Rosmarini folium - herbal medicinal product
Rosemary leaf
Herbal productHumanHerbal
Overview
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of Rosemary leaf. It summarises the Committee’s recommendations on the use of Rosemary leaf.
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing Rosemary leaf. When a Member State authorises a medicine containing Rosemary leaf, detailed instructions on how to take it will be available in the package leaflet that comes with medicine.
The information in this summary report concerns herbal medicinal products containing Rosemary leaf which are only authorised when they comply with the strict pharmaceutical quality and other requirements for herbal medicinal products. They are approved by the competent authorities to be placed on the market as medicinal products. Other products, like food, food supplements, cosmetic products or medical devices do not follow the same criteria and regulatory requirements as medicinal products and are excluded from this summary.
Rosemary leaf is the common name for the leaves of the plant Rosmarinus officinalis L. Medicinal products with Rosemary leaf contain whole, fragmented (reduced into tiny pieces) or powdered dry leaves.
Herbal medicines containing these Rosemary leaf preparations are usually available as herbal tea to be drunk and as bath additive.
Rosemary leaf preparations have traditional medicinal use for the symptomatic relief of dyspepsia and mild spasmodic disorders of the gastrointestinal tract and for the relief of minor muscular and articular pain and in minor peripheral circulatory disorders. Traditional medicinal use means that the use in the specified indication is exclusively based upon long-standing medicinal use and not based on results from clinical studies.
You can find detailed instructions on how to take Rosemary leaf medicines and who can use them in the package leaflet that comes with the medicine.
Do not use Rosemary leaf:
- for children and adolescents under 12 year of age.
- if you are pregnant or breast feed your child.
- if you are allergic to Rosemary leave.
- when you are known with obstruction of the bile duct, inflammation of the gallbladder, gallstones or any liver disease.
Do not apply to broken or irritated skin.
Consult a doctor or a pharmacist:
- if the symptoms persist longer than 2 weeks during the use of the medicinal product for the oral use for the symptomatic relief of dyspepsia and mild spasmodic disorders of the gastrointestinal tract.
- if the symptoms persist longer than 4 weeks or worsen during the use of the medicinal product, for the use as a bath additive for the relief of minor muscular and articular pain and in minor peripheral
circulatory disorders.
No interactions with other medicines have been described in the literature at the time of assessment when using Rosemary leaf with other medicines.
You may experience some side effects with Rosemary leaf medicines. You may get a hypersensitivity reaction, like contact dermatitis.
The frequency is of this undesirable effect is not known.
The HMPC conclusions on the use of these Rosemary leaf medicines for the symptomatic relief of dyspepsia and mild spasmodic disorders of the gastrointestinal tract and for the relief of minor muscular and articular pain and in minor peripheral circulatory disorders 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).
Any applications for the licensing of medicines containing Rosemary leaf have to be submitted to the national authorities responsible for medicinal products. Before approval, the national authorities assess the quality, safety and efficacy of the herbal medicine. The HMPC conclusions are taken into account when evaluating applications for the licensing of herbal medicines.
Information on approved Rosemary leaf medicines in EU Member States may be obtained from the relevant national authorities.
BG (bulgarski): Розмарин, лист
CS (čeština): rozmarýnový list
DA (dansk): Rosmarinblad
DE (Deutsch): Rosmarinblätter
EL (elliniká): λιβανωτίδος φύλλο
EN (English): Rosemary leaf
ES (español): romero, hoja de
ET (eesti keel): rosmariinileht
FI (suomi): rosmariini, lehti
FR (français): romarin (feuille de)
HR (hrvatski): ružmarinov list
HU (magyar): rozmaringlevél
IT (italiano): Rosmarino foglia
LT (lietuvių kalba): Rozmarinų lapai
LV (latviešu valoda): Rozmarīna lapa
MT (Malti): werqa u fjura tal-klin
NL (Nederlands): Rozemarijn
PL (polski): Liść rozmarynu
PT (português): alecrim
RO (română): frunză de rosmarin
SK (slovenčina): list rozmarínu
SL (slovenščina): list navadnega rožmarina
SV (svenska): rosmarin, blad
NO (norsk): rosmarinblad
Key facts
- Latin name
- Rosmarini folium
- English common name
- Rosemary leaf
- Botanical name
Rosmarinus officinalis L.
- Therapeutic area
- Circulatory disorders
- Gastrointestinal disorders
- Status
- F: Assessment finalised
- Date added to the inventory
- Date added to priority list
- Outcome of European assessment
- European Union herbal monograph