Each 1 tsp serving contains: Cassia angustifolia 235 mg • Rhamnus frangula 95 mg. Other Ingredients: Bitter Orange, Cyani, Fennel, Licorice, Mate, Saffron, Varech (kelp).
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 T 15. 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 T 15. 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. Tea prepared with alder buckthorn bark 2 grams has been used with apparent safety for up to 8 days (12). Only properly aged bark should be used, and the recommended dose should not be exceeded (12).
POSSIBLY UNSAFE ...when used orally for more than 8 to 10 days (12). In 1993 the FDA removed Generally Recognized As Safe (GRAS) status from alder buckthorn due to lack of safety data. Chronic use of anthraquinone laxatives, such as alder buckthorn, for 9 months or longer is associated with damage to gastrointestinal epithelial cells and pigmentation of the colonic mucosa, known as pseudomelanosis coli (30743,37266). There is some data linking this condition to an increased risk of colorectal cancer (30743,37266,37269), although there is also contradictory evidence that does not show a link (6138).
CHILDREN: LIKELY UNSAFE
when used orally in children younger than 12 years of age (12); avoid using.
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally (12); avoid using.
LIKELY SAFE ...when used orally and appropriately, short-term. Senna is an FDA-approved nonprescription drug (8424,15429,15431,15442,40086,40088,74535,74545,74548,74562)(74567,74570,74583,74585,74586,74587,74593,74603,74606,74607)(74609,74613,74615,74624,74636,74639,74644,74650,74653,92711)(92712).
POSSIBLY UNSAFE ...when used orally long-term or in high doses. Long-term, frequent use, or use of high doses has been linked to serious side effects including laxative dependence and liver toxicity (13057,13095).
CHILDREN: LIKELY SAFE
when used orally and appropriately, short-term.
Senna is an FDA-approved nonprescription drug for use in children 2 years and older. (15429,15434,15435).
CHILDREN: POSSIBLY UNSAFE
when used orally long-term or in high doses.
Long-term, frequent use, or use of high doses has been linked to serious side effects including laxative dependence and liver toxicity (13057,13095,105956).
PREGNANCY: POSSIBLY SAFE
when used orally and appropriately, short-term (15429,24480).
POSSIBLY UNSAFE...when used orally long-term or in high doses. Long-term, frequent use, or use of high doses has been linked to serious side effects including laxative dependence and liver toxicity (13057,13095).
LACTATION: POSSIBLY SAFE
when used orally and appropriately, short term.
Although small amounts of constituents of senna cross into breast milk, senna has been taken while breast-feeding with apparent safety. Senna does not cause changes in the frequency or consistency of infants' stools. (6026,15429,15436,15437,24482,24484,24485,24486,24487,74545).
Below is general information about the interactions of the known ingredients contained in the product Formule T 15. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Alder buckthorn has stimulant laxative effects. Theoretically, concomitant use of corticosteroids with alder buckthorn can increase the risk of potassium depletion (2).
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Alder buckthorn has stimulant laxative effects. Theoretically, potassium depletion associated with alder buckthorn might increase the risk of digoxin toxicity (19).
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Alder buckthorn has stimulant laxative effects. Theoretically, overuse of alder buckthorn might compound diuretic-induced potassium loss (19). There is some concern that people taking alder buckthorn along with potassium depleting diuretics might have an increased risk for hypokalemia.
 Details
Some diuretics that can deplete potassium include chlorothiazide (Diuril), chlorthalidone (Thalitone), furosemide (Lasix), and hydrochlorothiazide (HCTZ, HydroDIURIL, Microzide), and others.
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Alder buckthorn has stimulant laxative effects. Concomitant use with stimulant laxative medications might compound fluid and electrolyte loss (19).
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Alder buckthorn has stimulant laxative effects. In some people alder buckthorn can cause diarrhea. Diarrhea can increase the effects of warfarin, increase international normalized ratio (INR), and increase the risk of bleeding. Advise patients who take warfarin not to take excessive amounts of alder buckthorn.
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Theoretically, senna might increase the risk of adverse effects when taken with digoxin.
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Overuse/abuse of senna increases the risk of adverse effects from cardiac glycosides, such as digoxin, due to potassium depletion (15425).
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Theoretically, senna might increase the risk of hypokalemia when taken with diuretic drugs.
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Overuse of senna might compound diuretic-induced potassium loss and increase the risk for hypokalemia (15425).
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Theoretically, taking senna may interfere with the absorption of exogenous estrogens.
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Theoretically, senna might increase the risk for fluid and electrolyte loss when taken with other stimulant laxatives.
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Theoretically, excessive use of senna might increase the effects of warfarin.
Details
Senna has stimulant laxative effects and can cause diarrhea. Diarrhea can increase the effects of warfarin, increase international normalized ratio (INR), and increase the risk of bleeding. In one case report, excessive use of senna for 3 weeks resulted in diarrhea, bloody stools, and an elevated INR of 11.9 (16530).
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Below is general information about the adverse effects of the known ingredients contained in the product Formule T 15. 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, alder buckthorn seems to be well tolerated when properly aged bark is used appropriately for no more than 8 to 10 days (12). Adverse effects include cramp-like discomfort (2). Chronic use, especially for 9 months or longer, is associated with damage to gastrointestinal epithelial cells and pigmentation of the colonic mucosa, known as pseudomelanosis coli (30743,37266). There is some data linking this condition to an increased risk of colorectal cancer (30743,37266,37269), although there is also contradictory evidence which does not show a link (6138). Alder buckthorn has also been associated with potassium depletion, albuminuria, and hematuria when used orally (2).
Gastrointestinal ...Orally, adverse effects include cramp-like discomfort (2). Chronic use, especially for 9 months or longer, is associated with damage to gastrointestinal epithelial cells and pigmentation of the colonic mucosa, known as pseudomelanosis coli (30743,37266). The fresh bark contains free anthrone, which can cause severe vomiting. This constituent is destroyed by aging the bark naturally for one year or artificially with heat and aeration (2).
Genitourinary ...Orally, adverse effects to alder buckthorn include albuminuria and hematuria (2).
Oncologic ...Orally, there is also some data linking pseudomelanosis coli to an increased risk of colorectal cancer (30743,37266,37269), although there is also contradictory evidence which does not show a link (6138).
General
...Orally, senna is generally well-tolerated when used short-term in appropriate doses.
Most Common Adverse Effects:
Orally: Abdominal pain and discomfort, cramps, diarrhea, flatulence, nausea, fecal urgency, and urine discoloration.
Serious Adverse Effects (Rare):
Orally: Skin eruptions.
Cardiovascular ...Excessive use can cause potassium depletion and other electrolyte abnormalities (15425). In theory, this could cause potentially dangerous changes in heart rhythm. A small decrease in heart rate was seen in one clinical study (74587).
Dermatologic ...In adults, there are rare case reports of skin eruptions associated with senna, including erythema multiforme, fixed drug eruption, lichenoid reaction, toxic epidermal necrolysis, urticaria, photosensitivity, and contact dermatitis (96558). Infants and young children given senna products have experienced contact reactions on the buttocks due to prolonged exposure to stool while wearing a diaper overnight. These reactions range from erythema with small blisters, to large fluid-filled blisters with skin sloughing, as occurs with second degree burns (96559). In a case series of children treated with senna for chronic constipation, burn-like reactions occurred in 2.2%, typically with higher doses (mean 60 mg/day, range 35.2 to 150 mg/day) (96558,96559). These reactions can be avoided by giving senna early in the day, so that bowel movements occur at a time when diapers can be changed quickly (96559).
Gastrointestinal ...Orally, senna can cause abdominal pain and discomfort, cramps, bloating, flatulence, nausea, fecal urgency, and diarrhea (15427,15434,15435,15436,15439,15440,15441,105955). Chronic use has also been associated with "cathartic colon," radiographically diagnosed anatomical changes to the colon such as benign narrowing, colonic dilation, and loss of colonic folds (15428). The clinical relevance of these findings is unclear. Chronic use can also cause pseudomelanosis coli (pigment spots in intestinal mucosa) which is harmless, usually reverses with discontinuation, and is not associated with an increased risk of developing colorectal adenoma or carcinoma (6138). The cathartic properties of senna leaf are greater than the fruit (15430). Thus, the American Herbal Products Association only warns against long-term use of senna leaf (12).
Hepatic ...Chronic liver damage, portal vein thrombosis, and hepatitis have been reported following oral use of senna alkaloids, such as in tea made from senna leaves (13057,13095,41431,74560,74564,74584,105956). There is a case report of hepatitis in a female who consumed moderate amounts of senna tea. The patient was a poor metabolizer of cytochrome P450 2D6 (CYP2D6). It's thought that moderate doses of senna in this patient led to toxic hepatitis due to the patient's reduced ability to metabolize and eliminate the rhein anthrone metabolites of senna, which are thought to cause systemic toxicity (13057). There is also a case of liver failure, encephalopathy, and renal insufficiency in a female who consumed 1 liter/day of senna tea, prepared from 70 grams of dried senna fruit, over 3 years (13095). In another case report, a 3-year-old female presented with hepatitis that led to pancytopenia after drinking tea made from 2-3 grams dry senna leaves three times or more weekly for over one year (105956).
Immunologic ...In one case report, a 19-year-old male developed anaphylaxis with dyspnea, facial edema, and hives. This reaction was determined to be caused by the senna content in a specific combination product (Delgaxan Plus, Pompadour Ibérica) that the patient ingested (105957).
Musculoskeletal ...Hypertrophic osteoarthropathy, finger clubbing, cachexia, and tetany have been reported from excessive oral senna use in humans (15426,74580,74582,74620,74625).
Renal ...Nephrocalcinosis has been reported as a result of oral senna overuse (74582).
