FLORISED-ZDOROVYA FORTE

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT FLORISED-ZDOROVYE FORTE (FLORISED-ZDOROVYE FORTE)

Composition:

Active ingredients: 1 capsule contains 467.25 mg of dry sedative herbal extract (extraction solvent – purified water); the sedative herbal mixture consists of: Urtica dioica herb, Humulus lupulus L. strobiles, Mentha × piperita L. leaves, Valeriana officinalis L. rhizomes with roots, Glycyrrhiza glabra L. roots and rhizomes (ratio 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 yellow body. The capsule contents are a powder or mass ranging in color from yellowish-brown to reddish-brown, with a faint specific odor. The presence of particle agglomerates and white specks is permissible. The manufacturer's trademark "ZT" may be printed on the capsule.

Pharmacotherapeutic group. Psycholeptics. Hypnotics and sedatives. ATC code N05CM.

Pharmacological properties.

Pharmacodynamics. A complex herbal medicinal product whose effects are determined by 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 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, 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, chronic 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 suppression of central nervous system activity.

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 sedatives and cardiovascular drugs is possible.

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

Special precautions for use. During treatment, alcohol consumption should be avoided. The drug should be administered with caution in patients with gastroesophageal reflux (heartburn), myocarditis, pericarditis, myocardial infarction, bradycardia.

The drug contains lactose; therefore, 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 use of the drug is necessary, breastfeeding should be discontinued.

Effect on ability to drive or operate machinery. During treatment, driving or operating machinery is not recommended.

Administration and dosage. Take orally, 1 capsule 1–2 times daily (in the morning and evening) 15–20 minutes before meals to adults and children aged 12 years and older. Maximum daily dose – 2 capsules.

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

Duration of treatment course depends on therapeutic response and usually lasts 7 days. Treatment may be repeated after 1–2 weeks.

Children. Not to be used 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, intensification 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.

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.

Supply category. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's address and place of business. 22, Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.