Arnica montana 3C • Arum triphyllum 3C • Belladonna 3C • Bromium 3C • Bryonia alba 3C • Mercurus Solubilis 3C • Pulsatilla 3C • Phytolacca decandra 3C • Spongia tosta 3C. Other Ingredients: Lactose, Magnesium Stearate, Sucrose.
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 Roxalia. 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
There is insufficient reliable information available about the effectiveness of bryonia.
There is insufficient reliable information available about the effectiveness of pokeweed.
There is insufficient reliable information available about the effectiveness of pulsatilla.
Below is general information about the safety of the known ingredients contained in the product Roxalia. 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 used orally in amounts commonly found in foods. Arnica has Generally Recognized As Safe (GRAS) status for use as a food flavoring in the US (4912). However, Canadian regulations do not allow its use as a food ingredient (12). ...when used orally in homeopathic dilutions of 30C and up to 5C (19110,19111,19117,19124,19126,96769). ...when used topically on unbroken skin, short-term (12).
LIKELY UNSAFE ...when used orally or when applied topically to broken skin. Arnica is considered poisonous and has caused severe or fatal poisonings (5). Arnica can cause gastroenteritis, muscle paralysis, bleeding, arrhythmia, hypertension, shortness of breath, nausea and vomiting, multi-organ failure, and death (4,5,17,104,19101,19102,19103,19104,19105,19106,19107,19108).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally or topically; avoid using (12).
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).
LIKELY UNSAFE ...when the root or berries are used orally (2,18). Consuming 40 berries might be fatal (18).
CHILDREN: LIKELY UNSAFE
when the root or berries are used orally (2,18).
Consuming as few as 15 berries can be fatal in children (18).
PREGNANCY: UNSAFE
when the root is used orally.
Bryonia root might have abortifacient effects (2). ...when the berries are used orally (2).
LACTATION: LIKELY UNSAFE
when the root or berries are used orally (2).
LIKELY UNSAFE ...when pokeweed is used orally. All parts of the pokeweed plant, especially the root, are considered to be toxic (3477,3479). The Herb Trade Association recommends against selling pokeweed as an herbal beverage or food (3478). Severe poisoning has been reported from ingesting tea brewed from pokeweed root (3478) and pokeweed leaves (3480,69094). Poisoning also has resulted from ingestion of pokeberry wine and pokeberry pancakes (3479). Consuming just 10 berries can be toxic to an adult (6). Green berries are considered more toxic than mature, red berries (4). ...when applied topically to the skin. Skin contact can cause hematological changes (3477,3481,3482). Protective gloves should be used to handle the plant (3477).
CHILDREN: UNSAFE
when used orally.
Children have died after ingesting pokeweed berries. Consumption of even one berry can be toxic (3479).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when pokeweed is used orally or applied topically; avoid using.
Evidence suggests the pokeweed berry has uterine stimulant and abortifacient effects (4,19). Pokeweed is generally considered unsafe for any use.
LIKELY UNSAFE ...when fresh above ground parts are used orally or topically; pulsatilla is a severe local irritant (4). There is insufficient reliable information available about the safety of the use of dried pulsatilla.
PREGNANCY: LIKELY UNSAFE
when used orally.
The fresh or dried above ground parts are contraindicated due to abortifacient and teratogenic effects (2,4). ...when the fresh above ground parts are used topically. There is insufficient reliable information available about the safety of topical dried pulsatilla during pregnancy.
LACTATION: LIKELY UNSAFE
when the fresh above ground parts are used for oral or topical use (19).
There is insufficient reliable information available about the safety of dried pulsatilla during breast-feeding.
Below is general information about the interactions of the known ingredients contained in the product Roxalia. 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, arnica might have additive effects with anticoagulant and antiplatelet drugs. Homeopathic arnica preparations are unlikely to have this interaction.
 Details
In vitro evidence shows that sesquiterpene lactones in arnica flowers can decrease platelet aggregation (104). However, this effect has not been reported in humans.
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Belladonna may increase the risk of adverse effects when used concomitantly with anticholinergic drugs.
Details
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Theoretically, belladonna might reduce the effects of cisapride.
Details
Belladonna contains atropine. In vivo evidence suggests that atropine can prevent cisapride from increasing motility in the gastrointestinal tract (25191).
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Below is general information about the adverse effects of the known ingredients contained in the product Roxalia. 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, arnica is unsafe and can cause toxicity.
When used in homeopathic amounts, arnica seem to be generally well tolerated. Topically, arnica also seems to be generally well tolerated.
Most Common Adverse Effects:
Orally: Bleeding, gastroenteritis, hypertension, muscle paralysis, nausea and vomiting, shortness of breath.
Topically: Contact dermatitis and irritation.
Serious Adverse Effects (Rare):
Orally: Arrhythmia, coma, multi-organ failure, and death.
Cardiovascular ...Orally, arnica can cause tachycardia or a faster heart rate (11,17113,19101,19102). A 24-year-old female presented to the emergency department with palpitations and vomiting 24 hours after ingesting a cup of tea that reportedly contained arnica flowers picked from her local area of mountainous Southern California. The species was not specified in the article and there was no indication by the authors that any testing had been done to confirm the identity of the plant (90610).
Dermatologic ...Orally, arnica can cause irritation of mucous membranes (11,17113). Topically, arnica can cause contact itchiness, dry skin, and rash (17113). Oral lesions resulted in a woman who used a mouthwash incorrectly by not following dilution instructions. The mouthwash was 70% alcohol and contained arnica and oil of peppermint (19106).
Gastrointestinal ...Orally, arnica can cause stomach pain, nausea, vomiting, and diarrhea (11,17113,19101,19102). Homeopathic arnica has been reported to cause dry mouth (30C) and sore tongue (6C) (19107). A 24-year-old female presented to the emergency department with palpitations and vomiting 24 hours after ingesting a cup of tea that reportedly contained arnica flowers picked from her local area of mountainous Southern California. The species was not specified in the article and there was no indication by the authors that any testing had been done to confirm the identity of the plant (90610).
Musculoskeletal ...Adverse effects after ingesting arnica include muscle weakness (19101). Homeopathic arnica has been reported to result in the feeling of a "throbby" head or neck (19107).
Neurologic/CNS ...Orally, arnica may cause drowsiness, nervousness, and headache (11,17113,19101,19107).
Ocular/Otic ...In a case report, accidental intake of a large amount of a homeopathic Arnica-30 resulted in acute vision loss due to bilateral toxic optic neuropathy (19105).
Psychiatric ...Oral homeopathic arnica (6C) may cause depressed feelings, specifically a feeling of unhappiness (19107).
Pulmonary/Respiratory ...Orally, arnica can cause shortness of breath (11,17113).
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, bryonia root can cause dizziness, vomiting, convulsions, colic, bloody diarrhea, abortion, nervous excitement, and kidney damage.
Large doses of bryonia can cause anuria, collapse, paralysis, and death (2). Bryonia berries can be fatal when taken orally; 40 berries can be fatal in adults, and 15 berries can be fatal in children (18).
Topically, skin contact with fresh bryonia may cause irritation (19).
Dermatologic ...Topically, skin contact with fresh bryonia may cause irritation (19).
Gastrointestinal ...Orally, bryonia root can cause vomiting, colic, and bloody diarrhea (2).
Genitourinary ...Orally, bryonia root can cause abortion (2). Large doses of bryonia can cause anuria and death (2).
Musculoskeletal ...Orally, large doses of bryonia can cause paralysis and death (2).
Neurologic/CNS ...Orally, bryonia root can cause dizziness, convulsions, and nervous excitement (2). Large doses of bryonia can cause paralysis and death (2).
Renal ...Orally, bryonia root can cause kidney damage (2). Large doses of bryonia can cause anuria and death (2).
Other ...Orally, bryonia berries can be fatal. Consuming 40 berries can be fatal in adults and as few as 15 berries can be fatal in children (18).
General
...Pokeweed is generally regarded as unsafe for use.
Any benefits of therapy may not outweigh the risk of toxicity. Orally, all parts of the pokeweed plant can cause nausea, vomiting, cramping, abdominal pain, diarrhea, a burning sensation in the mouth and throat, weakness, hypotension, bloody emesis, bloody diarrhea, tachycardia, difficulty breathing, salivation, urinary incontinence, spasms, convulsions (3477,3478,3479), severe thirst, somnolence, transient blindness, respiratory failure (3477,3479), and death (3477).
Orally and topically, pokeweed has been reported to cause plasmacytosis, mitotic changes in peripheral blood cells, eosinophilia, thrombocytopenia, abnormal platelet morphology, and other hematologic abnormalities (3477,3478,3481,3482). Protective gloves should be used to handle the plant (3477).
Cardiovascular ...Orally, all parts of the pokeweed plant can cause hypotension and tachycardia (3477,3478,3479).
Gastrointestinal ...Orally, all parts of the pokeweed plant can cause nausea, vomiting, cramping, abdominal pain, diarrhea, a burning sensation in the mouth and throat, bloody emesis, and bloody diarrhea (3477,3478,3479).
Genitourinary ...Orally, all parts of the pokeweed plant can cause urinary incontinence (3477,3478,3479).
Hematologic ...Orally and topically, pokeweed has been reported to cause plasmacytosis, mitotic changes in peripheral blood cells, eosinophilia, thrombocytopenia, abnormal platelet morphology, and other hematologic abnormalities. When used topically, these effects are more likely to occur in individuals with cuts or abrasions on the skin (3477,3478,3481,3482). Protective gloves should be used to handle the plant (3477).
Neurologic/CNS ...Orally, all parts of the pokeweed plant can cause weakness, salivation, spasms, convulsions (3477,3478,3479), severe thirst, and somnolence (3477,3479).
Ocular/Otic ...Orally, all parts of the pokeweed plant can cause transient blindness (3477,3479),
Pulmonary/Respiratory ...Orally, all parts of the pokeweed plant can cause difficulty breathing (3477,3478,3479), respiratory failure (3477,3479), and death (3477).
General
...Orally, fresh pulsatilla is a toxic gastrointestinal irritant (4,19).
It can also cause kidney and urinary tract irritation (2).
Topically, contact with the fresh plant can cause skin irritation, mucous membrane irritation, itching, and pustule formation known as ranunculus dermatitis (2). Allergic reactions to pulsatilla volatile oil have been documented with patch tests (4).
Inhalation of pulsatilla volatile oil may cause nasal mucosal and conjunctival irritation (4).
Dermatologic ...Topically, contact with the fresh plant can cause skin irritation, mucous membrane irritation, itching, and pustule formation known as ranunculus dermatitis (2).
Gastrointestinal ...Orally, fresh pulsatilla is a toxic gastrointestinal irritant (4,19).
Genitourinary ...Orally, fresh pulsatilla can cause urinary tract irritation (2).
Immunologic ...Topically, allergic reactions to the protoanemonin-containing volatile oil of pulsatilla have been documented with patch tests (4).
Ocular/Otic ...Inhalation of the protoanemonin-containing volatile oil of pulsatilla may cause conjunctival irritation (4).
Pulmonary/Respiratory ...Inhalation of the protoanemonin-containing volatile oil of pulsatilla may cause nasal mucosal irritation (4).
Renal ...Orally, fresh pulsatilla can cause kidney irritation (2).
