Rubi idaei folium

Raspberry leaf is the common name for the leaf of the plant Rubus idaeus L.

The HMPC conclusions only cover raspberry leaf preparations which are obtained by drying and comminuting (reducing into tiny pieces) the leaves and as dry extracts. Dry extracts are obtained by putting the plant material in a solvent to dissolve compounds and form a liquid extract. The solvent is then evaporated to obtain a dry extract.

Herbal medicines containing raspberry leaf preparations are usually available as herbal tea to be drunk, as infusions to be applied to the lining of the mouth and in solid forms to be swallowed.

Raspberry leaf 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, these raspberry leaf preparations can be used for relief of minor spasms associated with menstrual periods, for treatment of mild mouth or throat inflammation and for treatment of mild diarrhoea.

Raspberry leaf medicines should only be used in adults. When taking the medicine for period spasms or for mouth or throat inflammation, a doctor or a qualified healthcare practitioner should be consulted if symptoms last longer than 1 week or worsen. When taking the medicine for diarrhoea, a doctor or a qualified healthcare practitioner should be consulted if symptoms worsen or last longer than 3 days. Detailed instructions on how to take raspberry leaf 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 raspberry leaf medicines for relief of period spasms, mouth or throat inflammation and diarrhoea 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.

The HMPC noted the lack of clinical studies with raspberry leaf medicines for the above-mentioned uses. Data from laboratory studies were also very limited. The HMPC conclusions are therefore based on the long-standing use of these medicines.

For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.

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

Any applications for the licensing of medicines containing raspberry leaf 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 raspberry leaf medicines in EU Member States should be obtained from the relevant national authorities.

For more information about treatment with raspberry leaf medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.