Tricardin heart drops

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT TRIKARDIN Heart Drops

Composition:

Active substances: 1 ml of drops contains: valerian tincture (tinctura Valerianae) (1:5) (extraction solvent – ethanol 70%) – 0.34 ml, hawthorn tincture (tinctura Crataegi) (1:10) (extraction solvent – ethanol 70%) – 0.33 ml, motherwort tincture (tinctura Leonuri) (1:5) (extraction solvent – ethanol 70%) – 0.33 ml.

Pharmaceutical form. Oral drops.

Main physico-chemical properties: liquid, ranging in color from yellowish-brown to reddish-brown, with the odor of valerian. Formation of sediment may occur during storage.

Pharmacotherapeutic group. Various combined cardiac preparations.

ATC code C01EX.

Pharmacological Properties.

Pharmacodynamics. A cardiological and sedative agent. The therapeutic effect of the medicinal product “Tricardin Heart Drops” is due to the action of a complex of biologically active substances derived from valerian roots and rhizomes, hawthorn fruits, and vitex herb.

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

Biologically active substances contained in valerian roots and rhizomes (a complex ester of borneol and isovaleric acid, borneol, isovaleric acid, alkaloids, tannins, sugars) reduce central nervous system (CNS) excitability, alleviate tension and irritability associated with mental stress and intellectual fatigue, exhibit sedative, hypnotic, and spasmolytic effects, and enhance the effects of other agents that suppress CNS activity, specifically 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 vitex 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 neuropathy), as a sedative in nervous excitement and insomnia.

Contraindications.

History of alcoholism; concomitant use of alcohol-containing preparations; gastric and duodenal peptic 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 agents, and antihypertensive drugs, as well as intensify the effect of alcohol. Concomitant use with alkaloid salts is not recommended due to the possibility of forming adverse complexes. The drug should not be used together with class III antiarrhythmic agents or cisapride. The drug enhances the effects of cardiac glycosides.

Inform your doctor about the concomitant use of any other medicinal products.

Special precautions for use.

During the use of the medicinal product “Tricardin heart drops”, alcohol consumption should be avoided. The product is not recommended to be taken during meals to avoid interaction with food components.

The product contains ethanol! Prolonged use is not recommended.

Use during pregnancy or breastfeeding.

Use is contraindicated.

Ability to affect reaction speed when driving or operating machinery.

During the use of this medicinal product, driving vehicles or operating machinery should be avoided.

Dosage and Administration.

"Trykardin heart drops" should be administered orally to adults at a dose of 20–30 drops three times daily before meals.

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

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

Children.

Do not administer to children under 12 years of age.

Overdose.

In case of significant exceeding of recommended doses, the following 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, which require discontinuation of the drug and implementation of symptomatic therapy.

Adverse reactions.

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, reduced mental and physical performance.

If any adverse events occur, consult a physician.

Shelf life. 4 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

25 mL in a dropper bottle № 1 or in a bottle № 1, or 50 mL in a bottle № 1.

Prescription status. Over-the-counter.

Manufacturer/Applicant.

LLC "Ternopharm".

Manufacturer's address and location of its business activity / Applicant's address.

LLC "Ternopharm".

46010, Ternopil, Fabrychna St., 4, Ukraine.

Tel./fax: (0352) 521-444, www.ternopharm.com.ua

INSTRUCTION

for medical use of medicinal product

TRIKARDIN Heart Drops

Composition:

Active ingredients: 1 mL of drops contains: Valerian tincture (tinctura Valerianae) (1:5) (extractant – 70% ethanol) – 0.34 mL, Hawthorn tincture (tinctura Crataegi) (1:10) (extractant – 70% ethanol) – 0.33 mL, Motherwort tincture (tinctura Leonuri) (1:5) (extractant – 70% ethanol) – 0.33 mL.

Pharmaceutical form. Oral drops.

Main physicochemical properties: yellowish-brown to brownish-brown liquid with a valerian odor. Sediment may form during storage.

Pharmacotherapeutic group. Various combined cardiological preparations. ATC code C01EX.

Pharmacological properties.

Pharmacodynamics.

Cardiological and sedative agent. The therapeutic effect of "Trikarдин Heart Drops" is due to the action of biologically active substances complex from valerian roots and rhizomes, hawthorn fruits, and motherwort herb.

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

Biologically active substances contained in valerian roots and rhizomes (isovaleric acid ester of borneol, borneol, isovaleric acid, alkaloids, tannins, saccharides) reduce excitability of the central nervous system (CNS), reduce tension and nervousness during mental strain and intellectual fatigue, exhibit sedative, hypnotic, and spasmolytic effects, enhance the action of other drugs with CNS depressant effects such as sedatives, hypnotics, and tranquilizers. In addition, valerian biologically active substances have choleretic effects, slow heart rate, dilate coronary vessels of the heart, and enhance secretory activity of the gastric mucosa.

Biologically active substances contained in motherwort 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 cardiovascular system (neurocirculatory dystonia, vegetative neurosis), as a sedative in nervous excitement and insomnia.

Contraindications.

History of alcoholism; concomitant use of alcohol-containing medications; peptic ulcer of stomach and duodenum; 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, and also enhances the effect of alcohol. Concomitant use with alkaloid salts is not recommended due to the possibility of forming negative complexes. The drug should not be used with Class III antiarrhythmic agents or with cisapride. The drug enhances the effects of cardiac glycosides.

When using any other medicinal products simultaneously, inform your physician.

Special precautions.

During treatment with "Trikarдин Heart Drops", alcohol consumption should be avoided. The drug is not recommended to be taken during meals to prevent interaction with food components.

The drug contains ethanol! Prolonged use is not recommended.

Use during pregnancy or breastfeeding.

Use is contraindicated.

Ability to influence reaction rate when driving or operating machinery.

During treatment, avoid driving or operating machinery.

Method of administration and dosage.

"Trikarдин Heart Drops" are administered orally to adults at 20–30 drops three times daily before meals.

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

Duration of treatment is determined individually for each patient, depending on the nature, severity of the pathological process, disease course characteristics, drug tolerance, and stability of the therapeutic effect achieved.

Children.

Not recommended for 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 vision acuity, palpitations, mental excitement, and hypersensitivity reactions, which require discontinuation of the drug and symptomatic therapy.

Adverse reactions.

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, reduced mental and physical performance.

In case of any adverse events, consult a physician.

Shelf life. 4 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

25 mL in a dropper bottle № 1 or in a bottle № 1, or 50 mL in a bottle № 1.

Prescription status. Over-the-counter.

Manufacturer/Applicant.

LLC "Ternopharm".

Manufacturer's address and location of its business activity.

LLC "Ternopharm".

46010, Ternopil, Fabrychna St., 4, Ukraine.

Tel./fax: (0352) 521-444, http://www.ternopharm.com.ua