Convallaria-valerian drops

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT Convallaria-Valeriana Drops

Composition:

Active substances: 1 ml of drops contains Convallaria tincture (tinctura convallariae) (1:10) (extraction solvent – 70% ethanol) – 0.5 ml, Valeriana tincture (tinctura valerianae) (1:5) (extraction solvent – 70% ethanol) – 0.5 ml.

Pharmaceutical form. Oral drops.

Main physicochemical properties: liquid, ranging in color from yellowish-brown to reddish-brown, with characteristic odor. Sediment formation may occur during storage.

Pharmacotherapeutic group. Combined cardiovascular preparations.

ATC code C01E X.

Pharmacological properties.

Pharmacodynamics. Biologically active substances contained in the roots and rhizomes of valerian (essential oil, valeric acid, borneol, alkaloids, tannins, sugars) reduce excitation processes in the central nervous system and enhance the effect of other sedative, hypnotic, analgesic, and spasmolytic agents.

Cardiac glycosides contained in the Convallaria tincture exert cardiotonic and hypertensive effects. Under the influence of the drug, myocardial contractility increases, stroke volume and minute volume of the heart increase, while dilation of the heart chambers, arrhythmia, and edema are somewhat reduced. The agent exerts a tonic effect on blood vessels and exhibits sedative properties. Glycosides have a diuretic effect.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

Cardioneurosis, neurocirculatory dystonia of cardiac type.

Contraindications.

Hypersensitivity to the components of the drug, bradycardia, atrioventricular block, Adams–Stokes–Morgagni syndrome, unstable angina, hypercalcemia, hypokalemia, glycoside intoxication, depression and other conditions associated with suppression of central nervous system activity; significant organic changes in the myocardium and blood vessels, acute myocarditis, endocarditis, pronounced cardiomyosclerosis.

Interaction with other medicinal products and other forms of interaction.

The drug may potentiate the effects of sedatives, hypnotics, analgesics, spasmolytics, and cardiac agents; enhance the effects of alcohol, antihypertensive, and anxiolytic agents. When glucocorticoids are administered and hypokalemia develops, the adverse effects of cardiac glycosides may increase.

Special precautions for use.

Do not exceed the recommended doses of the drug.

Alcohol consumption should be avoided during use of this drug.

The drug contains ethanol! Prolonged use of the drug is not recommended.

Valerian may produce a moderate depressant effect; therefore, concomitant use of the drug with synthetic sedatives is not recommended due to potentiation of the effect.

In cases of pronounced cerebral vascular atherosclerosis, the drug may be used only under medical supervision.

Specific sensitivity to the smell of valerian may occur.

Use during pregnancy or breastfeeding.

Since ethanol is an ingredient of the drug, the tincture should not be used by women during pregnancy or breastfeeding.

Ability to affect reaction speed when driving vehicles or operating machinery.

During treatment with this drug, driving vehicles and operating machinery should be avoided.

Method of administration and dosage.

For adults, administer orally 15–20 drops 2–3 times daily. For children aged 12 years and older, administer 10–15 drops 2–3 times daily.

The duration of treatment is determined individually by a physician, depending on the clinical response, nature of concomitant therapy, and drug tolerability.

The patient should consult a physician if disease symptoms do not resolve during treatment or if any adverse reactions occur.

Children.

Do not use in children under 12 years of age.

Overdose.

Possible symptoms include headache, dizziness, drowsiness, and bradycardia. Treatment is symptomatic.

Side effects.

Cardiovascular system: arrhythmia, rarely – bradycardia, atrioventricular conduction disturbances.

Central nervous system: drowsiness, emotional depression, depression, decreased mental and physical performance, headache, muscle weakness.

Gastrointestinal tract: nausea, vomiting, diarrhea.

Immune system: allergic skin reactions – rashes, itching, hyperemia, swelling. With prolonged use – headache, decreased hearing and vision acuity, hallucinations, suppression of digestive processes.

Shelf life. 3 years.

Storage conditions.

Store in a light-protected place at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

25 ml in dropper bottles, in a carton or without a carton.

Availability. Over-the-counter.

Manufacturer/Applicant.

LLC "Ternopharm".

Manufacturer's address and place of business.

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