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Monograph: Chamomile, German - Oral

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. It is a referenced document to be used as a labelling standard. Note: Text in parentheses is additional optional information which can be included on the PLA and product labels at the applicants' discretion. The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant.

Date: 2009-07-31

NHPID Name

Matricaria chamomilla (USDA 2008)

Proper Name(s)

Common Name(s)

Source Material

Flower ( Mills and Bone 2005 , ESCOP 2003 , Blumenthal et al. 2000 , WHO 1999 , Bradley 1992 )

Route Of Administration

Oral ( ESCOP 2003 , Blumenthal et al. 2000 , WHO 1999 , Bradley 1992 )

Dosage Form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
  • This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:

Dose(s)

Children 2 - 4 years:

Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): 0.3 - 4 Grams per day, dried flowers

Children and adolescents 5 - 9 years:

Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): 0.4 - 6 Grams per day, dried flowers

Adolescents 10 - 14 years:

Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): 0.8 - 12 Grams per day, dried flowers

Adults and adolescents 15 and over:

Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): 1.5 - 24 Grams per day, dried flowers

  • Adolescents and adults include pregnant and breastfeeding women
  • Children and adolescent doses were calculated as a proportion of the adult dose (JC 2012).
  • See Appendix 1 for examples of appropriate dosage preparations and frequencies of use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration of use

No statement is required

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • Consult a health care practitioner if symptoms persist.
  • Consult a health care practitioner if symptoms worsen.

Contraindication(s):
Do not use if you are allergic to plants of the Asteraceae/Compositae/Daisy family  (ESCOP 2003, Brinker 2001, WHO 1999)

Known Adverse Reaction(s):
Hypersensitivity (e.g. allergy) has been known to occur; in which case, discontinue use  (ESCOP 2003, Bradley 1992)

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database 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 NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).
  • The medicinal ingredient may comply with the specifications outlined in the following pharmacopoeial monographs: 'Matricaria Flowers' from British Pharmacopoeia (BP), 'Matricaria Flower' and 'Matricaria Liquid Extract' from European Pharmacopoeia (Ph.Eur.) or 'Chamomile' from United States Pharmacopoeia (USP).

References cited

  • Blumenthal M, Goldberg A, Brinckmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
  • Bove M. An Encyclopedia of Natural Healing for Children and Infants. New Canaan (CT): Keats Publishing, Incorporated; 1996
  • BP 2008: British Pharmacopoeia, Volume 1. Londron (UK): British Pharmacopoeia Commission. The Stationary Office.
  • Bradley PR, editor. 1992. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 1. Bournemouth (GB): British Herbal Medicine Association.
  • Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • Brinker F. 2010. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Updated 2010 July 13; Accessed 2013 January 30]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
  • Ellingwood F. 1983. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications [Reprint of 1919 original].
  • ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
  • European Pharmacopoeia, 6th edition. Strasbourg (France): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).; 2008
  • Felter HW, Lloyd JU. 1983. King's American Dispensatory, Volume 2, 18th edition. Sandy (OR): Eclectic Medical Publications [Reprint of 1898 original].
  • Felter HW. The Eclectic Materia Medica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1922 original].
  • JC 2008: Justice Canada. Food and Drug Regulations. (C.01.021). Ottawa (ON): Health Canada; 2008. [Accessed 2008-01-31] Available from: http://laws.justice.gc.ca/en/F-27/C.R.C.-c.870/text.html
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
  • Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
  • Schilcher H. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists. Stuttgart (D): Medpharm Scientific Publishers; 1997.
  • USDA 2008: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-01-21]. Available at http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • USP 32 : United States Pharmacopeial Convention. 2009. United States Pharmacopeia and the National Formulary (USP 32 - NF 27). Rockville (MD): The United States Pharmacopeial Convention.
  • WHO 1999: World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 1. Geneva (CH): World Health Organization; 1999.

References reviewed

  • Aronson JK, editor. 2009. Meyler's Side Effects of Herbal Medicines. Amsterdam (NL): Elsevier.
  • Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3rd edition. London (GB): 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.
  • 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. Potential interactions between alternative therapies and warfarin. American Journal of Health-System Pharmacy 2000;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.htmE.%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/jdsml/research-curation/research/projects/linnaean-typification/detail.dsml?ID=559000&listPageURL=list%2edsml%3fVarqtype%3dstarts%2bwith%26CVarqtype%3dstarts%2bwith%26CGenusqtype%3dstarts%2bwith%26CSpeciesqtype%3dstarts%2bwith%26Species%3drecutita%26sort%3dGenus%252cSpecies%26Speciesqtype%3dstarts%2bwith%26Genus%3dMatricaria%26Genusqtype%3dstarts%2bwith%26CSspqtype%3dstarts%2bwith
  • 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 2008: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-01-21]. Available at http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl

Appendix 1: Examples of appropriate dosage preparations, frequencies of use and directions for use

ORAL:

Dried flower:

  • 6 - 12 g, per day (Mills and Bone 2005)
  • 2 - 8 g, 3 times per day (WHO 1999)
  • 2 - 4 g, 3 times per day (Bradley 1992)

Infusion:

  • 6 - 12 g dried flower, per day (Mills and Bone 2005)
  • 3 g dried flower heads(ESCOP 2003)
  • 3 g dried flower, 3-4 times per day (Blumenthal et al. 2000)
  • Directions for use: Pour 150 ml of boiling water on dried flower heads and steep for 5-10 minutes (ESCOP 2003).

Fluid extract:

  • 3 g dried equivalent, 3-4 times per day (1:1, 3 ml) (Blumenthal et al. 2000)
  • 1 - 4 g dried equivalent, 3 times per day (1:1, 45% ethanol, 1-4 ml) (WHO 1999; Bradley 1992)

Tincture:

  • 1.5 - 6 g dried equivalent, per day (1:2, 3-12 ml) (Mills and Bone 2005)
  • 1.8 - 4 g dried equivalent, per day (1:5, 9-20 ml) (Mills and Bone 2005)
  • 1.5 - 3 g dried equivalent, 3-4 times per day (1:2, 50% ethanol, 3-6 ml) (ESCOP 2003)
  • 3 g dried equivalent, 3-4 times per day (1:5, 15 ml) (Blumenthal et al. 2000)
  • 0.6 - 2 g dried equivalent, 3 times per day (1:5, 45% ethanol, 3-10 ml) (Bradley 1992)