Each tablet contains: Rhamnus cathartica 24 mg • Rhamnus Purshiana 24 mg. Other Ingredients: Barberry, FD&C Red No 3, Lactose, Magnesium Stearate, Marshmallow, Mauve, Melissa Officinalis, Peppermint Oil, Povidone, Sodium Starch Glycolate, Confectioner's Sugar, Yellow 5.
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 Formule C 5 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
Below is general information about the safety of the known ingredients contained in the product Formule C 5 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 and appropriately, short-term. Cascara sagrada seems to be safe when used for less than one week (272,25023,40087). Cascara sagrada was formerly approved by the US Food and Drug Administration (FDA) as a safe and effective over-the-counter (OTC) laxative, but this designation was removed in 2002 due to a lack of supporting evidence (8229).
POSSIBLY UNSAFE ...when used orally, long-term. Using cascara sagrada for more than 1-2 weeks can lead to dependence, electrolyte loss, and hypokalemia (272).
CHILDREN: POSSIBLY UNSAFE
when used orally in children.
Cascara sagrada should be used cautiously in children due to the risk of electrolyte loss and hypokalemia (272).
PREGNANCY:
Insufficient reliable information available; avoid using.
LACTATION: POSSIBLY UNSAFE
when used orally.
Cascara sagrada is excreted into breast milk and might cause diarrhea (272).
POSSIBLY SAFE ...when standardized preparations of the berry are used orally and appropriately for up to 8-10 days (12). If watery stools or diarrhea occur, discontinue use (12).
POSSIBLY UNSAFE ...when standardized preparations are used for more than ten days due to risk for diarrhea and potassium depletion (2,12).
LIKELY UNSAFE ...when non-standardized preparations are used orally (12).
CHILDREN: LIKELY UNSAFE
when used orally in children younger than 12 years of age (12).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally (12); avoid using.
Below is general information about the interactions of the known ingredients contained in the product Formule C 5 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, cascara sagrada might increase the risk of hypokalemia when taken with corticosteroids.
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Theoretically, cascara sagrada might decrease the effects of CYP3A4 substrates.
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In vitro research suggests that cascara sagrada can induce CYP3A4 enzymes, albeit to a much lower degree than rifampin, a known CYP3A4 inducer (110704).
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Theoretically, cascara sagrada might cause hypokalemia, potentially increasing the risk of digoxin toxicity.
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Theoretically, cascara sagrada might increase the risk of hypokalemia when taken with diuretic drugs.
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Theoretically, cascara sagrada might have additive adverse effects when taken with stimulant laxatives.
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Cascara sagrada has stimulant laxative effects and might compound fluid and electrolyte losses when taken with stimulant laxatives (19).
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Theoretically, cascara sagrada might increase the risk of bleeding when taken with warfarin.
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Cascara sagrada has stimulant laxative effects (19). In some people, cascara sagrada can cause diarrhea. Diarrhea can increase the effects of warfarin, increase international normalized ratio (INR), and increase the risk of bleeding.
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European buckthorn has stimulant laxative effects. Theoretically, the overuse or abuse of European buckthorn might increase the toxicity of cardiac glycoside drugs (19).
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European buckthorn has stimulant laxative effects. Theoretically, overuse of European buckthorn might compound diuretic-induced potassium loss (19). There is some concern that taking European buckthorn along with potassium-depleting diuretics might increase the risk for hypokalemia.
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Some diuretics that can deplete potassium include chlorothiazide (Diuril), chlorthalidone (Thalitone), furosemide (Lasix), hydrochlorothiazide (HCTZ, Hydrodiuril, Microzide), and others.
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European buckthorn has stimulant laxative effects. Concomitant use with stimulant laxative medications might compound fluid and electrolyte loss (19).
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European buckthorn has stimulant laxative effects (19), which can cause diarrhea in some people. Diarrhea can increase the effects of warfarin, which can increase the international normalized ratio (INR) and the risk of bleeding. Advise patients who take warfarin not to take excessive amounts of European buckthorn.
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Below is general information about the adverse effects of the known ingredients contained in the product Formule C 5 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, cascara sagrada seem to be well tolerated when used appropriately, short-term.
Most Common Adverse Effects:
Orally: Mild abdominal discomfort and cramps.
Serious Adverse Effects (Rare):
Orally: Hepatotoxicity. Fresh or improperly aged cascara sagrada bark can cause severe vomiting.
Endocrine ...Orally, long-term use of cascara sagrada can lead to potassium depletion (4).
Gastrointestinal
...Orally, cascara sagrada can commonly cause mild abdominal discomfort, colic, and cramps (4).
In some cases, chronic use can cause pseudomelanosis coli. Pseudomelanosis coli (pigment spots in intestinal mucosa) is believed to be harmless, usually reverses with discontinuation, and is not directly associated with an increased risk of developing colorectal adenoma or carcinoma (6138).
Fresh or improperly aged cascara sagrada bark can cause severe vomiting due to the presence of free anthrone constituents (2,92307).
Genitourinary ...Orally, long-term use of cascara sagrada can lead to albuminuria and hematuria (4).
Hepatic ...There is some concern about potential liver problems with cascara sagrada. In some cases, cascara sagrada bark 750-1275 mg (containing approximately 21 mg cascaroside) daily in divided doses for three days resulted in cholestatic hepatitis, ascites, and portal hypertension. Symptoms resolved following discontinuation of cascara sagrada (6895,92306).
Musculoskeletal ...Orally, long-term use of cascara sagrada can lead to muscle weakness and finger clubbing (4).
Other ...Orally, long-term use of cascara sagrada can lead to cachexia (4).
General ...Orally, European buckthorn seems to be well tolerated, short term. It can cause abdominal pain, cramps, or watery diarrhea (12). Chronic use or abuse of the berry can lead to potassium depletion, albuminuria, and hematuria. Potassium depletion can lead to disturbed heart function and muscle weakness (2). Chronic use can cause pseudomelanosis coli (pigment spots in intestinal mucosa) which is harmless, usually reverses with discontinuation (2), and is not associated with an increased risk of developing colorectal adenoma or carcinoma (6138).
Cardiovascular ...Orally, chronic use or abuse of the berry from European buckthorn can lead to potassium depletion. This might lead to disturbed heart function (2).
Gastrointestinal ...Orally, European buckthorn can cause abdominal pain, cramps, or watery diarrhea (12). Chronic use can cause pseudomelanosis coli (pigment spots in intestinal mucosa) which is harmless, usually reverses with discontinuation (2), and is not associated with an increased risk of developing colorectal adenoma or carcinoma (6138).
Hematologic ...Orally, chronic use or abuse of the berry from European buckthorn can lead to hematuria (2).
Musculoskeletal ...Orally, chronic use or abuse of the berry from European buckthorn can lead to potassium depletion. This might lead to muscle weakness (2).
Renal ...Orally, chronic use or abuse of the berry from European buckthorn can lead to albuminuria and hematuria (2).
