INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT FLORISED-ZDOROV'YA

Composition:

Active substances: 1 capsule contains 311.5 mg of dry sedative extract mixture (the sedative mixture consists of dog nettle herb, common hop cones, peppermint leaves, rhizomes with roots of valerian, roots and rhizomes of licorice (ratio 4:2:1.5:1.5:1));

Excipients: calcium stearate; lactose monohydrate; capsule shell contains titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), gelatin.

Pharmaceutical form. Capsules.

Main physicochemical properties: hard gelatin capsules of light brown color with pinkish hue. The capsule contents are powder, particle agglomerates, or a mass ranging from yellowish-brown to reddish-brown in color, with a weak specific odor. The presence of white specks is permissible.

Pharmacotherapeutic group. Psycholeptics. Hypnotics and sedatives.

ATC code N05CM.

Pharmacological properties.

Pharmacodynamics. A complex herbal preparation, whose action is determined by the properties of biologically active substances of dog nettle, hops, mint, valerian, and licorice (hydroxycinnamic acids, flavonoids, terpene glycosides, etc.). Exerts a comprehensive sedative effect on the central nervous system: has a mild calming effect, reduces psycho-emotional tension, increased sensitivity 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, fear and tension, irritability, depression, 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"); impaired memory and concentration; climacteric syndrome.

Contraindications. Hypersensitivity to the components of the drug; acute inflammatory diseases of the stomach and intestines; irritable bowel syndrome; gastric ulcer; bronchial asthma; hepatic and renal function disorders; hypokalemia; severe obesity; depression and other conditions 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 products is possible.

The drug may potentiate the effects of alcohol, cardiac glycosides, hypnotics, psychotropic agents, analgesics, spasmolytics, and centrally-acting antihypertensive drugs. When used concomitantly with cardiac glycosides, antiarrhythmic agents (quinidine), thiazide and loop diuretics, and laxatives, hypokalemia may be intensified.

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, or bradycardia.

If a patient has known intolerance to certain sugars, medical advice should be sought before taking this medicinal product.

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

Ability to affect reaction speed when driving or operating machinery. Driving or operating machinery is not recommended during treatment.

Dosage and Administration

Take orally. For adults and children aged 12 years and older: 1–2 capsules 1–2 times daily (in the morning and evening), 15–20 minutes before meals.

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|study|use|consumption| absent).

Overdose. Symptoms: general weakness, decreased hearing and visual acuity, palpitations, mental excitement, pronounced fatigue, water-electrolyte imbalance, and intensified adverse reactions.

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

Adverse Reactions. The drug is generally well tolerated; however, in some patients the following may occur: fatigue, drowsiness, weakness, reduced work capacity, headache, dizziness, suppression of emotional responses, depression, decreased arterial blood pressure, nausea, spasmodic abdominal pain, and hypokalemia. 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.

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

Packaging. Capsules, 10×2 in blisters, in a box.

Prescription Status. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Manufacturer's Address and Location of Business Activity. 22, Shevchenka Street, Kharkiv, Kharkiv Region, 61013, Ukraine.