Each 9 g serving contains: Althaea officinalis 400 mg • Althaea officinalis 12.5 mg • Glycyrrhiza glabra 150 mg • Hibiscus sabdariffa 12.5 mg • Malvae sylvestris 12.5 mg • Papaver rhoeas 12.5 mg • Pimpinella Anisum 100 mg • Tussilago Farfara 200 mg • Tussilago Farfara 12.5 mg • Verbascum Thapsus 25 mg. Other Ingredients: Blueberry, Florentine Iris.
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 7. 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
There is insufficient reliable information available about the effectiveness of coltsfoot.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
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 Formule T 7. 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 in amounts commonly found in food. Anise and anise oil have Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when anise powder is used orally and appropriately in medicinal amounts. Anise powder has been used with apparent safety in clinical research at doses of up to 9 grams daily for up to 4 weeks (94944,94945). ...when anise oil is used orally and appropriately in medicinal amounts. Anise oil has been used with apparent safety in clinical research at doses of up to 600 mg daily for up to 4 weeks (94946,94947).
CHILDREN: LIKELY SAFE
when used orally in amounts commonly found in food.
Anise and anise oil have Generally Recognized as Safe (GRAS) status in the US (4912). There is insufficient reliable information available about the safety of anise when used by children in medicinal amounts.
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in food.
Anise and anise oil have Generally Recognized as Safe (GRAS) status in the US (4912). There is insufficient reliable information available about the safety of anise when taken orally in medicinal amounts during pregnancy or breast-feeding.
LIKELY UNSAFE ...when products containing hepatotoxic pyrrolizidine alkaloid (PA) constituents are used orally. Repeated exposure to low concentrations of hepatotoxic PAs can cause severe veno-occlusive disease. Hepatotoxic PAs might also be carcinogenic and mutagenic (12841,12842). Dietary supplement products sold in the US are not required to include the amount of PAs they may contain; therefore, all preparations used orally containing coltsfoot should be considered potentially unsafe (3484). Tell patients not to use coltsfoot preparations that are not certified and labeled as hepatotoxic PA-free.
PREGNANCY: LIKELY UNSAFE
when products containing hepatotoxic pyrrolizidine alkaloid (PA) constituents are used orally.
Coltsfoot preparations containing hepatotoxic pyrrolizidine alkaloid (PA) constituents might be teratogenic and hepatotoxic (575,12841,12842). There is one case report of fatal hepatic veno-occlusive disease in a neonate associated with regular maternal consumption during pregnancy of an herb tea containing several pyrrolizidine alkaloid herbs, including coltsfoot (575). There is insufficient reliable information available about the safety of using coltsfoot products certified and labeled as hepatotoxic PA-free during pregnancy; avoid using.
LACTATION: LIKELY UNSAFE
when used orally.
Hepatotoxic pyrrolizidine alkaloid (PA) constituents in coltsfoot are excreted in milk (12841,12842). There is insufficient reliable information available about the safety of using coltsfoot products certified and labeled as hepatotoxic PA-free during lactation; avoid using.
POSSIBLY SAFE ...when dried corn poppy flower petals are used orally and appropriately (2,18). POSSIBLY UNSAFE ...when dried corn poppy flower petals are consumed in amounts over 250 grams. At least 5 cases of intoxication have been reported. Symptoms include nausea and vomiting, seizures, arrythmias, and loss of consciousness (101432).
CHILDREN: POSSIBLY UNSAFE
when the fresh leaves or blossoms are eaten; this can cause poisoning (18).
There is insufficient reliable information available about the safety of dried corn poppy flower petals used in children.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Hibiscus sabdariffa has Generally Recognized As Safe (GRAS) status for use in foods in the US (4912).
POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts. Hibiscus sabdariffa tea has been safely consumed in amounts of up to 720 mL daily for up to 6 weeks (16894,93805,93814). Hibiscus sabdariffa extracts, including a specific Hibiscus sabdariffa leaf extract (Green Chem), have also been safely used in doses of up to 1000 mg daily for up to 90 days (17415,54989,93805,93809,105307).
CHILDREN: POSSIBLY SAFE
when used orally and appropriately.
Hibiscus sabdariffa calyx powder has been used with apparent safety at a dose of 2 grams three times daily for 4 weeks by adolescents aged 12-18 years (93816).
PREGNANCY: POSSIBLY UNSAFE
when used orally.
Hibiscus sabdariffa is thought to be a menstrual stimulant, and might have abortifacient effects (19).
LACTATION: POSSIBLY UNSAFE
when used orally in large amounts.
Animal research found that administering large doses of Hibiscus sabdariffa during lactation decreases food and water intake during pregnancy and delays puberty in offspring (93810); however, this has not been assessed in humans.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Licorice has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when licorice products that do not contain glycyrrhizin (deglycyrrhizinated licorice) are used orally and appropriately for medicinal purposes. Licorice flavonoid oil 300 mg daily for 16 weeks, and deglycyrrhizinated licorice products in doses of up to 4.5 grams daily for up to 16 weeks, have been used with apparent safety (6196,11312,11313,17727,100984,102960). ...when licorice products containing glycyrrhizin are used orally in low doses, short-term. Licorice extract 272 mg, containing glycyrrhizin 24.3 mg, has been used daily with apparent safety for 6 months (102961). A licorice extract 1000 mg, containing monoammonium glycyrrhizinate 240 mg, has been used daily with apparent safety for 12 weeks (110320). In addition, a syrup providing licorice extract 750 mg has been used twice daily with apparent safety for 5 days (104558). ...when applied topically. A gel containing 2% licorice root extract has been applied to the skin with apparent safety for up to 2 weeks. (59732). A mouth rinse containing 5% licorice extract has been used with apparent safety four times daily for up to one week (104564).
POSSIBLY UNSAFE ...when licorice products containing glycyrrhizin are used orally in large amounts for several weeks, or in smaller amounts for longer periods of time. The European Scientific Committee on Food recommends that a safe average daily intake of glycyrrhizin should not exceed 10 mg (108577). In otherwise healthy people, consuming glycyrrhizin daily for several weeks or longer can cause severe adverse effects including pseudohyperaldosteronism, hypertensive crisis, hypokalemia, cardiac arrhythmias, and cardiac arrest. Doses of 20 grams or more of licorice products, containing at least 400 mg glycyrrhizin, are more likely to cause these effects; however, smaller amounts have also caused hypokalemia and associated symptoms when taken for months to years (781,3252,15590,15592,15594,15596,15597,15599,15600,16058)(59731,59740,59752,59785,59786,59787,59792,59795,59805,59811)(59816,59818,59820,59822,59826,59828,59849,59850,59851,59867)(59882,59885,59888,59889,59895,59900,59906,97213,110305). In patients with hypertension, cardiovascular or kidney conditions, or a high salt intake, as little as 5 grams of licorice product or 100 mg glycyrrhizin daily can cause severe adverse effects (15589,15593,15598,15600,59726).
PREGNANCY: UNSAFE
when used orally.
Licorice has abortifacient, estrogenic, and steroid effects. It can also cause uterine stimulation. Heavy consumption of licorice, equivalent to 500 mg of glycyrrhizin per week (about 250 grams of licorice per week), during pregnancy seems to increase the risk of delivery before gestational age of 38 weeks (7619,10618). Furthermore, high intake of glycyrrhizin, at least 500 mg per week, during pregnancy is associated with increased salivary cortisol levels in the child by the age of 8 years. This suggests that high intake of licorice during pregnancy may increase hypothalamic-pituitary-adrenocortical axis activity in the child (26434); avoid using.
LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when marshmallow root and leaf are used in amounts commonly found in foods. Marshmallow root has Generally Recognized As Safe (GRAS) status for use in foods in the US (4912).
POSSIBLY SAFE ...when marshmallow root and leaf are used orally in medicinal amounts (4,12). ...when used topically (4,62020). There is insufficient reliable information available about the safety of marshmallow flower.
PREGNANCY AND LACTATION:
Insufficient reliable information available.
Below is general information about the interactions of the known ingredients contained in the product Formule T 7. 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, anise oil might decrease the levels and clinical effects of acetaminophen.
 Details
Animal research shows that taking anise oil with acetaminophen decreases peak plasma levels of acetaminophen but does not reduce overall bioavailability (94951). Whether this interaction will occur in humans is unclear.
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Theoretically, anise seed might increase the risk of hypoglycemia when taken with antidiabetes drugs.
Details
A small clinical study shows that anise seed powder decreases fasting blood glucose levels by 36% when compared to baseline (94953).
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Theoretically, anise oil might decrease the efficacy of caffeine.
Details
Animal research shows that taking anise oil with caffeine decreases the bioavailability of caffeine (94951). Whether this interaction will occur in humans is unclear.
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Theoretically, anise oil might increase the effects and adverse effects of codeine.
Details
Animal research shows that anise oil increases the analgesic effects of codeine, possibly by inducing its phase I metabolism and increasing conversion to morphine (94950). Whether this interaction occurs in humans is unclear.
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Theoretically, anise might interfere with contraceptive drug therapy.
Details
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Theoretically, anise oil might increase the effects and adverse effects of diazepam.
Details
Animal research shows that taking anise oil with diazepam increases the motor impairment associated with diazepam, possibly by inhibiting its breakdown by cytochrome P450 3A4 (94950). Whether this interaction occurs in humans is unclear.
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Theoretically, anise might interfere with estrogen-based hormone replacement therapy.
Details
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Theoretically, anise oil might decrease the efficacy of fluoxetine.
Details
Animal research shows that taking anise oil with fluoxetine reduces the antidepressant effects of fluoxetine, possibly by promoting its breakdown by cytochrome P450 2D6 (94950). Whether this interaction occurs in humans is unclear.
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Theoretically, anise oil might decrease the efficacy of imipramine.
Details
Animal research shows that taking anise oil with imipramine reduces the antidepressant effects of imipramine, possibly by promoting its breakdown by cytochrome P450 2D6 (94950). Whether this interaction occurs in humans is unclear.
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Theoretically, anise oil might increase the effects and adverse effects of midazolam.
Details
Animal research shows that taking anise oil with midazolam increases the motor impairment associated with midazolam, possibly by inhibiting its breakdown by cytochrome P450 3A4 (94950). Whether this interaction occurs in humans is unclear.
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Theoretically, anise might interfere with tamoxifen therapy.
Details
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Concomitant use might increase the risk of bleeding due to decreased platelet aggregation. Coltsfoot has been reported to inhibit platelet aggregation (12864); avoid concomitant use. Some of these drugs include aspirin, clopidogrel (Plavix), dalteparin (Fragmin), enoxaparin (Lovenox), heparin, ticlopidine (Ticlid), warfarin (Coumadin), and others.
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Theoretically, excessive doses of coltsfoot may interfere with antihypertensive or cardiovascular therapy (12858).
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Hepatotoxic pyrrolizidine alkaloids (PA) are substrates of cytochrome P450 3A4 (CYP3A4) (12841,12860). Theoretically, drugs that induce CYP3A4 might increase the conversion of PAs to toxic metabolites. Some drugs that induce CYP3A4 include carbamazepine (Tegretol), phenobarbital, phenytoin (Dilantin), rifampin, rifabutin (Mycobutin), and others.
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Theoretically, concomitant use of corn poppy with CNS depressants might increase the risk of sedation.
Details
Animal research suggests that corn poppy leaf extract has sedative effects (46271).
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Theoretically, taking Hibiscus sabdariffa with acetaminophen might decrease the clinical effects of acetaminophen.
Details
There is some evidence that consuming a Hibiscus sabdariffa beverage (Zobo drink) before taking acetaminophen can decrease the elimination half-life of acetaminophen. Hibiscus sabdariffa does not seem to decrease maximum concentration or area under the curve of acetaminophen (12184). The clinical significance of this is unknown.
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Theoretically, taking Hibiscus sabdariffa with antidiabetes drugs might increase the risk of hypoglycemia.
Details
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Theoretically, taking Hibiscus sabdariffa with antihypertensive drugs might increase the risk of hypotension.
Details
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Taking Hibiscus sabdariffa tea along with chloroquine seems to reduce levels of chloroquine.
Details
When taken together, Hibiscus sabdariffa tea significantly reduces the bioavailability of chloroquine (55004). This may reduce its clinical effects. People taking chloroquine for the treatment or prevention of malaria should avoid Hibiscus sabdariffa tea.
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Theoretically, Hibiscus sabdariffa extract might reduce the metabolism of CYP1A2 substrates.
Details
In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP1A2 (93811). This interaction has not been reported in humans.
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Theoretically, Hibiscus sabdariffa extract might reduce the metabolism of CYP2A6 substrates.
Details
In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP2A6 (93811). This interaction has not been reported in humans.
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Theoretically, Hibiscus sabdariffa extract might reduce the metabolism of CYP2B6 substrates.
Details
In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP2B6 (93811). This interaction has not been reported in humans.
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Theoretically, Hibiscus sabdariffa extract might reduce the metabolism of CYP2C19 substrates.
Details
In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP2C19 (93811). This interaction has not been reported in humans.
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Theoretically, Hibiscus sabdariffa might reduce the metabolism of CYP2C8 substrates.
Details
In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP2C8 (93811). This interaction has not been reported in humans.
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Theoretically, Hibiscus sabdariffa extract might reduce the metabolism of CYP2C9 substrates.
Details
In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP2C9 (93811). This interaction has not been reported in humans.
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Theoretically, Hibiscus sabdariffa extract might reduce the metabolism of CYP2D6 substrates.
Details
In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP2D6 (93811). This interaction has not been reported in humans.
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Theoretically, Hibiscus sabdariffa extract might reduce the metabolism of CYP2E1 substrates.
Details
In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP2E1 (93811). This interaction has not been reported in humans.
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Theoretically, Hibiscus sabdariffa extract might reduce the metabolism of CYP3A4 substrates.
Details
In vitro research shows that Hibiscus sabdariffa calyx extract inhibits CYP3A4 (93811). This interaction has not been reported in humans.
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Taking Hibiscus sabdariffa with diclofenac may increase the levels and adverse effects of diclofenac.
Details
Pharmacokinetic research in humans shows that drinking a beverage made with Hibiscus sabdariffa flowers reduces the excretion of diclofenac by approximately 38% when compared with water. The clinical significance of this is unknown (101726).
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Theoretically, Hibiscus sabdariffa might increase the levels and clinical effects of losartan.
Details
Animal research in rats with laboratory-induced hypertension shows that providing Hibiscus sabdariffa for 14-17 days prior to a single administration with losartan modestly increases losartan concentrations and increases hypotensive effects when compared with a single administration of losartan alone (102459). It is not clear if Hibiscus sabdariffa alters the concentration or effects of losartan when taken continuously. Additionally, this interaction has not been shown in humans.
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Taking Hibiscus sabdariffa with simvastatin might reduce the levels and clinical effects of simvastatin.
Details
A pharmacokinetic study in humans shows that taking a beverage prepared with dried Hibiscus sabdariffa flower 300 grams concurrently with a single dose of simvastatin 40 mg increases the clearance of simvastatin by about 45% and reduces peak levels of simvastatin by 18% (96270).
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Theoretically, licorice might reduce the effects of antihypertensive drugs.
Details
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Theoretically, licorice might reduce the effects of cisplatin.
Details
In animal research, licorice diminished the therapeutic efficacy of cisplatin (59763).
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Theoretically, concomitant use of licorice and corticosteroids might increase the side effects of corticosteroids.
Details
Case reports suggest that concomitant use of licorice and oral corticosteroids, such as hydrocortisone, can potentiate the duration of activity and increase blood levels of corticosteroids (3252,12672,20040,20042,48429,59756). Additionally, in one case report, a patient with neurogenic orthostatic hypertension stabilized on fludrocortisone 0.1 mg twice daily developed pseudohyperaldosteronism after recent consumption of large amounts of black licorice (108568).
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Theoretically, licorice might increase levels of drugs metabolized by CYP2B6.
Details
In vitro research shows that licorice extract and glabridin, a licorice constituent, inhibit CYP2B6 isoenzymes (10300,94822). Licorice extract from the species G. uralensis seems to inhibit CYP2B6 isoenzymes to a greater degree than G. glabra extract in vitro (94822). Theoretically, these species of licorice might increase levels of drugs metabolized by CYP2B6; however, these interactions have not yet been reported in humans.
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Theoretically, licorice might increase levels of drugs metabolized by CYP2C19.
Details
In vitro, licorice extracts from the species G. glabra and G. uralensis inhibit CYP2C19 isoenzymes in vitro (94822). Theoretically, these species of licorice might increase levels of drugs metabolized by CYP2C19; however, this interaction has not yet been reported in humans.
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Theoretically, licorice might increase levels of drugs metabolized by CYP2C8.
Details
In vitro, licorice extract from the species G. glabra and G. uralensis inhibits CYP2C8 isoenzymes (94822). Theoretically, these species of licorice might increase levels of drugs metabolized by CYP2C8; however, this interaction has not yet been reported in humans.
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Theoretically, licorice might increase or decrease levels of drugs metabolized by CYP2C9.
Details
There is conflicting evidence about the effect of licorice on CYP2C9 enzyme activity. In vitro research shows that extracts from the licorice species G. glabra and G. uralensis moderately inhibit CYP2C9 isoenzymes (10300,94822). However, evidence from an animal model shows that licorice extract from the species G. uralensis can induce hepatic CYP2C9 activity (14441). Until more is known, licorice should be used cautiously in people taking CYP2C9 substrates.
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Theoretically, licorice might increase or decrease levels of drugs metabolized by CYP3A4.
Details
Pharmacokinetic research shows that the licorice constituent glycyrrhizin, taken in a dosage of 150 mg orally twice daily for 14 days, modestly decreases the area under the concentration-time curve of midazolam by about 20%. Midazolam is a substrate of CYP3A4, suggesting that glycyrrhizin modestly induces CYP3A4 activity (59808). Animal research also shows that licorice extract from the species G. uralensis induces CYP3A4 activity (14441). However, licorice extract from G. glabra species appear to inhibit CYP3A4-induced metabolism of testosterone in vitro. It is thought that the G. glabra inhibits CYP3A4 due to its constituent glabridin, which is a moderate CYP3A4 inhibitor in vitro and not present in other licorice species (10300,94822). Until more is known, licorice should be used cautiously in people taking CYP3A4 substrates.
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Theoretically, concomitant use of licorice with digoxin might increase the risk of cardiac toxicity.
Details
Overuse or misuse of licorice with cardiac glycoside therapy might increase the risk of cardiac toxicity due to potassium loss (10393).
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Theoretically, concomitant use of licorice with diuretic drugs might increase the risk of hypokalemia.
Details
Overuse of licorice might compound diuretic-induced potassium loss (10393,20045,20046,59812). In one case report, a 72-year-old male with a past medical history of hypertension, type 2 diabetes, hyperlipidemia, arrhythmia, stroke, and hepatic dysfunction was hospitalized with severe hypokalemia and uncontrolled hypertension due to pseudohyperaldosteronism. This was thought to be provoked by concomitant daily consumption of a product containing 225 mg of glycyrrhizin, a constituent of licorice, and hydrochlorothiazide 12.5 mg for 1 month (108577).
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Theoretically, licorice might increase or decrease the effects of estrogen therapy.
Details
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Theoretically, loop diuretics might increase the mineralocorticoid effects of licorice.
Details
Theoretically, loop diuretics might enhance the mineralocorticoid effects of licorice by inhibiting the enzyme that converts cortisol to cortisone; however, bumetanide (Bumex) does not appear to have this effect (3255).
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Theoretically, licorice might increase levels of methotrexate.
Details
Animal research suggests that intravenous administration of glycyrrhizin, a licorice constituent, and high-dose methotrexate may delay methotrexate excretion and increase systemic exposure, leading to transient elevations in liver enzymes and total bilirubin (108570). This interaction has not yet been reported in humans.
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Theoretically, licorice might decrease levels of midazolam.
Details
In humans, the licorice constituent glycyrrhizin appears to moderately induce the metabolism of midazolam (59808). This is likely due to induction of cytochrome P450 3A4 by licorice. Until more is known, licorice should be used cautiously in people taking midazolam.
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Theoretically, licorice might decrease the absorption of P-glycoprotein substrates.
Details
In vitro research shows that licorice can increase P-glycoprotein activity (104561).
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Theoretically, licorice might decrease plasma levels and clinical effects of paclitaxel.
Details
Multiple doses of licorice taken concomitantly with paclitaxel might reduce the effectiveness of paclitaxel. Animal research shows that licorice 3 grams/kg given orally for 14 days before intravenous administration of paclitaxel decreases the exposure to paclitaxel and increases its clearance. Theoretically, this occurs because licorice induces cytochrome P450 3A4 enzymes, which metabolize paclitaxel. Notably, a single dose of licorice did not affect exposure or clearance of paclitaxel (102959).
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Theoretically, licorice might decrease plasma levels and clinical effects of warfarin.
Details
Licorice seems to increase metabolism and decrease levels of warfarin in animal models. This is likely due to induction of cytochrome P450 2C9 (CYP2C9) metabolism by licorice (14441). Advise patients taking warfarin to avoid taking licorice.
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Theoretically, marshmallow flower might have antiplatelet effects.
Details
Animal research suggests that marshmallow flower extract has antiplatelet effects (92846). However, the root and leaf of marshmallow, not the flower, are the plant parts most commonly found in dietary supplements. Theoretically, use of marshmallow flower with anticoagulant/antiplatelet drugs can have additive effects, and might increase the risk for bleeding in some patients.
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Theoretically, due to potential diuretic effects, marshmallow might reduce excretion and increase levels of lithium.
Details
Marshmallow is thought to have diuretic properties. To avoid lithium toxicity, the dose of lithium might need to be decreased when used with marshmallow.
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Theoretically, mucilage in marshmallow might impair absorption of oral drugs.
Details
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Below is general information about the adverse effects of the known ingredients contained in the product Formule T 7. 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, anise seems to be well tolerated.
Most Common Adverse Effects:
Topically: Contact dermatitis in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Anaphylaxis in sensitive individuals.
Dermatologic ...Topically, anise, in combination with other herbs, has been reported to cause localized pruritus (13483).
Immunologic ...Anise can cause allergic reactions in sensitive individuals. Orally or by inhalation, anise can cause rhinoconjunctivitis, occupational asthma, and anaphylaxis (13484). Topically, anise can cause contact dermatitis, rhinitis, and asthma (31319,31341). Contact dermatitis and cheilitis have also been reported following the use of toothpaste containing anethole, a constituent of anise (31403,31528).
General ...Orally, the major concern with coltsfoot use is its pyrrolizidine alkaloid (PA) content. These alkaloids can cause liver and lung injury (12841,12842). Chronic exposure to other plants containing hepatotoxic PA constituents has been associated with hepatic veno-occlusive disease (4021). Sub-acute veno-occlusive disease can cause vague symptoms, including colicky pains, vomiting, diarrhea, and ascites within several days; persistent liver enlargement occurs within a few weeks (4021,12842). Deep vein thrombosis (DVT) and pulmonary embolus (PE) thought to be associated with coltsfoot have been reported (18242). Coltsfoot products containing PAs should be avoided. There is currently a limited amount of information available about the adverse effects of PA-free coltsfoot.
Cardiovascular ...Orally, a single case report associates coltsfoot and its PA content with deep vein thrombosis (DVT) and pulmonary embolus (PE). A 27-year-old man with no history of coagulation disorders developed a DVT and several PE after consuming unknown quantities of coltsfoot and several other herbs. However, he also had other risk factors for thrombosis, including smoking and recent bed rest (18242).
Hepatic ...Orally, coltsfoot might cause liver damage. Coltsfoot contains hepatotoxic pyrrolizidine alkaloids (PAs) (12841,12842). Chronic exposure to other plants containing hepatotoxic PAs is associated with veno-occlusive disease (4021). Sub-acute veno-occlusive disease can cause vague symptoms, including colicky pains, vomiting, diarrhea, and ascites within several days; persistent liver enlargement occurs within a few weeks (4021,12842).
Pulmonary/Respiratory ...Orally, coltsfoot might cause lung damage. The major concern with coltsfoot use is its pyrrolizidine alkaloid (PA) content. These constituents can cause lung damage with pulmonary-arterial hypertension (12841,12842).
General
...Orally, corn poppy seems to be well tolerated when used in appropriate doses.
Large doses of 250 grams or more can cause intoxication.
Most Common Adverse Effects:
Topically: Urticaria.
Dermatologic ...Topically, corn poppy flowers may cause allergic contact urticaria (46284).
General ...Orally, Hibiscus sabdariffa is generally well tolerated.
Gastrointestinal ...Orally, taking a specific Hibiscus sabdariffa leaf extract (Green Chem) 1 gram daily has been associated with reports of transient gastrointestinal symptoms such as abdominal distention, flatulence, and epigastric pain in one clinical trial. However, the overall rate of these adverse effects was similar to placebo (17415). Taking Hibiscus sabdariffa calyx extract 6 grams daily has been associated with single cases of nausea in one clinical trial (55000). Taking Hibiscus sabdariffa calyx powder 6 grams daily has been associated with reports of mild and transient constipation in one clinical trial (93816). Taking 0.5-1 liters of tea daily, made by steeping 10-15 grams of dried Hibiscus sabdariffa calyces, has been associated with one report of stomach pain in one clinical trial (101733).
Genitourinary ...Orally, taking Hibiscus sabdariffa calyx extract 6 grams daily has been associated with one report of dysuria in one clinical trial (55000).
Neurologic/CNS ...Orally, taking Hibiscus sabdariffa calyx extract 3 grams daily has been associated with one report of tremor and headache in one clinical trial (55000).
Ocular/Otic ...Orally, taking Hibiscus sabdariffa calyx extract 3 grams daily has been associated with one report of tinnitus in one clinical trial (55000).
Pulmonary/Respiratory ...Taking 0. 5-1 liters of tea daily, made by steeping 10, 15, or 20 grams of dried Hibiscus sabdariffa calyces, has been associated with two reports of dyspnea in one clinical trial. A clear association with Hibiscus sabdariffa could not be made (101733).
General
...Orally, licorice is generally well tolerated when used in amounts commonly found in foods.
It seems to be well tolerated when licorice products that do not contain glycyrrhizin (deglycyrrhizinated licorice) are used orally and appropriately for medicinal purposes or when used topically, short-term.
Most Common Adverse Effects:
Orally: Headache, nausea, and vomiting.
Topically: Contact dermatitis.
Intravenously: Diarrhea, itching, nausea, and rash.
Serious Adverse Effects (Rare):
Orally: Case reports have raised concerns about acute renal failure, cardiac arrest, cardiac arrhythmias, hypertension, hypokalemia, muscle weakness, paralysis, pseudohyperaldosteronism, and seizure associated with long-term use or large amounts of licorice containing glycyrrhizin.
Cardiovascular
...Orally, excessive licorice ingestion can lead to pseudohyperaldosteronism, which can precipitate cardiovascular complications such as hypertension and hypertensive crisis, ventricular fibrillation or tachycardia, sinus pause, and cardiac arrest.
These effects are due to the licorice constituent glycyrrhizin and usually occur when 20-30 grams or more of licorice product is consumed daily for several weeks (781,15590,15592,15594,15596,15597,15599,15600,16835,97213) (104563,108574,108576,110305,112234). In one case report, an 89-year-old female taking an herbal medicine containing licorice experienced a fatal arrhythmia secondary to licorice-induced hypokalemia. The patient presented to the hospital with recurrent syncope, weakness, and fatigue for 5 days after taking an herbal medicine containing licorice for 2 months. Upon admission to the hospital, the patient developed seizures, QT prolongation, and ventricular arrhythmia requiring multiple defibrillations. Laboratory tests confirmed hypokalemia and pseudohyperaldosteronism (112234).
However, people with cardiovascular or kidney conditions may be more sensitive, so these adverse events may occur with doses as low as 5 grams of licorice product or glycyrrhizin 100 mg daily (15589,15593,15598,15600,59726). A case report in a 54-year-old male suggests that malnutrition might increase the risk of severe adverse effects with excessive licorice consumption. This patient presented to the emergency room with cardiac arrest and ventricular fibrillation after excessive daily consumption of licorice for about 3 weeks. This caused pseudohyperaldosteronism and then hypokalemia, leading to cardiovascular manifestations. In spite of resuscitative treatment, the patient progressed to kidney failure, refused dialysis, and died shortly thereafter (103791).
Dermatologic
...There have been reports of contact allergy, resulting in an itchy reddish eruption, occurring in patients that applied cosmetic products containing oil-soluble licorice extracts (59912).
There have also been at least 3 cases of allergic contact dermatitis reported with the topical application of glycyrrhizin-containing products to damaged skin. In one case report, a 31-year-old female with acne presented with a 2-year history of pruritic erythematous-scaly plaques located predominantly on the face and neck after the use of a cosmetic product containing licorice root extract 1%. The patient had a positive skin patch test to licorice root extract, leading the clinicians to hypothesize that the use of benzoyl peroxide, a strong irritant, might have sensitized the patient to licorice (108578). Burning sensation, itching, redness, and scaling were reported rarely in patients applying a combination of licorice, calendula, and snail secretion filtrate to the face. The specific role of licorice is unclear (110322).
In rare cases, the glycyrrhizin constituent of licorice has caused rash and itching when administered intravenously (59712).
Endocrine
...Orally, excessive licorice ingestion can cause a syndrome of apparent mineralocorticoid excess, or pseudohyperaldosteronism, with sodium and water retention, increased urinary potassium loss, hypokalemia, and metabolic alkalosis due to its glycyrrhizin content (781,10619,15591,15592,15593,15594,15595,15596,15597,15598)(15600,16057,16835,25659,25660,25673,25719,26439,59818,59822)(59832,59864,91722,104563,108568,108574,110305,112234).
These metabolic abnormalities can lead to hypertension, edema, EKG changes, fatigue, syncope, arrhythmias, cardiac arrest, headache, lethargy, muscle weakness, dropped head syndrome (DHS), rhabdomyolysis, myoglobinuria, paralysis, encephalopathy, respiratory impairment, hyperparathyroidism, and acute kidney failure (10393,10619,15589,15590,15593,15594,15596,15597,15599)(15600,16057,16835,25660,25673,25719,26439,31562,59709,59716)(59720,59740,59787,59820,59826,59882,59889,59900,91722,97214,100522) (104563,108576,108577). These effects are most likely to occur when 20-30 grams of licorice products containing glycyrrhizin 400 mg or more is consumed daily for several weeks (781,15590,15592,15594,15596,15597,15599,15600,16835,108574). However, some people may be more sensitive, especially those with hypertension, diabetes, heart problems, or kidney problems (15589,15593,15598,15600,59726,108576,108577) and even low or moderate consumption of licorice may cause hypertensive crisis or hypertension in normotensive individuals (1372,97213). The use of certain medications with licorice may also increase the risk of these adverse effects (108568,108577). One case report determined that the use of large doses of licorice in an elderly female stabilized on fludrocortisone precipitated hypokalemia and hypertension, requiring inpatient treatment (108568). Another case report describes severe hypokalemia necessitating intensive care treatment due to co-ingestion of an oral glycyrrhizin-specific product and hydrochlorothiazide for 1 month (108577). Glycyrrhetinic acid has a long half-life, a large volume of distribution, and extensive enterohepatic recirculation. Therefore, it may take 1-2 weeks before hypokalemia resolves (781,15595,15596,15597,15600). Normalization of the renin-aldosterone axis and blood pressure can take up to several months (781,15595,108568). Treatment typically includes the discontinuation of licorice, oral and intravenous potassium supplementation, and short-term use of aldosterone antagonists, such as spironolactone (108574,108577).
Chewing tobacco flavored with licorice has also been associated with toxicity. Chewing licorice-flavored tobacco, drinking licorice tea, or ingesting large amounts of black licorice flavored jelly beans or lozenges has been associated with hypertension and suppressed renin and aldosterone levels (12671,12837,97214,97215,97217,108574). One case report suggests that taking a combination product containing about 100 mg of licorice and other ingredients (Jintan, Morishita Jintan Co.) for many decades may be associated with hypoaldosteronism, even up to 5 months after discontinuation of the product (100522). In another case report, licorice ingestion led to hyperprolactinemia in a female (59901). Licorice-associated hypercalcemia has also been noted in a case report (59766).
Gastrointestinal ...Nausea and vomiting have been reported rarely following oral use of deglycyrrhizinated licorice (25694,59871). Intravenously, the glycyrrhizin constituent of licorice has rarely caused gastric discomfort, diarrhea, or nausea (59712,59915).
Immunologic ...There have been reports of contact allergy, resulting in an itchy reddish eruption, occurring in patients that applied cosmetic products containing oil-soluble licorice extracts (59912). There have also been at least 3 cases of allergic contact dermatitis reported with the topical application of glycyrrhizin-containing products to damaged skin. In one case report, a 31-year-old female with acne presented with a 2-year history of pruritic erythematous-scaly plaques located predominantly on the face and neck after the use of a cosmetic product containing licorice root extract 1%. The patient had a positive skin patch test to licorice root extract, leading the clinicians to hypothesize that the use of benzoyl peroxide, a strong irritant, might have sensitized the patient to licorice (108578).
Musculoskeletal ...In a case report, excessive glycyrrhizin-containing licorice consumption led to water retention and was thought to trigger neuropathy and carpal tunnel syndrome (59791).
Neurologic/CNS ...Orally, licorice containing larger amounts of glycyrrhizin may cause headaches. A healthy woman taking glycyrrhizin 380 mg daily for 2 weeks experienced a headache (59892). Intravenously, the glycyrrhizin constituent of licorice has rarely caused headaches or fatigue (59721). In a case report, licorice candy ingestion was associated with posterior reversible encephalopathy syndrome accompanied by a tonic-clonic seizure (97218).
Ocular/Otic ...Orally, consuming glycyrrhizin-containing licorice 114-909 grams has been associated with transient visual loss (59714).
Pulmonary/Respiratory ...Orally, large amounts of licorice might lead to pulmonary edema. In one case report, a 64-year old male consumed 1020 grams of black licorice (Hershey Twizzlers) containing glycyrrhizin 3.6 grams over 3 days, which resulted in pulmonary edema secondary to pseudohyperaldosteronism (31561). Intravenously, the glycyrrhizin constituent of licorice has caused cold or flu-like symptoms, although these events are not common (59712,59721).
General ...Orally and topically, no adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.
General ...Information regarding the adverse effects of mullein is limited. A thorough evaluation of safety outcomes has not been conducted.
Dermatologic ...Two case reports have described dermatitis, with positive patch tests, after topical exposure to the whole plant, or by occupational inhalation of plant dust (92839,97316). In the case of topical exposure, the patient also had positive patch tests to other plants.
