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Drugs and Health Products

Bitter Fennel

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.

Notes
  • Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
  • The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant.

Date

July 18, 2017

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)

Essential oil:
Bitter fennel essential oil

Source material(s)

Seed (EMEA 2007a,b)

Route(s) of administration

Oral

Dosage form(s)

This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Dosage forms by age group:

  • Children 4-5 years: The acceptable dosage forms are limited to chewables, emulsion/ suspension, powders and solution/drops (Giacoia et al. 2008; EMEA/CHMP 2006).
  • Children 6-12 years, Adolescents 13-17 years, and Adults ≥ 18 years: The acceptable dosage forms include, but are not limited to capsules, chewables (e.g., gummies, tablets), liquids, powders, strips or tablets.

Use(s) or Purpose(s)

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).

Essential oil:

Subpopulation:

Adults ≥ 18 years (EMEA 2007b)

Quantity:

Preparations equivalent to 0.2 ml essential 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

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).

Essential 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 Natural Health Products Ingredients Database (NHPID) 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 Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the 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: Next link will take you to another Web site 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: Next link will take you to another Web site http://www.emea.europa.eu/pdfs/human/hmpc/foeniculi_amari_fructus_aetheroleum/2632906enfin.pdf
  • EMEA/CHMP 2006: European Medicines Agency: Pre-authorization Evaluation of Medicines for Human Use. Committee for Medicinal Products for Human Use. Reflection Paper: Next link will take you to another Web siteFormulations of choice for the paediatric population. Adopted September 2006. EMEA/CHMP/PEG/194810/2005. [Accessed on 2013 June 29].
  • Giacoia GP, Taylor-Zapata P, Mattison D. Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Formulation Initiative: selected reports from working groups. Clinical Therapeutics 2008; 30(11):2097-2101.
  • 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: Next link will take you to another Web site http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl.