Ruta graveolens 6 X. Other Ingredients: Lactose.
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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 Ruta Graveolens Tablets. 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 Ruta Graveolens Tablets. 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 SAFE ...when used orally in amounts commonly found in foods. Rue and rue oil have Generally Recognized as Safe (GRAS) status for use in foods at concentrations that do not exceed 2 parts per million (ppm) (12,4912).
POSSIBLY SAFE ...when products containing dried rue leaves are used medicinally in appropriate doses (6,12,18,515). However, therapeutic doses can cause drowsiness, dizziness, and gastrointestinal irritation and cramps (12).
LIKELY UNSAFE ...when fresh rue and rue oil are used orally, or when large doses of the dried herb are used orally (2,12,18). Overdose is associated with severe abdominal pain, vomiting, liver damage, kidney damage, vertigo, respiratory distress, and delirium, and can be fatal (12,18). ...when fresh rue is applied topically. Rue can cause contact dermatitis and severe photodermatitis (2,6,11,19,104119,107948).
PREGNANCY: LIKELY UNSAFE
when used orally.
Rue has uterine stimulant and abortifacient effects (12,19); avoid using. Deaths have been reported in women who used rue as an abortifacient (2).
LACTATION:
There is insufficient reliable information available about the use of rue when breast-feeding; avoid use.
Below is general information about the interactions of the known ingredients contained in the product Ruta Graveolens Tablets. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, rue might increase the risk for phototoxicity when used with photosensitizing drugs.
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Below is general information about the adverse effects of the known ingredients contained in the product Ruta Graveolens Tablets. 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, rue is well tolerated when taken in the amounts found in foods.
The dried herb seems to be generally well tolerated when taken in medicinal doses; however, a thorough evaluation of safety outcomes has not been conducted. Fresh rue is generally considered unsafe.
Most Common Adverse Effects:
Orally: Cramps, drowsiness, depression, dizziness, gastrointestinal irritation, and sleep disturbances with medicinal use of the dried herb.
Topically: Contact dermatitis and phototoxic skin reactions with the fresh plant.
Cardiovascular ...Orally, large doses of rue have been associated with bradycardia (2).
Dermatologic ...Topically, rue can cause contact dermatitis (2). Exposure to the fresh rue plant followed by sun exposure within 48 hours can lead to severe phototoxic reactions (2,6). Multiple case reports describe patients who developed pruritus, erythema, and severe blistering on the back of the hands and wrists, equivalent to a partial thickness burn, after contact with the fresh plant leaves and exposure to sunlight (104119,107948). One patient was successfully treated with cetirizine and oral and topical corticosteroids (107948).
Gastrointestinal ...Orally, rue can cause gastrointestinal irritation and cramps at therapeutic doses (2,12). When taken in large doses, it causes severe abdominal pain and vomiting (2,12,18).
Genitourinary ...Orally, rue can cause uterine stimulation and abortion (2).
Hepatic ...Orally, high doses of rue can cause liver damage (2,12,18).
Neurologic/CNS ...Orally, therapeutic doses of rue can cause tremor, dizziness, drowsiness, sleep disorders, and depression. High doses can cause vertigo, seizures, and delirium (2,12,18).
Pulmonary/Respiratory ...Orally, high doses of rue can cause respiratory distress (2,12,18).
Renal ...Orally, high doses of rue can cause kidney damage (2,12,18).