HEALTH CANADA ADVISORY
February 4, 2014
Health Canada has issued new restrictions concerning the use of ramipril. 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: Ramipril 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 taking 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: People taking ramipril may develop a dry, persistent cough that usually disappears only after stopping or lowering the dose of ramipril.
Kidney function: Changes in kidney function have occurred in certain people who take this medication. The use of diuretics (water pills) may further increase the risk of kidney problems for those 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. People with kidney function impairment may require lower doses of this medication.
Liver function: This medication may cause liver problems. 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. If you have liver problems, you will need to be closely monitored by your doctor while taking this medication.
Low blood pressure: Occasionally, blood pressure drops too low after taking ramipril. 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 diuretics, have a salt-restricted diet, are on dialysis, have diarrhea, or are vomiting. 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 a doctor.
Potassium: Increases in blood levels of potassium can occur with use of this medication. This rarely causes problems, but your doctor may want to monitor your potassium levels through blood tests.
Reduced alertness: This medication may reduce alertness, especially at the beginning of treatment. Do not drive or perform tasks that require alertness until you know how this medication affects you.
Pregnancy: ACE inhibitors such as ramipril 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: This medication passes into breast milk. If you are a breast-feeding mother and are taking ramipril it may affect your baby. This medication is not recommended for breast-feeding women. 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. The use of ramipril by this age group is not recommended.