Dr Willmar Schwabe

Dormiplant 160mg + 80mg

Mild Sedative To Promote Night Rest

Composition

One tablet contains: Valerian root dry extract (3–6: 1) 160 mg Lemon balm leaves dry extract (4–6: 1) 80 mg Excipient: hydrogenated castor oil, sucrose For a 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 caramelose, polysorbate 80, macrogol 6000, povidone, hypromellose, sodium dodecyl sulfate, titanium dioxide (E17 ), indigo carmine (E132), polyethylacrylate methylacrylate, carnauba wax.

Therapeutic indications

Mild sedative, also to promote night rest.

Contraindications

Individual hypersensitivity to the components of the product or strictly correlated substances from a chemical point of view. Generally contraindicated in pregnancy and lactation (see section 4.6).

Dosage

1–2 tablets to be taken twice daily, swallowed with water. Do not exceed the recommended dose. The use is not recommended in children under 12 years of age (see par. 4.4)

Warnings and Precautions

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

Interactions

Interactions with other medicinal products are not documented in the literature. However, valerian extracts are likely to potentiate the central nervous system depressant effects induced by other substances, such as barbiturates and chlorpromazine. It follows that the simultaneous use with psychotropic drugs, barbiturates or major sedatives is not recommended. The effects of valerian and lemon balm can be enhanced by alcohol; Therefore, the simultaneous intake of Dormiplant and 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

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

Format: 50 coated tablets