HEALTH CANADA ADVISORY
February 4, 2014
Health Canada has issued new restrictions concerning the use of benazepril. 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: Angioedema (a serious allergic reaction that causes the area around the throat and tongue to swell) may occur with the use of ACE inhibitors, including benazepril. If you experience swelling of the face, tongue, or throat, stop taking benazepril at once and get immediate medical attention. Other medications known as 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 an ACE inhibitor.
Diabetes: People with diabetes who take benazepril may experience reduced blood sugar control. If you have diabetes, 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. You may find it helpful to increase the number of times a day your check your blood sugar.
Fluid and electrolyte balance: Increases in blood levels of potassium occur in approximately 1.1% of patients receiving benazepril. This rarely causes problems, but your doctor will monitor your potassium levels regularly with blood tests. Contact your doctor as soon as possible if you experience symptoms of increased potassium in the body, such as confusion, irregular heartbeat, unusual nervousness, or tingling in the hands and feet. Avoid using salt substitutes while taking benazepril.
Infection: Some people taking benazepril experience a reduction in the cells that fight infection (white blood cells), which results in infections. Tell your doctor as soon as possible if you begin to notice the signs of an infection such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests to monitor the number of specific types of blood cells in your blood.
Kidney function: Changes in kidney function have been seen in certain people who use benazepril (e.g., people with narrowed blood vessels in their kidneys, or those with severe congestive heart failure). The use of diuretics (water pills) or nonsteroidal anti-inflammatory drugs (NSAIDs) may further increase the risk of kidney problems for those people already at risk. 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: Occasionally, hepatitis (inflammation of the liver) occurs with the use of benazepril. If you have reduced liver function or liver 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.
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, blood pressure drops too low after taking benazepril. This usually happens after the first or second dose, or when the dose is increased. It is more likely to occur in those who take water pills, have a salt-restricted diet, are on dialysis, are suffering from diarrhea or vomiting, or have been sweating excessively and not drinking enough liquids. If low blood pressure causes you to faint or feel lightheaded, contact a doctor.
Surgery: Benazepril may affect how anaesthetics work. If you are scheduled for surgery, inform all doctors involved in your care that you take benazepril.
Pregnancy: Benazepril, like other ACE inhibitors, can cause birth defects and even death to the developing fetus when taken by a women who is pregnant. Pregnant women should not take this medication. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking benazepril, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of benazepril have not been established for children.