Dormiplant-Valeriana^® (Tablets) Instructions for Use

Marketing Authorization Holder

Dr. Willmar Schwabe GmbH & Co. KG (Germany)

ATC Code

N05CM09 (Valerian roots)

Active Substance

Valerian (BP British Pharmacopoeia)

Dosage Form

Dormiplant-Valerian

Film-coated tablets, 500 mg: 25 or 50 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets of a greyish-blue color, oblong, biconvex.

* Valeriana officinalis L. (family Valerianaceae).
Extraction solvent ethanol 70%.

Excipients: microcrystalline cellulose – 162 mg, hydrogenated castor oil – 40 mg, croscarmellose sodium – 30 mg, precipitated silicon dioxide – 12 mg, magnesium stearate – 6 mg.

Shell composition: microcrystalline cellulose – 5.35 mg, stearic acid – 5.35 mg, hypromellose – 42.8 mg, titanium dioxide (E171) – 5.2 mg, indigo carmine lake (E132) – 3.5 mg, talc – 1 mg, vanillin – 0.6 mg, sodium saccharin – 0.1 mg, simethicone – 0.092 mg, methylcellulose – 0.0077 mg, sorbic acid – 0.0003 mg.

25 pcs. – blisters (1) – cardboard packs.
25 pcs. – blisters (2) – cardboard packs.

Clinical-Pharmacological Group

Sedative herbal preparation

Pharmacotherapeutic Group

Herbal sedative

Pharmacological Action

A herbal medicinal product. 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 possess sedative properties.

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

Valerenic acid and valepotriates have a weak antispasmodic effect.

Furthermore, the complex of biologically active substances of Valeriana officinalis exerts a choleretic effect, enhances the secretory activity of the gastrointestinal mucosa, slows the heart rate, and dilates the coronary vessels.

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 manifests with systematic and long-term course treatment.

Indications

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

ICD codes

Dosage Regimen

Administer orally. Swallow the tablet whole with a sufficient amount of liquid. Do not chew.

For adults and adolescents aged 12 years and older, take one 500 mg tablet two to three times daily.

For sleep disorders, take the last dose 30 to 60 minutes before bedtime.

The maximum single dose is one 500 mg tablet. The maximum daily dose is three 500 mg tablets (1500 mg total).

Adjust the dosage based on individual patient response and therapeutic need. Use the lowest effective dose.

The sedative effect develops gradually. Continue treatment for 2 to 4 weeks to achieve a stable therapeutic outcome.

Do not exceed the recommended daily dose. Discontinue use if symptoms persist or worsen. This product is not intended for long-term continuous use without medical supervision.

Contraindicated in children under 12 years of age.

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 therapeutic benefit for the mother outweighs the potential risk to the fetus or breastfed 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

Contraindicated for use in children under 12 years of age.

Geriatric Use

Used in elderly patients.

Drug Interactions

Concomitant use with medicinal products that have a depressant effect on the central nervous system potentiates their action.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°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.