Monograph: Psyllium - Plantago afra

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) 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. Notes: Text in parentheses is additional optional information which can be included on the PLA and product labels at the applicant's discretion.

Date: 2018-10-30

NHPID name

Plantago afra ( Germplasm Resources Information Network Taxonomy )

Proper name(s)

Plantago afra ( USDA 2008 )

Common name(s)

African plantain ( Unavailable )
Black psyllium ( Unavailable )
Psyllium ( EMEA 2006 a )

Source material

Seed ( EMEA 2006 , ESCOP 2003 )

Route Of administration

Oral

Dosage form(s)

Use(s) or purpose(s)

Statement(s) to the effect of:

(Used in Herbal Medicine as a) bulk-forming laxative.
(Used in Herbal Medicine to) promote(s) bowel movements (by increasing bulk volume and water content).
(Used in Herbal Medicine to) provide(s) gentle relief of constipation and/or irregularity.
(Used in Herbal Medicine as a) bulk-forming laxative to provide gentle relief of constipation and/or irregularity and promote bowel movements (by increasing bulk volume and water content).

Dose(s)

Adults:

Dose(s):

1 Day per day

Directions for use:

Effects observed 12-24 hours after first dose, and may take 2-3 days.
For each gram of psyllium, mix with 30 ml of liquid (water, milk, fruit juice or similar aqueous beverage). Stir briskly and drink immediately. Maintain adequate fluid intake.
Minimum daily dose may be increased, up to the maximum daily dose, until desired effect is obtained.
Take a few hours before or after taking other medications or natural health products.
Take during the day (not immediately prior to bedtime).

For psyllium seed, the maximum single dose (13 g) for adults and adolescents (equal or greater than 13 y) is based on the consensus of evidence from several references. The maximum single dose (8 g) for children and adolescents (6-12 y) was calculated as a fraction of the maximum adult doses
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 /health care provider/health care professional/doctor/ physician if symptoms worsen or if laxative effect does not occur within seven days.
Consult a health care practitioner/health care provider/health care professional/doctor/ physician immediately if you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product.
Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you have symptoms such as abdominal pain, nausea, vomiting or fever (as these could be signs of other serious conditions).

Contraindication(s):

Do not use this product if you are experiencing a sudden change in bowel habits that has persisted for more than 2 weeks, undiagnosed rectal bleeding, or failure to defaecate following the use of another laxative product.
Do not use this product if you have diabetes mellitus in which blood sugar is difficult to regulate.
Do not use this product if you have difficulty swallowing.

Known Adverse Reaction(s):

May cause temporary gas and/or bloating.
Stop use if hypersensitivity/allergy occurs.

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 one of the following pharmacopoeial monographs: 'Psyllium Seed' or 'Ispaghula Seed' monograph in British Pharmacopoeia, 'Psyllium Seed' or 'Ispaghula Seed' monograph in European Pharmacopoeia, and 'Plantago Seed' or 'Psyllium Hydrophilic Mucilloid for Oral Suspension' or 'Psyllium Hemicellulose' monograph in US Pharamcopoeia.

References cited

Blumenthal M, Goldberg A, Brinckmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
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.
CPA 2002: Canadian Pharmacists Association. Patient Self-Care. Helping Patients Make Therapeutic Choices. Ottawa (ON): Canadian Pharmacists Association; 2002.
EMEA 2006a. European Medicines Agency. Final Community Herbal Monograph on Plantago afra L. et Plantago indica L., semen. London (UK): EMEA Committee on Herbal Medicinal Products (HMPC), 26 October 2006. [Accessed 2009 January 27]. Available from: http://www.emea.europa.eu/pdfs/human/hmpc/psyllii_semen/34086505enfin.pdf
EMEA 2006b. European Medicines Agency. Final Community Herbal Monograph on Plantago ovata Forssk., seminis tegumentum. London (UK): EMEA Committee on Herbal Medicinal Products (HMPC), 26 October 2006. [Accessed 2009 January 27]. Available from: http://www.emea.europa.eu/pdfs/human/hmpc/plantaginis_ovatae_seminis_tegumentum/34085705enfin.pdf
EMEA 2006c. European Medicines Agency. Final Community Herbal Monograph on Plantago ovata Forssk., semen. London (UK): EMEA Committee on Herbal Medicinal Products (HMPC), 26 October 2006. [Accessed 2009 January 27]. Available from: http://www.emea.europa.eu/pdfs/human/hmpc/plantaginis_ovatae_semen/34086105enfin.pdf
ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
FDA 1985: Unites States Food and Drug Administration. Laxative Drug Products for Over-the-Counter Human Use; Tentative Final Monograph. Proposed Rules sections 334.10 and 334.52. [online]. Federal Register Volume 50, Number 10, Tuesday, January 15, 1985. Rockville (MD): Department of Health and Human Services, U.S. Food and Drug Administration. [Accessed 2009 January 27]. Available from: http://www.fda.gov/cder/otcmonographs/category_sort/laxative.htm
Gennaro AR, editor. Remington: The Science and Practice of Pharmacy, 20th edition. Washington (DC): Lippincott Williams and Wilkins; 2000
McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
Pray WS. Non-Prescription Product Therapeutics, 2nd edition. New York (NY): Lippincott Williams & Wilkins; 2006.
Sweetman SC , editor. Martindale: The Complete Drug Reference, 35th edition. London (UK): Pharmaceutical Press; 2007.
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
WHO 1999: World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 1. Geneva (CH): World Health Organization; 1999.
WHO 2007: World Health Organization (WHO) Monographs on Selected Medicinal Plants, Volume 3. Geneva (CHE): World Health Organization.
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

Ashraf W, Pfeiffer RF, Park F, Lof J, Quigley EM. 1997. Constipation in Parkinson's disease: objective assessment and response to psyllium. Movement Disorders: Official Journal of the Movement Disorder Society 12(6):946-951.
Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 13th edition. Washington (DC): American Pharmaceutical Association; 2002.
BHP 1983: British Herbal Pharmacopoeia. Cowling (GB): British Herbal Medical Association; 1983.
BP 2008: British Pharmacopoeia, Volume 1. Londron (UK): British Pharmacopoeia Commission. The Stationary Office.
Cheskin LJ, Kamal N, Crowell MD, Schuster MM, Whitehead WE. 1995. Mechanisms of constipation in older persons and effects of fiber compared with placebo. Journal of the American Geriatrics Society 43(6):666-669.
European Pharmacopoeia, 6th edition. Strasbourg (France): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).; 2008
HC 1994. Health Canada. TPD/NHPD Category IV Labelling Standard, Bulk Forming Laxatives [online]. Ottawa (ON): Therapeutic Products Directorate, Health Canada. [Accessed 2009 January 27]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/label-etiquet-pharm/laxb_laxm-eng.php
HC 1994. Health Canada. TPD/NHPD Category IV Labelling Standard, General Laxatives [online]. Ottawa (ON): Therapeutic Products Directorate, Health Canada. [Accessed 2009 January 27]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/label-etiquet-pharm/laxat-eng.php
Liel Y, Harman-Boehm I and Shany S. 1996. Evidence for a clinically important adverse effect of fiber-enriched diet on the bioavailability of levothyroxine in adult hypothyroid patients. Journal of Clinical Endocrinology and Metabolism 81(2):857-859.
Marteau P, Flourié B, Cherbut C, Corrèze JL, Pellier P, Seylaz J, Rambaud JC.1994. Digestibility and bulking effect of ispaghula husks in healthy humans. Gut 35(12):1747-1752.
McRorie JW, Daggy BP, Morel JG, Diersing PS, Miner PB, Robinson M. 1998. Psyllium is superior to docusate sodium for treatment of chronic constipation. Alimentary Pharmacology & Therapeutics 12(5):491-497.
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.
Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 3rd edition. Stuttgart (D): Medpharm GmbH Scientific Publishers; 2004.

Appendix 1: Examples of appropriate dosage preparations and frequencies of use

Seed:

Adults and adolescents, ≥ 13 years:

Plantago seed (P. ovata, P. arenaria or P. afra (USP 32; WHO 1999)):

7.5 g, 1-3 times per day (WHO 1999)
2.5-30 g, per day (FDA 1985)

P. arenaria and P. afra:

25-40 g divided into 3 doses, per day (EMEA 2006a)
10-30 g, per day (ESCOP 2003a)
6-12 g, per day (Williamson 2003)
5-10 g, 2-3 times per day (Blumenthal et al. 2000a)

P. ovata:

8-40 g divided into 2-3 doses, per day (EMEA 2006b)
7-30 g, per day (ESCOP 2003b)
5-10 g, per day (Williamson 2003)
5-10 g, 3-4 times per day (Blumenthal et al. 2000b)

Children and adolescents, 6-12 years:

Plantago seed (P. ovata, P. arenaria or P. afra (WHO 1999)):

3.8 g, 1-3 times per day (WHO 1999)
1.25-15 g, per day (FDA 1985)

P. arenaria and P. afra:

12-25 g divided into 3 doses, per day (EMEA 2006a)
5-15 g, per day (ESCOP 2003a)

P. ovata:

4-25 g divided into 2-3 doses, per day (EMEA 2006b)
3.5-15 g, per day (ESCOP 2003b)

Seed Husk:

Adults and adolescents, ≥ 13 years:

Psyllium seed husks (P. ovata or P. arenaria):

2.5-30 g, per day (FDA 1985)

P. ovata:

7-11 g divided into 1-3 doses, per day (EMEA 2006c)
4-20 g divided into 2-3 doses, per day (ESCOP 2003c)
3.5-7 g, per day (Williamson 2003)
4-5 g, 1-4 times per day (Blumenthal et al. 2000c)
3-5 g, 1-3 times per day (Bradley 1992)

Children and adolescents, 6-12 years:

Psyllium seed husks (P. ovata or P. arenaria):

1.25-15 g, per day (FDA 1985)

P. ovata:

3-8 g [divided into] in 1-3 doses, per day (EMEA 2006c)
2-10 g [divided into] in 2-3 doses, per day (ESCOP 2003c)