HEALTH CANADA ADVISORY
February 4, 2014
Health Canada has issued new restrictions concerning the use of candesartan. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Drowsiness/reduced alertness: Candesartan may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how this medication affects you.
Kidney problems: Candesartan may affect kidney function, especially for people who already have kidney problems. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver function: Candesartan is removed from the body by the liver. Rarely, it may cause liver problems. If you have liver disease or decreased liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Low blood pressure: Occasionally, a larger-than-expected decrease in blood pressure occurs after taking candesartan. In some cases, this happens after the first dose. It is more likely to occur if you take diuretics or the medication aliskiren, have a reduced salt intake, are on dialysis, or are experiencing diarrhea or vomiting. Blood pressure should be monitored more often in these situations. Those with low blood pressure or those just starting to take this medication should move slowly from a reclining to an upright position to reduce the risk of dizziness.
Potassium levels: This medication may affect potassium levels in the blood, especially when used for heart failure, or when taken with other medications called ACE inhibitors or diuretics such as spironolactone. Your doctor will monitor your potassium levels while on this medication. Avoid using salt substitutes that contain potassium while you are taking candesartan.
Pregnancy: Candesartan may cause severe harm to an unborn fetus and should not be used during pregnancy. If you discover you are pregnant while taking this medication, stop taking it and tell your doctor at once.
Breast-feeding: It is not known if candesartan passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for the treatment of hypertension in children less than 6 years of age and for the treatment of heart failure in children less than 18 years of age.