HEALTH CANADA ADVISORY
February 4, 2014
Health Canada has issued new restrictions concerning the use of trandolapril. 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.
Angioedema: This medication may cause a serious allergic reaction called angioedema, which may be fatal if not treated promptly. If you have difficulty breathing or notice hives or swelling of the face, lips, tongue, or throat, stop taking this medication and get emergency medical help at once. Other ACE inhibitors should not be taken in the future. People who have had angioedema caused by other substances may be at increased risk of angioedema while receiving this medication.
Blood disorders: In rare cases, a low white blood cell count has been reported with people taking this medication. Your doctor may occasionally monitor your level of white blood cells by performing blood tests. Low white blood cell levels may increase your risk for infection. If you notice any signs of infection (e.g., fever, sore throat), contact your doctor as soon as possible.
Cough: A persistent, dry cough may occur when taking this medication. Be sure to tell your doctor of any cough which does not seem to be related to a usual cause.
Heart problems: This medication can cause changes to your heart rate. If you have heart failure or heart rhythm 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.
Kidney function: Changes in kidney function have been seen in certain people who take this medication. Taking diuretics (water pills) or aliskiren may further increase the risk of kidney problems. If you have 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 problems: 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.
Liver damage is possible with this medication. If you experience any signs of liver problems such as yellowing of the skin or eyes, fever, generally feeling unwell, abdominal pain, nausea, vomiting, loss of appetite, itching, muscle pain, rash, or swollen glands, contact your doctor immediately. You will need to be closely monitored by your doctor while taking this medication if you have pre-existing liver problems.
Low blood pressure and heart rate: Low blood pressure symptoms of tiredness and weakness with faintness have been reported following single doses and even after several months of treatment with this medication. Some people may require a reduced dose. This medication can also cause very low heart rate for some people. If you notice that your heart rate has become abnormally low (less than 50 beats per minute), contact your doctor.
Potassium levels: Increases in blood levels of potassium occur for a small percentage of people taking this medication. This rarely causes problems, but potassium levels should be monitored by your doctor.
Pregnancy: ACE inhibitors such as trandolapril may cause severe harm or death to the developing baby if taken by the mother during pregnancy. This medication should not be used during pregnancy. If you become pregnant while taking this medication, stop taking it immediately and contact your doctor.
Breast-feeding: It is not known if trandolapril passes into breast milk. Verapamil passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. This medication is not recommended for breast-feeding women. Talk to your doctor.
Children: The safety and effectiveness of using this medication have not been established for children. Its use by this age group is not recommended.