Dormiplant film-coated tablets blister pack No. 25

Pharmacological properties

Pharmacodynamics. Valerian and lemon balm extracts, which are part of the drug, have a calming effect, and also help improve falling asleep and the course of sleep.

Pharmacokinetics: No data available.

Indication

Anxiety, sleep disturbances due to nervous tension.

Application

For sleep disorders in adults and children over 12 years of age, take 2 tablets ½-1 hour before bedtime.

For anxiety, adults and children over 12 years of age should take 2 tablets up to 3 times a day.

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

The duration of use is determined by the doctor depending on the therapeutic effect.

If, despite following the prescribed dosage, there is no improvement in the condition, the patient should inform the doctor.

Contraindication

Hypersensitivity to the active ingredients or any of the excipients; depression; central nervous system depression; hypotensive conditions.

Side effects

Allergic reactions are possible, including skin redness, rash, itching, skin swelling; suppression of emotional reactions, as well as the occurrence of abdominal cramps, nausea, headache, hypotension, bradycardia, arrhythmia, weakness, drowsiness; decreased performance; depression; dizziness,

Special instructions

When using the medicine, it is necessary to refrain from drinking alcoholic beverages.

Patients with severe hepatic impairment or a history of severe liver disease should be cautious when using the drug.

Specific sensitivity to the smell of valerian is possible.

If the patient has an intolerance to some sugars, he should consult a doctor before using the drug.

Hydrogenated ketamine can cause stomach upset and diarrhea.

Pregnancy and breastfeeding. Since there are no experimental studies on the use of valerian root and lemon balm leaves during pregnancy and breastfeeding, the drug should not be prescribed during pregnancy and breastfeeding.

Children: Since there is insufficient data on the use of the drug in this age group, the drug should be prescribed to children over 12 years of age.

Effects on the ability to drive or operate machinery. The drug may affect the speed of reaction when driving or operating machinery. Therefore, it should not be taken less than 2 hours before driving or operating machinery. Since valerian preparations may cause drowsiness and depression in some patients, caution should be exercised when driving or operating machinery during treatment.

Interactions

In some patients, the drug may enhance the effects of alcohol, sedatives, hypnotics, hypotensive, anxiolytic, antispasmodic and analgesic drugs. Such a combination requires medical diagnosis and supervision.

No clinical interactions with drugs metabolized by CYP 2D6, CYP 3A4/5, CYP 1A2, or CYP 2E1 were observed.

The effect of drugs containing valerian root extract may be enhanced if large amounts of alcohol are consumed simultaneously.

Overdose

In case of overdose, side effects may be increased. The following are the symptoms characteristic of an overdose of valerian preparations: lethargy, general weakness, hand tremors, dilated pupils, a feeling of tightness in the chest, spastic abdominal pain. Also, in case of overdose, depression, lethargy, suppression of emotional reactions, dizziness, drowsiness, decreased performance, headache, bradycardia, arrhythmia, hypotensive state, vegetative-vascular dystonia of the hypotonic type are possible.

Treatment: in case of overdose, the drug should be discontinued. Therapy is symptomatic.

Storage conditions

At a temperature not exceeding 30 °C, out of the reach of children.

Exclusive distributor: PrJSC "Naturpharm", 30a Lisova St., Kyiv, Pushcha-Vodytsia, 04075; phone: (044) 401-81-03.

Supplier: Alpen Pharma AG (Switzerland).