Passiflora incarnata L.

3licensed products
1 monograph
Capsule, Liquid

Health Canada Monographs

1

Approved Health Claims

7
  • (Traditionally) used in Herbal Medicine to help relieve restlessness and/or nervousness (calmative)
  • (Traditionally) used in Herbal Medicine as a sleep aid (during times of mental stress)
  • The above claims can be combined on the product label if from the same traditional or non-traditional system of medicine (e.g. Traditionally used in Herbal Medicine to help relieve restlessness and/or nervousness and as a sleep aid during times of mental stress)
  • For multi-ingredient products:
  • To prevent the product from being represented as a "traditional medicine," any indicated traditional use claim must refer to the specific medicinal ingredient(s) and recognized traditional system of medicine from which the claim originates when 1) both traditional and modern claims are present or 2) when claims originate from multiple systems of traditional medicine (e.g. Passionflower is traditionally used in Herbal Medicine as a sleep aid during times of mental stress). When ALL of the medicinal ingredients (MIs) in the product are used within the SAME identified system of traditional medicine AND the product makes ONLY traditional claims, listing of MIs in the traditional claim(s) is not required
  • To prevent the product from being represented as a "traditional medicine," any indicated traditional use claim must refer to the specific medicinal ingredient(s) and recognized traditional system of medicine from which the claim originates when 1) both traditional and modern claims are present or 2) when claims originate from multiple systems of traditional medicine (e.g. Passionflower is traditionally used in Herbal Medicine as a sleep aid during times of mental stress)
  • When ALL of the medicinal ingredients (MIs) in the product are used within the SAME identified system of traditional medicine AND the product makes ONLY traditional claims, listing of MIs in the traditional claim(s) is not required

Approved Dose Ranges

2
PopulationDose RangeFrequency
Adolescents 12-17 years and Adults 18 years and older (EMA 2014)0.25–8 gramsper day
Adolescents 12-17 years and Adults 18 years and older (EMA 2014)1–8 gramsper day

Cautions & Contraindications

6
cautionAsk a health care practitioner/health care provider/health care professional/doctor/physician if sleeplessness persists for more than 4 weeks (chronic insomnia) (Berardi et al. 2002: DiPiro et al. 2002).
cautionAsk a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
cautionAsk a health care practitioner/health care provider/health care professional/doctor/ physician before use if you are pregnant or breastfeeding (EMA 2014).
cautionWhen using this product avoid taking with alcohol or products that cause drowsiness (EMA 2014; Brinker 2010).
cautionWhen using this product exercise caution if you drive or use machinery as you may experience drowsiness (EMA 2014).
adverse_reactionStop use if hypersensitivity/allergy occurs (EMA 2014).

Alternative Names

5
Apricot-vine(common)Maypop(common)Maypop passionflower(common)Passionflower(common)Passiflora incarnata

Common Quantities in Licensed Products

3
0.5 Grams1 licensed products
56 mg1 licensed products
125 milligrams1 licensed products

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