Valerian extract Renewal (Tablets) Instructions for Use

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

ATC Code

N05CM09 (Valerian roots)

Active Substance

Valerian (BP British Pharmacopoeia)

Dosage Form

Valerian extract Renewal

Film-coated tablets 20 mg: 10, 20, or 50 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow in color, round, biconvex; the core on the cross-section is brown, the presence of light and dark inclusions is allowed.

Excipients: magnesium hydroxycarbonate – 50.5 mg, potato starch – 26.69 mg, talc – 2.58 mg, gelatin – 0.23 mg.

Shell composition: OPADRY^® COMPLETE FILM COATING SYSTEM 20F230009 YELLOW [hypromellose – 5 mg, talc – 2.35 mg, titanium dioxide – 1.28 mg, macrogol (polyethylene glycol) – 0.5 mg, hyprolose (hydroxypropylcellulose) – 0.5 mg, quinoline yellow dye (E104) – 0.345 mg, sunset yellow FCF dye (E110) – 0.013 mg, iron oxide yellow dye (E172) – 0.012 mg]
OPADRY^® II COMPLETE FILM COATING SYSTEM 85F19250 CLEAR [polyvinyl alcohol – 0.523 mg, talc – 0.3 mg, macrogol (polyethylene glycol) – 0.147 mg, polysorbate 80 – 0.03 mg]

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.

Clinical-Pharmacological Group

Sedative herbal preparation

Pharmacotherapeutic Group

Psycholeptics; hypnotics and sedatives; other hypnotics and sedatives

Pharmacological Action

It is a herbal remedy. It causes a moderately pronounced sedative effect.

The action is due to the content of essential oil, most of which is the ester of borneol and isovaleric acid. Valepotriates and alkaloids – valerine and chotenine – also have sedative properties.

Valerian facilitates the onset of natural sleep. The sedative effect develops slowly but is quite stable.

Valeric acid and valepotriates have a weak antispasmodic effect. Furthermore, the complex of biologically active substances of Valeriana officinalis has a choleretic effect, enhances the secretory activity of the gastrointestinal mucosa, slows the heart rate, and dilates the coronary vessels.

The regulation of cardiac activity is mediated through neuroregulatory mechanisms and a direct influence on the automation and conduction system of the heart. The therapeutic effect is manifested with systematic and long-term course treatment.

Indications

States of excitation; sleep disorders associated with overexcitation; migraine; mild functional disorders of the cardiovascular and digestive systems (usually as part of combination therapy).

ICD codes

Dosage Regimen

Take orally with a small amount of water.

Swallow the tablet whole; do not crush or chew.

For adults and adolescents aged 12 years and older, the typical dose is one to two tablets (20-40 mg).

Take the dose two to three times daily.

For sleep disorders, take a single dose of two tablets (40 mg) 30-60 minutes before bedtime.

The maximum daily dose is six tablets (120 mg).

Determine the exact dosage and duration of treatment individually based on clinical indications and patient response.

The sedative effect develops gradually; use systematically for a stable therapeutic outcome.

Discontinue use if lethargy or depression occurs.

Adverse Reactions

In some cases hypersensitivity reactions; when used in high doses – lethargy, depression, weakness, decreased performance.

Contraindications

Children under 12 years of age, first trimester of pregnancy, hypersensitivity to valerian.

Use in Pregnancy and Lactation

Use is contraindicated in the first trimester of pregnancy.

Use in the second and third trimesters of pregnancy and during breastfeeding is possible in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus or infant.

Use in Hepatic Impairment

Can be used in cases of impaired liver function.

Use in Renal Impairment

Can be used in cases of impaired renal function.

Pediatric Use

Use is contraindicated in children under 12 years of age.

Geriatric Use

Used in elderly patients.

Drug Interactions

When used concomitantly with drugs that have a depressant effect on the central nervous system, their effect is potentiated.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.