VITANGO

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VITANGO (VITANGO®)

Composition:

Active substance: dry extract of rhizome and roots of Rhodiola rosea (Rhodiola rosea);

One film-coated tablet contains 200 mg of dry extract of rhizome and roots of Rhodiola rosea (Rhodiola rosea) (1.5–5:1) (extraction solvent: ethanol 60% m/m);

Excipients: microcrystalline cellulose, sodium croscarmellose, colloidal silicon dioxide, magnesium stearate, hypromellose, stearic acid, iron oxide red (E 172), titanium dioxide (E 171), anti-adherent emulsion: simethicone, methylcellulose, sorbic acid.

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: round, red film-coated tablets.

Pharmacotherapeutic group.

Tonics. ATC code: A13A.

Pharmacological properties.

Pharmacodynamics.

Rhodiola rosea extract WS® 1375 is an adaptogen that enables the body to adapt to stressful conditions. It exerts its adaptogenic effects by modulating the hypothalamic-pituitary-adrenal axis, which plays a primary role in organizing the body's response to stress. In addition, Vitango normalizes the level and activity of neurotransmitters in the central nervous system. Thus, it eliminates stress-induced disturbances in appetite, locomotor activity, and sexual function in animals, and also enhances cellular energy production by increasing adenosine triphosphate levels.

Clinical studies of Vitango show clinically significant improvement of stress-related symptoms such as physical and mental fatigue, exhaustion, irritability, impaired mood, and concentration after 4–8 weeks of treatment. A 12-week clinical study demonstrated the drug's ability to increase individual stress resistance, thereby reducing the risk of burnout syndrome development. Vitango's capacity to prevent stress was confirmed in another study after 12 weeks of treatment, which showed a positive effect on attention and mental resource allocation in individuals at risk for stress-related symptoms.

Pharmacokinetics.

Data are lacking.

Clinical characteristics.

Indications.

For temporary relief of mental and physical symptoms of stress and fatigue (tiredness, irritability, tension).

Contraindications.

Hypersensitivity to the active substance or to any component of the medicinal product. Pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction.

Data on interactions are lacking.

Special precautions

The medicinal product is not recommended for patients with impaired liver or kidney function due to lack of relevant data.

The product contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. it is practically sodium-free.

Use during pregnancy or breastfeeding.

Contraindicated.

Pregnancy

Data on the use of Vitango in pregnant women are lacking or limited. Animal studies do not indicate harmful effects on human reproductive function.

Lactation

It is unknown whether Vitango or its metabolites are excreted in breast milk. Risk to the breastfed infant cannot be excluded.

Fertility

Animal studies have not revealed any harmful effects on fertility or on embryonic or fetal development.

Dosage and Administration

Adults should take 1 tablet twice daily (in the morning and at noon), 30 minutes before meals, with a glass of water. The duration of treatment is determined individually by a physician.

If symptoms persist for 2 weeks or worsen during treatment, consult a doctor.

Children

The product is not recommended for use in children (under 18 years of age).

Overdose

No cases of overdose have been reported.

Adverse Effects

From the nervous system

Mild headache, restlessness, insomnia, dizziness. Frequency unknown.

From the gastrointestinal tract

Mild gastrointestinal complaints (abdominal pain, diarrhea, nausea, and vomiting). Frequency unknown.

From the skin and subcutaneous tissues / from the immune system

Mild hypersensitivity reactions (allergic reactions such as skin rash and itching). Frequency unknown.

If other adverse reactions occur, consult a doctor.

Reporting suspected adverse reactions after drug registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the drug. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of drug efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life. 5 years.

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

Storage conditions. No special storage conditions required. Keep out of reach of children.

Packaging. 15 tablets in a blister pack; 1 or 2 blisters per cardboard box.

Release category.

Over-the-counter (without prescription).

Manufacturer.

Dr. Willmar Schwabe GmbH & Co. KG.

Manufacturer's address and place of business.

Willmar-Schwabe-Strasse 4, 76227 Karlsruhe, Germany.