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 lisinopril. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Angioedema: Angioedema (a serious allergic reaction which causes the area around the throat and tongue to swell) may occur with the use of lisinopril. If you experience swelling of the face, tongue, or throat, stop taking lisinopril at once and get immediate medical attention. Other medications in the class of 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.
Cough: People taking lisinopril may develop a dry, persistent cough that usually disappears only after stopping or lowering the lisinopril dose. Be sure to tell your doctor of any cough that does not seem to be related to a usual cause.
Diabetes: ACE inhibitors such as lisinopril may lead to hypoglycemia (low blood sugar levels) in people with diabetes. 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.
Fluid and electrolyte balance: Increases in blood levels of potassium may occur for some patients who receive lisinopril. This rarely causes problems, but potassium levels should be monitored by your doctor.
Kidney function: Changes in kidney function have been seen for certain people (e.g., people with narrowed blood vessels in their kidneys, or those with severe congestive heart failure). The use of diuretics (water pills), nonsteroidal anti-inflammatory drugs (NSAIDs) or aliskiren may further increase risk of kidney problems for people already at risk for this problem. 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. If you have kidney function impairment you may require lower doses of this medication.
Liver function: Lisinopril may reduce liver function and can cause liver failure. 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.
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.
Low blood pressure: Occasionally, blood pressure drops too low after taking lisinopril. This usually happens after the first or second dose or when the dose is increased. It is more likely to occur for those who take water pills or the medication aliskiren, 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 your doctor.
To reduce the risk of dizziness, get up slowly from a lying or sitting position. If low blood pressure causes you to faint or feel lightheaded, contact your doctor.
Potassium levels: Increases in blood levels of potassium occur for approximately 2% of people who take this medication. This rarely causes problems, but your doctor will likely want to monitor your potassium levels through blood tests. Avoid using salt substitutes that contain potassium while you are taking lisinopril.
Reduced alertness: Lisinopril may cause drowsiness or dizziness, especially at the beginning of treatment or after a dose increase. This can affect your ability to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how this medication affects you.
Pregnancy: ACE inhibitors such as lisinopril 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 lisinopril immediately and contact your doctor.
Breast-feeding: It is not known whether lisinopril 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 lisinopril for children less than 6 years of age have not been established. Lisinopril is not recommended for this age group. This medication may be used by children more than 6 years old to reduce blood pressure.