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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

13 August 2013

EMA/HM PC/441263/2013

Committee on Herbal Medicinal Products (HMPC)

Herbal medicine: summary for the public

Dittany of Crete herb

Origanum dictamnus L., herba

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

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

What is dittany of Crete herb?

Dittany of Crete herb is the common name for the flowering above-ground (aerial) parts of Origanum dictamnus L. The plant is cultivated or gathered to obtain the above-ground parts for medicinal use.

Preparations of the herb are obtained by comminuting (reducing into tiny pieces) the harvested material. Herbal medicines are usually available as comminuted herbal material that is used to make herbal teas or added to water to produce a liquid (infusion) to be applied to the skin.

What are the HMPC conclusions on its medicinal uses?

The HMPC concluded that, on the basis of its long-standing use, dittany of Crete herb can be used as a herbal tea for the relief of cough associated with cold and for mild disorders of the stomach and gut such as a sensation of fullness or digestive problems. The infusion can also be used to soak a dressing and applied to the skin for minor skin inflammations and bruises.

Herbal teas containing dittany of Crete should only be used in adults and should not be used for longer than a week for cough, or for longer than two weeks for stomach and gut problems, without seeking advice from a qualified healthcare practitioner. When used for skin problems the infusion may be used in those above the age of 12 years for up to two weeks; if symptoms last longer than this, advice should be sought from a qualified healthcare practitioner.

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Detailed instruction on how to use dittany of Crete medicines and who can use them can be found in the package leaflet that comes with the medicine.

What evidence supports the use of dittany of Crete herb medicines?

The HMPC conclusions on the use of dittany of Crete herb medicines for cough, stomach, gut and skin problems are based on their 'traditional use' in these conditions. 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.

In its assessment the HMPC took into account the well documented and longstanding use of dittany of Crete for these conditions. It also considered published experimental studies and reports which supported the plausibility of the use of dittany of Crete herb in the approved indications. For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.

What are the risks associated with dittany of Crete herb medicines?

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

Further information on the risks associated with dittany of Crete herb 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 dittany of Crete herb medicines approved in the EU?

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

Other information about dittany of Crete herb medicines

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

Dittany of Crete herb EMA/HMPC/441263/2013