o

EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

2 February 2016 EMA/283374/2014

Herbal medicine: summary for the public

Eleutherococcus root

Eleutherococcus senticosus (Rupr. et Maxim.) Maxim., radix

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

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

What is eleutherococcus root?

Eleutherococcus root is the common name for the root of the plant Eleutherococcus senticosus (Rupr. et Maxim.) Maxim.

Eleutherococcus root preparations are obtained by drying and comminuting (reducing into tiny pieces) or powdering the root. They are also obtained by using a technique to extract compounds from plant material by dissolving them in a solvent (such as ethanol or water) to form a liquid extract or tincture (an alcoholic extract). In some cases the solvent is evaporated to obtain a dry extract.

Herbal medicines containing eleutherococcus root are usually available as herbal teas to be drunk, or in solid or liquid forms to be taken by mouth.

Eleutherococcus root can also be found in combination with other herbal substances in some herbal medicines. These combinations are not covered in this summary.

What are the HMPC conclusions on its medicinal uses?

The HMPC concluded that, on the basis of its long-standing use, eleutherococcus root can be used for the relief of symptoms of asthenia (abnormal loss of strength and energy) such as tiredness and weakness.

Eleutherococcus root should only be used in adults and adolescents over the age of 12 years and should not be taken for more than 2 months. A doctor or a qualified healthcare practitioner should be

30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

consulted if the symptoms continue for more than 2 weeks of treatment. Detailed instructions on how to take eleutherococcus root medicines and who can use them can be found in the package leaflet that comes with the medicine.

What evidence supports the use of eleutherococcus root medicines?

The HMPC conclusions on the use of eleutherococcus root medicines for relieving symptoms of asthenia are based on their 'traditional use' in this condition. 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 also considered numerous clinical studies with eleutherococcus root. Although a possible effect on tiredness and weakness was observed, shortcomings in the design of the studies prevented any firm conclusions being drawn. Therefore, the HMPC conclusions on the use of eleutherococcus root 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 eleutherococcus root medicines?

Insomnia, irritability, tachycardia (rapid heartbeat) and headaches have been reported as side effects with eleutherococcus root medicines, although their frequency is not known.

Further information on the risks associated with eleutherococcus root 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 eleutherococcus root medicines approved in the EU?

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

Other information about eleutherococcus root medicines

Further information on the HMPC assessment of eleutherococcus root 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 eleutherococcus root medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.

Eleutherococcus root EMA/283374/2014