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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

2 February 2016 EMA/827287/2015

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. Extracts are prepared using a technique to extract compounds from plant material by dissolving them in a solvent such as ethanol (alcohol). For dry extracts the solvent is then evaporated to obtain the extract, while for soft extracts the solvent is only partially evaporated.

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 and children from the age of two years. If symptoms last longer than one 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 clinical studies with ivy leaf showing that ivy leaf was as effective as the medicine ambroxol in improving cough symptoms in adults with long-term bronchitis (inflammation of the airways in the lungs). Studies in children showed ivy leaf to be comparable to another 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?

Ivy leaf medicines must not be given to children under two years of age because of the risk of worsening respiratory symptoms. The side effects affecting the stomach and gut such as nausea, vomiting, 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.

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: ema.europa.eu/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: ema.europa.eu/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

EMA/827287/2015