Bitter Fennel

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

---

Date: March 19, 2008

Proper name(s): Foeniculum vulgare Mill. subsp. vulgare var. vulgare (Apiaceae) (EMEA 2007a; EMEA 2007b; USDA 2006)

Common name(s): Bitter fennel (EMEA 2007a; EMEA 2007b; USDA 2006)

Source material(s): Seed (EMEA 2007a) or oil (EMEA 2007b)

Route(s) 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:

All source materials: Traditionally used in Herbal Medicine as an expectorant to help relieve coughs associated with colds (EMEA 2007a; EMEA 2007b)

Seed:

• 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):

Seed:

Subpopulation: Adults, adolescents, and children ≥ 4 years (EMEA 2007a)

Quantity:

Adults, and adolescents ≥ 13 years: Infusion: 1.5-2.5 g comminuted (crushed) seed, 3 times per day (EMEA 2007a)

Children and adolescents 4-12 years: Infusion: 1-1.7 g comminuted (crushed) seed, 3 times per day (EMEA 2007a)

Directions for use (for infusion): Pour 250 ml (1 cup) of boiling water over seed and infuse for 15 minutes (EMEA 2007a).

Oil:

Subpopulation: Adults ≥ 18 years (EMEA 2007b)

Quantity: Preparations equivalent to 0.2 ml oil, per day (EMEA 2007b)

Duration of use:

Adults, and adolescents ≥ 13 years: Consult a health care practitioner for use beyond 2 weeks (EMEA 2007a; EMEA 2007b).

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

Risk information: Statement(s) to the effect of:

Caution(s) and warning(s):

All source materials:

• Consult a health care practitioner if symptoms persist or worsen.
• Consult a health care practitioner prior to use if you are pregnant or breastfeeding (EMEA 2007a; EMEA 2007b).

Oil: 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; EMEA 2007b).

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

Non-medicinal ingredients: Must be chosen from the current NHPD List of Acceptable Non-medicinal Ingredients and must meet the limitations outlined in the list.

Specifications:

• The finished product must comply with the minimum specifications outlined in the current NHPD Compendium of Monographs.
• 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 2006: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). Foeniculum vulgare Miller subs. vulgare. var. vulgare. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-03-19]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl