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Drugs and Health Products

Sweet 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. dulce (Mill.) Batt. (Apiaceae) (EMEA 2007; USDA 2006)

Common name(s)

Sweet fennel (EMEA 2007; USDA 2006)

Source material(s)

Seed (EMEA 2007)

Route(s) of administration

Oral (EMEA 2007)

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)

  • 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)

Subpopulation:

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

Quantity:

Adults, and adolescents ≥ 13 years:

  • Preparations equivalent to 0.4 g dried seed, 3 times per day (EMEA 2007)
  • Infusion: 1.5-2.5 g comminuted (crushed) seed, 3 times per day (EMEA 2007)

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

Directions for use (for infusion):

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

Duration of use

Adults, and adolescents ≥ 13 years:
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

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 (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 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: Next link will take you to another Web site http://www.emea.europa.eu/pdfs/human/hmpc/foeniculi_dulcis_fructus/26329306enfin.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. dulce. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-03-11]. Available from: Next link will take you to another Web site http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl.