Aesculus hippocastanum L. (hippocastanaceae) • Carbo Vegetabilis 1.0 X 31.7%. Other Ingredients: Cottonseed Oil, Lactose, Purified Water, Soybean Oil, Organic Grain Alcohol.
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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.
Below is general information about the effectiveness of the known ingredients contained in the product Freedhem. 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
Below is general information about the safety of the known ingredients contained in the product Freedhem. 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 SAFE ...when used orally, short-term (12392,12393,93200,93609,93610,93611,93613). ...when activated charcoal-containing wound dressings are used topically (93603,94731).
POSSIBLY SAFE ...when used orally, long-term. Activated charcoal has been used with apparent safety in doses up to 1.2 grams three times daily for up to 3 years (103193).
PREGNANCY AND LACTATION: POSSIBLY SAFE
when used orally short-term.
Activated charcoal 50 grams three times daily for 8 days has been used with apparent safety in pregnancy (126).
LIKELY SAFE ...when standardized horse chestnut seed extracts are used orally and appropriately, short-term. These extracts, from which esculin, a toxic constituent, has been removed (9420), have been used with apparent safety for 2-12 weeks (281,282,283,284,285,12113,95429,95430).
UNSAFE ...when the raw seed, bark, flower, or leaf is used orally. Horse chestnut contains significant amounts of the toxin esculin, and can be lethal (17). There is insufficient reliable information available about the safety of horse chestnut when used topically, intravenously, or intramuscularly.
CHILDREN: UNSAFE
when the raw seeds, bark, flower, or leaves are used orally.
Poisoning has been reported from children drinking tea made with twigs and leaves (9,55528).
PREGNANCY AND LACTATION: UNSAFE
when the raw seed, bark, flower, or leaf are used orally.
Horse chestnut preparations can be lethal (17); avoid using. There is insufficient reliable information available about the safety of horse chestnut seed extract when used during pregnancy and lactation; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Freedhem. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
The binding action of activated charcoal may be reduced by alcohol.
Details
Alcohol may lower the adsorptive capacity of activated charcoal (12400).
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Activated charcoal may reduce the clinical effects of oral contraceptives.
Details
Activated charcoal, taken in a dose of 5 grams four times daily for 3 days, may bind to, and reduce the absorption of, oral contraceptives, thereby limiting their effectiveness and increasing the risk of contraceptive failure. However, some clinical research shows that the risk for this interaction is minimal when activated charcoal is taken either 3 hours after or at least 12 hours before oral contraceptives (103192).
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Activated charcoal reduces systemic exposure to many drugs, including those that undergo enterohepatic recirculation, regardless of the route of administration.
Details
Activated charcoal adsorbs various drugs and may reduce their absorption and/or half-life. Examples of affected drugs include acetaminophen, aminophylline, amiodarone, atenolol, carbamazepine, dapsone, digoxin, disopyramide, fluoxetine, indomethacin, moxifloxacin, nadolol, phenytoin, phenobarbital, piroxicam, quinine, sotalol, theophylline, tricyclic antidepressants, valproate, and verapamil (12392,12400,93198,93602,93610,93612,93613,94730,105543). Avoid co-administration, except after drug overdose.
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Syrup of ipecac is inactivated by activated charcoal.
Details
Activated charcoal adsorbs and inactivates syrup of ipecac (12394). Avoid co-administration.
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Horse chestnut may have antiplatelet effects and may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
Details
Horse chestnut contains the constituent esculin which has been shown to have antithrombotic effects. Therefore, horse chestnut might have antiplatelet effects (19). This has not been shown in humans.
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Below is general information about the adverse effects of the known ingredients contained in the product Freedhem. 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, activated charcoal is generally well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, black stools, bloating, constipation, and flatulence.
Serious Adverse Effects (Rare):
Orally: Gastrointestinal obstruction and pulmonary aspiration.
Gastrointestinal ...The most common adverse reactions reported with activated charcoal are gastrointestinal in nature. Constipation appears to be the most frequent complaint, but is typically transient. Black stools, abdominal pain, bloating, and flatulence have also been reported (12392,12398,93611,103193). Rarely, activated charcoal may lead to gastrointestinal obstruction (12392).
Pulmonary/Respiratory ...Rarely, pulmonary aspiration has been reported in patients taking activated charcoal orally. This may happen if activated charcoal is regurgitated or if a misplaced nasogastric tube delivers activated charcoal to the lungs rather than the stomach (12392).
General
...Orally, horse chestnut seed extract, from which the toxic constituent esculin has been removed, seems to be well-tolerated.
Topically, no adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally (extract): Dizziness, gastrointestinal upset, headache, and pruritus.
Orally (seed or bark): Gastrointestinal irritation and toxic nephropathy.
Cardiovascular ...Orally, there is one case report of pericardial tamponade following exudative pericardial effusion in a previously healthy 32-year-old male who consumed three boxes of horse chestnut paste over 6 weeks. The patient was treated with steroid therapy for 2 months, as well as colchicine 0.5 mg twice daily and ibuprofen 600 mg twice daily for 3 months. These cardiovascular events were considered to be possibly related to the antiplatelet activity of horse chestnut or to an immunologic response to antigens present in horse chestnut paste (91972). A case of atrial fibrillation is also reported in a previously healthy 46-year-old male after accidental ingestion of a horse chestnut seed. The patient also presented with abdominal pain, nausea, sweating, and palpitations. The arrhythmia resolved within a few hours without medical intervention (110439).
Dermatologic ...Orally, horse chestnut seed extract has been reported to cause pruritus (282,12113,55486).
Gastrointestinal ...Orally, horse chestnut seed extract has been reported to cause nausea, vomiting, diarrhea, abdominal pain, constipation, dry mouth, gastrointestinal upset, and dyspepsia (282,12113,55477,55486,55493,55520,110439).
Hepatic
...Orally, there is one case report of hepatotoxicity in a 69-year-old female who took 6-15 tablets of a specific product (Venencapsan) containing horse chestnut leaf, milfoil, celandine, sweet clover, milk thistle, and dandelion root daily for 6 weeks.
The patient's symptoms disappeared 6 weeks after discontinuing the product and reappeared following re-initiation (55518). Another case report describes a 70-year-old male presenting with acholia, choluria, and jaundice after 3 weeks of self-treatment with an unspecified dose of a specific combination product (Venenkraft) containing horse chestnut. The patient presented with elevated liver transaminase and bilirubin levels, and was diagnosed with drug-induced liver injury. Following discontinuation, laboratory values and symptoms progressively resolved (107702). In both of these case reports, it is unclear if hepatotoxicity was due to horse chestnut, another ingredient, or the combination.
Intravenously and intramuscularly, isolated cases of liver toxicity have occurred after administration of horse chestnut extract containing aescin (2,512,552).
Immunologic
...Pollen from the horse chestnut flower can cause allergic reactions in children (7775).
Horse chestnut can also cause hypersensitivity reactions, which occur more commonly in people who are allergic to latex (7853,8418).
Rectally, the horse chestnut constituent esculin has caused severe allergic contact dermatitis and proctitis in a 38-year old man (10383).
Intravenously, administration of aescin can cause anaphylaxis (18,553).
Musculoskeletal ...Orally, calf spasms have been reported in patients with CVI who took horse chestnut seed extract (282).
Neurologic/CNS ...Orally, horse chestnut seed extract has been reported to cause headache or dizziness (55486,55520).
Renal
...Orally, high doses of aescin have been reported to cause kidney toxicity (55525).
Horse chestnut seed and bark can cause toxic nephropathy (4). A case of life-threatening kidney rupture occurred in a patient who was taking horse chestnut seed extract and had been diagnosed with angiomyolipoma, a condition characterized by increased risk of kidney rupture with hemorrhage. The rupture was attributed to the anticoagulant effects of horse chestnut seed extract, which may have increased the risk of hemorrhage (55496).
Intravenously, isolated cases of kidney toxicity have occurred after administration of horse chestnut containing aescin (512).