SWEET FENNEL - FOENICULUM VULGARE

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Monograph: Sweet Fennel (PDF Version - 46 KB)

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

Date

October 30, 2018

Proper name(s), Common name(s), Source information

Table 1. Proper name(s), Common name(s), Source information
Proper name(s) Common name(s)
Source information
Source material(s) Part(s) Preparation(s)

Foeniculum vulgare subsp. vulgare var. dulce
  • Roman fennel
  • Sweet fennel

Foeniculum vulgare subsp. vulgare var. dulce

Seed

Dried and crushed

References: Proper name: USDA 2018, EMEA 2007; Common names: USDA 2018, EMEA 2007; Source information: EMEA 2007.

Route 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.

Acceptable dosage forms by age group:

Children 4-5 years: The acceptable dosage forms are limited to chewables, emulsion/suspension, powders and solution/liquid preparations (Giacoia et al. 2008; EMEA/CHMP 2006).

Children 6-11 years, Adolescents 12-17 years, and Adults 18 years and older: The acceptable dosage forms for this age category and specified route of administration are indicated in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

The following combined use(s) or purpose(s) is/are also acceptable:

Traditionally used in Herbal Medicine to help relieve the pain associated with menstruation and digestive upset including bloating and flatulence (EMEA 2007).

Note

Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".

Dose(s)

Subpopulation(s)

Children 4-11 years, Adolescents 12-17 years and Adults 18 years and older (EMEA 2007).

Quantity(ies)

Children 4-11 years

Methods of preparation: Dry, Infusion

3-5 grams of comminuted (crushed) dried seed, per day; Not to exceed 1.6 grams per single dose (EMEA 2007).

Note: Comminuted (crushed) dried seeds should be prepared as an infusion (see direction for use).

Adolescents 12-17 years and Adults 18 year and older

Methods of preparation: Dry, Powder, Non-Standardised Ethanolic Extracts (Dry extract, Tincture, Fluid extract).

1.2 grams of comminuted (crushed) dried seed, per day; Not to exceed 0.4 grams per single dose (EMEA 2007).

Methods of preparation: Dry, Infusion

4.5 -7.5 grams of comminuted (crushed) dried seed, per day; Not to exceed 2.5 grams per single dose (EMEA 2007).

Note: Comminuted (crushed) dried seeds should be prepared as an infusion (see direction for use).

Direction(s) for use

Dried seeds

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

Duration(s) of Use

Children 4-11 years

Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 1 week (EMEA 2007).

Adolescents 12-17 years and Adults 18 years and older

Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 2 weeks (EMEA 2007).

Risk Information

Caution(s) and warning(s)

Contraindication(s)

No statement required.

Known adverse reaction(s)

Stop use if hypersensitivity/allergy occurs (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.

Storage conditions

No statement required.

Specifications

References Cited