VALERIANA EXTRACT ARTERIUM

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VALERIAN EXTRACT Arterium (VALERIAN EXTRACT Arterium)

Composition:

Active substance: 1 tablet contains 20 mg of valerian dry extract (valerianae extractum spissum), with ethanol (40%) as extraction solvent, calculated with respect to the dry substance;

Excipients: lactose monohydrate, heavy magnesium carbonate, sodium croscarmellose, stearic acid, castor oil, talc;

Coating: heavy magnesium carbonate, sucrose, hypromellose, talc, povidone, titanium dioxide (E 171), colloidal anhydrous silicon dioxide, beeswax, paraffin, sunflower oil, tartrazine (E 102).

Pharmaceutical form. Coated tablets.

Main physicochemical properties: coated tablets of yellow color with a biconvex surface. Three layers are visible in cross-section.

Pharmacotherapeutic group.
Sedatives and hypnotics. ATC code N05CM09.

Pharmacological Properties.

Pharmacodynamics.

The drug 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 hootinine. The sedative effect develops slowly but is sufficiently stable. Valeric acid and valepotriates have weak spasmolytic activity.

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 drug. 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 drugs.

Special precautions for use.

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

The preparation contains lactose; therefore, it should not be administered to patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

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

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

Specific sensitivity to the smell of valerian may occur.

The medicinal product contains the azo dye tartrazine (E 102), which may cause allergic reactions.

Use during pregnancy or breastfeeding.

The use of this 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, patients should refrain from driving vehicles 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 decision to administer the drug to children aged 6 years and older is made by a physician on a case-by-case basis.

The tablets should be taken without chewing and swallowed with liquid.

The duration of treatment is determined individually by a physician.

Children

Use for treatment of children aged 12 years and older. The decision to administer the drug to children aged 6 years and older is made by a physician on a case-by-case basis.

Overdose

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

Treatment: discontinue the drug, perform gastric lavage, administer activated charcoal. Provide 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 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.

10 or 50 tablets in a blister, 5 blisters №10 in a pack.

Availability.

Over-the-counter.

Manufacturer.

PJSC "Halychpharm".

Manufacturer's address and place of business.

6/8 Opryshkivska Street, Lviv, 79024, Ukraine.