Valerika

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VAlERICA (VALERICA)

Composition:

Active substance: 1 capsule contains valerian root (Valerianae Radix) powder – 350 mg;

Excipients: calcium stearate;

gelatin capsule size № 0: azorubine (E 122), ponceau 4R (E 124), quinoline yellow (E 104), titanium dioxide (E 171), indigotine (E 132).

Medicinal form. Capsules.

Main physico-chemical properties: hard gelatin capsules of cylindrical shape with hemispherical ends, with a cap of pale pink color and a brown-colored body.

The capsule contents – powder from yellowish (greenish)-grey to greyish-brown in color with a characteristic odor. White and dark particles may be present.

Pharmacotherapeutic group. Hypnotics and sedatives. Valerian.

ATC Code N05CM09.

Pharmacological Properties

Pharmacodynamics

The drug exerts a sedative effect, restores the macrostructure of sleep, and stabilizes vegetative functions.

This is a plant-derived agent. Its action is due to the ester compound of borneol and isovaleric acid, valepotriates, and alkaloids (valerine, hoteinin). The drug improves the efficiency and quality of sleep. The sedative effect develops slowly but is sufficiently stable. Valeric acid and valepotriates exert a weak spasmolytic action. In addition, the complex of biologically active substances of Valeriana officinalis has choleretic properties, enhances secretory activity of the gastrointestinal mucosa, slows heart rate, and dilates coronary vessels. Regulation of cardiac activity is achieved via neurohumoral mechanisms and direct influence on the heart's automaticity and conduction system. Therapeutic effects become apparent only with systematic and prolonged course treatment. The drug reduces both spontaneous and heightened excitability of the central nervous system and provides mild anticonvulsant activity. The medicinal product does not produce local irritant effects.

Pharmacokinetics

Not studied.

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;
• arterial hypotension;
• depression or other conditions accompanied by suppression of central nervous system activity, drowsiness;
• cholelithiasis.

Interaction with other medicinal products and other forms of interaction.

Valerian enhances the effects of sedatives, tranquilizers, sedative agents, anxiolytics, analgesics, spasmolytics, centrally acting antihypertensive agents, neuroleptics, ethyl alcohol, nootropic agents, anesthetic agents, curare-like muscle relaxants.

Concomitant use with synthetic sedative agents is not recommended.

Also, concomitant use of alcohol should be avoided.

Special precautions for use.

Do not exceed the recommended doses of the medicinal product.

Alcoholic beverages should be avoided during use of this medicine.

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

Valerian may produce a moderate depressant effect; therefore, concomitant use of this medicine with synthetic sedatives is not recommended due to potential enhancement of the sedative effect.

In patients with pronounced atherosclerosis of cerebral vessels, the medicine should be used only under medical supervision.

The medicine contains the dye "Ponceau 4R" (E 124), which may cause allergic reactions, including bronchial asthma. The risk of allergy is higher in patients with hypersensitivity to acetylsalicylic acid.

Specific sensitivity to the odor of valerian may occur.

Use during pregnancy or breastfeeding.

The use of this medicine during pregnancy or breastfeeding is not recommended due to insufficient safety data for these periods.

Ability to affect reaction speed when driving or operating machinery.

Patients should avoid driving or operating machinery while taking this medicine.

Dosage and Administration.

For adult use only. Take orally, 1 capsule three times daily.

The duration of treatment is determined individually by a physician.

Children.

This medication is not intended for use in children.

Overdose.

Symptoms: possible increased fatigue, general weakness, headache, dizziness, drowsiness, abdominal cramps and pain, nausea, chest tightness, tachycardia, hand tremors, pupillary dilation, decreased hearing and visual acuity.

Treatment: discontinue the drug, perform gastric lavage, administer activated charcoal. If necessary, symptomatic therapy should be provided.

Cases of withdrawal syndrome (delirium) have been reported following long-term intake of very high doses of valerian root (approximately 30 g per day) over several years.

Side effects.

Nervous system: headache, dizziness, fatigue, drowsiness, suppression of emotional responses, depression, general weakness, decreased mental and physical performance, concentration difficulties; in individual cases – psychic excitement, anxiety, insomnia.

Cardiovascular system: arterial hypotension, chest tightness, palpitations, chest pain, cardiac arrhythmias (including bradycardia, tachycardia).

Gastrointestinal tract: nausea, diarrhea, abdominal cramps and pain; with prolonged use, possible suppression of digestion, constipation.

Hepatobiliary system: possible signs of hepatotoxicity.

Immune system: allergic reactions, including skin rashes, itching, urticaria, hyperemia, edema, dyspnea, bronchial asthma.

Side effects occur very rarely, are reversible, and usually develop during prolonged use or significant exceeding of recommended doses.

If any adverse events occur, the patient must consult a physician.

Shelf life. 2 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

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

Keep out of reach of children.

Packaging.

10 capsules in a blister; 2 blisters per carton.

Prescription status.

Over-the-counter.

Manufacturer.

Public Joint-Stock Company "Scientific-Production Center "Borshchahivskiy Chemical-Pharmaceutical Plant".

Manufacturer's address and place of business.

17, Miru Street, Kyiv, 03134, Ukraine.