Secale cornutum 3 D. Other Ingredients: Lactose, Sucrose.
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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 Secale Cornutum (Globule). Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
There is insufficient reliable information available about the effectiveness of ergot.
Below is general information about the safety of the known ingredients contained in the product Secale Cornutum (Globule). Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Below is general information about the interactions of the known ingredients contained in the product Secale Cornutum (Globule). Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Ergotamine, a constituent of ergot, is a substrate of cytochrome P450 3A4 (CYP3A4) (11163). Theoretically, drugs that inhibit CYP3A4 might increase the risk of ergot toxicity. Some of these drugs include amiodarone (Cordarone), clarithromycin (Biaxin), diltiazem (Cardizem), erythromycin (E-mycin, Erythrocin), indinavir (Crixivan), ritonavir (Norvir), saquinavir (Fortovase, Invirase), and many others.
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Concomitant use of ergot with ergot alkaloids or derivatives may increase the risk of adverse effects (11163). Some of these include bromocriptine (Parlodel), dihydroergotamine (Migranal, DHE-45), ergotamine (Cafergot), and pergolide (Permax).
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Certain ergot alkaloids, such as dihydroergotamine, act as serotonin agonists. Theoretically, combining serotonergic drugs with ergot might increase the risk of serotonergic side effects including serotonin syndrome and cerebral vasoconstrictive disorders (8056,11163). Monitor patients for signs of serotonin syndrome and other serotonergic side effects if using ergot with serotonergic drugs.
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Serotonergic drugs include the selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine (Prozac), paroxetine (Paxil), and sertraline (Zoloft); tricyclic and atypical antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), and imipramine (Tofranil); triptans such as sumatriptan (Imitrex), zolmitriptan (Zomig), and rizatriptan (Maxalt); opioids such as methadone (Dolophine) and tramadol (Ultram); and many other medications.
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Co-administration of stimulant drugs with ergot may increase the risk of vasoconstriction (11163).
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Some stimulant drugs include albuterol (Proventil, Ventolin), diethylpropion (Tenuate), dopamine, epinephrine, phentermine (Ionamin), pseudoephedrine (Sudafed), and many others.
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Below is general information about the adverse effects of the known ingredients contained in the product Secale Cornutum (Globule). 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, ergot can cause gastrointestinal symptoms such as nausea and abdominal pain.
Weakness, muscle pain of the extremities, and numbness and tingling of the fingers and toes may also occur (9). Symptoms of acute overdose include nausea, vomiting, diarrhea, extreme thirst, coldness, tingling and itching of the skin, a rapid and weak pulse, hypotension, shock, confusion, seizures, unconsciousness, and death (9).
Chronic toxicity, or ergotism, rarely occurs after a single oral dose. It usually results from cumulative doses over a short period of time (11163). Ergotism from food is rare today. It is more common from overdoses of prescription ergot alkaloids (11164). Symptoms of ergotism are related to circulatory disturbances. Numbness, coldness, and tingling of the extremities, particularly the feet and legs occur along with paleness or cyanosis. There may be no pulse in the affected area, which may develop into gangrene, especially in the toes (9,11163). A convulsive form of ergotism may also occur. Symptoms include muscle spasms in the trunk and limbs, painful involuntary flexion of the fingers and wrists, and either flexion or extension of the ankles. Neurologic adverse effects such as drowsiness, delirium, lethargy, mental changes, and visual disturbances can also occur. Sweating, fever, muscle stiffness, twitching and seizures have also been reported (9,11163).
Cardiovascular ...Orally, chronic toxicity with ergot, or ergotism, results from cumulative doses over a short period of time. Symptoms are often related to circulatory disturbances. Numbness, coldness, and tingling of the extremities, particularly the feet and legs occur along with paleness or cyanosis. There may be no pulse in the affected area, which may develop into gangrene, especially in the toes (9,11163)
Gastrointestinal ...Orally, ergot can cause gastrointestinal symptoms such as nausea, vomiting, diarrhea, and abdominal pain (9).
Musculoskeletal ...Orally, chronic toxicity from cumulative ergot doses over a short period of time can present as a convulsive form of ergotism. Symptoms include muscle spasms in the trunk and limbs, painful involuntary flexion of the fingers and wrists, and either flexion or extension of the ankles. Sweating, fever, muscle stiffness, twitching and seizures have also been reported (9,11163).
Neurologic/CNS ...Orally, ergot can cause drowsiness, delirium, lethargy, mental changes, and visual disturbances (9,11163).
Other ...Symptoms of acute ergot oral overdose include nausea, vomiting, diarrhea, extreme thirst, coldness, tingling and itching of the skin, a rapid and weak pulse, hypotension, shock, confusion, seizures, unconsciousness, and death (9).
