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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

10 July 2015

EMA/HMPC/334023/2015

Committee on Herbal Medicinal Products (HMPC)

Herbal medicine: summary for the public

California poppy

Eschscholzia californica Cham., herba

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

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

What is California poppy?

California poppy is the common name for the above-ground parts of the plant Eschscholzia californica Cham. The plant is cultivated or gathered when flowering to obtain the above-ground parts for medicinal use.

California poppy preparations are obtained by powdering the dried above-ground parts of the plant. Herbal medicines containing California poppy 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, California poppy can be used for the relief of mild symptoms of mental stress and to aid sleep.

California poppy preparations should only be used in adults. If symptoms last longer than two weeks during treatment, a doctor or a qualified healthcare practitioner should be consulted. Detailed instruction on how to take California poppy medicines and who can use them can be found in the package leaflet that comes with the medicine.

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What evidence supports the use of California poppy medicines?

The HMPC conclusions on the use of California poppy medicines to relieve mild symptoms of mental stress and to aid sleep 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 conclusions on the use of California poppy medicines are based on their long-standing use.

In its assessment, the HMPC also considered a few available clinical studies, including a study in patients suffering from sleep disorders, which suggested a positive effect on sleep. For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.

What are the risks associated with California poppy medicines?

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

Further information on the risks associated with California poppy 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 California poppy medicines approved in the EU?

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

Other information about California poppy medicines

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

California poppy EMA/HMPC/334023/2015