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.
HEALTH CANADA ADVISORY
February 4, 2014
Health Canada has issued new restrictions concerning the use of irbesartan. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Drowsiness/reduced alertness: Irbesartan, like other medications for blood pressure may cause dizziness and lightheadedness, especially if you have been taking a diuretic (water pill). This may affect your ability to drive or operate machinery. Avoid these and other activities until you have determined that this medication does not affect you in this way.
Heart disease: If you have a history of heart problems, such as a recent heart attack or stroke, narrowing of the heart valves (valvular stenosis) or other heart 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.
Kidney function: Irbesartan may affect the function of the kidneys, 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: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, 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. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.
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 irbesartan. In some cases, this happens after the first dose. It is more likely to occur if you take diuretics (water pills) 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. If you have low blood pressure or are just starting to take this medication, 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 you are on this medication. Avoid using salt substitutes that contain potassium while you are taking irbesartan.
Pregnancy: Irbesartan can cause severe harm or death to a developing baby if it is taken by the mother during pregnancy. Therefore, this medication should not be taken by pregnant women. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if irbesartan 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 children.
Older adults may be more likely to experience side effects of this medication.