Valerian extract

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VALERIANA EXTRACTUM

Composition:

Active substance: 1 tablet contains 20 mg of dry extract of valerian root (Valerianae radix) (extraction agent – 40% ethanol) (calculated as isovaleric acid, not less than 0.004 g);

Excipients: heavy magnesium carbonate, potato starch, talc, povidone;

Coating composition: confectionery sugar, heavy magnesium carbonate, talc, titanium dioxide (E 171), anhydrous colloidal silicon dioxide, povidone, yellow wax, paraffin, sunflower oil, tartrazine (E 102).

Pharmaceutical form. Coated tablets.

Main physicochemical properties: coated tablets, yellow in color, biconvex in shape. Three layers are visible in cross-section.

Pharmacotherapeutic group. Sedatives and hypnotics. ATC code N05CM09.

Pharmacological properties.

Pharmacodynamics.

The medicinal product reduces excitability of the central nervous system. The effect is due to the essential oil content, the major part of which is a complex ester of borneol alcohol and isovaleric acid. Sedative properties are also exhibited by valepotriates and alkaloids—valerin and chatinine. The sedative effect manifests slowly but quite steadily. Valeric acid and valepotriates exert a weak spasmolytic effect.

Pharmacokinetics. Data are lacking.

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 any other components of the medicinal product. Depression and other conditions associated with central nervous system depression.

Interaction with other medicinal products and other forms of interaction.

Medicinal products containing valerian may enhance the effects of alcohol, sedatives, hypnotics, analgesics, spasmolytics, and anxiolytics.

Special precautions for use.

During the use of the medicinal product, alcohol consumption should be avoided.

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

Caution is advised in patients with severe hepatic impairment or a history of severe liver disease.

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

Specific sensitivity to the smell of valerian may occur.

Use during pregnancy or breastfeeding. The use of the medicinal product is not recommended due to insufficient data on safety during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery. When using this medicinal product, driving vehicles or operating potentially hazardous machinery should be avoided.

Dosage and Administration

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

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

The decision to administer the medicinal product to children aged 6 years and older is determined by a physician on a case-by-case basis.

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

The duration of treatment is determined individually by a physician.

Children. This medicinal product is indicated for use in children aged 12 years and older. The decision to administer the medicinal product to children aged 6 years and older is determined by a physician on a case-by-case basis.

Overdose.

Symptoms: headache, dizziness, drowsiness, lethargy, general weakness, hand tremors, pupil dilation, chest tightness, abdominal pain, nausea, decreased hearing and visual acuity, tachycardia.

Treatment: discontinue the medicinal product, gastric lavage, administration of activated charcoal. Symptomatic therapy.

Adverse reactions.

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.

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. Tablets, 50 in bottles or blisters, or 10 tablets in a blister, 5 blisters per pack.

Availability category. Over-the-counter.

Manufacturer. JSC "FITOPHARM".

Manufacturer's address and location of business activity.

2 Sybirtseva Street, Bakhmut, Donetsk region, 84500, Ukraine.

Marketing Authorization Holder. JSC "FITOPHARM".

Address of the Marketing Authorization Holder.

7, Verkhovnoyi Rady Avenue, Kyiv, 02100, Ukraine, 3rd floor, room 18.