INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT FLORA

Composition:

Active substances: 100 ml of elixir contains liquid extract from medicinal plant raw materials (1:8.5; extractant: 45% ethanol, 40% ethanol): Meliloti herba (Melilotus officinalis (L.) Lam.) 59.3 mg; Glycyrrhizae radix 22.7 mg; Calendulae flos (Calendula officinalis L.) 11.9 mg; Silybi mariani fructus (Silybum marianum L.) 16.5 mg; Coriandri fructus (Coriandrum sativum L.) 59.6 mg.

Excipients: citric acid monohydrate; ascorbic acid; sucrose; ammonia caramel sulphite (E 150d); colouring agent Sunset Yellow FCF (E 110); food flavouring "Apricot 696" containing propylene glycol; alcoholic apple juice; ethanol 96%; purified water.

Pharmaceutical form. Oral elixir.

Main physicochemical characteristics: clear light brown liquid with a characteristic odour.

Pharmacotherapeutic group. Sedatives and hypnotics. ATC code N05CM.

Pharmacological properties.

Pharmacodynamics. A combination drug containing a complex of herbal extracts: Leonuri cardiaca (herb), Glycyrrhizae glabrae (roots and rhizomes), Calendulae officinalis (flowers), Cardui mariae (fruits), Coriandri (fruits).

Leonurus cardiaca exerts a calming effect on the central nervous system, has an anticonvulsant effect, increases cardiac minute volume, improves cerebral and peripheral blood supply and circulation in abdominal organs. It exhibits anticoagulant activity.

Glycyrrhiza glabra exerts anti-inflammatory effects due to suppression of inflammatory reactions caused by histamine, serotonin, and bradykinin; has a spasmolytic effect on smooth muscles; accelerates healing of gastric ulcers. Calendula officinalis (marigold) exhibits bactericidal, anti-inflammatory, spasmolytic, choleretic, analgesic, and antipruritic properties.

Silybum marianum has hepatoprotective properties, as well as choleretic and spasmolytic effects. Coriander exhibits choleretic and wound-healing properties, improves digestion.

The therapeutic effect of Flora elixir is due to the combined action of its components. The drug exerts sedative, anxiolytic, antiseptic, anti-inflammatory, and choleretic effects; reduces manifestations of anxiety and mental tension, thereby normalizing sexual potency. It exerts a calming effect on the central nervous system by activating the limbic system of the brain. Stimulates spermatogenesis.

Clinical characteristics.

Indications. In the complex treatment of neurotic and neurosis-like conditions accompanied by feelings of fear, tension, and anxiety; mild forms of sleep disturbances and headache; sexopathological syndromes associated with decreased libido and psychoemotional disorders; climacteric disorders; peptic ulcer of the stomach and duodenum; dermatoses accompanied by pruritus.

Contraindications. Increased individual sensitivity to the components of the drug, impaired blood coagulation, severe obesity, hypokalemia, hepatic and renal dysfunction, liver cirrhosis, arterial hypertension, organic heart lesions (myocarditis, pericarditis, myocardial infarction), alcoholism.

Interaction with other medicinal products and other types of interactions. May enhance the effects of anticoagulant, anti-inflammatory, choleretic agents, and drugs that suppress the central nervous system (antipsychotics, anxiolytics, antidepressants, barbiturates, ethanol). With prolonged use in combination with cardiac glycosides, thiazide and loop diuretics, adrenocorticosteroids, antiarrhythmics, laxatives, and drugs affecting heart rhythm (quinidine), the risk of developing hypokalemia increases.

Special precautions for use.

Prolonged use of the medicinal product is not recommended.

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

The dye Sunset Yellow FCF (E 110) may cause allergic reactions.

This medicinal product contains 3.3 g/ dose of ethanol. It is harmful for patients suffering from alcoholism. Caution should be exercised when administered to patients with epilepsy.

The medicinal product contains sugar, which may be harmful to teeth.

Use during pregnancy or breastfeeding. Do not use.

Ability to affect reaction speed when driving or operating machinery. Caution is required when driving or operating machinery, as the product has a sedative effect.

Method of administration and dosage.

For adults: orally, 5–10 mL (1 teaspoon – 1 tablespoon) three times daily for 7–14 days.

Children. There is no experience with the use of the drug in children.

Overdose. Cases of overdose have not been reported; however, nausea, vomiting, diarrhea, increased diuresis, headache, and weakness are theoretically possible. Overdose and prolonged use (more than 2 months) may cause disturbances in water-electrolyte balance, potentially leading to hypokalemic myopathy and myoglobinuria. Exacerbation of adverse effects is possible.

Side effects.

Very rarely, allergic reactions (including rash, itching, redness of the skin, swelling) may occur in individuals with hypersensitivity, as well as hypokalemia, burning sensation/epigastric pain, bitter taste in the mouth, increased blood pressure. If adverse reactions occur, discontinue use of the product and consult a physician.

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. 100 ml in a bottle in a box; 100 ml in a bottle.

Prescription status. Over-the-counter.

Manufacturer. Limited Liability Company "Pharmaceutical Company "Zdorovye".

Manufacturer's address. 22 Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.