Foeniculum vulgare Miller subsp. vulgare var. vulgare
Apiaceae
Fennel, bitter
BG (bălgarski): Горчиво резене, плод
CS (čeština): Plod fenyklu obecného pravého
DA (dansk): Fennikel, bitter
DE (Deutsch): Bitterer Fenchel
EL (elliniká): Μαραθόσπορος πικρός
EN (English): Bitter fennel, fruit
ES (español): Hinojo amargo, fruto de
ET (eesti keel): Mõru apteegitill, vili
FI (suomi): Karvasfenkoli, hedelmä
FR (français): Fruit de fenouil amer
HU (magyar): Keserűédeskömény-termés
IT (italiano): Finocchio amaro (o selvatico), frutto
LT (lietuvių kalba): Karčiųjų pankolių vaisiai
LV (latviešu valoda): Rūgtā fenheļa augļi
MT (malti): Bużbież morr, frotta
NL (nederlands): Venkelvrucht, bitter
PL (polski): Owoc kopru włoskiego (odmiana gorzka)
PT (português): Fruto de funcho amargo
RO (română): Fruct de fenicul amar
SK (slovenčina): Feniklový plod horký
SL (slovenščina): Plod grenkega navadnega komarčka
SV (svenska): Bitterfänkål, frukt
IS (íslenska): Bitur fennel aldin
NO (norsk): Fenikkel, bitter
Fennel, bitter, dried comminuted(1) fruit.
Foeniculi amari fructus (01/2005:0824).
Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence.
Traditional herbal medicinal product for symptomatic treatment of minor spasm associated with menstrual periods.
Traditional herbal medicinal product used as an expectorant in cough associated with cold.
The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.
European, Chinese.
Please see ‘Specified posology’.
Single dose
1,5 to 2,5 g of (freshly(2)) comminuted fennel fruits with 0,25 l of boiling water (brew for 15 minutes) three times daily as a herbal tea.
Adult dose
Average daily dose
3-5 g of (freshly) comminuted fruits as a herbal tea, in three divided doses, for short-term use in mild transitory symptoms only (less than one week).
The use in children under four years of age is not recommended (see section ‘Special warnings and precautions for use’).
Oral use.
Not to be taken for more than two weeks.
For short-term use in mild transitory symptoms only (less than one week).
If the symptoms persist during the use of the medicinal product, a doctor or a qualified health-care practitioner should be consulted.
Hypersensitivity to the active substance or to Apiaceae (Umbelliferae) (aniseed, caraway, celery, coriander and dill) or to anethole.
The use in children under four years of age is not recommended due to the lack of adequate data and a paediatrician’s advice should be sought.
None reported.
There are no data from the use of fennel fruit in pregnant patients.
It is unknown if fennel constituents are excreted in human breast milk.
In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
No studies on the effect on the ability to drive and use machines have been performed.
Allergic reactions to fennel, affecting the skin or the respiratory system may occur. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified health-care practitioner should be consulted.
No case of overdose has been reported.
Not applicable.
Not applicable.
‘Comminuted fruit’ is intended to cover also ‘crushed fruit’.
For commercial preparation of comminuted fennel fruits the applicant must carry out appropriate stability testing related to the content of essential oil components.