Valeriana extract

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VALERIANA EXTRACT

Composition:

Active substance: valerian root extract, thick (Valerianae radix extractum spissum) (2.6–5.6 : 1) [extracting agent — ethanol 70.0% (v/v)];

One tablet contains thick valerian root extract (Valerianae radix extractum spissum) (2.6–5.6 : 1) [extracting agent — ethanol 70.0% (v/v)], calculated on dry substance — 20 mg;

Excipients: microcrystalline cellulose, light magnesium carbonate, sodium croscarmellose, anhydrous colloidal silicon dioxide, magnesium stearate, film coating "Wincoat WT-MPAQ-01618P ORANGE" [polyvinyl alcohol, polyethylene glycol 400, titanium dioxide (E 171), talc, yellow sunset FCF (E 110)].

Medicinal form. Film-coated tablets.

Main physicochemical properties: round, biconvex tablets coated with a film layer ranging in color from pale orange to orange.

Pharmacotherapeutic group. Hypnotics and sedatives.

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 valerates and alkaloids—valerin and hootinin. The sedative effect develops slowly but is quite stable. Valeric acid and valerates exert a weak spasmolytic effect.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Increased nervous excitability, insomnia. Mild functional disorders of the cardiovascular system — as part of combination therapy.

Contraindications.

Increased individual sensitivity to valerian and/or other components of the medicinal product; depression and other conditions associated with central nervous system depression, drowsiness, arterial hypotension, cholelithiasis.

Interaction with other medicinal products and other types of interactions.

The effect of the medicinal product "Valerian extract" does not depend on food intake.

Valerian preparations may enhance the effects of hypnotics, tranquilizers, sedatives, anxiolytics, analgesics, spasmolytics, centrally acting antihypertensive agents, neuroleptics, ethyl alcohol, nootropic agents, anesthetics, and curare-like muscle relaxants.

Concomitant use with synthetic sedative drugs is not recommended.

Also, concomitant use of alcohol should be avoided.

Special precautions for use

"Valerian extract" is a traditional herbal medicinal product used according to indications supported by long-standing use.

The patient should consult a physician if symptoms do not improve during treatment with the medicinal product or if adverse reactions occur that are not listed in this instruction.

Alcoholic beverages should be avoided during treatment with this medicinal product.

Caution is required 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 sodium compounds. Caution is advised in patients on a sodium-restricted diet.

Due to the presence of the colouring agent "Yellow West FCF" (E 110) in the formulation, allergic reactions may occur.

Use during pregnancy or breastfeeding.

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

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 prescribe the medicinal product to children aged 6 years and older is determined by a physician on an individual basis for each specific case.

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

The duration of treatment is determined individually.

Children.

This medicinal product is indicated for treatment of children aged 12 years and older. The decision to prescribe the medicinal product to children aged 6 years and older should be made individually by a physician in each specific case.

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.

Side effects.

Adverse reactions to the medicinal product are very rare and are reversible. Usually, adverse reactions occur with prolonged use and significant exceeding of the recommended doses.

Central and peripheral nervous system: headache, dizziness, lethargy, drowsiness, suppression of emotional responses, depression, general weakness, decreased mental and physical performance, reduced concentration; in individual cases — mental excitement, anxiety, insomnia.

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

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

Hepatobiliary system: signs of hepatotoxicity.

Immune system: allergic reactions; in cases of individual hypersensitivity to components of the medicinal product, skin rashes, itching, urticaria, hyperemia, skin swelling, dyspnea, bronchial asthma.

If any other adverse reactions occur, the patient should discontinue use of the medicinal product and consult a physician.

Reporting of adverse reactions after registration of the medicinal product is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

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 tablets per blister; 5 or 10 blisters per cardboard box.

Availability category. Over-the-counter.

Manufacturer/Marketing Authorization Holder.

TOV "Ternofarm".

Manufacturer's address and location of its operations / Marketing Authorization Holder's address.

Ukraine, 46010, Ternopil, Fabrychna St., 4.

Tel./fax: (0352) 521-444, www.ternopharm.com.ua