Belladonna 10.0 D, 30.0 D, 200.0 D, 1000.0 D • Chelidonium majus 10.0 D, 30.0 D, 200.0 D. Other Ingredients: Ethanol, Purified Water.
Brand name products often contain multiple ingredients. To read detailed information about each ingredient, click on the link for the individual ingredient shown above.
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 Chelidonium Homaccord N. 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
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Chelidonium Homaccord N. 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 UNSAFE ...when used rectally. It is not known whether significant amounts of the toxic alkaloids are absorbed from the rectum (106909). ...when used topically. It is not known whether significant amounts of the toxic alkaloids are absorbed through the skin (106909).
LIKELY UNSAFE ...when used orally. Belladonna contains toxic alkaloids and has been linked to reports of serious adverse effects (12,553,34144).
CHILDREN: LIKELY UNSAFE
when used orally.
Fatalities in children may occur at doses of belladonna providing atropine 0.2 mg/kg (34168). Two belladonna berries, which contain 2 mg atropine per fruit, may be lethal for a small child (34144). Severe adverse effects and fatalities have been reported in infants treated with topical homeopathic teething products containing belladonna (17493,34142,34146,93537).
PREGNANCY: LIKELY UNSAFE
when used orally.
Belladonna contains toxic alkaloids and has been linked to reports of serious adverse effects (12,553,34144).
LACTATION: LIKELY UNSAFE
when used orally.
Belladonna can reduce milk production and is secreted into breast milk (15).
POSSIBLY UNSAFE ...when used orally. Greater celandine has been implicated in dozens of cases of liver damage, primarily in European countries including Germany (363,13410,16839,41412,53502,53504,53506,53507,53510). There is insufficient reliable information available about the safety of greater celandine when used topically or when derivatives of greater celandine constituents are used intravenously.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Chelidonium Homaccord N. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Belladonna may increase the risk of adverse effects when used concomitantly with anticholinergic drugs.
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Theoretically, belladonna might reduce the effects of cisapride.
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Belladonna contains atropine. In vivo evidence suggests that atropine can prevent cisapride from increasing motility in the gastrointestinal tract (25191).
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Research in vitro shows that chelidonine, a constituent of greater celandine, inhibits cytochrome P450 2D6 (CYP2D6) enzyme activity (99455). Theoretically, greater celandine might increase levels of drugs metabolized by CYP2D6.
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Some drugs metabolized by CYP2D6 include amitriptyline (Elavil), clozapine (Clozaril), codeine, desipramine (Norpramin), donepezil (Aricept), fentanyl (Duragesic), flecainide (Tambocor), fluoxetine (Prozac), meperidine (Demerol), methadone (Dolophine), metoprolol (Lopressor, Toprol XL), olanzapine (Zyprexa), ondansetron (Zofran), tramadol (Ultram), trazodone (Desyrel), and many others.
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There is some concern that greater celandine can adversely affect the liver. Greater celandine has been linked to many cases of hepatotoxicity (363,13410,16839,41412,53502,53504,53506,53507,53510). Theoretically, concomitant use with other potentially hepatotoxic drugs might increase the risk of developing liver damage. Some of these drugs include acarbose (Precose, Prandase), amiodarone (Cordarone), atorvastatin (Lipitor), azathioprine (Imuran), carbamazepine (Tegretol), cerivastatin (Baycol), diclofenac (Voltaren), felbamate (Felbatol), fenofibrate (TriCor), fluvastatin (Lescol), gemfibrozil (Lopid), isoniazid, itraconazole, (Sporanox), ketoconazole (Nizoral), leflunomide (Arava), lovastatin (Mevacor), methotrexate (Rheumatrex), nevirapine (Viramune), niacin, nitrofurantoin (Macrodantin), pioglitazone (Actos), pravastatin (Pravachol), pyrazinamide, rifampin (Rifadin), ritonavir (Norvir), rosiglitazone (Avandia), simvastatin (Zocor), tacrine (Cognex), tamoxifen, terbinafine (Lamisil), valproic acid, and zileuton (Zyflo).
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Preliminary clinical research suggests that taking a specific semi-synthetic derivative of the greater celandine constituent chelidonine (Ukrain; not available in North America) might stimulate immune responses in cancer patients (53473,53497). Theoretically, taking greater celandine might decrease the effects of immunosuppressive therapy. Immunosuppressant drugs include azathioprine (Imuran), basiliximab (Simulect), cyclosporine (Neoral, Sandimmune), daclizumab (Zenapax), muromonab-CD3 (OKT3, Orthoclone OKT3), mycophenolate (CellCept), tacrolimus (FK506, Prograf), sirolimus (Rapamune), prednisone (Deltasone, Orasone), and other corticosteroids (glucocorticoids).
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Theoretically taking monoamine oxidase inhibitors (MAOIs) with greater celandine might increase the risk of serotonergic side effects including serotonin syndrome. In vitro research shows that chelerythrine, an isoquinoline alkaloid in greater celandine, strongly, selectively, and reversibly inhibits an isoform of recombinant human monoamine oxidase-A (MAO-A). It was also a weak but selective inhibitor of monoamine oxidase-B (MAO-B) (99454). Some MAOIs include phenelzine (Nardil), tranylcypromine (Parnate), and others.
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Below is general information about the adverse effects of the known ingredients contained in the product Chelidonium Homaccord N. 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, belladonna can cause anticholinergic side effects even at low doses, and is considered poisonous.
Most Common Adverse Effects:
Orally: Anticholinergic side effects, including blurred vision, constipation, delirium, dilated pupils, dizziness, dry mouth, fever, headache, hypertension, muscle rigidity and tremor, psychosis, respiratory failure, and slurred speech.
Cardiovascular ...Orally, belladonna can cause anticholinergic side effects such as hypertension, hypotension, tachycardia, and ventricular premature beats (553,34168,34180).
Dermatologic
...Orally, belladonna can cause anticholinergic side effects such as dry, red skin and decreased perspiration (553,34146,34152).
One case of rash and another case of hives have been reported in patients taking belladonna with phenobarbital and ergotamine orally; it is unclear if the adverse effects were due to belladonna or the other ingredients (34154).
Topically, belladonna plaster (Cuxon Gerrard) can cause contact dermatitis (34152).
Gastrointestinal ...Orally, belladonna can cause anticholinergic side effects such as dry mouth and constipation (553,34162,34163,34176,34180,34181).
Genitourinary ...Orally, belladonna can cause anticholinergic side effects such as urinary retention (553,34145,34150,34163).
Neurologic/CNS ...Orally, belladonna can cause anticholinergic side effects such as memory and attention impairment, headache, and confusion (553,34163,34180).
Ocular/Otic ...Orally and topically, belladonna can cause anticholinergic side effects such as dilation of pupils and blurred vision (553,34157,34168,34169,34180). A case report describes anisocoria (unequal pupil sizes) in a 70-year-old female who used homeopathic pink eye relief drops (Similasan) containing belladonna, eyebright, and hepar sulphuris (calcium sulfide) in one eye for 3 days. The pupil dilation lasted more than 2 weeks and did not respond to bright light or pilocarpine (106907). Another report describes a case of acute angle closure glaucoma, requiring referral to an ophthalmologist, in a 55-year-old female who used these eye drops for 2 days (106906).
General
...Orally, greater celandine has been implicated in dozens of cases of liver damage (363,13410,16839,41412,53502,53504,53506,53507,53510).
Greater celandine can also cause rash (13410). Greater celandine extract has caused a single case of hemolytic anemia (53508).
Topically, greater celandine can cause contact dermatitis (13411).
Intravenously, a derivative of the greater celandine constituent chelidonine (Ukrain) can cause gastrointestinal symptoms, increased body temperature, general burning sensations, and bleeding (13409,53460).
Dermatologic ...Orally, greater celandine can cause rash (13410). Topically, greater celandine can cause contact dermatitis (13411).
Gastrointestinal ...Intravenously, a derivative of the greater celandine constituent chelidonine (Ukrain) can cause gastrointestinal symptoms, including obstipation, nausea, and diarrhea (13409,53460).
Hematologic
...Orally, greater celandine extract has caused a single case of hemolytic anemia.
This resulted in thrombocytopenia, destruction of liver cells, and kidney failure, requiring treatment (53508).
Intravenously, a derivative of the greater celandine constituent chelidonine (Ukrain) can cause bleeding (13409,53460).
Hepatic ...Orally, greater celandine has been implicated in dozens of cases of liver damage (363,13410,16839,41412,53502,53504,53506,53507,53510). The cause is unknown, but appears to be idiopathic. It seems to be independent of dose, and the amount of time before development of liver disease is generally long and variable (363,53506). The main symptom is usually jaundice (53506). Liver enzymes are elevated at least two-fold in all cases where measurements were completed (53506). Although other causes of liver toxicity cannot be ruled out in some cases, many reported cases of hepatotoxicity are probably or likely associated with the use of greater celandine. Recurrence of hepatitis with unintentional re-exposure has also been reported (53506,94282). Discontinuation of greater celandine usually results in a fairly rapid recovery although liver enzymes need months to return to normal (53506,94282). Death has occurred in one patient with hepatitis due to bleeding associated with colonic diverticulitis. Causality was described as possible, not probable, in this case (53506).
Neurologic/CNS ...Intravenously, a derivative of the greater celandine constituent chelidonine (Ukrain) can cause increased body temperature and general burning sensations (13409).
