Overview

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

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

Caraway fruit is the common name for the fruit of the plant Carum carvi L. The plant is cultivated or gathered to obtain the fruit for medicinal use.

Herbal medicines containing whole or comminuted (reduced into tiny pieces) caraway fruit are usually available as a herbal tea to be drunk.

The HMPC concluded that, on the basis of its long-standing use, caraway fruit medicines can be used for the relief of problems of the digestive system such as bloating and flatulence.

Caraway fruit medicines should only be used in adults and adolescents over the age of 12 years. 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 caraway fruit medicines and who can use them can be found in the package leaflet that comes with the medicine.

The HMPC conclusions on the use of caraway fruit medicines for the relief of digestive problems such as bloating and flatulence are based on their 'traditional use' in this condition. 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 on the effects of caraway fruit in patients, but took into account the well documented use of this herbal medicine for the above-mentioned use. For further information, see the HMPC assessment report.

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

Caraway fruit medicines must not be used in patients who are hypersensitive (allergic) to caraway fruit or other plants of the Apiaceae (Umbelliferae) family (fennel, anise, celery, coriander and dill), to mugwort or birch.

Further information on the risks associated with caraway fruit medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab 'All documents'.

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

Further information on the HMPC assessment of caraway fruit medicines, including details of the Committee's conclusions, can be found under the tab 'All documents'.

For more information about treatment with caraway fruit medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.

Caraway fruit - Summary for the public

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Key facts

Latin name
Carvi fructus
English common name
Caraway fruit
Botanical name

Carum carvi L.

Therapeutic area
Gastrointestinal disorders
Status
F: Assessment finalised
Date added to the inventory
Date added to priority list
Outcome of European assessment
European Union herbal monograph

Documents

First version

Final European Union herbal monograph on Carum carvi L., fructus

Opinion of the HMPC on a European Union herbal monograph on Carum carvi L., fructus

Final assessment report on Carum carvi L.,fructus and Carum carvi L., aetheroleum

Final list of references supporting the assessment of Carum carvi L.,fructus and Carum carvi L., aetheroleum

Overview of comments received on European Union herbal monograph on Carum carvi L., fructus

Consultation

Call for scientific data for the periodic review of the monograph on Carum carvi L., fructus - Revision 1

Call for scientific data for use in HMPC assessment work on Carum carvi L., fructus

Draft European Union herbal monograph on Carum carvi L., fructus

Draft assessment report on Carum carvi L., fructus and Carum carvi L. aetheroleum

Draft list of references supporting the assessment of Carum carvi L., fructus and Carum carvi L. aetheroleum

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