RHODIOLA EXTRACT LIQUID

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT RHODIOLAE EXTRACTUM FLUIDUM

Composition:

Active substance: liquid extract from rhizomes with roots of Rhodiola rosea (Rhodiolae radix);

1 bottle of the preparation contains liquid extract from rhizomes with roots of Rhodiola rosea (Rhodiolae radix) (1 : 1) (extractant – ethanol 40%) 25 ml or 50 ml.

Pharmaceutical form. Liquid extract.

Main physico-chemical properties: dark brown liquid with a characteristic aroma.

Pharmacotherapeutic group. Tonics. ATC code A13A.

Pharmacological properties.

Pharmacodynamics.

Liquid Rhodiola extract belongs to the group of toning agents and is characterized by adaptogenic properties due to the presence in rhizomes with roots of organic acids, tannins, beta-sitosterol, and two crystalline substances: n-phenyl-β-ethanol, n-tyrosine, and its glycoside n-phenyl-β-(β-α-glucopyranoside)-ethanol—rhodioloside.

The drug enhances the body's resistance to adverse factors (hypothermia, overheating, oxygen deficiency, various stresses), reduces mental strain, and increases mental and physical performance by optimizing energy processes and stimulating functions of the central nervous system. Experimental data have been obtained on the antiarrhythmic effect of liquid Rhodiola extract.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Asthenic conditions, increased fatigue, neurasthenia, vegetative-vascular dystonia, convalescence period, reduced work capacity.

Contraindications.

Arterial hypertension, hyperthyroidism, increased sensitivity to the components of the drug, pregnancy, breastfeeding, pediatric age (under 18 years).

Interaction with other medicinal products and other forms of interaction.

The drug may enhance the effects of monoamine oxidase inhibitors and other psychostimulant agents.

Special precautions for use.

Rhodiola liquid extract is not recommended to be taken in the second half of the day to prevent insomnia. The preparation should be administered with caution to individuals with cardiovascular diseases and diabetes mellitus.

Use during pregnancy or breastfeeding.

Contraindicated.

Ability to affect reaction speed when driving or operating machinery.

Not observed.

Method of Administration and Dosage.

The drug is administered orally to adults, 5–10 drops 2–3 times daily, 10 minutes before meals.
In cases of asthenia and in psychiatric practice, treatment is initiated with 10 drops 2–3 times daily, gradually increasing the dose up to 30–40 drops per dose.
The duration of treatment is 1–2 months.

Children.

Do not administer to children (under 18 years of age).

Overdose.

There is currently no information regarding cases of overdose. Excessive excitability may occur, in which case the drug should be discontinued.

Adverse reactions.

Central nervous system: increased excitability, insomnia, headache.

Cardiovascular system: increased arterial pressure.

Possible cases of hypersensitivity to the drug, for which desensitization therapy is required.

Laboratory findings: hypoglycemia.

If any adverse symptoms occur, consult a physician.

Shelf life.

5 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 ºC.

Keep out of reach of children.

Packaging.

25 ml, 50 ml in bottles; 25 ml, 50 ml in bottle, 1 bottle in a cardboard box.

Availability category.

Over-the-counter.

Manufacturer.

JSC "Biolyk".

Manufacturer's address and location of business activity.

131, Nezalezhnosti Str., m. Ladizhin, Vinnytsia region, Ukraine, 24321.

Marketing authorization holder.

LLC "Ukrainian Pharmaceutical Company".

Address of the marketing authorization holder.

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