Each tablet contains: Alisma orientale 7.5:1 extract (DHE: 1458 mg) 194.4 mg • Atractylodes Macrocephala 7.5:1 extract (DHE: 832.5 mg) 111 mg • Cinnamomum cassia 7.5:1 extract (DHE: 544.5 mg) 72.6 mg • Polyporous umbellatus 7.5:1 extract (DHE: 832.5 mg) 111 mg • Poria cocos 7.5:1 extract (DHE: 832.5 mg) 111 mg. Other Ingredients: Cellulose, 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.
Below is general information about the effectiveness of the known ingredients contained in the product Poria Five Formula. 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 Asian water plantain.
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 Poria Five Formula. 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 safety of Asian water plantain.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
There is insufficient reliable information available about the safety of atractylodes.
PREGNANCY: POSSIBLY UNSAFE
when used orally.
In animals, atractylodes has caused reproductive toxicity, including fetal death, as well as changes in gestation, growth, and skeletal formation (94304).
LACTATION:
There is insufficient reliable information available about the safety of atractylodes when used during breast-feeding.
LIKELY SAFE ...when consumed in amounts commonly found in foods. Cassia cinnamon has Generally Recognized As Safe (GRAS) status in the US for use as a spice or flavoring agent (4912) ...when used orally and appropriately, short-term. Cassia cinnamon 1-2 grams daily has been used safely for up to 3 months (17011,21914). Cassia cinnamon 3-6 grams daily has been used safely for up to 6 weeks (11347,14344). Cassia cinnamon extract corresponding to 3 grams daily of cassia cinnamon powder has also been used safely for up to 4 months (21916).
POSSIBLY SAFE ...when used topically, short-term. Cassia cinnamon oil 5% cream applied topically to the legs has been used safely in one clinical trial (59580).
POSSIBLY UNSAFE ...when used orally in high doses, long-term. Some cassia cinnamon products contain high levels of coumarin. Coumarin can cause hepatotoxicity in animal models (15299,21920). In humans, very high doses of coumarin from 50-7000 mg daily can result in hepatotoxicity that resolves when coumarin use is discontinued (15302). In most cases, ingestion of cassia cinnamon will not provide a high enough amount of coumarin to cause significant toxicity; however, in especially sensitive people, such as those with liver disease, prolonged ingestion of large amounts of cassia cinnamon might exacerbate the condition.
CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term.
Cassia cinnamon 1 gram daily has been used safely in adolescents 13-18 years of age for up to 3 months (89648).
PREGNANCY AND LACTATION: LIKELY SAFE
when consumed in amounts commonly found in foods (4912).
There is insufficient reliable information available about the safety of cassia cinnamon when used in medicinal amounts during pregnancy and breast-feeding. Stay on the safe side and stick to food amounts.
There is insufficient reliable information available about the safety of poria mushroom.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Poria Five Formula. 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, atractylodes might increase the risk of bleeding when used concomitantly with anticoagulant and antiplatelet drugs.
Details
Laboratory research suggests that atractylenolides II and III, constituents of atractylodes, reduce platelet activation (94299). So far, this has not been shown in humans.
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Theoretically, atractylodes may have an additive effect when used with other aromatase inhibitors.
Details
Laboratory research suggests that atractylodes and its constituents exhibit aromatase inhibitor effects (94302).
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Theoretically, atractylodes might decrease the levels of CYP1A2 substrates.
Details
In animals, atractylodes administered at high doses has been shown to induce CYP1A2 activity (112828). This effect has not been shown in humans.
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Theoretically, atractylodes might increase the levels of CYP3A4 substrates.
Details
In animals, atractylodes administered at high doses has been shown to inhibit CYP3A1 activity, which is a homolog to the human CYP3A4 enzyme (112828). This effect has not been shown in humans.
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Theoretically, taking atractylodes may prolong the therapeutic and adverse effects of hexobarbital.
Details
In animals, atractylodes has been shown to prolong the effects of hexobarbital (94303). These effects have not been shown in humans.
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Theoretically, cassia cinnamon may have additive effects with antidiabetes drugs.
Details
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Theoretically, large doses of cassia cinnamon might cause additive effects when used with hepatotoxic drugs.
Details
There is some concern that ingesting large amounts of cassia cinnamon for an extended duration might cause hepatotoxicity in some people. Cassia cinnamon contains coumarin, which can cause hepatotoxicity in animal models (15299,21920). In humans, very high doses of coumarin from 50-7000 mg/day can result in hepatotoxicity that resolves when coumarin use is discontinued (15302,97249). Lower amounts might also cause liver problems in sensitive people, such as those with liver disease or those taking potentially hepatotoxic agents.
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Theoretically, poria mushroom might decrease the clinical effects of anticholinergic drugs.
Details
In animal research, poria mushroom essential oil reduces acetylcholinesterase activity (111917). This interaction has not been shown in humans.
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Theoretically, poria mushroom might have additive effects when used with cholinergic drugs.
Details
In animal research, poria mushroom essential oil reduces acetylcholinesterase activity (111917). This interaction has not been shown in humans.
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Theoretically, taking poria mushroom extract may enhance the therapeutic and adverse effects of sedatives.
Details
Animal research shows that poria mushroom extract has sedative properties (111916). This interaction 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 Poria Five Formula. 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 ...There is limited information available about the potential adverse effects of Asian water plantain. Orally, it has been used as a part of Traditional Chinese Medicine (TCM) with apparent safety; there have been no reported adverse effects in most patients. However, one case of hepatotoxicity and nephrotoxicity has been reported with the use of a combination TCM product containing Asian water plantain (99434).
Hepatic ...One case report of drug-induced systemic toxicity, including hepatotoxicity, has occurred in a 59-year-old man with chronic hepatitis B who had taken six doses of a combination product containing Asian water plantain 3 weeks prior to admission. He presented with gum bleed and petechiae, and his admission lab values indicated fulminant liver failure. His condition progressed to include renal failure and eventual death after 4 weeks. It is not clear if Asian water plantain, the other ingredients, or the combination caused this toxicity. However, the authors identified Asian water plantain as the likely causative ingredient based on animal research (99434).
Renal ...One case report of drug-induced systemic toxicity, including nephrotoxicity, has occurred in a 59-year-old man with chronic hepatitis B who had taken six doses of a combination product containing Asian water plantain 3 weeks prior to admission. He initially presented with hepatic failure, which progressed to include renal failure and eventual death after 4 weeks. It is not clear if Asian water plantain, the other ingredients, or the combination caused this toxicity. However, the authors identified Asian water plantain as the likely causative ingredient based on animal research (99434).
General
...There is currently a limited amount of information on the adverse effects of atractylodes.
A thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Allergic reaction, dry mouth, nausea.
Gastrointestinal ...Orally, atractylenolide I, an isolated constituent of atractylodes, can cause bad taste, nausea, and dry mouth (15706).
Immunologic ...Atractylodes can cause an allergic reaction in people sensitive to the Asteraceae/Compositae family (12450). Members of this family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs.
General
...Orally, cassia cinnamon appears to be well-tolerated.
Significant side effects have not been reported in most patients.
Most Common Adverse Effects:
Topically: Burning mouth, stomatitis.
Dermatologic
...In one clinical trial, a rash was reported in one patient taking cassia cinnamon 1 gram daily for 90 days (17011).
In one case, a 58-year-old female with a documented allergy to topically applied cinnamic alcohol presented with eyelid dermatitis, which was found to be a manifestation of systemic contact dermatitis to cinnamon in the diet. Symptoms improved in two days and completely cleared five days after discontinuing the addition of cinnamon to food products (95599). In other case reports, two adults presented with allergic contact cheilitis following the ingestion of chai tea with cinnamon and yogurt with cinnamon. Cinnamon components were confirmed as the causative allergic agents with patch tests, and both cases of allergic contact cheilitis completely resolved upon cessation of the cinnamon-containing products (113516,113515).
Topically, allergic skin reactions and stomatitis from toothpaste flavored with cassia cinnamon have been reported (11915,11920). Intraoral allergic reactions with symptoms of tenderness and burning sensations of the oral mucosa have also been reported in patients using breath fresheners, toothpaste, mouthwash, candy, or chewing gum containing cinnamon, cinnamic aldehyde or cinnamic alcohol as flavoring agents. Glossodynia, or burning mouth syndrome, has also been reported in a 62-year-old female who ate apples dipped in cinnamon nightly (95598), and allergic contact dermatitis has been reported in a teenage female using a homemade cinnamon sugar face scrub (95596).
Endocrine ...In one clinical trial, a hypoglycemic seizure was reported in one patient taking cassia cinnamon 1 gram daily for 3 months. The event occurred one day after enrolling in the study (89648). It is unclear if cassia cinnamon caused this event.
Hepatic ...There is some concern about the safety of ingesting large amounts of cassia cinnamon for extended durations due to its coumarin content. Coumarin can cause hepatotoxicity in animal models (15299). In humans, very high doses of coumarin from 50-7000 mg/day can result in hepatotoxicity that resolves when coumarin is discontinued (15302). In clinical trials, taking cassia cinnamon 360 mg to 12 grams daily for 3 months did not significantly increase levels of aspartate transaminase (AST) or alanine transaminase (ALT) (21918,96280,108259). However, in one case report, acute hepatitis with elevated AST and ALT occurred in a 73-year-old female who started taking a cinnamon supplement (dose unknown) one week prior to admission. The cinnamon supplement was added on to high-dose rosuvastatin, which may have led to additive adverse hepatic effects. After discontinuing both products, liver function returned to normal, and the patient was able to restart rosuvastati without further complications (97249). In most cases, ingestion of cassia cinnamon won't provide a high enough amount of coumarin to cause significant toxicity; however, in especially sensitive people, such as those with liver disease or taking potentially hepatotoxic agents, prolonged ingestion of large amounts of cassia cinnamon might exacerbate the condition.
Immunologic ...An unspecified allergic reaction was reported in one patient taking cassia cinnamon 1 gram daily for 3 months (89648).
General ...Orally, poria mushroom seems to be well tolerated. However, a thorough evaluation of safety outcomes has not been conducted.
Immunologic ...Allergic reactions have been reported rarely, including allergic rhinitis and allergic asthma (12).