Ginseng

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT GINSENG

Composition:

Active substance: 1 vial contains ginseng tincture (Tincturae Ginseng) (1:10) (extractant – ethanol 70.0% (v/v) ) – 50 ml or 100 ml.

Pharmaceutical form. Oral tincture.

Main physicochemical properties: clear yellowish liquid.

Sediment formation may occur during storage.

Pharmacotherapeutic group.

Tonizing agents. ATC code A13A.

Pharmacological properties.

Pharmacodynamics.

The drug exerts adaptogenic, tonic, and hypertensive effects. It enhances excitatory processes in neurons of the cerebral cortex and brainstem regions, improves reflex activity, activates metabolism, and increases work capacity. The effects of the drug are dose-dependent: when used in low doses, excitation is enhanced and inhibitory processes are reduced; at high doses, the latter are enhanced.

Clinical characteristics.

Indications.

Reduced mental and physical performance, asthenic conditions, convalescence period after severe illnesses, impaired sexual function of neurasthenic origin (as part of combination therapy).

Contraindications.

Hypersensitivity to the components of the drug. Arterial hypertension, increased excitation, insomnia, tendency to bleeding, acute infectious diseases, epilepsy.

Interaction with other medicinal products and other types of interactions.

Ginseng tincture enhances the effects of psychostimulants, analgesics, anesthetics, caffeine, camphor, phenamine, and other central nervous system (CNS) stimulants. It reduces the effects of hypnotics and neuroleptics. The drug is a physiological antagonist of barbiturates; therefore, their simultaneous use is not rational. Do not use together with antidepressants or alcohol.

Possible reduction in the anticoagulant effect of Warfarin. Interaction with other anticoagulants (e.g., heparin) may also occur. Interaction with phenelzine (MAO inhibitor) cannot be excluded.

The drug increases the clearance of sulfoalbendazole (anthelmintic agent).

When used in combination with digoxin, it should only be administered under medical supervision with monitoring of increased digoxin blood concentration.

The drug acts as an antagonist to agents that suppress CNS functions (tranquilizers, anticonvulsants).

Special precautions for use.

Ginseng tincture should not be taken in the second half of the day. It should be taken into account that the drug is most effective in autumn and winter.

Shake well before use.

The drug should be discontinued at least 2 weeks prior to surgical intervention. Patients suffering from diabetes mellitus should monitor their blood glucose levels.

Ginseng tincture is a traditional medicinal product used according to indications supported by long-term experience.

Use during pregnancy or breast-feeding.

Contraindicated.

Effect on ability to drive and use machines.

Since the product contains ethanol, Ginseng tincture is not recommended for use while driving or operating machinery.

Method of Administration and Dosage

Take orally, 30–40 minutes before meals. The single dose for adults is 15 to 20 drops. The medication should be taken twice daily for 30–40 days. Repeat treatment courses should be administered after 2–3 weeks, if necessary.

For children aged 12 years and older, administer at a dosage of 1 drop per year of life.

If the dropper cap is missing, use a medical glass pipette to measure the medication; the dosage remains unchanged.

The patient should consult a physician if symptoms do not improve during treatment or if adverse reactions not listed in the instructions occur.

Children

Use in children aged 12 years and older only under medical supervision and on a physician's prescription.

Overdose

Symptoms: headache and dizziness, insomnia, nausea, vomiting, elevated body temperature, respiratory disturbances, loss of consciousness, bleeding.

Treatment: gastric lavage, use of sorbents. Symptomatic therapy.

Adverse Reactions.

Possible allergic reactions (including skin redness, roseola-like rashes, itching), bleeding gums and nasal mucosa (in severe cases – presence of blood traces in vomit and feces), increased blood pressure, increased excitability, insomnia, headache, tachycardia, nausea, vomiting, diarrhea. The drug may cause estrogen-like effects manifested as mastalgia, menopausal vaginal bleeding, and gynecomastia.

If any adverse reactions occur, treatment should be discontinued and medical advice sought.

Reporting suspected adverse reactions.

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

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.

50 ml in glass or polymer bottles.

50 ml in glass or polymer bottles in a cardboard box.

100 ml in glass bottles.

100 ml in glass bottles in a cardboard box.

Availability.

Over-the-counter.

Manufacturer.

JSC "Lubnipharm".

Manufacturer's address and place of business.

16, Barvinkova Street, Lubny, Poltava region, 37500, Ukraine.