, peony tincture;

1 ml of drops contains: hawthorn tincture (Crataegi tinctura) (1:10) (extractant – 70% ethanol) – 0.25 ml; motherwort tincture (Leonuri tinctura) (1:5) (extractant – 70% ethanol) – 0.25 ml; valerian tincture (Valerianae tinctura) (1:5) (extractant – 70% ethanol) – 0.25 ml; peony tincture (Paeoniae tinctura) (1:10) (extractant – 40% ethanol) – 0.25 ml;

Excipients: none, except the extractant.

Pharmaceutical form. Oral drops.

Main physicochemical properties: liquid ranging from brown to brownish-yellow in color, with a specific odor. Formation of sediment during storage is permissible.

Pharmacotherapeutic group. Other combined cardiovascular preparations.

ATC code C01EX.

Pharmacological Properties

Pharmacodynamics

A cardiotonic and sedative agent. The therapeutic effect of the drug is due to the action of a complex of biologically active substances derived from hawthorn fruits, common valerian herb, valerian root, and herb, rhizomes and roots of Paeonia anomala.

Biologically active substances present in hawthorn fruits (flavonoids, choline, acetylcholine, tannins, phytosterols, triterpenic acids) possess hypotensive, spasmolytic, and antianginal properties; they exhibit a moderate cardiotonic and cardioprotective effect; enhance blood circulation in coronary and cerebral vessels; increase myocardial sensitivity to cardiac glycosides; slightly strengthen myocardial contractions while simultaneously reducing myocardial excitability.

Biologically active substances contained in common valerian herb (steroid and flavonoid glycosides, stachydrine, essential oil, saponins, tannins, alkaloids) reduce excitation processes in the central nervous system (CNS), exert a moderate anxiolytic and hypotensive effect, promote physiological sleep, and enhance the effects of other sedative and hypnotic agents.

Biologically active substances present in valerian root (a complex ester of borneol and isovaleric acid, borneol, isovaleric acid, alkaloids, tannins, sugars) reduce excitability of the central nervous system (CNS), alleviate tension and irritability associated with mental overload and intellectual fatigue, and exhibit sedative, hypnotic, anxiolytic, vasodilatory, and spasmolytic properties. They enhance the effects of other drugs with CNS depressant activity, including sedatives, hypnotics, and tranquilizers. In addition, biologically active substances of valerian demonstrate choleretic activity, slow heart rate, dilate coronary vessels of the heart, and enhance secretory activity of the gastric mucosa.

Biologically active substances present in the herb, rhizomes and roots of Paeonia anomala (phenols, tannins, organic acids, glycosides) increase the body's resistance to hypoxia, exhibit anti-inflammatory, spasmolytic, anticonvulsant, and antimicrobial effects, and are capable of increasing gastric acidity.

Pharmacokinetics. Not established.

Clinical characteristics.

Indications.

For functional disorders of the cardiovascular system: as an adjunctive medicinal agent in mild forms of cardiac arrhythmias (atrial fibrillation, paroxysmal tachycardia), after serious diseases have been excluded by a physician, in the early stages of arterial hypertension.

As a sedative in functional disorders of the central nervous system (increased emotional excitability, irritability, neurotic conditions of various origins, insomnia).

Contraindications.

History of alcoholism; concomitant use of medicinal products containing alcohol; depression and other disorders accompanied by central nervous system depression; pronounced arterial hypotension and bradycardia; peptic ulcer of the stomach and duodenum; liver cirrhosis; pregnancy or breastfeeding period; hypersensitivity to the components of the medicinal product; cholelithiasis. Pediatric age (under 18 years).

Interaction with other medicinal products and other forms of interaction.

The medicinal product may potentiate the pharmacological effects of tranquilizers, neuroleptics, nootropics, sedatives, hypnotics, analgesics, spasmolytics, antihypertensive agents, cardiac glycosides, anesthetic agents, curare-like muscle relaxants, as well as enhance the effect of alcohol.

Concomitant use with alkaloid salts is not recommended due to the possibility of forming unfavorable complexes. Simultaneous use of the drug with antacids should be avoided.

The drug should not be used together with antiarrhythmic agents of the III generation, as well as with cisapride.

Antibiotic-induced damage to intestinal flora may affect enzymatic transformations of paeonia aglycones and reduce treatment efficacy.

Patients should inform their physician about concomitant use of any other medicinal products.

Special precautions for use

The medicinal product should be shaken well before use.

Alcoholic beverages should be avoided during the period of taking this medicinal product.

The medicinal product should not be taken during meals in order to avoid interaction with food components.

When high doses are used for prolonged periods, gastric acidity should be monitored in patients predisposed to its increase.

Prolonged use is not recommended, as the medicinal product contains ethanol and may be harmful for patients suffering from alcoholism.

Caution is advised in patients with liver disease and in patients with epilepsy.

If disorders (indicated in the section "Indications") do not resolve after 4 weeks of treatment or if the condition worsens, a physician should be consulted.

Use during pregnancy or breastfeeding

Use during pregnancy or breastfeeding is contraindicated.

Ability to influence reaction speed when driving or operating machinery

The medicinal product contains ethanol and may cause drowsiness; therefore, driving or operating machinery should be avoided during treatment.

Method of administration and dosage.

The medicinal product is prescribed orally to adults, 20–30 drops 3 times a day before meals.

The duration of treatment is determined individually by a physician.

Children. Safety and efficacy in children have not been established.

Overdose.

In case of a significant exceeding of the recommended doses, the following symptoms may occur: headache, dizziness, drowsiness, bradycardia, decreased arterial pressure, general weakness, abdominal pain, nausea, reduced hearing and visual acuity, palpitations, mental excitement, and manifestations of hypersensitivity. These require discontinuation of the medicinal product and implementation of symptomatic therapy (gastric lavage, administration of sorbents).

Side effects.

Cardiovascular system: hypotension, tachycardia, bradycardia, chest tightness, palpitations, chest pain.

Nervous system: depression, suppression of emotional responses, dizziness, drowsiness, headache, decreased concentration.

Gastrointestinal tract: nausea, spasmodic abdominal pain, diarrhea, dyspepsia; with prolonged use, possible suppression of digestion, constipation.

Allergic reactions: redness, rash, itching, skin swelling, urticaria, shortness of breath, bronchial asthma.

General disorders: fatigue, lethargy, general weakness, decreased mental and physical performance.

Side effects occur very rarely, usually after prolonged use and significant exceeding of recommended doses, and are reversible.

If any adverse events occur, consult a physician immediately.

Reporting of side effects after drug registration is important. It enables continuous monitoring of the benefit-risk balance of this medicinal product. Healthcare professionals, as well as patients or their legal representatives, should report all suspected side effects and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging. 25 ml or 50 ml in a bottle with a dropper cap; 1 bottle per carton.

Availability. Over-the-counter.

Manufacturer: LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and location of operations: 4, Korolyova St., Stanyshivka, Zhytomyr District, Zhytomyr Oblast, 12430, Ukraine.