Hieracium

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Summary for the public

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

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

What is mouse-ear hawkweed?

Mouse-ear hawkweed is the common name for the above-ground parts (which may include flowers) and parts of the root of the plant Hieracium pilosella L. The plant is cultivated or gathered to obtain the plant parts for medicinal use.

Mouse-ear hawkweed preparations are obtained by comminuting (reducing into tiny pieces) or powdering the dried plant parts.

Herbal medicines containing mouse-ear hawkweed are usually available as a herbal tea to be drunk and 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, mouse-ear hawkweed can be used as a mild diuretic (a medicine to increase production of urine) for the relief of minor problems of the urinary tract (the structures that carry urine).

Mouse-ear hawkweed 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 instructions on how to take mouse-ear hawkweed medicines and who can use them can be found in the package leaflet that comes with the medicine.

What evidence supports the use of mouse-ear hawkweed medicines?

The HMPC conclusions on the use of mouse-ear hawkweed medicines for the relief of minor urinary problems 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 mouse-ear hawkweed, but took into account the well documented use of this herbal medicine for the above uses. For further information, see the HMPC assessment report.

What are the risks associated with mouse-ear hawkweed medicines?

Mouse-ear hawkweed medicines are generally well tolerated. At the time of the HMPC assessment, no side effects had been reported with these medicines.

Mouse-ear hawkweed medicines must not be used in patients with conditions in which a reduced fluid intake is recommended (such as severe heart or kidney disease).

Further information on the risks associated with mouse-ear hawkweed medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents’.

How are mouse-ear hawkweed medicines approved in the EU?

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

Other information about mouse-ear hawkweed medicines

Further information on the HMPC assessment of mouse-ear hawkweed medicines, including details of the Committee’s conclusions, can be found under the tab ‘All documents’.

For more information about treatment with mouse-ear hawkweed medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.

 

Name Language First published Last updated
Mouse-ear hawkweed - Summary for the public BG = bălgarski 03/08/2015  
Mouse-ear hawkweed - Summary for the public ES = español 03/08/2015  
Mouse-ear hawkweed - Summary for the public CS = čeština 03/08/2015  
Mouse-ear hawkweed - Summary for the public DA = dansk 03/08/2015  
Mouse-ear hawkweed - Summary for the public DE = Deutsch 03/08/2015  
Mouse-ear hawkweed - Summary for the public ET = eesti keel 03/08/2015  
Mouse-ear hawkweed - Summary for the public EL = elliniká 03/08/2015  
Mouse-ear hawkweed - Summary for the public EN = English 03/08/2015  
Mouse-ear hawkweed - Summary for the public FR = français 03/08/2015  
Mouse-ear hawkweed - Summary for the public IT = italiano 03/08/2015  
Mouse-ear hawkweed - Summary for the public LV = latviešu valoda 03/08/2015  
Mouse-ear hawkweed - Summary for the public LT = lietuvių kalba 03/08/2015  
Mouse-ear hawkweed - Summary for the public HU = magyar 03/08/2015  
Mouse-ear hawkweed - Summary for the public MT = Malti 03/08/2015  
Mouse-ear hawkweed - Summary for the public NL = Nederlands 03/08/2015  
Mouse-ear hawkweed - Summary for the public PL = polski 03/08/2015  
Mouse-ear hawkweed - Summary for the public PT = português 03/08/2015  
Mouse-ear hawkweed - Summary for the public RO = română 03/08/2015  
Mouse-ear hawkweed - Summary for the public SK = slovenčina 03/08/2015  
Mouse-ear hawkweed - Summary for the public SL = slovenščina 03/08/2015  
Mouse-ear hawkweed - Summary for the public FI = suomi 03/08/2015  
Mouse-ear hawkweed - Summary for the public SV = svenska 03/08/2015  
Mouse-ear hawkweed - Summary for the public HR = Hrvatski 03/08/2015  

Summary

Product details for Hieracium
Latin name of the genusHieracium
Latin name of herbal substancePilosellae herba cum radice
Botanical name of plantHieracium pilosella L.
English common name of herbal substanceMouse-ear hawkweed
StatusF: Assessment finalised
Date added to the inventory22/11/2011
Date added to priority list22/11/2011
Outcome of European assessment

European Union herbal monograph

Additional information

Consultation

Documentation

Key documents

Related information