Dormiplant

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DORMIPLANT DORMIPLANTÒ

Composition:

Active substances: dry extract of valerian root; dry extract of lemon balm leaves;

One film-coated tablet contains 160 mg of dry extract of valerian root (Valeriana officinalis) (3−6:1) [extraction solvent: ethanol 62% (v/v)]; 80 mg of dry extract of lemon balm leaves (Melissa officinalis) (4−6:1) [extraction solvent: ethanol 30% (v/v)];

Excipients: sucrose, crospovidone, hydrogenated castor oil, colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate, hypromellose, stearic acid, titanium dioxide (E 171), indigo carmine (E 132), talc, sodium saccharin, vanillin, simethicone, methylcellulose, sorbic acid.

Pharmaceutical form. Film-coated tablets.

Main physicochemical characteristics: blue-colored film-coated tablets, uniform in size, color, and shape.

Pharmacotherapeutic group. Hypnotics and sedatives.

ATC code N05CM.

Pharmacological properties.

Pharmacodynamics.

The valerian and lemon balm extracts contained in the medicinal product exert a calming effect and also promote improved sleep onset and sleep quality.

Pharmacokinetics.

Data are lacking.

Clinical characteristics.

Indications.

Anxiety states; sleep disturbances due to nervous tension.

Contraindications.

Hypersensitivity to the active ingredients or to any of the excipients. Depression. Central nervous system depression, hypotensive states.

Interaction with other medicinal products and other forms of interaction.

In some patients, may enhance the effects of alcohol, sedatives, hypnotics, antihypertensive agents, anxiolytics, spasmolytics, and analgesics. Such combinations require medical assessment and supervision.

Clinical interaction with medicinal products metabolized via CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 has not been observed.

The effect of valerian root preparations may be enhanced when large amounts of alcohol are consumed concurrently.

Special precautions for use.

Alcoholic beverages should be avoided during the use of this medicinal product.

Patients with severe liver function impairment or a history of severe liver disease should use this medicinal product with caution.

Specific sensitivity to the smell of valerian may occur.

If you have an intolerance to certain sugars, consult your doctor before taking this medicinal product.

Hydrogenated castor oil may cause stomach upset and diarrhea.

Use during pregnancy or breastfeeding.

As there are no experimental data on the use of valerian root and lemon balm leaf during pregnancy or breastfeeding, Dormiplant is not administered to women during pregnancy or breastfeeding.

Ability to influence reaction speed when driving or operating machinery.

This medicinal product may affect reaction speed when driving or operating machinery. Therefore, it should not be taken within 2 hours before driving a vehicle or operating machinery.

Since valerian-containing preparations may cause drowsiness or sedation in some patients, caution should be exercised when driving vehicles or operating machinery during treatment.

Dosage and Administration

For sleep disorders, adults and children aged 12 years and older should take 2 tablets 30 minutes to 1 hour before bedtime.

For states of anxiety, adults and children aged 12 years and older should take 2 tablets up to 3 times daily.

Dormiplant should be taken without chewing, regardless of food intake, with a small amount of liquid.

The duration of treatment is determined by the physician depending on the therapeutic effect.

If, despite following the prescribed dosage, no improvement is observed, the patient should inform the physician.

Children

The medicinal product should be prescribed to children aged 12 years and older, as there is insufficient data available.

Overdose

In case of overdose, adverse reactions may be intensified. Listed below are symptoms commonly observed in valerian overdose: lethargy, general weakness, hand tremors, dilated pupils, chest tightness, spasmodic abdominal pain. Overdose may also cause depression, apathy, suppression of emotional responses, dizziness, drowsiness, reduced work capacity, headache, bradycardia, arrhythmia, hypotensive condition, and vegetative-vascular dystonia of the hypotonic type.

Treatment: in case of overdose, administration of the drug should be discontinued. Symptomatic therapy should be applied.

Side effects.

Allergic reactions are possible, including skin redness, rash, itching, skin swelling. Suppression of emotional responses, as well as abdominal spasms, nausea, headache, hypotensive condition, bradycardia, arrhythmia, weakness, drowsiness, reduced work capacity, depression, dizziness.

Shelf life. 3 years.

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

Storage conditions. Store at a temperature not exceeding 30 °C, in a place inaccessible to children.

Packaging.

25 tablets in a blister. 1 or 2 blisters in a cardboard box.

Availability category. Over-the-counter.

Manufacturer.

Dr. Willmar Schwabe GmbH & Co. KG.

Manufacturer's address and location of business activity:

Willmar-Schwabe-Strasse 4, 76227 Karlsruhe, Germany.