TRIVALUMEN-ZDOROVYA FORTE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TRIVALUMEN-ZDOROVYEFORTE (TRIVALUMEN-ZDOROVYEFORTE)

Composition:

Active substances: 1 capsule contains 467.25 mg of dry extract of sedative herbal mixture (extraction agent – purified water) (the sedative mixture contains: Herba Leonuri – motherwort herb, Strobili Lupuli – hops strobili, Folia Menthae Piperitae – peppermint leaves, Rhizomata cum radicibus Valerianae – valerian rhizomes with roots, Radices et rhizoma Glycyrrhizae – licorice roots and rhizomes) in a ratio of (4:2:1.5:1.5:1);

Excipients: calcium stearate, monohydrate lactose;

Capsule shell contains: titanium dioxide (E 171), erythrosine (E 127), quinoline yellow (E 104), indigotine (E 132), gelatin.

Pharmaceutical form. Capsules.

Main physicochemical properties: hard gelatin capsules with a green cap and a yellow body. The contents of the capsules are powder or a mass ranging in color from yellowish-brown to reddish-brown, with a weak specific odor. The presence of particle agglomerates and white specks is permissible.

Pharmacotherapeutic group.

Psycholeptics. Hypnotics and sedatives. Other hypnotics and sedatives. ATC code N05CM.

Pharmacological properties.

A complex herbal preparation, whose action is determined by the properties of biologically active substances: dog nettle, hops, mint, valerian, and licorice (hydroxycinnamic acids, flavonoids, terpene glycosides, etc.). Exerts a comprehensive sedative effect on the central nervous system (CNS): has a mild calming effect, reduces psychoemotional tension, hypersensitivity to external stimuli and associated manifestations of vegetative dysfunction, and eliminates sleep disturbances. Does not cause drug dependence when used long-term.

Clinical characteristics.

Indications.

Mild forms of neurasthenia and neuroses accompanied by increased excitability, anxiety, feelings of fear and tension, irritability, depression, and fatigue; cardiovascular neuroses with cardialgia and arterial hypertension; mild forms of sleep disturbances due to nervous and/or mental overstrain, persistent psychoemotional stress ("manager’s syndrome"); decreased memory and concentration; climacteric syndrome.

Contraindications.

Hypersensitivity to the components of the drug, acute inflammatory diseases of the stomach and intestines, irritable bowel syndrome, peptic ulcer, bronchial asthma, hepatic and renal dysfunction, hypokalemia, severe obesity; depression and other disorders associated with central nervous system (CNS) depression.

Interaction with other medicinal products and other types of interactions.

When using any other medicinal products, consult a physician regarding the possibility of taking this drug.

Concomitant use with other sedative and cardiovascular medicinal agents is possible.

The drug may potentiate the effects of alcohol, cardiac glycosides, hypnotics, psychotropic drugs, analgesics, spasmolytics, and centrally-acting antihypertensive agents; concomitant use with cardiac glycosides, antiarrhythmic agents (quinidine), thiazide and loop diuretics, and laxatives may intensify hypokalemia.

Special precautions for use.

During treatment, alcohol consumption should be avoided. The drug should be administered with caution to patients with gastroesophageal reflux (heartburn), myocarditis, pericarditis, myocardial infarction, and bradycardia.

The drug contains lactose, which should be taken into account when prescribing to patients with rare hereditary disorders of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy. If it is necessary to use the drug, breastfeeding should be discontinued.

Ability to affect reaction rate when driving or operating machinery.

Driving or operating machinery is not recommended during treatment.

Dosage and Administration.

Oral administration for adults and children aged 12 years and older: 1 capsule 1–2 times daily (in the morning and evening), 15–20 minutes before meals. Maximum daily dose – 2 capsules.

For sleep disorders, take 1–2 capsules once daily in the evening before bedtime.

The duration of treatment depends on the therapeutic effect and usually lasts 7 days. Treatment may be repeated after 1–2 weeks.

Children.

Do not use in children under 12 years of age (experience of use is lacking).

Overdose.

Symptoms: general weakness, decreased hearing and visual acuity, palpitations, mental excitement, pronounced fatigue, disturbances in water-electrolyte balance, increased severity of adverse reactions.

Treatment: gastric lavage; if necessary, symptomatic therapy; in case of pronounced neurological adverse effects, caffeine should be administered.

Side effects.

The drug is generally well tolerated; however, in some patients, fatigue, drowsiness, weakness, reduced work capacity, headache, dizziness, suppression of emotional responses, depression, decreased arterial pressure, nausea, spasmodic abdominal pain, and hypokalemia may occur. In individual patients, dyspeptic symptoms and hypersensitivity reactions (including hyperemia, rash, itching, skin swelling, urticaria) are possible.

If any adverse events or unusual reactions occur, consult a physician regarding further use of the drug.

Shelf life. 2 years from the manufacturing date of the bulk product.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

No. 20 (10×2): 10 capsules in a blister, 2 blisters per pack.

Availability. Over-the-counter.

Manufacturer.

LLC "FARMEX GROUP".

Manufacturer's location and address of business operations.

100, Shevchenka Street, Boryspil, Kyiv region, Ukraine, 08301.