VALERIANA

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VALERIAN (VALERIANA)

Composition:

Active substance: dry extract of valerian root (valerianae radix);

One tablet contains dry extract of valerian root (valerianae radix) (5-8:1) (extraction solvent: aqueous-ethanolic solution) – 30 mg;

Excipients: microcrystalline cellulose, lactose monohydrate, copovidone, colloidal anhydrous silicon dioxide, magnesium stearate, polyvinyl alcohol, polyethylene glycol (macrogol) 3350, titanium dioxide (E 171), sunset yellow FCF (E 110), iron oxide yellow (E 172), ponceau 4R (E 124).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: round, biconvex film-coated tablets, 7 mm in diameter, pale orange in color, with a characteristic valerian odor.

Pharmacotherapeutic group.
Hypnotics and sedatives. ATC code N05CM09.

Pharmacological properties.

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 valerates and alkaloids – valerin and chatinine. The sedative effect manifests slowly but is sufficiently stable.

Valeric acid and valerates 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.

Increased individual sensitivity to valerian or to 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.

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

Specific sensitivity to the smell of valerian may occur.

This medicinal product contains lactose; therefore, patients with rare hereditary conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this product. The medicinal product contains azo dyes: sunset yellow FCF (E 110) and ponceau 4R (E 124), which may cause allergic reactions.

Use during pregnancy and breastfeeding.

The use of this medicinal product 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 vehicles or operating potentially hazardous machinery.

Method of Administration and Dosage.

The drug should be taken orally after meals. The recommended dose for adults and children aged 12 years and older is 30–60 mg (1–2 tablets) 3–4 times daily. Swallow the tablets whole with sufficient liquid, without chewing.

The duration of treatment is determined based on the therapeutic effect and the patient's tolerance of the drug.

Children.

The drug can be used for treatment of children aged 12 years and older. The appropriateness of prescribing the drug to children aged 6 years and older should be determined 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.

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: hypersensitivity reactions, including rash, itching, hyperemia.

Shelf life . 2 years.

Storage conditions.

Store in the original packaging, out of reach of children, at a temperature not exceeding 25 °C.

Packaging. 10 tablets in a blister, 3 blisters in a cardboard box. 20 tablets in a blister, 5 blisters in a cardboard box.

Dispensing category. Over-the-counter.

Manufacturer. JSC "Sofarma".

Manufacturer's address and location of business activity.

2800, Sandanski, Industrial Zone, Bulgaria.