HEALTH CANADA ADVISORY
February 4, 2014
Health Canada has issued new restrictions concerning the use of cilazapril. 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 which causes the area around the face, throat, and tongue to swell) may occur with use of this medication. If you experience difficulty breathing or swelling of the face, tongue, or throat, stop taking this medication at once and get immediate medical attention. 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.
Cholesterol: Increases in cholesterol and triglyceride levels may occur when taking hydrochlorothiazide. Your doctor will monitor you for these changes while you are taking this medication.
Cough: People taking cilazapril may develop a dry, persistent cough that usually disappears only after stopping this medication.
Diabetes: Cilazapril - hydrochlorothiazide may make it more difficult to control your blood sugar if you have diabetes. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.
If you have diabetes or are at risk for developing 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.
Drowsiness/reduced alertness: When you first start taking cilazapril – hydrochlorothiazide, you may experience 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.
Fluid and electrolyte balance: Your levels of electrolytes such as potassium, sodium, magnesium, and chloride may change due to this medication. Your doctor may periodically arrange for tests to check to see if these are in balance. If you experience symptoms of fluid and electrolyte imbalance such as muscle pains or cramps; dry mouth; numb hands, feet, or lips; or racing heartbeat, contact your doctor as soon as possible.
Gout: Some people taking hydrochlorothiazide may experience episodes of gout. If this occurs while you are taking this medication, contact your doctor. If you have a history of gout, 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: This medication may affect kidney function for certain people. Taking 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.
Let your doctor know if you notice any decrease in urine output, or increased swelling of the lower limbs, which may indicate an accumulation of fluid due to decreased urination.
Liver function: 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.
This medication may worsen liver function. People with liver disease or poor liver function should be closely monitored by their doctor while taking this medication. If you notice any signs of liver problems (e.g., abdominal pain, itchy skin, yellow eyes or skin, loss of appetite, vomiting), contact your doctor immediately.
Low blood pressure: Occasionally, blood pressure drops too low after taking this medication. 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 aliskiren, other medications for blood pressure, have a salt-restricted diet, are on dialysis, have diarrhea or are vomiting, or have been sweating excessively and not drinking enough liquids. 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.
Surgery: It is important that your physician and anesthesiologist know that you are taking this medication before you undergo any surgical procedures requiring general anesthesia.
White blood cells: In rare cases, a low white blood cell count has been reported for 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.
Pregnancy: ACE inhibitors such as cilazapril 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: Hydrochlorothiazide passes into breast milk. It is not known if cilazapril 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. 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. Its use by this age group is not recommended.