GERMAN CHAMOMILE - MATRICARIA CHAMOMILLA
Oral
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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
October 30, 2018
Proper name(s), Common name(s), Source material(s)
Proper name(s) | Common name(s) | |||
---|---|---|---|---|
Proper name(s) | Part(s) | |||
Matricaria chamomilla |
|
Matricaria chamomilla |
Flower |
Dried |
References: Proper name: USDA 2018; Common names: USDA 2018, McGuffin 2000 et al. 2000; Source material: 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)
This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.
Acceptable dosage forms by age group:
Children 2 years: The acceptable dosage forms are limited to emulsion/suspension and solution/liquid preparations (Giacoia et al. 2008; EMEA/CHMP 2006).
Children 3-5 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)
- Used in Herbal Medicine to help relieve inflammatory conditions of the gastrointestinal tract (Blumenthal et al. 2000; Bradley 1992).
- (Traditionally) used in Herbal Medicine to help relieve mild digestive upset (such as dyspepsia, flatulence, bloating and belching) (Mills and Bone 2005; ESCOP 2003; Bradley 1992; Felter 1922; Ellingwood 1919; Felter and Lloyd 1898).
- (Traditionally) used in Herbal Medicine to help relieve restlessness and/or nervousness (calmative) (Blumenthal et al. 2000; WHO 1999; Bradley 1992; Felter 1922; Ellingwood 1919; Felter and Lloyd 1898).
The following combined use(s) or purpose(s) is/are also acceptable:
Used in Herbal Medicine to help relieve inflammatory conditions of the gastrointestinal tract and mild digestive upset (Mills and Bone 2005; ESCOP 2003; Blumenthal et al. 2000; Bradley 1992; Felter 1922; Ellingwood 1919; Felter and Lloyd 1898).
Note
Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".
Dose(s)
Subpopulation(s)
As specified below.
Quantity(ies)
Methods of preparation: Dry, Powder, Non-Standardised Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)
Proper name(s), Common name(s), Source material(s)
Subpopulation(s) | |||
---|---|---|---|
Children 1 |
2-4 years |
0.3 |
4.0 |
5-9 years |
0.4 |
6.0 |
|
10-11 years |
0.8 |
12.0 |
|
Adolescents 1 |
12-14 years |
0.8 |
12.0 |
15-17 years |
1.5 |
24.0 |
|
18 years and older |
1.5 |
24.0 |
|
Table 2 Footnotes
|
Direction(s) for use
No statement required.
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.
- Bradley PR, editor. 1992. British Herbal Compendium, Volume 1. Bournemouth (GB): British Herbal Medicine Association.
- Ellingwood F. 1919. The American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications.
- 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 2018 June 1]. 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, 2nd edition. Exeter (GB): European Scientific Cooperative on Phytotherapy and Thieme.
- 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].
- 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.
- JC 2018: Justice Canada. 2018. Food and Drug Regulations (C.01.021) [online]. Ottawa (ON): Justice Canada. [Accessed 2018 August 8] Available from: http://laws-lois.justice.gc.ca/eng/regulations/c.r.c.,_c._870/page-95.html#docCont
- 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 2018 August 8]. 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, 3rd 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.
- 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