Pilosellae herba cum radice - herbal medicinal product
Mouse-ear hawkweed
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 Mouse-ear hawkweed, whole plant. It summarises the Committee’s recommendations on the use of Mouse-ear hawkweed, whole plant.
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing Mouse-ear hawkweed, whole plant. When a Member State authorises a medicine containing Mouse-ear hawkweed, 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 Mouse-ear hawkweed, whole plant 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.
Mouse-ear hawkweed whole plant is the common name for the above and underground part of Pilosella officinarum Vall., synonym Hieracium pilosella L.
Medicinal products with Mouse-ear hawkweed whole plant contain comminuted (reduced into tiny pieces) or powered, above and under-ground part of the plant.
Herbal medicines containing these Mouse-ear hawkweed preparations are usually available as herbal tea to be drunk, and in solid or liquid forms to be taken by mouth.
Mouse-ear hawkweed preparations have a traditional use for the relief of symptoms associated with minor urinary tract complaints in addition to the general recommendation of a sufficient fluid intake to increase the amount of urine.
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 Mouse-ear hawkweed medicines and who can use them in the package leaflet that comes with the medicine.
Do not use Mouse-ear hawkweed whole plant:
- for children and adolescents under 18 year of age.
- if you are pregnant or breast feed your child.
- if you are allergic to the Mouse-ear hawkweed plant or to plants of the Asteraceae (Compositae) family.
- when reduced fluid intake is advised by a doctor.
Consult a doctor or a pharmacist:
- if complaints or symptoms occur during the use of Mouse-ear hawkweed medicines such as fever, painful urination, spasms, or blood in the urine.
- if your symptoms persist longer than 2 weeks during the use of the medicinal product.
No interactions with other medicines have been described in the literature at the time of assessment when using Mouse-ear hawkweed whole plant, with other medicines.
No side effects have been reported with Mouse-ear hawkweed medicines at the time of assessment.
The HMPC conclusions on the use of these Mouse-ear hawkweed medicines for the relief of symptoms associated with minor urinary tract complaints in addition to the general recommendation of a sufficient fluid intake to increase the amount of urine 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 Mouse-ear hawkweed 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 Mouse-ear hawkweed medicines in EU Member States may be obtained from the relevant national authorities.
BG (bulgarski): Рунянка, стрък с корен
CS (čeština): nať jestřábníku chlupáčku s kořenem
DA (dansk): Håret gøgeurt
DE (Deutsch): Kleines Habichtskraut mit Wurzeln
EL (elliniká): πιλοσέλλας πόα με ρίζα
EN (English): Mouse-ear hawkweed
ES (español): vellosilla, partes aéreas con raíz de
EE (eesti keel): karutubakaürt koos juurtega
FI (suomi): huopakeltano, verso juurineen
FR (français): piloselle (plante entière de)
HR (hrvatski): zelen s korijenom male runjike
HU (magyar): ezüstös hölgymál virágos hajtás gyökérrel
IT (italiano): Pilosella parti aeree fiorite con radice
LT (lietuvių kalba): Kudlių žolė su šaknimis
LV (latviešu valoda): Mazās mauragas laksts ar sakni
MT (Malti): ħaxixa bl-għeruq tal-heraċju
NL (Nederlands): Muizenoor, kruid en wortel
PL (polski): ziele jastrzębca kosmaczka z korzeniem
PT (português): pilosela, partes aéreas e raízes
RO (română): iarba si radcina de vulturica
SK (slovenčina): vňať chlpánika s koreňom
SL (slovenščina): zel in korenina dolgodlakave škržolice
SV (svenska): gråfibbla, ört och rot
NO (norsk): hårsveve, urt med rot
Key facts
- Latin name
- Pilosellae herba cum radice
- English common name
- Mouse-ear hawkweed
- Botanical name
Hieracium pilosella L.
- Therapeutic area
- Urinary tract and genital disorders
- Status
- F: Assessment finalised
- Date added to the inventory
- Date added to priority list
- Outcome of European assessment
- European Union herbal monograph