HEALTH CANADA ADVISORY
February 4, 2014
Health Canada has issued new restrictions concerning the use of telmisartan. 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: Telmisartan 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 disease: Telmisartan 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 disease: Telmisartan is removed from the body by the liver. On rare occasions, 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: If you have orthostatic hypotension (a sudden drop in blood pressure caused by standing up, which may lead to fainting), you should be cautious while taking telmisartan, as it can worsen the condition. The first time this medication is taken, it may cause dizziness, lightheadedness, or fainting. This may be reduced by taking the medication in a sitting position and being careful to rise slowly to a standing position. The dizziness usually improves after the first dose, but if the medication is stopped and then started again, it may reappear. Your doctor may also adjust the dose.
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 telmisartan.
Pregnancy: Telmisartan may cause severe harm to an unborn fetus and should not be taken during pregnancy. If you discover you are pregnant while taking this medication, stop taking the medication and tell your doctor at once.
Breast-feeding: It is not known if telmisartan 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.