Valeriana forte

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VALERIANA FORTE

Composition:

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

One tablet contains thick valerian root extract (Valerianae radix extractum spissum) (2.6–5.6 : 1) [extractant – ethanol 70.0% (v/v)], calculated as dry residue – 40 mg;

Excipients: microcrystalline cellulose, light magnesium carbonate, sodium croscarmellose, colloidal anhydrous 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)].

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: round, biconvex tablets with a film coating, pale orange to orange in color.

Pharmacotherapeutic group. Sedatives and hypnotics.

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 sufficiently 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.

Hypersensitivity to valerian and/or other components of the medicinal product; depression and other conditions associated with suppression of central nervous system activity, somnolence, arterial hypotension, cholelithiasis.

Interaction with other medicinal products and other forms of interactions.

The effect of Valeriana Forte is independent of food intake.

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

Concomitant use with synthetic sedative drugs is not recommended.

Alcohol consumption should also be avoided during treatment.

Special precautions for use

During the use of this medicinal product, consumption of alcoholic beverages should be avoided.

Valerian may have a moderate depressant effect; therefore, simultaneous use of Valerian Forte with synthetic sedatives is not recommended due to potentiation of the effect.

In cases of pronounced atherosclerosis of cerebral vessels, the medicinal product should be used only under medical supervision.

Patients who have had severe liver function impairment or a history of severe liver disease should exercise caution when taking this product.

The recommended doses of the medicinal product should not be exceeded.

Specific sensitivity to the smell of valerian may occur.

This medicinal product contains sodium compounds. Caution is advised when administering to patients on a sodium-restricted diet.

Specific sensitivity to the smell of valerian may occur.

The medicinal product contains the colouring agent E 110, which may cause allergic reactions.

Use during pregnancy or breastfeeding

The use of this medicinal product 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 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 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 medicinal product to children aged 6 years and older is determined 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.

Children.

This medicinal product is indicated for use in children aged 12 years and older. The decision to prescribe the medicinal product to children aged 6 years and older is determined individually by a physician in each specific case.

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 medicinal product, perform gastric lavage, administer activated charcoal. Symptomatic therapy.

Side effects.

Side effects of the medicinal product are very rare and 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, decreased concentration; in individual cases – mental excitement, anxiety, insomnia.

Cardiovascular system: arterial hypotension, feeling of 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: 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 may occur.

If any other undesirable side effects 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 monitoring of the benefit-risk balance of this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance 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 in a blister; 5 or 10 blisters in a cardboard box.

Availability. Over-the-counter.

Manufacturer/Marketing Authorization Holder.

LLC "Ternopharm".

Manufacturer's address / Marketing Authorization Holder's address.

4 Fabrychna Street, Ternopil, 46010, Ukraine.

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