PASSIONFLOWER - PASSIFLORA INCARNATA

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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

Date

April 26, 2024

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

Table 1. Proper name(s), Common name(s), Source information
Proper name(s) Common name(s) Source information
Source material(s) Part(s) Preparation(s)

Passiflora incarnata

  • Apricot-vine
  • Maypop
  • Maypop passionflower
  • Passionflower

Passiflora incarnata

Herb top

Dry

References: Proper name: USDA 2023, EMA 2014; Common names: USDA 2023, EMA 2014; Source information: EMA 2014.

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 oral use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications.

Use(s) or Purpose(s)

Notes

Dose(s)

Subpopulation(s)

Adolescents 12-17 years and Adults 18 years and older (EMA 2014)

Quantity(ies)

Methods of preparation: Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract*, Tincture, Fluid extract)

0.25 - 8 grams of dried herb top, per day (EMA 2014)

*Note: Solvents allowed for the method of preparation “Non-Standardized Ethanolic Extracts (Dry extract)” as part of this monograph are a mixture of ethanol and water, but not water only.

Methods of preparation: Non-Standardized Aqueous Extracts (Dry extract*, Decoction, Infusion)

1 - 8 grams of dried herb top, per day (EMA 2014).

*Note: Solvent allowed for the method of preparation “Non-standardized aqueous extracts (Dry extract)” as part of this monograph is water only.

Direction(s) for use

Sleep aid

Take (1 hour) before bedtime, as needed (EMA 2014).

Restlessness/nervousness

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

Sleep aid

Ask 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).

Restlessness/nervousness

Ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.

All uses

Contraindication(s)

No statement required.

Known adverse reaction(s)

Stop use if hypersensitivity/allergy occurs (EMA 2014).

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

Must be established in accordance with the requirements described in the Natural Health Products Regulations.

Specifications

EXAMPLE OF PRODUCT FACTS:

Consult the Guidance Document, Labelling of Natural Health Products for more details.

Product Facts Table

References Cited

References Reviewed