SENNA - SENNA ALEXANDRINA

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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

December 18, 2018

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

Table 1. Proper name(s), Common name(s), Source material(s)
Proper name(s)	Common name(s)	Source material(s)
Proper name(s)	Common name(s)	Proper name(s)	Part(s)	Preparation
Senna alexandrina	Alexandrian senna Indian senna Senna Tinnevelly senna True senna	Senna alexandrina	Fruit Fruit and leaf Leaf	Dried

References: Proper name: USDA 2018; Common names: USDA 2018, EMEA 2006a,b, McGuffin 2000; Source materials: EMEA 2006a,b.

Route of Administration

Oral

Dosage Form(s)

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

Acceptable dosage forms for any age category listed in this monograph for the specified route of administration are listed in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

(Traditionally used in Herbal Medicine as a) stimulant laxative (Sweetman 2007; Williamson 2003; Blumenthal et al. 2000; Felter and Lloyd 1983).

(Used in Herbal Medicine for the) short-term relief of occasional constipation (EMEA 2006a,b; Mills and Bone 2005; ESCOP 2003; WHO 1999).

(Used in Herbal Medicine to) promote(s) bowel movement (by direct action on the large intestine) (Sweetman 2007; Pray 2006; McGuffin et al. 1997).

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

(Used in Herbal Medicine as a) stimulant laxative to promote bowel movement and short-term relief of occasional constipation (EMEA 2006a,b; Sweetman 2007; Pray 2006; Mills and Bone 2005; Williamson 2003; Blumenthal et al. 2000; WHO 1999; McGuffin et al. 1997; Felter and Lloyd 1983).

Note

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

Dose(s)

Subpopulation(s)

Adolescents 12-17 years and Adults 18 years and older (Mills and Bone 2005; ESCOP 2003; WHO 1999)

Quantity(ies)

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

0.5 - 3 grams of dried fruit and/or leaf, per day (Mills and Bone 2005; Williamson 2003; Blumenthal et al. 2000; WHO 1999; McGuffin et al. 1997; Felter and Lloyd 1983).

Methods of preparation: Standardized extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

15 - 30 milligrams of sennoside B (i.e. hydroxyanthracene derivatives calculated as sennoside B), per day (EMEA 2006a,b; Mills and Bone 2005).

Direction(s) for use

Take two to three times per week. If results are not observed, the frequency of use may be increased up to once daily (EMEA 2006a,b).

Take a single dose at bedtime (EMEA 2006a,b; ESCOP 2003; WHO 1999).

Take a few hours before or after taking other medications or natural health products (Brinker 2010; Repchinsky et al. 2005).

Allow at least 6 to 12 hours for laxative effect to occur (EMEA 2006a,b; Berardi et al. 2002).

Products providing a dosage range (Optional)

The correct individual dose is the smallest required to produce a soft-formed stool (EMEA 2006a,b; ESCOP 2003; Blumenthal et al. 2000; WHO 1999).

Duration(s) of Use

Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 7 days (Berardi et al. 2002).

Risk Information

Caution(s) and warning(s)

Consult a health care practitioner/health care provider/health care professional/doctor/ physician if symptoms persist or worsen.
Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you have a kidney disorder, faecal impaction or symptoms such as abdominal pain, nausea, vomiting or fever (Brinker 2010; EMEA 2006a,b; Blumenthal et al. 2000; WHO 1999).
Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are taking cardiac medications such as cardiac glycosides or antiarrhythmic medications, thiazide diuretics, corticosteroids, licorice root or other medications or health products which may aggravate electrolyte imbalance (Brinker 2010; EMEA 2006a,b; Blumenthal et al. 2000; WHO 1999).
Reduce dose or stop use if you experience abdominal pain, cramps, spasms and/or diarrhoea (EMEA 2006a,b; Blumenthal et al. 2000; WHO 1999; McGuffin et al. 1997).

Contraindication(s)

Do not use this product if you have abnormal constrictions of the gastrointestinal tract, potential or existing intestinal blockage, atonic bowel, appendicitis, inflammatory colon disease such as Crohn's disease or ulcerative colitis, abdominal pain of unknown origin, undiagnosed rectal bleeding, severe dehydration with depleted water or electrolytes or diarrhoea (Brinker 2010; EMEA 2006a,b; WHO 1999; McGuffin et al. 1997).
Do not use this product if you are pregnant or breastfeeding (Brinker 2010; EMEA 2006a,b; Blumenthal et al. 2000; McGuffin et al. 1997).

Known adverse reaction(s)

Stop use if hypersensitivity/allergy occurs (EMEA 2006a,b).

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

Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, éditeurs. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 13e édition. Washington (DC): American Pharmaceutical Association; 2002.

Blumenthal M, Goldberg A, Brinkmann J, éditeurs. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.

Brinker F. Herb Contraindications and Drug Interactions, 4th edition. Sandy (OR): Eclectic Medical Publications; 2010.

EMEA 2006a: European Medicines Agency. Community Herbal Monograph on Cassia Senna L., fructus and Cassia angustifolia Vahl, fructus. London (UK): EMEA Committee on Herbal Medicinal Products (HMPC), 26 October 2006. [Accessed 2018 October 1]. Available from: https://www.ema.europa.eu/documents/herbal-monograph/final-community-herbal-monograph-cassia-senna-l-fructus-cassia-angustifolia-vahl-fructus_en.pdf

EMEA 2006b: European Medicines Agency. Community Herbal Monograph on Cassia senna L. and Cassia angustifolia Vahl, folium. London (UK): EMEA Committee on Herbal Medicinal Products (HMPC), 26 October 2006. [Accessed 2018 October 1]. Available from: https://www.ema.europa.eu/documents/herbal-monograph/final-community-herbal-monograph-cassia-senna-l-cassia-angustifolia-vahl-folium_en.pdf

ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.

Felter HW, Lloyd JU. King's American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].

McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press.

McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.

Mills S, Bone K. 2005. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.

Pray WS. Non-Prescription Product Therapeutics, 2e édition. New York (NY): Lippincott Williams & Wilkins; 2006.

Repchinsky C, Welbanks L, Bisson R, Bhalla A, Dang T, Fortin K, et al., editors. Compendium of Pharmaceuticals and Specialties. The Canadian Drug Reference for Health Professionals. Ottawa (ON): Canadian Pharmacists Association; 2005.

Sweetman SC, éditeur. Martindale : The Complete Drug Reference, 35e édition. London (UK) : Pharmaceutical Press; 2007

USDA 2018: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). Senna alexandrina Mill. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2018 October 1]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxonomydetail.aspx?id=100067

WHO 1999: World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 1. Geneva (CH): World Health Organization; 1999.

Wichtl M, Anton R, éditeurs. Plantes thérapeutiques : Tradition, pratique officinale, sciences et thérapeutique, 2nd edition. Paris (F) : Lavoisier; 2003.

Williamson EM. Potter's Herbal Cyclopaedia: The Authoritative Reference work on Plants with a Known Medical Use. Saffron Walden (UK): The C.W. Daniel Company Limited; 2003.

References Reviewed

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. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2010. [Accessed 2015 june 4]. 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].

HC 1997. Health Canada. TPD/NHPD Category IV Labelling Standard, Stimulant Laxatives [online]. Ottawa (ON): Therapeutic Products Directorate, Health Canada. [Accessed 2008 August 26]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/label-etiquet- pharm/laxstimu-eng.php

Moerman DE. 1998. Native American Ethnobotany. Portland (OR): Timber Press.

Wiersema J, León B. 1999. World Economic Plants: A Standard Reference. Boca Raton (FL): CRC Press LLC.