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Monograph: Fennel, Bitter

Date: 2008-03-19

NHPID Name

Foeniculum vulgare subsp. vulgare var. vulgare ( USDA 2008 )

Proper Name(s)

Foeniculum vulgare Mill. subsp. vulgare var. vulgare (Apiaceae) ( USDA 2008 , EMEA 2007a )

Common Name(s)

Bitter fennel ( USDA 2008 , EMEA 2007 a )

Source Material

Seed ( EMEA 2007 )

Route Of Administration

Oral

Dosage Form(s)

Those suited to the allowable route(s) of administration. This monograph is not intended toinclude food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:

General Traditionally used in Herbal Medicine as an expectorant to help relieve coughs associatedwith colds ( EMEA 2007a )

Infusion

Traditionally used in Herbal Medicine to help relieve digestive disturbances includingbloating and flatulence ( EMEA 2007a )

Traditionally used in Herbal Medicine to help relieve the pain associated withmenstruation ( EMEA 2007a )

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Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s) :

Consult a health care practitioner if symptoms persist. Consult a health care practitioner if symptoms worsen. Consult a health care practitioner prior to use if you are pregnant or

breastfeeding ( EMEA 2007a ) Oil, Essential (water steam distillation) :

Consult a health care practitioner prior to use if you are taking oral contraceptives,hormone therapy, hormone replacement therapy or other medications or naturalhealth products ( EMEA 2007b )

Contraindication(s) :Do not use if you are allergic to anethole or plants of the Apiaceae/Carrot family ( EMEA

2007a )

Known Adverse Reaction(s) :Hypersensitivity (e.g. allergy) has been known to occur (rare cases); in which case,discontinue use ( EMEA 2007a )

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database and mustmeet the limitations outlined in the database.

Specifications

The finished product specifications must be established in accordance with therequirements described in the NHPD Quality of Natural Health Products Guide.

The medicinal ingredient must comply with the requirements outlined in the NaturalHealth Products Ingredient Database (NHPID).

The medicinal ingredient may comply with the specifications outlined in the BitterFennel or Bitter-Fennel Fruit Oil Monographs published in the European or BritishPharmacopoeias

References cited

EMEA 2007a. European Medicines Agency. Community Monograph on Foeniculumvulgare Miller subs. vulgare var. vulgare. London (UK): EMEA Committee on HerbalMedicinal Products (HMPC), 5 July 2007. [Accessed 2008-03-19]. Available from:

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http://www.emea.europa.eu/pdfs/human/hmpc/foeniculi_amari_fructus/13742806enfin.pdf

EMEA 2007b. European Medicines Agency. Community Monograph on Foeniculumvulgare Miller subs. vulgare var. vulgare oil. London (UK): EMEA Committee onHerbal Medicinal Products (HMPC), 5 July 2007. [Accessed 2008-03-19]. Availablefrom:

http://www.emea.europa.eu/pdfs/human/hmpc/foeniculi_amari_fructus_aetheroleum/2632906enfin.pdf

USDA 2008: ARS, National Genetic Resources Program. Germplasm ResourcesInformation Network (GRIN). National Germplasm Resources Laboratory, Beltsville(MD). [Accessed 2008-01-21]. Available at http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl