Mono - Psyllium Plantago Afra - English
Mono - Psyllium Plantago Afra - English
Mono - Psyllium Plantago Afra - English
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 labels 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.
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 the age category listed in this monograph and specified route of
administration are indicated in the Compendium of Monographs Guidance Document.
Use(s) or Purpose(s)
Dose(s)
Subpopulation(s)
As specified below.
Quantity(ies)
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
(EMEA 2013a; EMEA 2013b; EMEA 2013c; ESCOP 2003a; ESCOP 2003b; ESCOP 2003c;
Blumenthal et al. 2000a; Blumenthal et al. 2000b; Blumenthal et al. 2000c; WHO 1999).
Take a few hours before or after taking other medications or natural health products (EMEA
2013a; EMEA 2013b; EMEA 2013c; Sweetman 2007; ESCOP 2003a; ESCOP 2003b;
ESCOP 2003c; Blumenthal et al. 2000b; Blumenthal et al. 2000c; Bradley 1992).
Effects observed 12-24 hours after first dose, and may take 2-3 days (EMEA 2013a; EMEA
2013b; EMEA 2013c).
Take during the day (not immediately prior to bedtime) (EMEA 2013a; EMEA 2013b; EMEA
2013c; ESCOP 2003a; ESCOP 2003b; ESCOP 2003c).
Minimum daily dose may be increased, up to the maximum daily dose, until desired effect is
obtained.
Duration(s) of use
No statement required.
Risk information
Contraindication(s)
Do not use this product if you have difficulty swallowing (EMEA 2013a; EMEA 2013b;
EMEA 2013c).
Do not use this product if you have diabetes mellitus in which blood sugar is difficult to
regulate (EMEA 2013a; EMEA 2013b; EMEA 2012c; ESCOP 2003a; ESCOP 2003b;
ESCOP 2003c; Blumenthal et al. 2000a; Blumenthal et al. 2000b; Blumenthal et al. 2000c;
Bradley 1992).
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 (EMEA 2013a; EMEA 2013b; EMEA 2013c;
ESCOP 2003a; ESCOP 2003b; ESCOP 2003c).
Stop use if hypersensitivity/allergy occurs (EMEA 2013a; EMEA 2013b; EMEA 2013c;
ESCOP 2003a; ESCOP 2003b; ESCOP 2003c; Blumenthal et al. 2000a; Blumenthal et al.
2000b; Blumenthal et al. 2000c; Bradley 1992).
May cause temporary gas and/or bloating (EMEA 2013a; EMEA 2013b; EMEA 2013c;
ESCOP 2003a; ESCOP 2003b; ESCOP 2003c; 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.
References cited
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