Myrtus communis . Other Ingredients: Ethyl Alcohol.
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In 2004, Canada began regulating natural medicines as a category of products separate from foods or drugs. These products are officially recognized as "Natural Health Products." These products include vitamins, minerals, herbal preparations, homeopathic products, probiotics, fatty acids, amino acids, and other naturally derived supplements.
In order to be marketed in Canada, natural health products must be licensed. In order to be licensed in Canada, manufacturers must submit applications to Health Canada including information about uses, formulation, dosing, safety, and efficacy.
Products can be licensed based on several criteria. Some products are licensed based on historical or traditional uses. For example, if an herbal product has a history of traditional use, then that product may be acceptable for licensure. In this case, no reliable scientific evidence is required for approval.
For products with non-traditional uses, some level of scientific evidence may be required to support claimed uses. However, a high level of evidence is not necessarily required. Acceptable sources of evidence include at least one well-designed, randomized, controlled trial; well-designed, non-randomized trials; cohort and case control studies; or expert opinion reports.
Finished products licensed by Health Canada must be manufactured according to Good Manufacturing Practices (GMPs) as outlined by Health Canada.
This is a homeopathic preparation. Homeopathy is a system of medicine established in the 19th century by a German physician named Samuel Hahnemann. Its basic principles are that "like treats like" and "potentiation through dilution." For example, in homeopathy, diarrhea would be treated with an extreme dilution of a substance that normally causes diarrhea when taken in high doses.
Practitioners of homeopathy believe that more dilute preparations are more potent. Many homeopathic preparations are so diluted that they contain little or no active ingredient. Therefore, most homeopathic products are not expected to have any pharmacological effects, drug interactions, or other harmful effects. Any beneficial effects are controversial and cannot be explained by current scientific methods.
Dilutions of 1 to 10 are designated by an "X." So a 1X dilution = 1:10, 3X=1:1000; 6X=1:1,000,000. Dilutions of 1 to 100 are designated by a "C." So a 1C dilution = 1:100; 3C = 1:1,000,000. Dilutions of 24X or 12C or more contain zero molecules of the original active ingredient.
Homeopathic products are permitted for sale in the US due to legislation passed in 1938 sponsored by a homeopathic physician who was also a Senator. The law still requires that the FDA allow the sale of products listed in the Homeopathic Pharmacopeia of the United States. However, homeopathic preparations are not held to the same safety and effectiveness standards as conventional medicines. For more information, see the Homeopathy monograph.
Below is general information about the effectiveness of the known ingredients contained in the product Myrtus Communis (Drops). Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Myrtus Communis (Drops). Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
POSSIBLY SAFE ...when myrtle berry is used orally, short term. Myrtle berry powder 2,250 mg daily has been used with apparent safety for up to 5 days (106778). ...when diluted myrtle leaf extract is used topically and appropriately, short term. A paste containing myrtle leaf extract 5% has been used with apparent safety for up to 6 days (98643). Other myrtle leaf extracts have been applied to the face for up to 16 weeks with apparent safety (106780). ...when myrtle leaf extract is used intravaginally and appropriately, short term. Vaginal suppositories containing myrtle leaf extract 10% and leaf essential oil 0.5% have been used with apparent safety for up to three menstrual cycles (98644).
LIKELY UNSAFE ...when the undiluted oil of myrtle leaf is used orally. Myrtle leaf contains cineole. Ingesting more than 10 grams of cineole can result in respiratory failure and collapse (18). There is insufficient reliable information available about the safety of myrtle leaf and branch when used orally. There is also insufficient reliable information available about the safety of myrtle berry when used topically or myrtle berry extract when used orally or topically.
CHILDREN: LIKELY UNSAFE
when myrtle oil is used orally.
Avoid facial contact with myrtle oil preparations which may cause glottal spasm, bronchospasm, asthma-like attacks, or respiratory failure in infants or small children (18).
There is insufficient reliable information available about the safety of myrtle berry or myrtle berry extract when used orally in children.
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally (18); avoid using.
Below is general information about the interactions of the known ingredients contained in the product Myrtus Communis (Drops). Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Below is general information about the adverse effects of the known ingredients contained in the product Myrtus Communis (Drops). Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General
...There is currently a limited amount of information on the adverse effects of oral and intravaginal myrtle.
A thorough evaluation of safety outcomes has not been conducted. Topically, myrtle leaf seems to be generally well tolerated in adults.
Most Common Adverse Effects:
Topically: Dry skin.
Intravaginally: Vaginal irritation and dryness.
Serious Adverse Effects (Rare):
Orally: Hypotension, respiratory failure.
Topically: Bronchial spasm and respiratory failure, most commonly in infants or children.
Cardiovascular ...Orally, very large amounts of undiluted myrtle leaf oil might lead to low blood pressure and circulatory disorders due to the cineole constituent (18).
Dermatologic ...Topically, myrtle leaf extract has been reported to cause dry skin (106777).
Gastrointestinal ...Orally, myrtle berry extract has been reported to cause constipation in infants and young children (106781).
Genitourinary ...Intravaginally, myrtle leaf extract suppositories have been reported to cause vaginal irritation and dryness (98644).
Pulmonary/Respiratory
...Orally, consumption of very large amounts of undiluted myrtle leaf oil might lead to respiratory failure and collapse (18).
Topically, facial contact with myrtle oil preparations may cause glottal or bronchial spasm, asthma-like attacks, or respiratory failure in infants and children (18).
