VIGOR-SANTO

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VIGOR-SANTO

Composition:

Active substances: aqueous-alcoholic extract of a mixture of medicinal plant raw materials (rhizomes of Acorus calamus, leaves of Menyanthes trifoliata, rhizomes with roots of Leuzea carthamoides (maral root), herb of Achillea millefolium, herb of Artemisia absinthium, leaves of Mentha piperita, flowers of Tilia, fruits of Anethum graveolens, bark of Quercus robur);

100 ml contain: aqueous-alcoholic extract of a mixture of medicinal plant raw materials (rhizomes of Acorus calamus (Rhizomata Acori Calami) – 0.072 g, leaves of Menyanthes trifoliata (Menyanthidis trifoliatae folium) – 0.014 g, rhizomes with roots of Leuzea carthamoides (Rhizomata cum radicibus Leuzeae carthamoides) – 0.007 g, herb of Achillea millefolium (Millefolii herba) – 0.097 g, herb of Artemisia absinthium (Absinthii herba) – 0.014 g, leaves of Mentha piperita (Menthae piperitae folium) – 0.030 g, flowers of Tilia (Tiliae flos) – 0.084 g, fruits of Anethum graveolens (Fructus anethi graveolentis) – 0.041 g, bark of Quercus robur (Quercus cortex) – 0.007 g), extracted with 40% ethanol – 3 ml;

Excipients: granulated sugar, purified water, 96% ethanol, colorant (E-150d).

1 ml contains not less than 34.5% v/v ethanol.

Pharmaceutical form. Oral solution.

Main physicochemical properties. Transparent, light brown liquid with a characteristic aromatic odor.

Pharmacotherapeutic group.
Tonic agents. ATC code A13A.

Pharmacological properties.

The pharmacological properties of the oral solution are determined by the action of the components contained in its composition. VIGOR-SANTO contains essential oils, tannins, flavonoids, carotene, organic acids, lactones, and phytoncides. The drug exerts adaptogenic, anti-stress, antitoxic, and anti-inflammatory effects, improves mental and physical performance, promotes digestion, and normalizes functions of the cardiovascular system. It increases the body's resistance to various endo- and exotoxic factors, hypoxia, activates the reticuloendothelial system, and exhibits a certain immunomodulatory effect and anti-allergic properties.

Clinical characteristics.

Indications.

Physical and emotional overload, stress, asthenovegetative syndrome (increased fatigability, reduced work capacity, neurasthenia, sleep disturbances). Conditions requiring immune status correction, convalescence period after severe infectious diseases, chronic gastrointestinal disorders. The oral solution is prescribed as a prophylactic agent for individuals working under conditions of exposure to chemical, radiation, and thermal factors.

Contraindications.

Individual intolerance to the drug components, hypersensitivity to plants of the Asteraceae family (Compositae). Pollinosis. Alcoholism. Increased gastric juice acidity, gastric and duodenal ulcer, cholelithiasis, pronounced liver and kidney function disorders, history of bleeding from pelvic organs. Increased blood coagulation, tendency to thrombosis, severe forms of ischemic heart disease and essential hypertension, anemia. Epilepsy. Spasmophilia, bronchial asthma.

Interaction with other medicinal products and other types of interactions.

Interaction is unknown.

Inform your physician about simultaneous use of any other medicinal products.

Special precautions for use.

Do not administer to individuals whose activities require increased attention. The oral solution contains sugar; therefore, use with caution in patients with diabetes mellitus. Use with caution in patients with gastroesophageal reflux due to the possibility of causing or exacerbating heartburn.

Use during pregnancy or breastfeeding.

During pregnancy and breastfeeding, the drug is contraindicated due to its ethanol content.

Ability to affect reaction speed when driving or operating machinery.

Do not use when driving or operating machinery due to the presence of ethanol.

Method of Administration and Dosage

The drug is intended for oral administration to adults, 20–30 ml (4–6 teaspoons) 2–3 times daily during meals. The treatment course lasts 7–14 days. A repeat course may be conducted after an interval of 5–7 days.

Children.

Not recommended for children under 18 years of age.

Overdose.

Significant overdose may lead to alcohol intoxication, requiring immediate discontinuation of the drug and symptomatic treatment. Increased intensity of adverse reactions, dizziness, tachycardia, chest pain, and atonic constipation may occur with prolonged use. Intake in higher than recommended doses, especially if prolonged, may result in poisoning (development of seizures, hallucinations) and may provoke so-called "wormwood" epilepsy. Long-term use of the solution in doses exceeding those recommended may lead to increased arterial blood pressure and headache.

Side effects.

With prolonged use of the solution in doses exceeding the recommended ones, possible side effects include increased arterial pressure, headache, allergic reactions (including urticaria, skin rash, itching, swelling, hyperemia), nausea, vomiting.

If any adverse effects occur, consult a physician immediately!

Shelf life.

2 years.

The product must not be used after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 ℃.

Keep out of reach of children. Sedimentation may occur during storage.

Packaging.

100 ml or 200 ml in a bottle, 500 ml in a bottle.

Prescription status.

100 ml and 200 ml in a bottle – available without prescription.

500 ml in a bottle – prescription only.

Manufacturer.

State Enterprise "Experimental Plant of Medical Products of the Institute of Organic Chemistry and Petrochemistry of the National Academy of Sciences of Ukraine".

Manufacturer's address.

15-A, Zroshuvana Street, Kyiv, 02099, Ukraine.

Marketing Authorization Holder:

LLC "GemoPlasma".

Address of the Marketing Authorization Holder.

26/1, Druzhby Narodiv Boulevard/Professora Pidvysotskoho Street, building A, Kyiv, 01103, Ukraine.