Berberis vulgaris 4 D • Calcium Phosphoricum 12 D • Causticum Hahnemanni 6 D • Dulcamara 4 D • Nux vomica 4 D • Rhododendron 4 D • RhusToxicodendron 4 D. Other Ingredients: Croscarmellose Sodium, Lactose Monohydrate, 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 Dr. Reckeweg T R11. 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 Dr. Reckeweg T R11. 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 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.
LIKELY SAFE ...when the fruit is consumed orally in food amounts (13527). There is insufficient reliable information available about the safety of European barberry when used orally in medicinal amounts or when used topically.
CHILDREN: LIKELY UNSAFE
when used orally in newborns.
The berberine constituent of European barberry can cause kernicterus in newborns, particularly preterm neonates with hyperbilirubinemia (2589). There is insufficient reliable information available about the safety of European barberry when used orally in older children.
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 berberine (2589).
LACTATION: LIKELY UNSAFE
when used orally.
Berberine and other harmful constituents can be transferred to the infant through breast milk (2589).
UNSAFE ...when used orally (2,13,18,505). Nux vomica in doses of 30-50 mg contains approximately 5 mg of strychnine, and can cause severe adverse effects. 1-2 grams of nux vomica contains 60-90 mg of strychnine, and can be fatal (13,18,65345). Chronic ingestion of lesser amounts can cause death after a period of weeks (18).
PREGNANCY AND LACTATION: UNSAFE
when used orally (2,13,18,505); avoid using.
Below is general information about the interactions of the known ingredients contained in the product Dr. Reckeweg T R11. 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 European barberry with anticholinergic drugs might cause additive effects.
Details
In vitro evidence suggests that European barberry might have anticholinergic properties (13527).
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Theoretically, European barberry may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
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Theoretically, taking European barberry with antidiabetes drugs might increase the risk of hypoglycemia.
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Preliminary clinical evidence suggests that European barberry juice reduces fasting glucose levels in patients with type 2 diabetes who are also taking antidiabetes drugs (98575). Additionally, some animal studies show that berberine, a constituent of European barberry, has antiglycemic potential (33622,33667). Monitor blood glucose levels closely.
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Theoretically, taking European barberry with antihypertensive drugs might increase the risk of hypotension.
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Theoretically, taking European barberry with cholinergic drugs might decrease the effects of cholinergic drugs.
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In vitro evidence suggests that European barberry might have anticholinergic properties (13527).
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Theoretically, concomitant use with drugs that have sedative properties may cause additive effects.
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Theoretically, concomitant use with cyclosporine may cause additive effects.
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Berberine, a constituent of European barberry, can reduce the metabolism and increase serum levels of cyclosporine. This effect is attributed to the ability of berberine to inhibit cytochrome P450 3A4 (CYP3A4), which metabolizes cyclosporine (13524). Theoretically, European barberry might have a similar effect.
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Theoretically, European barberry might increase the levels and clinical effects of CYP3A4 substrates.
Details
There is very preliminary evidence suggesting that berberine, a constituent of European barberry, might inhibit the CYP3A4 enzyme (13524). Theoretically, European barberry might have a similar effect.
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Below is general information about the adverse effects of the known ingredients contained in the product Dr. Reckeweg T R11. 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
...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 ...European barberry is generally well tolerated when consumed in amounts commonly found in food. A thorough evaluation of safety outcomes has not been conducted for the use of larger, medicinal amounts. Topically, European barberry seems to be well tolerated.
Hepatic ...Orally, a case of hepatitis-associated aplastic anemia is reported in an adult male after consuming European barberry 15 drops and nannari root 15 drops twice a day for 2 weeks. The patient presented with lethargy, loss of appetite, and jaundice that progressed to high-grade fevers, chills, rigors, severe pancytopenia, and abnormal liver function tests. Liver biopsy was suggestive of drug-induced liver injury. The patient was hospitalized for multiple infections and symptomatic thrombocytopenia. Despite receiving supportive care, blood transfusions, and corticosteroids, the patient died 7 weeks after diagnosis (110021). The exact reason for this adverse effect is not clear.
General ...Orally, 30-50 mg nux vomica (5 mg strychnine) can cause restlessness, feelings of anxiety, heightening of sense perception, enhanced reflexes, equilibrium disorders, painful neck and back stiffness, followed later by twitching, tonic spasms of jaw and neck muscles, painful convulsions of the entire body triggered by visual or tactile stimulation with possible opisthotonos, muscle hypertonicity and agitation. Dyspnea may follow spasm of the respiratory muscles (18). Seizures occur within 15 minutes of ingestion (or 5 minutes of inhalation) and may result in hyperthermia, metabolic and respiratory acidosis, rhabdomyolysis, and myoglobinuric renal failure (17,65345). Nux vomica can be fatal (13,505); most deaths occur 3-6 hours post-ingestion from respiratory and subsequent cardiac arrest, anoxic brain damage, or multiple organ failure secondary to hyperthermia (18,505). Strychnine accumulates with extended administration (2).
Neurologic/CNS ...Orally, 30-50 mg nux vomica (5 mg strychnine) can cause restlessness, feelings of anxiety, heightening of sense perception, enhanced reflexes, equilibrium disorders, painful neck and back stiffness, followed later by twitching, tonic spasms of jaw and neck muscles, painful convulsions of the entire body triggered by visual or tactile stimulation with possible opisthotonos, muscle hypertonicity and agitation. Dyspnea may follow spasm of the respiratory muscles (18). Seizures occur within 15 minutes of ingestion (or 5 minutes of inhalation) and may result in hyperthermia, metabolic and respiratory acidosis, rhabdomyolysis, and myoglobinuric renal failure (17). In one case report, a 58-year old woman developed dizziness with abdominal and leg pain following a seizure, after ingestion of one nux vomica fruit. Her muscles were tense and hyper-reflexive and she had lactic acidosis and nystagmus (65345). Most deaths occur 3-6 hours post-ingestion from respiratory and subsequent cardiac arrest, anoxic brain damage, or multiple organ failure secondary to hyperthermia (18,505). Strychnine accumulates with extended administration, particularly in individuals with liver damage (2).