Hyoscyamus niger 3 DH. 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 Hyoscyamus 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 henbane.
Below is general information about the safety of the known ingredients contained in the product Hyoscyamus 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.
POSSIBLY SAFE ...when henbane leaf is used orally and appropriately, short-term. Henbane leaf powder has been used with apparent safety in single doses of up to 1 gram, which have been standardized to contain 500-700 mg of total alkaloids. The maximum daily dosage should not exceed 3 grams, corresponding to 1500-2100 mg of total alkaloids (2,18).
LIKELY UNSAFE ...when the leaf is used orally in doses above 3 grams daily. This maximum tolerated dose contains 1500-2100 mg of total alkaloids, which include hyoscyamine and scopolamine. These alkaloids have a narrow therapeutic range; excessive doses can cause poisoning and death (2,18). There is insufficient reliable information available about the safety of henbane seed and flower.
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally because of its risk of poisoning (18).
Below is general information about the interactions of the known ingredients contained in the product Hyoscyamus 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.
Concomitant use of henbane can have additive anticholinergic effects and adverse effects with amantadine, antihistamines, atropine, belladonna alkaloids, hyoscyamine, phenothiazines, procainamide, scopolamine, and tricyclic antidepressants (2).
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Below is general information about the adverse effects of the known ingredients contained in the product Hyoscyamus 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, henbane can cause anticholinergic effects including dry mouth, vision disturbances, tachycardia, difficult urination, constipation, and skin flushing (2,18). At higher doses, poisoning can occur due to the hyoscyamine and scopolamine constituents of henbane. Symptoms of toxicity include hyperpyrexia and somnolence, followed by CNS stimulation with restlessness, hallucinations, delirium, memory impairment, ataxia, and manic episodes, followed by exhaustion and coma. Henbane can cause death by asphyxiation (2,18,100917).
Cardiovascular ...Orally, henbane can cause tachycardia, especially at higher doses (2,18,100917).
Dermatologic ...Orally, henbane reduces sweating, resulting in flushing of the skin and hyperpyrexia (2,18,100917).
Gastrointestinal ...Orally, henbane causes reduced muscle activity in the bowel, leading to constipation (2,18,100917).
Genitourinary ...Orally, henbane can cause difficulty with urination (2,18,100917).
Neurologic/CNS ...Orally, high doses of henbane can cause toxicity due to its hyoscyamine and scopolamine constituents. Neurologic symptoms of henbane toxicity include somnolence, followed by CNS excitation involving restlessness, hallucinations, memory impairment, delirium, and manic episodes, followed by exhaustion and coma (2,18,100917).
Ocular/Otic ...Orally, high doses of henbane can cause toxicity due to its hyoscyamine and scopolamine constituents. Ocular symptoms of henbane toxicity include visual disturbances (2,18,100917).
Other ...Orally, high doses of henbane can cause toxicity due to its hyoscyamine and scopolamine constituents. Toxicity can result in coma and death by asphyxiation in some cases (2,18,100917). Treatment of henbane toxicity includes stomach lavage, activated charcoal, supportive therapy, and, in severe cases, the antidote physostigmine (100917).
