21 November 2017
EMA/821305/2017
Herbal medicine: summary for the public
Ivy leaf
Hedera helix L., folium
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products
(HMPC) on the medicinal uses of ivy leaf. The HMPC conclusions are taken into account by EU Member
States when evaluating applications for the licensing of herbal medicines containing ivy leaf.
This summary is not intended to provide practical advice on how to use medicines containing ivy leaf.
For practical information about using ivy leaf medicines, patients should read the package leaflet that
comes with the medicine or contact their doctor or pharmacist.
What is ivy leaf?
Ivy leaf is the common name for the leaves of the plant Hedera helix L.
Ivy leaf preparations are obtained as dry, liquid and soft extracts by putting the plant material in a
solvent (such as ethanol) to dissolve compounds and form a liquid extract. The solvent is then partially
or completely evaporated to obtain a soft or dry extract.
Herbal medicines containing ivy leaf are usually available in solid or liquid forms to be taken by mouth.
Ivy leaf preparations 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 ivy leaf preparations can be used as an expectorant (a medicine that helps to
bring up phlegm) for productive (chesty) coughs.
Ivy leaf medicines should only be used in adults, adolescents and children from the age of 2 years. If
symptoms worsen or last longer than 1 week during the use of the medicine, a doctor or a pharmacist
should be consulted. Detailed instructions on how to take ivy leaf medicines and who can use them can
be found in the package leaflet that comes with the medicine.
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How does ivy leaf work as a medicine?
The way ivy leaf acts is not fully known, but laboratory studies suggest that it may work by both
widening the bronchi (air passages) in the lungs and by stimulating the bronchial glands in the lungs to
secrete a watery fluid.
What evidence supports the use of ivy leaf medicines?
The HMPC conclusions on the use of ivy leaf medicines as an expectorant are based on their ‘well-
established use’ in this condition. This means that there are bibliographic data providing scientific
evidence of their effectiveness and safety when used in this way, covering a period of at least 10 years
in the EU.
In its assessment, the HMPC considered a number of studies with ivy leaf in adults including one that
showed ivy leaf was effective in reducing cough severity compared to dummy treatment. Studies in
children showed ivy leaf to be comparable to the medicine acetylcysteine in improving symptoms in
children with acute (sudden) bronchitis.
For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.
What are the risks associated with ivy leaf medicines?
Side effects affecting the stomach and gut such as nausea, vomiting and diarrhoea, and allergic
reactions such as hives, skin rash and difficulty breathing have been reported with ivy leaf medicines,
although their frequency is not known.
Ivy leaf medicines must not be taken by people who are hypersensitive (allergic) to ivy leaf or to other
plants of the ivy family (Araliaceae). Ivy leaf medicines must not be given to children under 2 years of
age because of the risk of worsening respiratory symptoms when using cough medicines at this age.
Further information on the risks associated with ivy leaf 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: [Link]/Find medicine/Herbal medicines for human use.
How are ivy leaf medicines approved in the EU?
Any applications for the licensing of medicines containing ivy leaf 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 ivy leaf medicines in EU Member States should be obtained
from the relevant national authorities.
Other information about ivy leaf medicines
Further information on the HMPC assessment of ivy leaf medicines, including details of the Committee’s
conclusions, can be found under the tab ‘All documents’ on the Agency’s website: [Link]/Find
medicine/Herbal medicines for human use. For more information about treatment with ivy leaf
medicines, read the package leaflet that comes with the medicine or contact your doctor or
pharmacist.
Ivy leaf
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