Presentation and Status in Health Basket
Film Coated Tablets
20 X 250 mg
Adults: 1-2 film coated tablets should be taken half to one hour before bed time.
Adolescents over 12 years of age: 1 film coated tablet should be taken half to one hour before bed time.
Elderly: Posology is the same as for adults. 1- 2 film coated tablets should be taken half to one hour before bed time.
The use in children below the age of 12 years is not recommended.
Duration of use: Because of its gradual onset of efficacy Dorminol Night is not suitable for acute interventional treatment of mild nervous tension or sleep disorders. To achieve optimal treatment effect, the continued use over 4 weeks is recommended.
If symptoms persist or worsen after 4 weeks of continued use, a doctor should be consulted.
Method of administration: Oral use. Crushing of the tablets is permissible but it may be difficult to crush the film coating.
Herbal medicinal product for problems falling asleep and staying asleep, as well as restless sleep.
Hypersensitivity to the active substance(s) or to any of the excipients.
The use of Dorminol Night is not recommended in children below the age of 12
years, due to lack of adequate data.
Gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea, abdominal pain) may occur after ingestion of valerian root preparations. The frequency is not known.
See package insert (OTC).
Only limited data on pharmacological interactions with other medicinal products are available. Clinically relevant interaction with drugs metabolised by the CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 pathway has not been observed.
Combination with synthetic sedatives requires medical diagnosis and supervision.
Pregnancy and Lactation
Safety during pregnancy and lactation has not been established. As a precautionary measure, because of lack of data, use during pregnancy and lactation is not recommended.
Valerian root at a dose of approximately 20 g caused benign symptoms (fatigue,
abdominal cramp, chest tightness, lightheadedness, hand tremor and mydriasis), which disappeared within 24 hours. If symptoms arise, treatment should be supportive.