Valerian extract

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VALERIANAE EXTRACTUM

Composition:

Active substance: 1 tablet contains 20 mg of valerian rhizomes with roots (Valerianae radix) dry extract (1:2) (extractant – ethanol 40% v/v);

Excipients: microcrystalline cellulose, potato starch, talc, colloidal anhydrous silicon dioxide, methylcellulose, titanium dioxide (E 171), povidone, tartrazine (E 102).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: intact, regular round cylinders with convex upper and lower surfaces, coated with a film layer, yellow in color. The cross-section reveals a core surrounded by a coating layer.

Pharmacotherapeutic group.
Sedatives and hypnotics. ATC code N05CM09.

Pharmacological Properties.

Pharmacodynamics.

The drug reduces excitability of the central nervous system. This effect is due to the essential oil content, the major part of which is a complex ester of borneol and isovaleric acid. Sedative properties are also exhibited by valepotriates and alkaloids—valerin and chatinine.

The sedative effect develops slowly but is sufficiently stable. Valeric acid and valepotriates exert a weak spasmolytic effect.

Clinical characteristics.

Indications.

Increased nervous excitability, insomnia. As part of combination therapy in mild functional disorders of the cardiovascular system.

Contraindications.

Hypersensitivity to valerian or to other components of the medicinal product.

Depression and other conditions associated with suppression of central nervous system activity.

Interaction with other medicinal products and other forms of interaction.

Valerian preparations may enhance the effects of alcohol, sedatives, hypnotics, analgesics, spasmolytics, and anxiolytic medicinal products.

Special precautions for use

Do not exceed the recommended doses of the medicinal product.

Alcoholic beverages should be avoided during the use of this medicinal product.

The medicinal product contains sugar, which should be taken into account in patients with diabetes mellitus.

The medicinal product contains ethanol. Valerianae extract should not be used for prolonged periods.

Caution should be exercised when administering the medicinal product to patients with a history of severe hepatic impairment or severe liver disease.

Valerian may exert a moderate depressant effect; therefore, concomitant use of the product with synthetic sedative medicinal products is not recommended due to potential potentiation of the effect.

In patients with pronounced cerebral vascular atherosclerosis, the medicinal product should be used only under medical supervision.

The presence of tartrazine (E 102) in the medicinal product may cause allergic reactions.

Specific sensitivity to the odor of valerian may occur.

Use during pregnancy or breastfeeding

Valerianae extract is not recommended due to insufficient data on safety during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery

When using this medicinal product, patients should refrain from driving or operating potentially hazardous machinery.

Dosage and Administration.

For adults and children aged 12 years and older: take 2–4 tablets three times daily.

For children aged 6 years and older: take 1–2 tablets three times daily.

The appropriateness of prescribing the drug to children aged 6 years and older is determined by a physician on an individual basis for each specific case.

The tablets should be swallowed whole, without chewing, with liquid.

The duration of treatment is determined individually by a physician.

Children.

The drug is used for the treatment of children aged 12 years and older. The appropriateness of prescribing the drug to children aged 6 years and older is determined individually by a physician for each specific case.

Overdose.

Symptoms: headache, dizziness, drowsiness, lethargy, general weakness, hand tremors, dilated pupils, chest tightness, abdominal cramps and pain, nausea, decreased hearing and visual acuity, tachycardia, mental agitation, increased fatigue.

Treatment: discontinue the drug, perform gastric lavage, take activated charcoal. Symptomatic therapy.

Cases of withdrawal syndrome (delirium) have been reported after ingestion of very high doses of Valerian extract over several years (approximately 30 g per day).

Side effects.

Central and peripheral nervous system: dizziness, drowsiness, suppression of emotional responses, depression, general weakness, decreased mental and physical performance;

Gastrointestinal tract: nausea;

Immune system: allergic reactions, including skin rash, itching, hyperemia, skin swelling.

If any adverse reactions occur, consult a physician.

Shelf life.

For 10 tablets in a blister; 10 tablets in a blister, 5 blisters per pack – 3 years.

For 50 tablets in a blister; 50 tablets in a container – 2 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

10 tablets per blister; 10 tablets per blister, 5 blisters per pack; 50 tablets per blister; 50 tablets per container.

Availability.

Over-the-counter.

Manufacturer.

JSC "Lubnipharm".

Manufacturer's address and location of business activity.

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