|By Marketwired .||
|February 27, 2014 03:21 PM EST||
OTTAWA, ONTARIO -- (Marketwired) -- 02/27/14 -- The issue:
Health Canada is informing Canadians that Les Importations Herbasante Inc. is voluntarily recalling Formule L1 and Detox Spring-Fall because the labels are missing important risk statements, including the contraindications and warnings associated with the use of these products. In addition, the two products are being sold in a single package and pose an increased risk to health when used together.
To date, Health Canada has not received any reports of adverse drug reactions related to the use of these products.
Who is affected:
-- Canadians who have purchased or have used these products and need to be aware of the important cautions, warnings and contraindications associated with these products.
What Consumers should do:
-- Consumers should be aware of the risks associated with these products. The complete list of cautions, warnings and contraindications associated with these products can be found in the Background section of this advisory. -- If you have used these products and are concerned about your health, please consult your healthcare practitioner. -- Consumers are also encouraged to return the products to the place of purchase or call Les Importations Herbasante Inc. at 1-800-446-4242.
What Health Canada is doing:
Health Canada is monitoring the recall of the affected products and will continue to provide updates, as warranted.
Formule L1 is sold as a herbal laxative and Detox Spring-Fall as a diuretic (water pill). These two products are being sold in a single package.
Detox Spring-Fall should not be used in combination with Formule L1, as Formule L1contains a laxative. The use of these products together may cause severe dehydration.
The complete list of cautions, warnings and contraindications associated with these products is listed below:
Formule L1 Risk Information:
Cautions and Warnings
Consult a health care practitioner if symptoms persist or worsen. Consult a health care practitioner if raised intraocular pressure or edema occurs. Consult a health care practitioner prior to use if you have a kidney disorder or are taking prescription medication (e.g. cardiac glycosides or antiarrhythmic medications); if you have faecal impaction or symptoms such as abdominal pain, nausea, vomiting or fever; if you have gallstones. Reduce dose or discontinue use if you experience abdominal pain, cramps, spasms, and/or diarrhea. Consult a health care practitioner prior to use if you are taking thiazide diuretics, corticosteroids, licorice root or other medications or health products that may aggravate electrolyte imbalance.
Do not take if you are pregnant or breastfeeding. Do not take if you are using anticoagulant or antiplatelet medication; if you are allergic to plants of the Asterceae/Compositae/Daisy family; if you have a bile duct obstruction. Do not use if you have abnormal constrictions of the gastrointestinal tract, potential or existing intestinal blockage, atonic bowel, appendicitis, inflammatory colon disease, abdominal pain of unknown origin, undiagnosed rectal bleeding, severe dehydration with depleted water or electrolytes, hemorrhoids or diarrhea.
Known Adverse Reactions
Hypersensitivity, such as allergy, has been known to occur; in which case, discontinue use.
Detox Spring-Fall Risk Information:
Cautions and Warnings
Consult a health care practitioner before using if you are pregnant or nursing, if you suffer from diabetes or have liver problems. Consult a health care practitioner if symptoms persist or worsen. Discontinue use and consult a health care practitioner immediately if you experience dizziness, vertigo, mental confusion, muscular weakness or pain, an irregular heart beat and/or difficulty breathing.
Do not use if you are allergic to plants of the Asteraceae/Compositae/Daisy family. Do not use if you have liver or gallbladder problems, or an intestinal obstruction. Discontinue use if you experience symptoms of liver problems. Do not use if you suffer from stomach irritation or acute stomach inflammation, or a gastric or duodenal ulcer. Do not use if you are taking thiazide diuretics, cardiac glycosides, corticosteroids, stimulant laxatives or other medications or health products that may aggravate electrolyte imbalance. Do not use if you have hypokalemia, high blood pressure, or cardiovascular or kidney problems. Do not use if you are dehydrated. Do not use if you suffer from heart, kidney or liver problems, high or low blood pressure, or oedema (swelling of hands, face or feet) or if you take products that contain diuretics.
Known Adverse Reactions
Hypersensitivity, such as allergy, has been known to occur; in which case, discontinue use. Some people may experience headaches.
Formule L1, sold co-packaged with Detox Spring Fall (24 Detox ampoules + 36 Formule L1 capsules)
For more information:
Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.
Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.
More information is also available from Les Importations Herbasante Inc. by calling 1-800-446-4242.
How to report side effects to health products to Health Canada:
Provide relevant details about how to report adverse reactions / problems / concerns, eg.:
- Call toll-free at 1-866-234-2345
- Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.
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