Public Advisory - Sivem ezetimibe 10 mg tablets: One lot recalled as some bottles may contain perindopril 4 mg tablets Français
Product: Sivem ezetimibe 10 mg tablets
Issue: Health products – Product safety
What to do: If your bottle of ezetimibe 10 mg tablets contains any perindopril 4 mg tablets, or if you are unsure, return it to your pharmacy immediately. If you are unable to return your tablets to the pharmacy right away, talk to your pharmacist or doctor for further guidance. Seek immediate medical attention if you are experiencing serious side effects, including symptoms of a severe allergic reaction, such as difficulty breathing or swallowing or severe swelling of the lips, mouth or throat.
Affected products
Issue
Sivem Pharmaceuticals ULC is recalling one lot of Sivem ezetimibe 10 mg tablets because some bottles may also contain perindopril 4 mg tablets. Taking perindopril when prescribed ezetimibe may pose serious health risks.
Ezetimibe is a prescription drug used by adults and children 10 years of age and older to lower cholesterol and other fats in the blood. Perindopril is a prescription drug used in adults to treat high blood pressure.
Patients not normally prescribed perindopril may experience side effects such as a drop in blood pressure, dizziness, light-headedness or fainting. Other possible effects could include headache, cough, or gastrointestinal discomfort (e.g., nausea, vomiting or diarrhea). The risk can be higher in people with low blood pressure, kidney problems, or those taking other medications that affect blood pressure. Patients unknowingly taking a medication could also have a severe allergic reaction to that medication.
Health Canada is monitoring the company's recall and investigation, including its implementation of corrective and preventive actions to prevent this issue from reoccurring. The Department will inform the public if any new health risks are identified.
What you should do
Check your medication bottle to ensure it only contains Sivem ezetimibe 10 mg tablets.
Sivem ezetimibe 10 mg is a white oblong tablet, with "93" stamped on one side and "A11" on the other.
Perindopril 4 mg is a spotted light green oblong tablet, with "4" stamped on one side and nothing stamped on the other. The tablet is scored (indented) on both middle edges.
If the bottle contains any unusual tablets, or if you are unsure, return it to your pharmacy immediately. Your pharmacist will check the tablets and provide you with a replacement, if needed.
If you are unable to return your tablets to the pharmacy right away, talk to your pharmacist or doctor for further guidance.
Seek immediate medical attention if you are experiencing serious side effects (e.g., dizziness, light-headedness or fainting, or severe allergic reaction).
If you have questions about this recall, contact Sivem Pharmaceuticals by calling 1-855-757-4836 or by emailing [email protected].
Report any health product-related side effects or complaints to Health Canada.
Additional information for health professionals:
Health care professionals, such as pharmacists, should check bottles of Sivem ezetimibe 10 mg tablets before dispensing to ensure they do not contain perindopril 4 mg tablets. Report any unusual bottles or other issues to the company and to Health Canada.
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