Tricardin

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT TRICARDIN

Composition:

Active substances: Valerian root dry extract (Valerianae radix extractum spissum) (2.6–5.6:1) [extraction solvent — ethanol 70.0% (v/v)], Hawthorn fruit dry extract (Crataegi fructus extractum spissum) (2.5–6.7:1) [extraction solvent — ethanol 70.0% (v/v)], Motherwort herb dry extract (Leonuri herba extractum spissum) (4.1–8.3:1) [extraction solvent — ethanol 70.0% (v/v)];

One tablet contains: Valerian root dry extract (Valerianae radix extractum spissum) (2.6–5.6:1) [extraction solvent — ethanol 70.0% (v/v)] equivalent to 30 mg of dry residue, Hawthorn fruit dry extract (Crataegi fructus extractum spissum) (2.5–6.7:1) [extraction solvent — ethanol 70.0% (v/v)] equivalent to 15 mg of dry residue, Motherwort herb dry extract (Leonuri herba extractum spissum) (4.1–8.3:1) [extraction solvent — ethanol 70.0% (v/v)] equivalent to 15 mg of dry residue;

Excipients: microcrystalline cellulose, light magnesium carbonate, sodium croscarmellose, colloidal anhydrous silicon dioxide, magnesium stearate, film coating "Wincoat WT-MPAQ-013002P Red" [polyvinyl alcohol, triethyl citrate, titanium dioxide (E 171), talc, Ponceau 4R (E 124)].

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: round, biconvex tablets with a film coating ranging in color from red-raspberry to dark red.

Pharmacotherapeutic group. Other combined cardiac preparations.

ATC code C01EX.

Pharmacological Properties

Pharmacodynamics. A cardiac and sedative agent. The therapeutic effect of Trikardin is due to the action of a complex of biologically active substances derived from valerian roots, hawthorn fruits, and black haw herb.

Biologically active substances contained in hawthorn fruits (flavonoids, choline, acetylcholine, tannins, phytosterols) possess hypotensive, cardioprotective, and spasmolytic properties; they enhance blood flow in the 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 present in valerian roots (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, such as sedatives, hypnotics, and tranquilizers. In addition, biologically active substances from valerian exert a choleretic effect, slow heart rate, dilate coronary vessels of the heart, and enhance secretory activity of the gastric mucosa.

Biologically active substances contained in black haw herb (essential oil, saponins, tannins, alkaloids) reduce excitatory processes in the central nervous system, promote normalization of arterial pressure and facilitate 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 after serious diseases have been excluded by a physician; as a sedative in nervous excitement and insomnia.

Contraindications.

Increased individual sensitivity to the components of the drug, pronounced arterial hypotension, pronounced bradycardia, depression and other conditions accompanied by suppression of central nervous system activity, cholelithiasis.

Children under 18 years of age.

Interaction with other medicinal products and other types of interactions.

Triocardine may enhance the effects of tranquilizers, neuroleptics, hypnotics, sedatives, analgesics, spasmolytics, nootropics, cardiac agents, antihypertensives, anxiolytics, anesthetics, 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 negative complexes. The drug should not be used together with antiarrhythmic agents of the III generation or with cisapride. The drug enhances the effects of cardiac glycosides.

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

Special precautions for use.

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

Prolonged use is not recommended. If disorders (indicated in the section "Indications") do not disappear after 4 weeks of taking the medicinal product or if the condition worsens, medical advice should be sought.

Specific sensitivity to the smell of valerian may occur.

This medicinal product contains sodium compounds. Caution is advised when administering to patients on a sodium-restricted diet.

Alcoholic beverages should be avoided during treatment with this medicine.

Caution is advised in patients with severe hepatic impairment or a history of severe liver disease.

The medicinal product contains the dye Ponceau 4R (E 124), which may cause allergic reactions.

Use during pregnancy or breastfeeding.

The use of this medicinal product is not recommended due to insufficient data on safety during pregnancy or breastfeeding.

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.

Take Tricardin orally, 1 tablet three times daily before meals.

For mild forms of insomnia — take 1–2 tablets 1 hour before bedtime.

The duration of treatment is determined individually for each patient, depending on the nature and severity of the pathological condition, disease course characteristics, individual tolerance to the drug, and stability of the therapeutic effect achieved.

Tablets should be swallowed whole with sufficient amount of liquid.

Children.

Do not use in children under 18 years of age.

Overdose.

In case of exceeding the recommended doses, the following may occur: headache, dizziness, drowsiness, lethargy, tachycardia or bradycardia, decreased arterial blood pressure, general weakness, abdominal pain, nausea, decreased hearing and visual acuity, palpitations, mental excitation, and manifestations of hypersensitivity. These symptoms require immediate discontinuation of the drug and initiation of symptomatic therapy (gastric lavage, activated charcoal, etc.).

Adverse reactions.

Cardiovascular system: tachycardia or bradycardia, decreased blood pressure, hypotension, significant slowing of heart rate, chest tightness, palpitations, chest pain.

Nervous system: depression, suppression of emotional responses, dizziness, drowsiness, headache, lethargy, general weakness, decreased mental and physical performance, decreased attention concentration.

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

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

General disorders: fatigue, decreased mental and physical performance.

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

If any adverse events occur, medical advice should be sought immediately.

Reporting of adverse reactions following marketing authorization is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions 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.

10 tablets in a blister; 2 or 4 blisters per cardboard box.

Supply category. Over-the-counter.

Manufacturer/Marketing Authorization Holder.

TOV "Ternopharm".

Address of manufacturer and location of its operations / address of marketing authorization holder.

4 Fabrychna Street, Ternopil, 46010, Ukraine.

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