Arnica montana 4 D • Bryonia alba 4 D • Causticum 6 D • Hydrastis canadensis 3 D • Kali Bromatum 3 D • Sanguinaria Canadensis 4 D • Solanum Dulcamara 4 D • Sulfur 4 D. Other Ingredients: Lactose, Magnesium Stearate.
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 Accouphenes Comprimes (Tablet). 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
There is insufficient reliable information available about the effectiveness of bryonia.
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 Accouphenes Comprimes (Tablet). 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 SAFE ...when the stem is used orally or topically and appropriately (2,18).
LIKELY UNSAFE ...when the leaves or berries are used orally. The plant contains the toxic compounds solanine, solanidine, and dulcamarin (6).
CHILDREN: LIKELY UNSAFE
when used orally; unripe berries have caused poisonings.
A lethal dose is estimated to be 200 berries (18). There is insufficient reliable information available about the safety of bittersweet nightshade when used topically in children; avoid using.
PREGNANCY: LIKELY UNSAFE
when used orally.
The alkaloids of the plant, solasodine, soladulcine, and related compounds have been linked to birth defects in animals (6); avoid using. There is insufficient reliable information available about the safety of bittersweet nightshade when used topically during pregnancy; avoid using.
LACTATION: LIKELY UNSAFE
when orally; avoid using.
There is insufficient reliable information available about the safety of bittersweet nightshade when used topically; avoid using.
POSSIBLY SAFE ...when used orally and appropriately short-term (4).
POSSIBLY UNSAFE ...when excessive doses are used orally. The bloodroot constituent sanguinarine, although thought to be poorly absorbed, is a toxic alkaloid (6,12). ...when applied topically. Use of toothpaste or mouthwash containing bloodroot has been associated with an increased risk of developing oral leukoplakia (36666,36668). When applied to the skin, bloodroot paste causes pain, skin erosion, and a thick scab called an eschar which falls off leaving an indented scar. The U.S. Food and Drug Administration recommends that patients avoid bloodroot containing topical products such as "black salve" (53499,95442,95444,95445,95446).
PREGNANCY: LIKELY UNSAFE
when used orally (12); avoid using.
LACTATION: POSSIBLY UNSAFE
when used orally (4); avoid using.
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).
POSSIBLY SAFE ...when used orally and appropriately as a single dose (260,261). There is insufficient reliable information available about the safety of goldenseal when used as more than a single dose.
CHILDREN: LIKELY UNSAFE
when used orally in newborns.
The berberine constituent of goldenseal can cause kernicterus in newborns, particularly preterm neonates with hyperbilirubinemia (2589).
PREGNANCY: LIKELY UNSAFE
when used orally.
Berberine is thought to cross the placenta and may cause harm to the fetus. Kernicterus has developed in newborn infants exposed to goldenseal (2589).
LACTATION:
LIKELY UNSAFE when used orally.
Berberine and other harmful constituents can be transferred to the infant through breast milk (2589). Use during lactation can cause kernicterus in the newborn and several resulting fatalities have been reported (2589).
POSSIBLY SAFE ...when used topically and appropriately, short-term. Topical products containing sulfur in concentrations up to 10% have been used safely in clinical research for up to 8 weeks (27846,27847,88107,88112,88123,88124,98205,98207,100735). There is insufficient reliable information available about the safety of using sulfur orally.
CHILDREN: POSSIBLY SAFE
when used topically and appropriately, short-term.
Topical products containing sulfur in concentrations up to 6% have been used safely when applied nightly in children and adolescents for up to 6 nights (27846,27847). In infants, topical products containing sulfur in concentrations up to 2% have been safely applied for 3 hours daily for up to 6 days (27847).
PREGNANCY AND LACTATION: POSSIBLY SAFE
when applied topically and appropriately, short-term.
Topical products containing sulfur in concentrations up to 6% have been safely applied nightly for up to 6 nights (27846,27847). There is insufficient reliable information available about the safety of sulfur when used orally; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Accouphenes Comprimes (Tablet). 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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Theoretically, goldenseal might increase the risk of bleeding when used with anticoagulant or antiplatelet drugs.
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Theoretically, goldenseal might increase the risk of hypoglycemia when used with antidiabetes drugs.
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Theoretically, goldenseal might increase the risk of hypotension when taken with antihypertensive drugs.
Details
Goldenseal contains berberine. Animal research shows that berberine can have hypotensive effects (33692,34308). Also, an analysis of clinical research shows that taking berberine in combination with amlodipine can lower systolic and diastolic blood pressure when compared with amlodipine alone (91956). However, this effect has not been reported with goldenseal.
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Theoretically, goldenseal might increase the sedative effects of CNS depressants.
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Theoretically, goldenseal might increase serum levels of drugs metabolized by CYP2C9.
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In vitro research shows that goldenseal root extract can modestly inhibit CYP2C9. This effect may be due to its alkaloid constituents, hydrastine and berberine (21117). However, this effect has not been reported in humans.
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Goldenseal might increase serum levels of drugs metabolized by CYP2D6.
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Theoretically, goldenseal might increase serum levels of drugs metabolized by CYP2E1.
Details
In vitro research shows that goldenseal root extract can inhibit the activity of CYP2E1 (94140). However, this effect has not been reported in humans.
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Goldenseal might increase serum levels of drugs metabolized by CYP3A4.
Details
Most clinical and in vitro research shows that goldenseal inhibits CYP3A4 enzyme activity and increases serum levels of CYP3A4 substrates, such as midazolam (6450,13536,21117,91740,111725). However, in one small clinical study, goldenseal did not affect the levels of indinavir, a CYP3A4 substrate, in healthy volunteers (10690,93578). This is likely due to the fact that indinavir has a high oral bioavailability, making it an inadequate probe for CYP3A4 interactions (13536,91740) and/or that it is primarily metabolized by hepatic CYP3A, while goldenseal has more potential to inhibit intestinal CYP3A enzyme activity (111725). Both goldenseal extract and its isolated constituents berberine and hydrastine inhibit CYP3A, with hydrastine possibly having more inhibitory potential than berberine (111725).
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Theoretically, goldenseal might increase serum levels of dextromethorphan.
Details
Goldenseal contains berberine. A small clinical study shows that berberine can inhibit cytochrome P450 2D6 (CYP2D6) activity and reduce the metabolism of dextromethorphan (34279).
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Goldenseal might increase serum levels of digoxin, although this effect is unlikely to be clinically significant.
Details
Clinical research shows that goldenseal modestly increases digoxin peak levels by about 14% in healthy volunteers. However, goldenseal does not seem to affect other pharmacokinetic parameters such as area under the curve (AUC) (15132). This suggests that goldenseal does not cause a clinically significant interaction with digoxin. Digoxin is a P-glycoprotein substrate. Some evidence suggests that goldenseal constituents might affect P-glycoprotein; however, it is unclear whether these constituents inhibit or induce P-glycoprotein.
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Theoretically, goldenseal might decrease the conversion of losartan to its active form.
Details
Goldenseal contains berberine. A small clinical study shows that berberine inhibits cytochrome P450 2C9 (CYP2C9) activity and reduces the metabolism of losartan (34279). However, this effect has not been reported with goldenseal.
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Theoretically, goldenseal might reduce blood levels of metformin.
Details
In vitro research shows that goldenseal extract decreases the bioavailability of metformin, likely by interfering with transport, intestinal permeability, or other processes involved in metformin absorption. It is unclear which, if any, of metformin's transporters are inhibited by goldenseal. Goldenseal does not appear to alter the clearance or half-life of metformin (105764).
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Theoretically, goldenseal might reduce the therapeutic effects of oseltamivir by decreasing its conversion to its active form.
Details
In vitro evidence suggests that goldenseal reduces the formation of the active compound from the prodrug oseltamivir (105765). The mechanism of action and clinical relevance is unclear.
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Theoretically, goldenseal might increase or decrease serum levels of P-glycoprotein (P-gp) substrates.
Details
There is conflicting evidence about the effect of goldenseal on P-gp. In vitro research suggests that berberine, a constituent of goldenseal, modestly inhibits P-gp efflux. Other evidence suggests that berberine induces P-gp. In healthy volunteers, goldenseal modestly increases peak levels of the P-gp substrate digoxin by about 14%. However, it does not seem to affect other pharmacokinetic parameters such as area under the curve (AUC) (15132). This suggests that goldenseal is not a potent inhibitor of P-gp-mediated drug efflux. Until more is known, goldenseal should be used cautiously with P-gp substrates.
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Theoretically, goldenseal might increase the sedative effects of pentobarbital.
Details
Animal research shows that berberine, a constituent of goldenseal, can prolong pentobarbital-induced sleeping time (13519). However, this effect has not been reported with goldenseal.
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Theoretically, goldenseal might increase serum levels of tacrolimus.
Details
Goldenseal contains berberine. In a 16-year-old patient with idiopathic nephrotic syndrome who was being treated with tacrolimus 6.5 mg twice daily, intake of berberine 200 mg three times daily increased the blood concentration of tacrolimus from 8 to 22 ng/mL. Following a reduction of tacrolimus dosing to 3 mg daily, blood levels of tacrolimus decreased to 12 ng/mL (91954).
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Below is general information about the adverse effects of the known ingredients contained in the product Accouphenes Comprimes (Tablet). 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
...When used orally, the leaves and berries of bittersweet nightshade may be unsafe.
There is limited information available about the adverse effects of the stem of bittersweet nightshade when used in medicinal amounts.
Serious Adverse Effects (Rare):
Orally: The leaves and berries can cause toxicity, including circulatory and respiratory depression, convulsions, cyanosis, diarrhea, dilated pupils, gastrointestinal bleeding, headache, scratchy throat, speech difficulties, subnormal temperature, vertigo, vomiting, and even death.
Cardiovascular ...Orally, bittersweet nightshade leaf and berry can cause circulatory depression (6).
Gastrointestinal ...Orally, bittersweet nightshade leaf and berry can cause diarrhea, gastrointestinal bleeding, scratchy throat, vomiting and (6).
Neurologic/CNS ...Orally, bittersweet nightshade leaf and berry can cause convulsions, headache, speech difficulties, subnormal temperature, and vertigo (6).
Ocular/Otic ...Orally, bittersweet nightshade leaf and berry can cause dilated pupils (6).
Pulmonary/Respiratory ...Orally, bittersweet nightshade leaf and berry can cause cyanosis and respiratory depression (6).
General ...Orally, bloodroot is generally well tolerated when used in appropriate doses, short term (4). Nausea, vomiting, and central nervous system depression have been reported. Higher oral doses can result in glaucoma, hypotension, shock, and coma (6,12). Long term use of bloodroot toothpaste or mouthwash has been associated with leukoplakia, keratoses of the mouth, impaired taste, and staining of the tongue, teeth, and fillings (36666,36668,36707). Topically, skin contact with fresh bloodroot can cause irritation or contact dermatitis (19). Avoid contact with the eyes and mucous membranes because of its irritant properties.
Cardiovascular ...Orally, high doses of bloodroot may cause hypotension (6).
Dermatologic ...Topically, skin contact with fresh bloodroot can cause irritation or contact dermatitis (19). Topical application of bloodroot can corrode skin and produce a thick dry scab called an eschar which falls off and results in a depressed scar. There are numerous cases of patients applying bloodroot salves topically for 3-4 hours daily for 3-12 days to skin cancers, moles and blemishes. These patients report experiencing severe pain, burning, skin erosion, and scarring (53499,95442,95444,95445,95446).
Gastrointestinal ...Orally, bloodroot may cause nausea and vomiting (12). Some research shows that bloodroot-containing toothpastes and mouth rinses can be used for up to six months without evidence of adverse effects (36679). However observational research has found an association between chronic use of bloodroot toothpaste or mouthwash and leukoplakia or keratoses of the mouth and lip. Discontinuing these products did not always result in a resolution of leukoplakia (36666,36668). Prolonged use of bloodroot oral rinse causes impaired sensation of taste, as well as staining of the tongue, teeth, and fillings. The impaired taste and staining do seem to resolve after discontinuation of the bloodroot rinse (36707).
Neurologic/CNS ...Orally, bloodroot may cause CNS depression. High oral doses may cause shock and coma (6).
Ocular/Otic ...There are reports of worsening vision after small oral doses of bloodroot (36680). Glaucoma has been reported after high oral doses of bloodroot (6). However, some experts disagree that oral use of bloodroot causes ocular toxicity (36680). Direct contact of bloodroot with the eyes and mucous membranes should be avoided because of its irritant properties.
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
...There is limited reliable information available about the safety of goldenseal when used in more than a single dose.
Berberine, a constituent of goldenseal, is generally well tolerated when used orally.
Most Common Adverse Effects:
Orally: Berberine, a constituent of goldenseal, can cause abdominal distension, abdominal pain, bitter taste, constipation, diarrhea, flatulence, headache, nausea, and vomiting.
Dermatologic ...Orally, berberine, a constituent of goldenseal, may cause rash. However, this appears to be rare (34285). A case of photosensitivity characterized by pruritic, erythematous rash on sun-exposed skin has been reported in a 32-year-old female taking a combination product containing goldenseal, ginseng, bee pollen, and other ingredients. The rash resolved following discontinuation of the supplement and treatment with corticosteroids (33954). It is not clear if this adverse effect is due to goldenseal, other ingredients, or the combination.
Endocrine ...A case of severe, reversible hypernatremia has been reported in an 11-year-old female with new-onset type 1 diabetes and diabetic ketoacidosis who took a goldenseal supplement (52592).
Gastrointestinal ...Orally, berberine, a constituent of goldenseal, may cause diarrhea, constipation, flatulence, vomiting, abdominal pain, abdominal distention, and bitter taste (33648,33689,34245,34247,34285,91953). Theoretically, these effects may occur in patients taking goldenseal. However, this hasn't been reported in clinical research or case reports.
Neurologic/CNS ...Orally, berberine, a constituent of goldenseal, may cause headache when taken in a dose of 5 mg/kg daily (33648). Theoretically, this may occur with goldenseal, but this hasn't been reported in clinical research or case reports.
General ...Topically, sulfur is generally well tolerated when used in concentrations of up to 10%. Adverse effects include skin dryness, irritation, and pruritus (27846,88112,88120,88121,88126). Orally, sulfur has been reported to cause diarrhea and metabolic acidosis (27845).
Dermatologic ...Topically, application of sulfur preparations can cause dryness, leading to local irritation and pruritus in up to 28% of patients (27846,88112,88120,88121,88126).
Gastrointestinal ...Orally, sulfur is converted to sulfide in the gastrointestinal tract, causing intestinal irritation which can lead to diarrhea (27845).
Renal ...There is one case report of metabolic acidosis occurring in a 57-year-old woman who had consumed approximately 250 grams of flowers of sulfur, a form of sulfur prepared by sublimation, over a 6-day period (27845). Underlying conditions, including diabetes and renal failure, may have contributed to the acidosis. Sulfur is converted to sulfide by colonic bacteria and then to sulfate in various tissues, generating hydrogen ions which can lead to acidosis when clearance mechanisms are overwhelmed (27845).
