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Drugs and Health Products

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 2007 a )

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 to include 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 associated with colds  (EMEA 2007a)

Infusion
  • Traditionally used in Herbal Medicine to help relieve digestive disturbances including bloating and flatulence  (EMEA 2007a)
  • Traditionally used in Herbal Medicine to help relieve the pain associated with menstruation  (EMEA 2007a)

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 2007a)

Adults and adolescents 13 and over:

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 2007a)

Adults:

Preparation: Oil, Essential (water steam distillation)

Dose(s): 0.2 Millilitres per day

Duration of use

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

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

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 natural health 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 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 Bitter Fennel or Bitter-Fennel Fruit Oil Monographs published in the European or British Pharmacopoeias

References cited

  • EMEA 2007a. European Medicines Agency. Community Monograph on Foeniculum vulgare Miller subs. vulgare var. vulgare. London (UK): EMEA Committee on Herbal Medicinal Products (HMPC), 5 July 2007. [Accessed 2008-03-19]. Available from: http://www.emea.europa.eu/pdfs/human/hmpc/foeniculi_amari_fructus/13742806enfin.pdf
  • EMEA 2007b. European Medicines Agency. Community Monograph on Foeniculum vulgare Miller subs. vulgare var. vulgare oil. London (UK): EMEA Committee on Herbal Medicinal Products (HMPC), 5 July 2007. [Accessed 2008-03-19]. Available from: http://www.emea.europa.eu/pdfs/human/hmpc/foeniculi_amari_fructus_aetheroleum/2632906enfin.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