Acorus calamus 4.0 D • Colchicum Autumnale 3.0 D • Colocynthis 3.0 D • Kali Iodatum 4.0 D • Rhus toxicodendron 4.0 D • Symphytum Officinale 1.0 D. Other Ingredients: Ethanol.
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 Polygonum. 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
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Polygonum. 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. The FDA prohibits calamus use in food products due to evidence of carcinogenic effects in animals receiving high doses of a calamus strain high in beta-asarone (93978,94727,94728). However, the beta-asarone content can vary widely among species from 0% to 96% (6); some products may be safer than others. There is insufficient reliable information available about the safety of calamus when used topically.
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally; avoid using (4,500).
POSSIBLY SAFE ...when used topically for less than 6 weeks on unbroken skin at a daily dose providing no more than 100 mcg of pyrrolizidine alkaloid (PA) constituents. PAs are absorbed through the skin (11990,44898,44902,92568).
POSSIBLY UNSAFE ...when used for extended durations or in high concentrations on unbroken skin. Topically, hepatotoxic pyrrolizidine alkaloids (PAs) in comfrey can be absorbed in quantities sufficient to cause toxicity with extended use for greater than 6 weeks or in quantities providing more than 100 mcg of PAs (11990,92568). ...when used topically on broken skin. PAs can be absorbed through broken skin. In countries where the PA content of comfrey is not regulated, including Australia and the United States, creams containing comfrey are required to include a warning not to use on broken skin (44950,44951).
LIKELY UNSAFE ...when used orally because of its potential for acute or chronic liver toxicity. Comfrey contains hepatotoxic pyrrolizidine alkaloids (PAs). Chronic ingestion of more than 1 mg daily for 2 weeks or more than 100 mcg daily for longer durations can cause liver disease. PAs may also be carcinogenic (11987,99068). The FDA has recommended removal of oral comfrey products from the market (11988).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally or topically.
In addition to hepatotoxicity and possible carcinogenicity, the pyrrolizidine alkaloids (PAs) in comfrey might be teratogenic. PAs are absorbed through the skin (11987,11988,11990).
LIKELY UNSAFE ...when used orally or topically (6). Poison ivy is highly irritant and allergenic (68970).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally or topically (6); avoid using.
Below is general information about the interactions of the known ingredients contained in the product Polygonum. 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, taking calamus might reduce the effectiveness of antacids.
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Some research suggests that calamus lowers gastric pH (19).
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Theoretically, concurrent use of anticholinergic drugs and calamus might decrease the effectiveness of the anticholinergic drug.
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In vitro evidence shows that calamus can inhibit acetylcholinesterase (AChE) (38418).
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Theoretically, taking calamus with other antihypertensive medications might increase the risk of hypotension.
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Animal research shows that calamus decreases the rate and strength of the heartbeat, which might lower blood pressure (38444). use with caution.
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Theoretically, concurrent use of cholinergic drugs and calamus might have an additive effect and increase the risk of cholinergic effects.
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In vitro evidence shows that calamus can inhibit acetylcholinesterase (AChE) (38418).
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Theoretically, concurrent use of CNS depressants and calamus might have an additive effect and increase the risk of sedative effects.
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Theoretically, taking calamus with drugs metabolized by CYP2D6 might increase drug levels and potentially increase the risk of adverse effects.
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In vitro research shows that calamus extract inhibits CYP2D6 enzyme (93975).
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Theoretically, taking calamus with drugs metabolized by CYP3A4 might increase drug levels and potentially increase the risk of adverse effects.
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In vitro research shows that calamus extract inhibits CYP3A4 enzyme (93975).
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Theoretically, taking calamus might reduce the effectiveness of H2-blockers.
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Some research suggests that calamus lowers gastric pH (19).
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Theoretically, calamus might potentiate the effects and adverse effects of MAOIs.
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Some reports suggest that calamus increases the effects of MAOIs (4).
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Theoretically, taking calamus might reduce the effectiveness of PPIs.
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Some research suggests that calamus lowers gastric pH (19).
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Theoretically, CYP3A4 inducers might increase the risk of adverse effects from the pyrrolizidine alkaloid constituents in comfrey.
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Theoretically, comfrey might have additive adverse effects on the liver when used with hepatotoxic drugs.
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Below is general information about the adverse effects of the known ingredients contained in the product Polygonum. 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 calamus.
Calamus is likely unsafe for use because it may cause cancer.
Most Common Adverse Effects:
Orally: Nausea, vomiting.
Serious Adverse Effects (Rare):
Orally: Cancer, intestinal paralysis.
Orally, nausea, vomiting, and intestinal paralysis have been reported with calamus use (33310,38458,93980). Tachycardia has also been reported (93980).
Cardiovascular ...Tachycardia has been reported as a toxic effect related to oral use of calamus oil (93980).
Gastrointestinal ...A case of gastrointestinal toxicity has been reported in a 19-year-old male who appeared to use calamus root for its euphoric effects. The man ingested a large amount of the root with water and later presented at the emergency department with continuous vomiting, paleness, and sweating. He was treated intravenously with saline and promethazine (38458). Both nausea and vomiting have been reported in patients using calamus oil orally (93980). Intestinal paralysis has also been reported with calamus use in children (33310).
Oncologic ...Beta-asarone, a constituent of calamus, increases the risk of cancer (93978,94727,94728).
General
...When used orally, comfrey may be unsafe.
Topically, comfrey is generally well tolerated when applied to intact skin.
Most Common Adverse Effects:
Topically: Eczema, erythema, irritation, itching, rash.
Serious Adverse Effects (Rare):
All ROAs: Ascites, cirrhosis, death, hepatic fibrosis, hepatomegaly, pulmonary hypertension, and sinusoidal obstruction syndrome. These adverse effects are likely related to the pyrrolizidine alkaloid constituents of comfrey.
Dermatologic ...Topically, comfrey-containing creams and ointments may cause skin redness, irritation, itching, rash, and eczema (44902,44912,44917,44919,92566,92570,92571).
Hepatic ...The pyrrolizidine alkaloid constituents of comfrey can cause acute sinusoidal obstruction syndrome characterized by sudden abdominal pain, vomiting, ascites, and hepatomegaly. In subacute disease, comfrey can cause ascites, hepatomegaly, abdominal pain, diarrhea, vomiting, and abdominal swelling. Chronic toxicity appears as asthenia and progressive ascites. Hepatic fibrosis and inflammation may resolve, but hepatic failure is common with more severe disease. This may occur as late as 2 years after the initial ingestion. Other signs and symptoms of pyrrolizidine toxicity include bile duct proliferation, fatty changes of the liver, fibrosis, cirrhosis, and vascular lesions (11988). The mortality associated with comfrey toxicity is 50%. However, specific toxic levels seem to vary among individuals (11990).
Pulmonary/Respiratory ...The pyrrolizidine alkaloid constituents of comfrey can damage the lungs, resulting in pulmonary hypertension (11987,11988,11990). A case report involving a 66-year-old female with known arterial hypertension, mild kidney insufficiency, and type 2 diabetes described severe partial respiratory insufficiency and pulmonary hypertension. The patient admitted to using a number of alternative therapies daily, including comfrey (44911).
Other ...Comfrey contains toxic pyrrolizidine alkaloids, which are carcinogenic and mutagenic (12841,12842).
General
...When used orally or topically, poison ivy may be unsafe.
Most Common Adverse Effects:
Orally: Diarrhea, dizziness, fever, intestinal colic, nausea, vomiting, severe mucous membrane irritation.
Topically: Contact dermatitis, herpes-like blisters, reddening, swelling.
Inhaled: Fever.
Serious Adverse Effects (Rare):
Orally: Fever, hematuria, nephritis, stupor, unconsciousness.
Topically: Erythema multiforme, black spot poison ivy dermatitis. Eye contact can cause severe conjunctivitis, corneal inflammations, or loss of sight.
Inhaled: Lung infection, respiratory distress syndrome, throat swelling.
Dermatologic ...Topically, poison ivy can cause contact dermatitis, reddening, swelling, and herpes-like blisters (18). These reactions occur at the area of contact, usually within a few hours, but are sometimes delayed for several days (68970). Sometimes papules and vesicles develop and can spread beyond the area of initial contact, but are generally self-limiting and eventually form crusts. (3839,68955,68960,68977,69007,69008,69038,69042). In a few cases, small white papules known as milia have developed on an area of poison ivy exposure after the typical skin reaction has subsided (94222). Occasionally, poison ivy causes more severe dermatologic reactions such as erythema multiforme (3839,68983,69032,112851). Black spot poison ivy dermatitis also occurs in rare cases, with black lacquer-like lesions on the skin that cannot be washed off, followed by the typical pruritic papules (112850). The black lesions are concentrated urushiol oleoresin that has darkened with exposure to oxygen and moisture (68960,68997,69027,69034). They eventually peel off and the skin heals normally (68960,112850).
Gastrointestinal ...Orally, poison ivy can cause severe mucous membrane irritation, nausea, vomiting, and diarrhea (18).
Genitourinary ...Orally, poison ivy can cause hematuria (18).
Immunologic ...Cross-allergenicity with poison ivy exists with cashew, mango, and ginkgo biloba (106574).
Neurologic/CNS ...Orally, poison ivy can cause dizziness, fever, stupor, and unconsciousness (18).
Ocular/Otic ...Topically, eye contact with urushiol from poison ivy can cause severe conjunctivitis, corneal inflammation, and potentially loss of sight (18).
Pulmonary/Respiratory ...Inhaled, urushiol in the smoke from burning of poison ivy can result in life-threatening throat swelling, fever, and secondary lung infections (6). Respiratory distress syndrome after smoke inhalation from burning poison ivy has also been reported (69036). Two fatal cases of acute respiratory distress and anaphylaxis after inhaling burned poison ivy are reported in patients with known allergies to poison ivy (112420).
Renal ...Orally, poison ivy can cause nephritis (18).