Dormiplant^® (Tablets) Instructions for Use

Marketing Authorization Holder

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

ATC Code

V30 (Not assigned)

Active Substances

Valerian (BP British Pharmacopoeia)

Melissa (DAB German Pharmacopoeia)

Dosage Form

Dormiplant®

Film-coated tablets, 160 mg+80 mg: 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets blue in color, uniform in shape, size, and color; the tablet core is brown with inclusions ranging from white to dark brown.

* Extraction solvent ethanol 62%.
** Extraction solvent ethanol 30%.

Excipients: sucrose – 2.5 mg, crospovidone – 15 mg, hydrogenated castor oil – 23 mg, colloidal silicon dioxide – 11 mg, microcrystalline cellulose – 67 mg, magnesium stearate – 1.5 mg.

Coating composition: hypromellose – 20.08 mg, microcrystalline cellulose – 2.51 mg, stearic acid – 2.51 mg, titanium dioxide (E171) – 2.421 mg, indigotine lake (E132) – 1.639 mg, talc – 0.46 mg, vanillin – 0.282 mg, sodium saccharin – 0.049 mg, antifoaming emulsion calculated as dry substance – 0.049 mg.

25 pcs. – blisters (2) – cardboard packs.
25 pcs. – blisters (4) – cardboard packs.

Clinical-Pharmacological Group

Sedative herbal preparation

Pharmacotherapeutic Group

Herbal sedative

Pharmacological Action

A combined herbal medicine with sedative and antispasmodic effects.

The extract of valerian rhizomes with roots has a sedative effect.

The extract of Melissa officinalis leaves has sedative and antispasmodic effects.

Indications

Increased nervous excitability; insomnia; irritability.

ICD codes

Dosage Regimen

Administer Dormiplant^® tablets orally.

Take one tablet as a single dose.

Administer this dose two to three times per day.

Ensure the last dose is taken 30 minutes to one hour before bedtime to address insomnia.

Adhere strictly to the recommended dosage; do not exceed it.

Discontinuation of treatment does not lead to withdrawal syndrome.

Limit the treatment duration; do not use the drug continuously for more than 1.5 to 2 months.

If symptoms persist or worsen after this period, consult a physician for re-evaluation.

For patients with GERD, monitor for a potential worsening of symptoms during use.

Exercise caution when engaging in activities requiring concentration, such as driving or operating machinery.

Adverse Reactions

Allergic reactions possible – hyperemia, skin rash, peripheral edema, allergic dermatitis), bronchospasm.

From the digestive system with prolonged use, constipation is possible.

Contraindications

Arterial hypotension; cholangitis, cholelithiasis and other diseases of the biliary tract; pregnancy, breastfeeding period; children under 12 years of age (depending on the dosage form used); hypersensitivity to the components of the drug.

With caution GERD.

Use in Pregnancy and Lactation

Use during pregnancy and lactation (breastfeeding) is contraindicated.

Pediatric Use

The use of the drug in children under 12 years of age is contraindicated.

Special Precautions

In patients with GERD, symptoms may worsen.

If symptoms persist or worsen during use, the patient should consult a doctor.

This product should not be used continuously for more than 1.5-2 months.

Effect on the ability to drive vehicles and operate machinery

During treatment, patients should exercise caution when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions (driving vehicles, working with moving machinery, work of a dispatcher, operator).

Drug Interactions

When used concomitantly with other drugs that depress the central nervous system (including hypnotics, centrally acting antihypertensive agents, analgesics), an enhancement of the effect on the central nervous system is possible (dose adjustment may be required).

Storage Conditions

Store at 15°C (59°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.