Dormiplant 160 mg +80 mg - promotes night rest - 25 coated tablets

Product Description

Dr Willmar Schwabe

Mild Sedative To Aid Night's Rest; 25 Coated Tablets

Composition

One tablet contains: Valerian root dry extract (3–6:1) 160 mg Melissa leaves dry extract (4–6:1) 80 mg Excipient: hydrogenated castor oil, sucrose For the full list of excipients, see section 6.1.

Excipients

Colloidal silica, sucrose, crospovidone, hydrogenated castor oil, microcrystalline cellulose, magnesium stearate, glucose syrup, calcium carbonate, talc, macrogol 1000, sodium carboxylate, polysorbate 80, macrogol 6000, povidone, hypromellose, sodium dodecyl sulfate, titanium dioxide (E171), indigo carmine (E132), polyethylene methyl acrylate, carnauba wax.

Therapeutic indications

Mild sedative, also to promote nighttime rest.

Contraindications

Known individual hypersensitivity to the components of the product or closely related substances from a chemical point of view. Generally contraindicated during pregnancy and breastfeeding (see section 4.6).

Dosage

1–2 tablets to be taken twice a day, swallowed with water. Do not exceed the recommended dose. Use is not recommended in children under 12 years of age (see section 4.4).

Warnings and precautions

The use of Dormiplant is not recommended in children under 12 years of age. Consult your doctor if symptoms persist for more than 2 weeks or if they worsen during treatment. It is recommended to take it after main meals and in the evening before going to bed. (see section 4.5). Important information about some of the excipients. The medicine contains hydrogenated castor oil: it can cause gastric disturbances and diarrhea. Patients with rare problems of glucose-galactose malabsorption should not take this medicine. The film-coated tablets should be swallowed with water.

Interactions

No interactions with other medicinal products have been documented in the literature. However, valerian extracts may likely enhance the depressant effects on the central nervous system induced by other substances, such as barbiturates and chlorpromazine. It follows that concomitant use with psychotropic drugs, barbiturates, or major sedatives is not recommended. The effects of valerian and lemon balm may be enhanced by alcohol; therefore, taking Dormiplant at the same time as excessive doses of alcohol is not recommended.

Side effects

Gastrointestinal disturbances (e.g., nausea, abdominal cramps) may occur. The frequency is unknown.

Pregnancy and breastfeeding

There is no documentation in the literature on possible contraindications during pregnancy or breastfeeding; it is likely, however, that these conditions have not been explicitly investigated. Since no data are available to evaluate the safety profile of the valerian and lemon balm combination during pregnancy, the administration of Dormiplant is not recommended in pregnant or breastfeeding women.