Each sachet contains: Achillea Millefolium 50 mg • Agropyron repens 350 mg • Arctium Lappa 150 mg • Equisetum arvense 400 mg • Juniperus communis 400 mg • Prunus cerasus 50 mg • Scrophularia nodosa 100 mg.
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 11 Reins. 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 couch grass.
There is insufficient reliable information available about the effectiveness of figwort.
INSUFFICIENT RELIABLE EVIDENCE to RATE
There is insufficient reliable information available about the effectiveness of juniper.
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 11 Reins. 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 in amounts commonly found in foods (12659,12660). Burdock root is commonly eaten as a vegetable (37422,92153,92154)
POSSIBLY SAFE ...when used topically, short-term. An emulsion containing burdock fruit extract 1.2% has been safely applied to the face twice daily for 4 weeks (37420). There is insufficient reliable information available about the safety of burdock when used orally in supplemental doses.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
There is insufficient reliable information available about the safety of couch grass.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
There is insufficient reliable information available about the safety of figwort.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY UNSAFE ...when horsetail products containing thiaminase are used orally, long-term. Thiaminase is an enzyme that destroys thiamine, which could theoretically lead to thiamine deficiency. In Canada, horsetail products are required to be thiaminase-free (105301).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Juniper, juniper berry, and juniper extract have Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when used topically on limited areas of skin (12230). ...when the oil is used by inhalation and appropriately as aromatherapy (7107). There is insufficient reliable information available about the safety of juniper when used orally in doses of less than 10 grams of berries or 100 mg of oil daily, short-term. Juniper oil and berry have a long history of traditional use (12,103759).
LIKELY UNSAFE ...when used orally in excessive amounts or long-term. Use of daily doses greater than 10 grams of juniper berries (about 60 berries) or 100 mg of juniper essential oil, or prolonged oral use longer than 4 weeks, have been reported to increase the risk of severe adverse effects such as convulsions or kidney damage (8,19,103759).
PREGNANCY: UNSAFE
when used orally.
Juniper can increase uterine tone, interfere with fertility and implantation, and cause abortion (4,19).
LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when the fruit is used in amounts commonly found in foods. ...when tart cherry fruit, fruit juice, or fruit juice concentrate is used orally in supplemental amounts for up to 3 months (17403,93149,93151,93152,93153,93154,93156,93157,93158,93160)(93161,93168,93179,105633).
POSSIBLY SAFE ...when tart cherry fruit extract or powder is used orally, short term. Cherry fruit extract or freeze-dried cherry powder up to 500 mg daily for up 7 days has been used with apparent safety (93157,93158,105631). There is insufficient reliable information available about the safety of tart cherry stem when used orally.
PREGNANCY AND LACTATION: LIKELY SAFE
when the fruit is consumed in typical food amounts.
There is insufficient reliable information available about the safety of tart cherry fruit or stem when used in medicinal amounts; avoid using.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Yarrow products that are thujone-free have Generally Recognized As Safe (GRAS) status for use in foods in the US (4912); however, products containing thujone might not be safe. Thujone is a chemical that stimulates the central nervous system and is poisonous in large doses.
POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts (2,12,100346). Yarrow whole plant extract has been used with apparent safety at a dose of 250-500 mg daily for 12 months (100346). ...when used intravaginally as a cream containing yarrow extract 2% daily for 7 days (105360). There is insufficient reliable information available about the safety of yarrow when applied topically.
PREGNANCY: LIKELY UNSAFE
when used orally; yarrow is believed to be an abortifacient and affect the menstrual cycle (12).
LACTATION:
Insufficient reliable information available; avoid use.
Below is general information about the interactions of the known ingredients contained in the product Formule 11 Reins. 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, taking burdock with anticoagulant or antiplatelet drugs might increase the risk of bleeding.
Details
In vitro research shows that lignans from burdock reduce rabbit platelet aggregation by inhibiting platelet activating factor (12619). This interaction has not been reported in humans. |
Theoretically, overuse of figwort might compound diuretic-induced potassium loss (18). There is some concern that people taking figwort along with potassium depleting diuretics might have an increased risk for hypokalemia. Initiation of potassium supplementation or an increase in potassium supplement dose may be necessary for some patients. Some diuretics that can deplete potassium include chlorothiazide (Diuril), chlorthalidone (Thalitone), furosemide (Lasix), hydrochlorothiazide (HCTZ, Hydrodiuril, Microzide), and others.
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Figwort is thought to have diuretic properties (18). Theoretically, due to these potential diuretic effects, figwort might reduce excretion and increase levels of lithium. The dose of lithium might need to be decreased.
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Theoretically, taking horsetail with antidiabetes drugs might increase the risk of hypoglycemia.
Details
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Theoretically, taking horsetail with diuretic drugs might increase potassium loss and the risk of hypokalemia.
Details
Laboratory research shows that various species of horsetail have diuretic properties (13574,13575). Due to its diuretic effects, there has been concern that taking horsetail along with potassium-depleting diuretics might increase the risk for hypokalemia. However, pharmacokinetic research in humans shows that taking horsetail 900 mg daily for 4 days does not affect urinary excretion of electrolytes, including potassium and sodium, despite having a diuretic effect similar to taking hydrochlorothiazide 25 mg daily (92288). It is unclear if taking horsetail for a longer duration would affect electrolyte levels. Until more is known, use with caution.
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Theoretically, horsetail might decrease the levels and clinical effects of efavirenz.
Details
In two case reports, patients were found to have detectable viral loads when taking horsetail-containing supplements along with an antiretroviral regimen that included efavirenz. In one case, the antiretroviral regimen included zidovudine, lamivudine, and efavirenz; in the other case, the regimen consisted of emtricitabine, tenofovir disoproxil fumarate, and efavirenz. One month after discontinuing horsetail, the viral loads became undetectable in both cases. The exact mechanism of this interaction is unknown (97573). It is also unclear if this interaction is specific to efavirenz or if it is related to various components of antiretroviral therapy.
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Theoretically, horsetail might increase the levels and adverse effects of lithium.
Details
Animal research suggests that horsetail has diuretic properties (13574). Theoretically, due to these potential diuretic effects, horsetail might reduce excretion and increase levels of lithium. The dose of lithium might need to be decreased.
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Theoretically, horsetail might decrease the levels and clinical effects of NRTIs.
Details
In two case reports, patients were found to have detectable viral loads when taking horsetail-containing supplements along with an antiretroviral therapy. In one case, the antiretroviral regimen included zidovudine, lamivudine, and efavirenz; in the other case, the regimen consisted of emtricitabine, tenofovir disoproxil fumarate, and efavirenz. One month after discontinuing the supplement, the viral loads became undetectable in both cases. The exact mechanism of these interactions is unknown (97573). It is also unclear if these interactions are specific to NRTIs or if they are related to various components of antiretroviral therapy.
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Animal research suggests that juniper berry has hypoglycemic activity (4). Theoretically, taking juniper berry with antidiabetes medications might cause additive blood glucose reduction. Monitor blood glucose levels closely. Dose adjustments to antidiabetes medications might be necessary.
Details
Some antidiabetes drugs include glimepiride (Amaryl), glyburide (DiaBeta, Glynase PresTab, Micronase), insulin, pioglitazone (Actos), rosiglitazone (Avandia), chlorpropamide (Diabinese), glipizide (Glucotrol), tolbutamide (Orinase), and others.
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Juniper berry can cause the body to lose water. Theoretically, juniper berry might increase the effectiveness of diuretic therapy, causing the body to lose too much water and increasing the likelihood of experiencing side effects (4, 512).
Details
Some diuretic drugs include chlorothiazide (Diuril), chlorthalidone (Thalitone), furosemide (Lasix), hydrochlorothiazide (HCTZ, Hydrodiuril, Microzide), and others.
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Juniper berry might have mild diuretic effects (4,512). Theoretically, due to these potential diuretic effects, juniper berry might reduce excretion and increase levels of lithium. The dose of lithium might need to be decreased.
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Theoretically, taking yarrow with lithium might increase the levels and adverse effects of lithium.
Details
Animal research shows that yarrow has diuretic activity (106018). Theoretically, due to these potential diuretic effects, yarrow might reduce excretion and increase levels of lithium. The dose of lithium might need to be decreased.
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Below is general information about the adverse effects of the known ingredients contained in the product Formule 11 Reins. 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, burdock is well tolerated when consumed as a food.
Although a thorough evaluation of safety outcomes is lacking, there has been long-standing historical use of burdock with few noted adverse effects.
Serious Adverse Effects (Rare):
All ROAs: Allergic reactions, including contact dermatitis and anaphylaxis.
Dermatologic ...Contact dermatitis has been reported secondary to burdock, especially after prolonged use of the root oil (37422). There are cases of allergic dermatitis secondary to using burdock plasters. Two males and a 14 year-old female developed erythematous and vesicular, pruritic, and exudative reactions in areas corresponding to the application of burdock root plasters (12667). Reactions occurred up to 7 days after initial use. Patch testing was positive for burdock sensitivity in all three patients and was nonreactive in matched controls.
Hematologic ...In one case report, a 38-year-old female developed immune-mediated thrombocytopenia after consuming a "cleansing" tea containing unknown amounts of burdock and yellow dock. The patient presented with bruising, mild weakness, and fatigue, which started 2-3 days after consuming the tea, and was found to have a platelet count of 5,000 per mcL. Symptoms resolved after platelet transfusion and treatment with oral dexamethasone (108971). It is unclear if these effects were caused by burdock, yellow dock, the combination, or other contributing factors.
Hepatic ...A case of idiosyncratic drug-induced liver disease (DILI) is reported in a 36-year-old female who presented with abdominal pain after 1 month of taking an herbal liver detox tea containing burdock and other ingredients. Remarkable laboratory values included elevated liver enzymes, alkaline phosphatase, and total bilirubin. The patient received a loading dose of N-acetylcysteine and was hospitalized for 12 days (112178). However, it is unclear if the adverse effect was due to burdock, other ingredients, or the combination.
Immunologic ...There is one case of anaphylactic shock secondary to eating boiled burdock. One hour after eating boiled burdock the patient presented with redness over the entire body and dyspnea. He was found to have low blood pressure and was treated with subcutaneous epinephrine 1 mg and intravenous lactated ringer's solution containing hydrocortisone 100 mg and dexamethasone 8 mg. The cause of anaphylactic shock was attributed to allergenicity to burdock based on positive skin prick test results. Previously, the patient had experienced urticaria after eating boiled burdock (12660).
Neurologic/CNS ...Anticholinergic reactions including dry mouth, dizziness, blurred vision, weakness, dilated pupils, inability to urinate, and bradycardia have been reported following the consumption of burdock products (12662,37421,37431,37434,37435). However, these anticholinergic reactions are believed result from contamination of burdock with belladonna alkaloids. Burdock itself does not contain atropine or other constituents that would be responsible for these reactions.
General ...No adverse effects have been reported; however, a thorough evaluation of safety outcomes has not been conducted.
General ...No adverse effects have been reported; however, a thorough evaluation of safety outcomes has not been conducted.
General
...There is limited clinical research evaluating the safety of horsetail.
Most Common Adverse Effects:
Orally: Abdominal distension, increased bowel movements, and nausea.
Dermatologic ...In one case report, a patient developed seborrheic dermatitis after topical application of horsetail, requiring treatment with local epinephrine and oral antihistamines. The nicotine component of horsetail was determined to be the likely cause of this reaction (13563).
Gastrointestinal ...Orally, horsetail has been associated with mild gastrointestinal side effects including abdominal distension, increased frequency of bowel movements, and nausea (55576). Orally, chronic consumption of horsetail infusion has been associated with acute pancreatitis. In a case report, a 56-year-old female presenting with recurrent mild acute pancreatitis every 6-7 months, previously thought to be drug-induced, discontinued ingesting horsetail infusions. The patient had a history of bilateral adrenal gland removal and was being treated for hypertension, dyslipidemia, and hormone replacement, and then self-medicated with horsetail infusions. After discontinuing horsetail infusions, there were no further recurrences of pancreatitis during a 14-month follow-up (97574).
Hepatic ...In one case report, a patient with asymptomatic hepatitis B developed symptomatic liver failure following consumption of boiled horsetail juice 500 mL daily for 2 weeks. Liver enzymes returned to normal following discontinuation of the juice (92291). It is not known if the horsetail juice was contaminated or mixed with other ingredients.
Immunologic ...Horsetail has been associated with cross-allergenicity with carrots (13577).
Renal ...There are at least 4 case reports of hyponatremia thought to be at least partially associated with horsetail consumption. In one case report, an elderly patient who had taken oral horsetail 15 mg daily for 10 years presented with hyponatremia and syndrome of inappropriate secretion of antidiuretic hormone (SIADH) secondary to reduced oral intake and nausea for the previous 2 days. Horsetail was thought to be a contributing factor. The patient's symptoms resolved after 5 days of treatment with oral sodium chloride and fluid restriction (108851).
Other ...Crude horsetail contains thiaminase, which can cause thiamine deficiency with prolonged consumption. Canadian Equisetum arvense products are required to be certified as free from thiaminase-like activity (55579,105301). In one case report, the development of autism in a child exposed to both horsetail and alcohol during pregnancy was thought to be caused by thiamine deficiency attributed to this combination (92292). However, it is not known if other genetic or environmental factors were involved in the development of this condition in utero.
General ...Orally and topically, juniper seems to be generally well tolerated when used short-term. However, a thorough evaluation of safety outcomes has not been conducted. Most reported adverse effects are related to ingestion of excessive amounts of juniper berry oil. Symptoms of overdose include kidney pain and irritation, diuresis, albuminuria, hematuria, purplish urine, tachycardia, hypertension, convulsions, metrorrhagia, and abortion (4). Topically, juniper can cause skin irritation (4,103756). Repeated exposure to the juniper pollen can cause occupational allergies (6).
Dermatologic ...Topically, juniper can cause skin irritation. Signs of topical poisoning include burning, erythema, inflammation with blisters, and edema (4). Repeated exposure to the juniper pollen can cause occupational allergies that affect the skin (6). In a case report, a 62-year-old woman developed burn-like blistering lesions after carrying juniper in close contact to her skin. Concurrent sun exposure was thought to worsen the skin irritation caused by juniper (103756).
Genitourinary ...Orally, large amounts of the juniper berry can cause purplish urine (4).
Pulmonary/Respiratory ...Repeated exposure to the juniper pollen can cause occupational allergies that affect the respiratory tract (6).
General
...Tart cherry is generally well tolerated when consumed as whole fruit, juice concentrate, or seed extracts.
Most Common Adverse Effects:
Orally: Abdominal pain, asthenia, gastrointestinal upset, loose stools.
Endocrine ...One case of hyperglycemia after drinking a specific blend of tart cherry and apple juices ) has been reported (93160).
Gastrointestinal ...In a clinical study, 29% of children who consumed 75 mL of tart cherry juice concentrate twice daily for 2 weeks reported abdominal pain (112815). Two cases of loose stools after consumption of 90 whole tart cherries, and one case of gastrointestinal disturbance after drinking 10.5 ounces of tart cherry concentrate (Cherrish, Cherrish Corp.) twice daily for 14 days have been reported (93186,93192). One case of gastrointestinal symptoms after drinking a specific blend of tart cherry and apple juice (Sour cherry juice, Cherrypharm Inc.) has been reported (93160).
Immunologic ...One case of a skin reaction possibly due to cherry allergy after drinking a specific blend of tart cherry and apple juice ) has been reported (93160).
Musculoskeletal ...In a clinical study, 31% of children who consumed tart cherry juice concentrate 75 mLl twice daily for 2 weeks reported asthenia (112815).
General
...Orally and intravaginally, yarrow seems to be well tolerated.
Most Common Adverse Effects:
Topically: Dermatitis.
Dermatologic
...Topically, yarrow can cause atopic or allergic dermatitis or urticaria due to its sesquiterpene lactone content (52558,68385,77007).
Yarrow has also been reported to cause phototoxic and photo-allergic dermatitis and airborne contact dermatitis (68385).
Intravaginally, aggravated facial acne was reported by 1 of 40 patients in a clinical trial (105360).
Endocrine ...Intravaginally, an early menses was reported by 1 of 40 patients in a clinical trial (105360).
Genitourinary ...Intravaginally, aggravated vaginal pruritus and dryness were reported by 1 of 40 patients in a clinical trial (105360).
Immunologic ...Topically, yarrow can cause atopic or allergic dermatitis or urticaria due to its sesquiterpene lactone content (52558,68385,77007,96911). It has also been reported to cause phototoxic and photo-allergic dermatitis and airborne contact dermatitis (68385). In one 44-year-old female, handling yarrow flowers resulted in rhinitis and asthma (96911).