GERMAN CHAMOMILE - MATRICARIA CHAMOMILLA

Buccal

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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 statements are synonymous. Either term or statement may be selected by the applicant.

Date

June 11, 2021

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)
Matricaria chamomilla	Blue chamomile Chamomile Common chamomile German chamomile Hungarian chamomile Matricaria Scented chamomile Scented mayweed Sweet false chamomile True chamomile Wild chamomile	Matricaria chamomilla	Flower	Dried

References: Proper name: USDA 2018; Common names: USDA 2018, McGuffin 2000; Source information: Mills and Bone 2005, ESCOP 2003, Blumenthal et al. 2000, WHO 1999, Bradley 1992.

Route of Administration

Buccal (ESCOP 2003; Blumenthal et al. 2000; Bradley 1992)

Dosage Form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Dosage forms must be suited for buccal administration which allow for direct contact between the affected tissue and the medicinal ingredient (i.e. liquid preparations, gargles and mouthwashes).

Use(s) or Purpose(s)

Used in Herbal Medicine to help relieve minor inflammation and/or irritation of the mucous membranes of the mouth and/or throat (ESCOP 2003; Bradley 1992; Blumenthal et al. 2000).

Dose(s)

Subpopulation(s)

Children 6-11 years, Adolescents 12-17 years and Adults 18 years and older (Bove 2001; Schilcher 1997) .

Quantity(ies)

Methods of preparation: Non-Standardised Extracts (Tincture, Fluid extract, Infusion)

• 3-10% w/v dried flower infusion (3-10 grams of dried flower in 100 milliliters of finished liquid formulation) (Mills and Bone 2005; ESCOP 2003; Blumenthal et al. 2000; WHO 1999; Bradley 1992).
• 1% v/v fluid extract (1 milliliters of fluid extract per 100 milliliters of finished liquid formulation) (ESCOP 2003; WHO 1999).
• 5% v/v tincture (5 milliliters of tincture per 100 milliliters of finished liquid formulation) (ESCOP 2003; WHO 1999).

Direction(s) for use

Rinse and/or gargle as needed.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

Consult a healthcare practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.

Contraindication(s)

No statement required.

Known adverse reaction(s)

Stop use if hypersensitivity/allergy occurs (ESCOP 2003; Bradley 1992).

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

• 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.

References Cited

• Blumenthal M, Goldberg A, Brinkmann J, editors. 2000. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications.
• Bove M. 1996. An Encyclopedia of Natural Healing for Children and Infants. New Canaan (CT): Keats Publishing, Incorporated.
• Bove M. 2001. An Encyclopedia of Natural Healing for Children and Infants, 2^nd edition. Toronto (ON): McGraw-Hill.
• Bradley PR, editor. 1992. British Herbal Compendium, Volume 1. Bournemouth (GB): British Herbal Medicine Association.
• Brinker F. Herb Contraindications and Drug Interactions, 4^th edition. Sandy (OR): Eclectic Medical Publications; 2010.
• EMEA/CHMP 2006: European Medicines Agency: Pre-authorization Evaluation of Medicines for Human Use. Committee for Medicinal Products for Human Use. Reflection Paper: Formulations of choice for the paediatric population. [Accessed 2018August 8]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003782.pdf
• ESCOP 2003: European Scientific Cooperative on Phytotherapy Scientific Committee. 2003. ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2^nd edition. Exeter (GB): European Scientific Cooperative on Phytotherapy and Thieme.
• 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.
• McGuffin M, Kartesz JT, Leung AY, Tucker AO. 2000. Herbs of Commerce. Silver Spring (MD): American Herbal Products Association.
• Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. Amsterdam (NL): Elsevier.
• Schilcher H. 1997. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists. Stuttgart (DE): Medpharm Scientific Publishers.
• USDA 2018: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [online database]. 2008. Matricaria recutita (L.). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2009 July 23]. Available at: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
• WHO 1999: World Health Organization. 1999. WHO Monographs on Selected Medicinal Plants, Volume 1. Geneva (CH): World Health Organization.

References Reviewed

• Aronson JK, editor. 2009. Meyler's Side Effects of Herbal Medicines. Amsterdam (NL): Elsevier.
• Barnes J, Anderson LA, Phillipson JD. 2007. Herbal Medicines, 3^rd edition. Grayslake (IL): Pharmaceutical Press.
• Crotteau CA, Towner Wright S. 2006. What is the best treatment for infants with colic? The Journal of Family Practice 55(7):634-636.
• Ellingwood F. 1919. The American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications.
• Felter HW. 1922. The Eclectic Materia Medica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications.
• Felter HW, Lloyd JU. 1983. King's American Dispensatory, Volume II. Sandy (OR): Eclectic Medical Publications; [Reprint of 1898 original].
• Grieve M. 1971. A Modern Herbal, Volume 1. New York (NY): Dover Publications; [Reprint of 1931 Harcourt, Brace & Company publication].
• Heck AM, DeWitt BA, Lukes AL. 2000. Potential interactions between alternative therapies and warfarin. American Journal of Health-System Pharmacy 57(13):1221-1227.
• Hurrel RF, Reddy M, Cook JD. 1999. Inhibition of non-haem iron absorption in man by polyphenolic-containing beverages. British Journal of Nutrition 81(4):289-295.
• IAPT 2007: International Association of Plant Taxonomy. International Code of Botanical Nomenclature (Vienna Code) adopted by the Seventeenth International Botanical Congress Vienna, Austria, July 2005. Regnum Vegetabile 146 [online]. Ruggell (Liechtenstein): A.R.G. Gantner Verlag. Last updated 10.03.2007. [Accessed 2009 July 23]. Available from: http://ibot.sav.sk/icbn/frameset/0109AppendixIIIBNSC.htm#E.%20SPERMATOPHYTA
• Jensen-Jarolim E, Reider N, Fritsch R, Breiteneder H. 1998. Fatal outcome of anaphylaxis to camomile-containing enema during labor: A case study. Journal of Allergy and Clinical Immunology 102(6 Pt 1):1041-1042.
• Madisch A, Holtmann G, Mayr G, Vinson B, Hotz J. 2004. Treatment of functional dyspepsia with herbal preparation. Digestion 69(1):45-52.
• McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press.
• NHM 2006: The Natural History Museum, Linnaean Plant Typification Database [online]. 2006. Matricaria chamomilla L. London (UK): The Natural History Museum. [Accessed 2009 June 24]. Available from: http://www.nhm.ac.uk/our-science/data/linnaean-typification/search/
• Pereira F, Santos R, Pereira A. 1997. Contact dermatitis from chamomile tea. Contact Dermatitis 36(6):307.
• Ross SM. 2003. An Integrative Approach to Eczema (Atopic Dermatitis). Holistic Nursing Practice 17(1):56-62.
• Segal R, Pilote L. 2006. Warfarin interaction with Matricaria chamomilla. Canadian Medical Association Journal 174(9):1281-1282.
• USDA 2009: United States Department of Agriculture, Natural Resources Conservation Service, The PLANTS Database [online]. 2009. Matricaria recutita L. Baton Rouge (LA): National Plant Data Center. [Accessed 2009 June 15] Available from: http://plants.usda.gov