Instructions Tricardin film-coated tablets blister No. 20
Composition
active ingredients: valerian root thick extract (Valerianae radix extractum spissum) (2.6–5.6:1) [extractant — ethanol 70.0% (v/v)], hawthorn fruit thick extract (Crataegi fructus extractum spissum) (2.5–6.7:1) [extractant — ethanol 70.0% (v/v)], motherwort herb thick extract (Leonuri herba extractum spissum) (4.1–8.3:1) [extractant — ethanol 70.0% (v/v)];
1 tablet contains: valerian root extract thick (Valerianae radix extractum spissum) (2.6–5.6:1) [extractant — ethanol 70.0% (v/v)] calculated on a dry matter basis of 30 mg, hawthorn fruit extract thick (Crataegi fructus extractum spissum) (2.5–6.7:1) [extractant — ethanol 70.0% (v/v)] calculated on a dry matter basis of 15 mg, motherwort herb extract thick (Leonuri herba extractum spissum) (4.1–8.3:1) [extractant — ethanol 70.0% (v/v)] calculated on a dry matter basis of 15 mg;
excipients: microcrystalline cellulose, light magnesium carbonate, croscarmellose sodium, 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)].
Dosage form
Film-coated tablets.
Main physicochemical properties: round tablets with a biconvex surface, coated with a film coating from red-crimson to dark red.
Pharmacotherapeutic group
Other combined cardiac drugs.
ATX code C01E X.
Pharmacological properties
Pharmacodynamics
Cardiological and sedative. The therapeutic effect of the drug Tricardin is due to the action of a complex of biologically active substances from valerian roots, hawthorn fruits, and motherwort herb.
Biologically active substances contained in hawthorn fruits (flavonoids, choline, acetylcholine, tannins, phytosterols) have hypotensive, cardioprotective, antispasmodic properties; they increase blood circulation in the coronary vessels and in the vessels of the brain, increase the sensitivity of the myocardium to the action of cardiac glycosides, slightly increase the contraction of the heart muscle and at the same time reduce its excitability.
Biologically active substances contained in valerian roots (borneol and isovaleric acid ester, borneol, isovaleric acid, alkaloids, tannins, sugars) reduce the excitability of the central nervous system (CNS), reduce tension and irritability during mental overload and mental fatigue, exhibit sedative, hypnotic, antispasmodic properties, enhance the effect of other drugs that have a depressing effect on the CNS, namely: sedatives, hypnotics, tranquilizers. In addition, biologically active substances of valerian exhibit choleretic effects, slow down the heart rate, dilate the coronary vessels of the heart, and enhance the 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, contribute to the normalization of blood pressure and the onset of physiological sleep, and also enhance the effects of other sedatives and hypnotics.
Pharmacokinetics
Not studied.
Indication
Functional disorders of the cardiovascular system, after serious diseases have been ruled out by a doctor; as a sedative for nervous excitement and insomnia.
Contraindication
Increased individual sensitivity to the components of the drug, severe arterial hypotension, severe bradycardia, depression and other diseases accompanied by suppression of the central nervous system, cholelithiasis.
Children's age (up to 18 years).
Interaction with other medicinal products and other types of interactions
The drug may enhance the effect of tranquilizers, neuroleptics, hypnotics, sedatives, analgesics, antispasmodics, cardiac, hypotensive and anxiolytic drugs, and also enhances the effect of alcohol. Taking with alkaloid salts is not recommended due to the possibility of forming negative complexes. The drug should not be used together with third-generation antiarrhythmic drugs, as well as with cisapride. The drug enhances the effects of cardiac glycosides.
The doctor should be informed about the simultaneous use of any other medications.
Application features
The drug is not recommended to be used during meals to avoid interaction with food components.
Not recommended for long-term use.
There may be a specific sensitivity to the smell of valerian.
This medicinal product contains sodium compounds. Caution should be exercised when administered to patients on a controlled sodium diet.
While using the drug, you should refrain from drinking alcoholic beverages.
Patients who have severe liver dysfunction or have had severe liver disease in the past should be cautious when taking the drug.
Use during pregnancy or breastfeeding
The drug is not recommended for use due to insufficient data on safety during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
During the period of use of the drug, you should refrain from driving vehicles and working with other mechanisms.
Method of administration and doses
Adults should take Tricardin orally, 1 tablet 3 times a day before meals.
For mild forms of insomnia, take 1–2 tablets 1 hour before bedtime.
The duration of the treatment course is determined individually for each patient, taking into account the nature and severity of the pathological process, the characteristics of the course of the disease, the tolerability of the drug, and the stability of the achieved therapeutic effect.
The tablets should be swallowed without chewing and washed down with sufficient liquid.
Children
Do not use in children (under 18 years of age).
Overdose
If the recommended doses are exceeded, headache, dizziness, drowsiness, lethargy, tachycardia or bradycardia, decreased blood pressure, general weakness, abdominal pain, nausea, decreased hearing and vision, palpitations, mental agitation, and manifestations of hypersensitivity may occur, which require discontinuation of the drug and symptomatic therapy (gastric lavage, administration of activated charcoal, etc.).
Adverse reactions
From the cardiovascular system: tachycardia or bradycardia, decreased blood pressure, hypotension, significant slowing of the heart rate, feeling of tightness behind the sternum, feeling of palpitations, heart pain.
From the nervous system: depression, suppression of emotional reactions, dizziness, drowsiness, headache, lethargy, general weakness, decreased mental and physical performance, concentration of attention.
Gastrointestinal: nausea, spastic abdominal pain, diarrhea, dyspepsia; in case of prolonged use, inhibition of the digestive process and constipation are possible.
Allergic reactions: redness, rash, itching, skin swelling, urticaria, hyperemia, shortness of breath, bronchial asthma.
General disorders: feeling of fatigue, decreased mental and physical performance.
Adverse reactions occur extremely rarely, usually when using the drug for a long time and significantly exceeding the recommended doses, and are reversible.
If any adverse reactions occur, you should consult a doctor.
Reporting adverse reactions after registration of a medicinal product is of great importance. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of a medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
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 in a cardboard pack.
Side effects
From the cardiovascular system: tachycardia or bradycardia, decreased blood pressure, hypotension, significant slowing of the heart rate.
From the nervous system: depression, inhibition of emotional reactions, dizziness, drowsiness.
Gastrointestinal: nausea, spastic abdominal pain, dyspepsia.
Allergic reactions: redness, rash, itching, skin swelling, urticaria.
General disorders: feeling of fatigue, decreased mental and physical performance.
If any adverse reactions occur, you should consult a doctor.
Vacation category
Without a prescription.
Manufacturer/applicant.
"Ternofarm" LLC.
Location of the manufacturer and address of its place of business / location of the applicant.
Ukraine, 46010, Ternopil, Fabrychna St., 4.
Phone/fax: (0352) 521-444, www.ternopharm.com.ua
Producer
"Ternofarm" LLC.
Location of the manufacturer and address of its place of business/location of the applicant
Ukraine, 46010, Ternopil, Fabrychna St., 4.
Phone/fax: (0352) 521-444, www.ternopharm.com.ua
