Vigor

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VIGOR (VIGOR)

Composition:

Active substance: liquid extract (1 : 9.1) from a mixture of herbal raw materials: rhizomes of sweet flag (Acorus calamus rhizomata) — 0.651 mg, rhizomes with roots of Leuzea carthamoides (maral root) (Rhizomata cum radicibus Leuzeae carthamoides) — 0.06 mg, yarrow herb (Millefolii herba) — 0.87 mg, wormwood herb (Absinthii herba) — 0.129 mg, peppermint leaves (Menthae piperitae folium) — 0.27 mg, bogbean leaves (Menyanthidis trifoliatae folium) — 0.129 mg, lime flowers (Tiliae flos) — 0.756 mg, dill fruits (Anethi graveolentis fructus) — 0.369 mg, oak bark (Quercus cortex) — 0.066 mg, (extraction agent: ethanol 40%) — 30 μL;

Excipients: sugar, caramel coloring, ethanol 96%, purified water.

Note: caramel coloring: sugar, purified water;

1 mL of the preparation contains 0.37 mL of ethanol.

Pharmaceutical form. Oral balm.

Main physicochemical properties: clear golden-brown liquid with a characteristic odor. Sediment formation may occur during storage.

Pharmacotherapeutic group.

Tonics.

ATC code A13A.

Pharmacological Properties

Pharmacodynamics

The pharmacological properties of the balm are determined by the action of its constituent components. Vigor balm contains essential oils, tannins, flavonoids, carotene, organic acids, lactones, and phytoncides. The medicinal product exerts adaptogenic, anti-stress, antitoxic, and anti-inflammatory effects; improves mental and physical performance; supports digestion and normalization of cardiovascular system functions. It increases the body's resistance to various endo- and exotoxic factors and hypoxia, activates the reticuloendothelial system, has a certain immunomodulatory effect and anti-allergic properties. It does not exert negative effects on vital organs and systems.

Clinical characteristics.

Indications.

Physical and emotional overloads, stress, astheno-vegetative syndrome (increased fatigue, reduced work capacity, neurasthenia, sleep disturbances). Conditions requiring immune status correction, convalescence period after severe infectious diseases, chronic gastrointestinal disorders. The balm is prescribed as a prophylactic agent for individuals working under exposure to chemical, radiation, and thermal factors.

Contraindications.

Individual hypersensitivity to components of the medicinal product. Alcoholism, severe forms of ischemic heart disease and essential hypertension, pronounced liver and kidney function disorders. Hypersensitivity to plants of the Asteraceae family (Compositae). Pollinosis. Increased gastric juice acidity. Gastric and duodenal ulcers, cholelithiasis; history of pelvic organ bleeding; anemia; epilepsy. Increased blood coagulation, predisposition to thrombosis. Spasmophilia, bronchial asthma.

Interaction with other medicinal products and other forms of interaction.

Reduces the effectiveness of antacids and H2-receptor blockers (ranitidine, famotidine).

Special precautions for use.

The medicinal product contains 34.5% (v/v) ethanol (alcohol), i.e. 5.4–8.1 g per dose, which is equivalent to 250 ml of beer or 130 ml of wine per dose.

This amount of alcohol may affect the action of other medicinal products.

The balm contains sugar; therefore, it should be prescribed with caution to patients with diabetes mellitus.

Use with caution in patients with gastroesophageal reflux (due to possible occurrence and/or exacerbation of heartburn).

Use during pregnancy or breastfeeding.

Contraindicated.

Ability to influence the reaction rate when driving or operating machinery.

During the use of this medicinal product, driving vehicles or operating potentially dangerous machinery is prohibited.

Dosage and Administration.

The medicinal product is prescribed for adults. Take orally, 20–30 ml 2–3 times daily during meals. The usual duration of treatment is 7–14 days; it may be extended up to 30 days as directed by a physician.

Children.

Not used in children.

Overdose.

Increased manifestations of adverse reactions, dizziness, tachycardia, chest pain.

Significant overdose may lead to alcohol intoxication, requiring discontinuation of the drug and symptomatic therapy.

With prolonged use of the medicinal product in doses exceeding the recommended ones: increased arterial blood pressure, headache, development of alcohol dependence.

Prolonged use of the balm may cause so-called wormwood epilepsy; thujone contained in wormwood, with prolonged use, may cause intestinal atony and contact dermatitis.

Adverse reactions.

Allergic reactions are possible in case of individual intolerance to the components of the medicinal product.

Skin and subcutaneous tissue disorders: hyperemia, skin rashes, urticaria, pruritus, skin edema. In such cases, the balm should be discontinued.

Gastrointestinal disorders: nausea, vomiting.

In case of any adverse events, consult a physician immediately!

Reporting of adverse reactions.

Reporting suspected adverse reactions after the medicinal product has been registered is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy through the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life.

2 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

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

Packaging.

100 mL in jars, 200 mL in bottles, 200 mL, 250 mL or 500 mL in bottles.

Supply category.

Over-the-counter — 100 mL, 200 mL.

By prescription — 250 mL, 500 mL.

Manufacturer.

JSC "Biolyk".

Manufacturer's address and location of operations.

131, Sh. Nezalezhnosti St., Ladizhin, Vinnytsia region, 24321, Ukraine.

Marketing Authorization Holder.

LLC "Ukrainian Pharmaceutical Company".

Address of the Marketing Authorization Holder.

1 U. Starosilska St., Kyiv, 02660, Ukraine.