Helleborus niger 3 D. Other Ingredients: Lactose, Sucrose.
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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 Helleborus Niger (Granule). Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
There is insufficient reliable information available about the effectiveness of black hellebore.
Below is general information about the safety of the known ingredients contained in the product Helleborus Niger (Granule). Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
LIKELY UNSAFE ...when used orally. Black hellebore contains cardiac glycosides with structure, activity, and adverse effects similar to digitalis (3).
PREGNANCY: LIKELY UNSAFE
when used orally because it can have menstrual stimulant (19) or abortifacient effects (18); avoid using.
LACTATION: LIKELY UNSAFE
when used orally (3); avoid using.
Below is general information about the interactions of the known ingredients contained in the product Helleborus Niger (Granule). Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Black hellebore contains cardiac glycosides. Using black hellebore in combination with digoxin might have additive effects and increase the risk of toxicity (18,19).
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Theoretically, concomitant use of potassium depleting diuretics and black hellebore can increase the risk of cardiac glycoside toxicity due to potassium depletion (506). Some diuretics that can deplete potassium include chlorothiazide (Diuril), chlorthalidone (Thalitone), furosemide (Lasix), hydrochlorothiazide (HCTZ, Hydrodiuril, Microzide), and others.
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Theoretically, concomitant use of macrolide antibiotics and black hellebore might increase risk of cardiac glycoside toxicity (17). Some of these drugs include erythromycin, azithromycin, and clarithromycin.
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Theoretically, concomitant use of quinine and black hellebore can increase the risk of cardiac glycoside toxicity (506).
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Theoretically, overuse or misuse of stimulant laxatives can increase the risk of cardiac glycoside toxicity due to potassium depletion (19,506).
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Theoretically, concomitant use of tetracyclic antibiotics and black hellebore might increase the risk of cardiac glycoside toxicity (17).
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Below is general information about the adverse effects of the known ingredients contained in the product Helleborus Niger (Granule). 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
...Orally, black hellebore can cause GI irritation and an irregular heartbeat (18,19).
The symptoms of poisoning from black hellebore include scratchy throat or mouth, salivation, nausea, vomiting, diarrhea, dizziness, shortness of breath, spasm, and asphyxiation (18).
Topically, the fresh plant may cause irritation or inflammation when handled (19).
Cardiovascular ...Orally, black hellebore can result in an irregular heartbeat. Black hellebore root contains cardioactive glycosides with digitalis-like effects (18).
Dermatologic ...Topically, the fresh black hellebore plant may cause irritation or inflammation when handled (19).
Gastrointestinal ...Orally, black hellebore can cause GI irritation (19). The symptoms of poisoning from black hellebore include scratchy throat or mouth, nausea, vomiting, and diarrhea (18).
Neurologic/CNS ...Orally, the symptoms of poisoning from black hellebore include salivation and dizziness (18).
Pulmonary/Respiratory ...Orally, the symptoms of poisoning from black hellebore include shortness of breath, spasm, and asphyxiation (18).
