Valeriana forte

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VALERIANA FORTE

Composition:

Active substance: 1 tablet contains 40 mg of valerian dry extract (Valerianae extractum spissum) 3.5:1 (extractant 40% (v/v) ethanol), calculated as dry substance;

Excipients: lactose monohydrate (Granulac - 70); sodium croscarmellose; light magnesium carbonate; castor oil; calcium stearate; talc; coating mixture "Opaglos II Yellow" 97W22039 (sodium carmellose (sodium carboxymethylcellulose); dextrin; glucose monohydrate; titanium dioxide (E 171); lecithin; quinoline yellow (E 104); yellow FCF (E 110)).

Pharmaceutical form. Film-coated tablets.

Main physicochemical characteristics: film-coated tablets, from yellow to yellow with a greenish tint, round-shaped, with a biconvex surface; a two-layer structure is visible upon breaking.

Pharmacotherapeutic group. Hypnotics and sedatives. ATC code N05CM09.

Pharmacological properties.

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 hootinin.

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 and/or to other components of the medicinal product; depression or other conditions associated with central nervous system depression.

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 medication.

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

The drug contains glucose, which should be taken into account in patients with diabetes mellitus.

Caution is advised in patients who have had severe hepatic impairment or a history of severe liver disease.

Specific sensitivity to the odor of valerian may occur.

The drug contains the azo dye sunset yellow (E 110), which may cause allergic reactions.

Use during pregnancy or breastfeeding.

The use of this drug is not recommended due to insufficient safety data during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

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

Dosage and Administration.

For adults and children aged 12 years and older: take 1–2 tablets three times a day.

For children aged 6 years and older: take 1 tablet three times a day.

The decision to prescribe the drug to children aged 6 years and older is made by a physician on an individual basis.

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

The duration of treatment is determined individually by a physician.

Children.

The drug is indicated for treatment of children aged 12 years and older. The decision to prescribe the drug to children aged 6 years and older is made by a physician on an individual basis in each specific case.

Overdose.

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

Treatment: discontinue the drug, gastric lavage, activated charcoal. 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: allergic reactions, including skin rash, itching, hyperemia, skin swelling.

Shelf life. 2 years.

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

Keep out of reach of children.

Packaging. 10 film-coated tablets in a blister, 5 blisters in a pack.

Availability category. Over-the-counter.

Manufacturer. JSC "Kyivmedpreparat", Ukraine.

Manufacturer's address and place of business.

139 Saksaganskogo Street, Kyiv, 01032, Ukraine.