Malvae sylvestris flos

Mallow flower is the common name for the flower of the plant Malva sylvestris L.

The HMPC conclusions only cover mallow flower preparations that are obtained by drying and comminuting the flowers (reducing them into tiny pieces).

Herbal medicines containing this mallow flower preparation are usually available as herbal tea to be drunk and in liquid forms to be taken by mouth or to be applied to the lining of the mouth.

Mallow flower preparations may also be found in combination with other herbal substances in some herbal medicines. These combinations are not covered in this summary.

The HMPC concluded that, on the basis of its long-standing use, this mallow flower preparation can be used to treat irritation of the mouth or throat and associated dry cough. It can also be used to relieve mild discomfort of the stomach and gut.

Mallow flower medicines should only be used in adults and adolescents from 12 years of age. A doctor or a qualified healthcare practitioner should be consulted if mouth or throat irritation lasts longer than 1 week or if stomach and gut discomfort lasts longer than 2 weeks during use of the medicine. Detailed instructions on how to take mallow flower medicines and who can use them can be found in the package leaflet that comes with the medicine.

The HMPC conclusions on the use of these mallow flower medicines for the mouth or throat irritation and associated dry cough, and mild stomach and gut discomfort are based on their ‘traditional use’. This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU). Moreover, the intended use does not require medical supervision.

In its assessment, the HMPC considered studies in laboratory tests showing cough reduction and anti-inflammatory effects of mallow flower preparations. The HMPC noted the lack of studies with mallow flower in patients. For detailed information on the studies assessed by the HMPC, see the HMPC assessment report under the section ‘Documents’ on the Agency’s website: ema.europa.eu/medicines/herbal/malvae-sylvestris-flos.

At the time of the HMPC assessment, no side effects had been reported with these medicines.

Further information on the risks associated with these mallow flower medicines, including the appropriate precautions for their safe use, can be found in the monograph under the section ‘Documents’ on the Agency’s website: ema.europa.eu/medicines/herbal/malvae-sylvestris-flos.

Any applications for the licensing of medicines containing mallow flower have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.

Information on the use and licensing of mallow flower medicines in EU Member States should be obtained from the relevant national authorities.

Further information on the HMPC assessment of mallow flower medicines, including details of the Committee’s conclusions, can be found under the section ‘Documents’ on the Agency’s website: ema.europa.eu/medicines/herbal/malvae-sylvestris-flos. For more information about treatment with mallow flower medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.