OLIVE LEAF - OLEA EUROPAEA

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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

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) Part(s) Preparation

Olea europaea

Olive leaf

Olea europaea

Leaf

  • Dried
  • Fresh

References: Proper name: USDA 2018; Common name: USDA 2018, EMA 2017; Source material: EMA 2017, Jemai et al. 2009.

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)

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Antioxidant

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

Not to exceed 3.5 grams of dried leaf, per day (Bone 2003).

Methods of preparation: Standardised Ethanolic Extract (Dry extract, Tincture, Fluid extract)

Not to exceed 3.5 grams of dried leaf, per day and 20.8 % oleuropein (Perrinjaquet-Moccetti et al. 2008; Bone 2003).

Method of preparation: Decoction

Method of preparation: Decoction standardised

Method of preparation: Infusion

Not to exceed 30 grams of dried leaves, per day and 8 grams per single dose (EMA 2017).

Method of preparation: Infusion standardised

Not to exceed 30 grams of dried leaves, per day, 8 grams per single dose and 20.8 % oleuropein (EMA 2017; Perrinjaquet-Moccetti et al. 2008).

Diuretic

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

0.6 - 3.5 grams of dried leaves, per day (EMA 2017; Bone 2003).

Methods of preparation: Standardised Ethanolic Extract (Dry extract, Tincture, Fluid extract)

0.6 - 3.5 grams of dried leaves, per day and not to exceed 20.8 % oleuropein (EMA 2017; Perrinjaquet-Moccetti et al. 2008; Bone 2003).

Method of preparation: Decoction

Method of preparation: Decoction standardised

Method of preparation: Infusion

7 - 8 g dried leaves, 1 to 3 times per day (EMA 2017).

Method of preparation: Infusion standardised

7 - 8 g dried leaves, 1 to 3 times per day and not to exceed 20.8 % oleuropein (EMA 2017; Perrinjaquet-Moccetti et al. 2008).

Note

For standardized extracts, as evidence mainly supports the quantity crude equivalent of olive leaves, both the quantity crude equivalent and the maximum concentration of the potency constituent must be met.

Direction(s) for use

Take with food (Bone 2003).

Duration(s) of Use

Diuretic

For occasional use only (APhA 2002; CPhA 2002).

Risk Information

Caution(s) and warning(s)

All products

All products except those making a diuretic claim

Diuretic effect may occur.

Contraindication(s)

No statement required.

Known adverse reaction(s)

No statement required.

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

References Cited

References Reviewed