RELACARDIN HEART DROPS

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT

Relacardin heart drops

Composition:

Active substances: 1 ml of drops contains:
Valerian root tincture (Valerianae radix) (1:5) (extractant – ethanol 70%) – 0.34 ml;
Hawthorn fruit tincture (Crataegi fructus) (1:10) (extractant – ethanol 70%) – 0.33 ml;
Motherwort herb tincture (Leonuri cardiacae herba) (1:5) (extractant – ethanol 70%) – 0.33 ml.

Pharmaceutical form. Oral drops.

Main physicochemical properties: Liquid, ranging in color from yellowish-brown to reddish-brown, with a characteristic odor of valerian. Formation of sediment may occur during storage.

Pharmacotherapeutic group. Various combined cardiac preparations.

ATC code C01EX.

Pharmacological Properties

Pharmacodynamics. A cardiac and sedative agent. The therapeutic effect of Relakardin heart drops is due to the action of a complex of biologically active substances derived from the roots and rhizomes of valerian, hawthorn fruits, and dog nettle herb.

Biologically active substances contained in hawthorn fruits (flavonoids, choline, acetylcholine, tannins, phytosterols) exhibit hypotensive, cardioprotective, and spasmolytic properties; they enhance blood flow in coronary and cerebral vessels, increase myocardial sensitivity to cardiac glycosides, slightly strengthen myocardial contractions, and at the same time reduce myocardial excitability.

Biologically active substances present in the roots and rhizomes of valerian (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 stress and intellectual fatigue, and exhibit sedative, hypnotic, and spasmolytic effects. They enhance the action of other agents that have a depressant effect on the CNS, namely sedatives, hypnotics, and tranquilizers. In addition, biologically active substances from valerian exert choleretic effects, slow heart rate, dilate coronary vessels of the heart, and enhance secretory activity of the gastric mucosa.

Biologically active substances contained in dog nettle herb (essential oil, saponins, tannins, alkaloids) reduce excitation processes in the central nervous system, promote normalization of arterial pressure and onset of physiological sleep, and also enhance the effects of other sedative and hypnotic agents.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

Functional disorders of the cardiovascular system (neurocirculatory dystonia, vegetative neurosis).

Nervous excitement and insomnia – as a sedative.

Contraindications.

History of alcoholism; concomitant use of medications containing alcohol; gastric and duodenal ulcer; liver cirrhosis; pregnancy or breastfeeding period; depression and other disorders accompanied by central nervous system depression; pronounced arterial hypotension and bradycardia; hypersensitivity to the components of the drug.

Interaction with other medicinal products and other types of interactions.

The drug may enhance the effects of tranquilizers, neuroleptics, hypnotics, sedatives, analgesics, spasmolytics, cardiac and antihypertensive agents, as well as enhance the effect of alcohol. Concomitant use with alkaloid salts is not recommended due to the possibility of forming negative complexes. Relakardin Heart Drops should not be used together with Class III antiarrhythmic agents or with cisapride. The drug enhances the effects of cardiac glycosides.

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

Special precautions for use.

During the use of Relakardin cardiac drops, patients should avoid consuming alcoholic beverages. The product should not be taken during meals to avoid interaction with food components.

This medicinal product contains 64–69% (v/v) ethanol (alcohol), i.e., approximately 310–507 mg/dose (20–30 drops), equivalent to about 8–12 ml of beer or about 3–5 ml of wine per dose.

Harmful for patients suffering from alcoholism. Caution should be exercised when used in pregnant women, breastfeeding women, children, and patients with liver disorders or epilepsy.

Use during pregnancy or breastfeeding.

Use is contraindicated.

Ability to influence reaction rate when driving or operating machinery.

During treatment with this medicinal product, patients should refrain from driving or operating machinery.

Method of administration and dosage.

Relakardin heart drops are taken orally by adults, 20–30 drops three times a day before meals.

For children aged 12 years and older – 1 drop per year of life, three times a day before meals.

The duration of treatment is determined individually for each patient, taking into account the nature and severity of the pathological process, the course of the disease, individual tolerance to the medication, and the stability of the therapeutic effect achieved.

Children.

Do not administer to children under 12 years of age.

Overdose.

Significant overdose may cause headache, dizziness, drowsiness, bradycardia, decreased arterial pressure, general weakness, abdominal pain, nausea, reduced hearing and visual acuity, palpitations, mental agitation, and symptoms of hypersensitivity, which require discontinuation of the medication and implementation of symptomatic therapy.

Side effects.

Cardiovascular system: hypotension, significant slowing of heart rate.

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

Gastrointestinal system: nausea, spasmodic abdominal pain.

Allergic reactions: redness, rash, itching, skin swelling.

General disorders: feeling of fatigue, decreased mental and physical performance.

If any adverse reactions occur, consult a physician.

Shelf life. 3 years.

Storage conditions.

Store in original packaging at a temperature not exceeding 25 °C. Precipitation may occur during storage. Keep out of reach of children.

Packaging.

25 ml or 50 ml in glass or polymer bottles.

Supply category. Over-the-counter.

Manufacturer.

LLC "MEDLEV".

Manufacturer's location and address of business activity.

171 Bohdana Khmelnytskoho St. (Bldg. B-1, K-1), Dnipro, Ukraine, 49000.