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Drugs and Health Products

Monograph: Fennel, Sweet

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Date: 2008-03-13

NHPID Name

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

Proper Name(s)

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

Common Name(s)

Sweet fennel ( USDA 2008 , EMEA 2007 )

Source Material

Seed ( EMEA 2007 )

Route Of Administration

Oral ( EMEA 2007 )

Dosage Form(s)

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

Use(s) or Purpose(s)

Statement(s) to the effect of:

  • Traditionally used in Herbal Medicine to help relieve digestive disturbances including bloating and flatulence  (EMEA 2007)
  • Traditionally used in Herbal Medicine to help relieve the pain associated with menstruation  (EMEA 2007)
  • Traditionally used in Herbal Medicine as an expectorant to help relieve coughs associated with colds  (EMEA 2007)

Dose(s)

Children and adolescents 4 - 12 years:

Preparation: Infusion

Dose(s): 1 - 1.7 Grams 3 times per day, comminuted (crushed) seed
Directions For Use: Pour 250 ml (1 cup) of boiling water over seed and infuse for 15 minutes (EMEA 2007)

Adults and adolescents 13 and over:

Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): 0.4 Grams 3 times per day, dried seed
Preparation: Infusion

Dose(s): 1.5 - 2.5 Grams 3 times per day, comminuted (crushed) seed
Directions For Use: Pour 250 ml (1 cup) of boiling water over seed and infuse for 15 minutes (EMEA 2007)

Duration of use

  • Adults and adolescents 13 and over:
    Consult a health care practitioner for use beyond 2 weeks  (EMEA 2007)

  • Children and adolescents 4 - 12 years:
    Consult a health care practitioner for use beyond 1 week  (EMEA 2007)

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • Consult a health care practitioner if symptoms persist or worsen  (EMEA 2007)
  • Consult a health care practitioner prior to use if you are pregnant or breastfeeding  (EMEA 2007)

Contraindication(s):
Do not use if you are allergic to anethole or plants of the Apiaceae/Carrot family  (EMEA 2007)

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

Non-medicinal ingredients

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

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).
  • The medicinal ingredient may comply with the specifications outlined in the Sweet Fennel Monographs published in the European or British Pharmacopoeias.

References cited

  • EMEA 2007. European Medicines Agency. Community Monograph on Foeniculum vulgare Miller. London (UK): EMEA Committee on Herbal Medicinal Products (HMPC), 5 July 2007. [Accessed 2008-03-11]. Available from: http://www.emea.europa.eu/pdfs/human/hmpc/foeniculi _dulcis_fructus/26329306enfin.pdf
  • USDA 2008: ARS, National Genetic Resources Program. Germplasm Resources Information 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