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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

09 December 2015 EMA/680058/2015

Herbal medicine: summary for the public

Fresh bilberry fruit

Vaccinium myrtillus L., fructus recens

This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of fresh bilberry fruit. The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing fresh bilberry fruit.

This summary is not intended to provide practical advice on how to use medicines containing fresh bilberry fruit. For practical information about using fresh bilberry fruit medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.

What is fresh bilberry fruit?

Fresh bilberry fruit is the common name for the fresh fruit of the plant Vaccinium myrtillus L.

Fresh bilberry fruit preparations are obtained using a technique to extract compounds from fresh plant material by dissolving them in a solvent (such as methanol), which is then evaporated to obtain a dry extract.

Herbal medicines containing fresh bilberry fruit preparations are usually available in solid forms to be taken by mouth.

What are the HMPC conclusions on its medicinal uses?

The HMPC concluded that, on the basis of its long-standing use, fresh bilberry fruit medicines can be used to relieve discomfort and heaviness of legs related to minor blood circulatory problems and to relieve symptoms of bleeding into the skin from tiny blood vessels.

Fresh bilberry fruit medicines should only be used in adults and should not be taken for longer than 4 weeks. If the symptoms persist for more than 2 weeks, a doctor or a qualified health care practitioner should be consulted. Detailed instructions on how to take fresh bilberry fruit medicines and who can use them can be found in the package leaflet that comes with the medicine.

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© European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.

What evidence supports the use of fresh bilberry fruit medicines?

The HMPC conclusions on the use of fresh bilberry fruit medicines for relief of discomfort and heaviness of legs related to minor blood circulatory problems and for relief of symptoms of bleeding into the skin from tiny blood vessels 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.

Results from laboratory studies indicate that bilberries are rich in anthocyanins, which are thought to improve blood circulation by relaxing and dilating (widening) blood vessels and protecting blood vessels from damage. The anthocyanins are also thought to repair tiny blood vessels after damage to the local circulation. In its assessment, the HMPC also considered clinical studies on disorders of the circulatory system which were performed 30 - 40 years ago. Although possible beneficial effects were observed, there were limitations in the way the studies were conducted and, therefore, the HMPC conclusions on the use of fresh bilberry fruit medicines are based on their long-standing use.

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

What are the risks associated with fresh bilberry fruit medicines?

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

Further information on the risks associated with fresh bilberry fruit medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab 'All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.

How are fresh bilberry fruit medicines approved in the EU?

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

Other information about fresh bilberry fruit medicines

Further information on the HMPC assessment of fresh bilberry fruit medicines, including details of the Committee's conclusions, can be found under the tab 'All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use. For more information about treatment with fresh bilberry fruit medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.

Fresh bilberry fruit EMA/680058/2015