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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

20 September 2016 EMA/307113/20166

Herbal medicine: summary for the public

Thyme

Thymus vulgaris L. and Thymus zygis L., herba

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

This summary is not intended to provide practical advice on how to use medicines containing thyme.

For practical information about using thyme medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.

What is thyme?

Thyme is the common name for the leaves and flowers of the plants Thymus vulgaris L. or Thymus zygis L.

The HMPC conclusions only cover thyme preparations which are obtained by drying and comminuting (reducing into tiny pieces) the leaves and flowers, by expressing the juice of the leaves and flowers or as dry, liquid and soft extracts. Extracts are obtained 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 these thyme preparations are usually available as herbal tea to be drunk or in liquid or solid forms to be taken by mouth.

Thyme preparations may 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, on the basis of its long-standing use, these thyme preparations can be used for productive (chesty) coughs associated with colds.

Most thyme preparations should only be used in adults and adolescents over the age of 12 years, but a few can also be used in children above 4 years. If symptoms last longer than one week or worsen during the use of the medicine, a doctor or a qualified healthcare practitioner should be consulted.

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Detailed instructions on how to take thyme medicines and who can use them can be found in the package leaflet that comes with the medicine.

What evidence supports the use of thyme medicines?

The HMPC conclusions on the use of these thyme medicines for productive coughs 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.

In its assessment, the HMPC also considered clinical studies in both adults and children. A clinical study involving 60 adults with productive cough treated either with a thyme preparation or bromhexine, an established treatment for productive coughs. Although no significant difference was observed between thyme and bromhexine in treating the cough, there were shortcomings in the study such as the small number of patients and lack of details of the thyme preparation, so firm conclusions could not be drawn. Therefore, the HMPC conclusions on the use of these thyme medicines are based on their longstanding use.

For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.

What are the risks associated with thyme medicines?

Thyme medicines must not be used in patients who are allergic to thyme or to other plants of the Lamiaceae (Labiatae) family. Stomach problems may occur.

Further information on the risks associated with these thyme 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 thyme medicines approved in the EU?

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

Other information about thyme medicines

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

Thyme

EMA/307113/2016