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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

9 November 2016 EMA/115825/2016

Herbal medicine: summary for the public

Ironwort

Sideritis scardica Griseb.; Sideritis clandestina (Bory & Chaub.) Hayek; Sideritis raeseri Boiss. & Heldr.; Sideritis syriaca L., herba

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

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

What is ironwort?

Ironwort is the common name for the aerial parts of various species of Sideritis plants (which include Sideritis scardica Griseb.; Sideritis clandestina (Bory & Chaub.) Hayek; Sideritis raeseri Boiss. & Heldr.; Sideritis syriaca L.).

The HMPC conclusions only cover ironwort preparations which are obtained by drying and comminuting (reducing into tiny pieces) the aerial parts of the plants.

Herbal medicines containing these ironwort preparations are usually available as herbal teas to be drunk.

Ironwort preparations may 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, these ironwort preparations can be used for the relief of cough associated with a cold and for the relief of mild stomach and gut discomfort.

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Ironwort medicines should be used only in adults. If symptoms of cough last longer than one week or worsen during treatment a doctor or a qualified healthcare practitioner should be consulted. If symptoms of stomach and gut discomfort last longer than two weeks or worsen during treatment a doctor or a qualified healthcare practitioner should be consulted. Detailed instructions on how to take ironwort medicines and who can use them can be found in the package leaflet that comes with the medicine.

What evidence supports the use of ironwort medicines?

The HMPC conclusions on the use of these ironwort medicines for 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 for these indications 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 noted the lack of clinical studies with ironwort but took into account the well documented use of ironwort for the above uses. The HMPC also considered laboratory studies which suggest that the plant has an anti-inflammatory and antimicrobial action as well as an effect in protecting the stomach and reducing contractions of gut muscles.

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

What are the risks associated with ironwort medicines?

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

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

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

Other information about ironwort medicines

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

Ironwort

EMA/115825/2016