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 Mylan Cilazapril.
Angioedema: Angioedema is a serious allergic reaction that causes the area around the face, throat, and tongue to swell. It may occur with use of cilazapril. If you experience swelling of the face, tongue, or throat, stop taking cilazapril at once and get immediate medical attention. Do not take other ACE inhibitors in the future. If you have had angioedema caused by other substances, you may be at increased risk of angioedema while receiving cilazapril.
Cough: ACE inhibitors such as Mylan Cilazapril may cause you to develop a dry, persistent cough within hours of the first dose to weeks or months after starting therapy. The cough usually resolves within 4 weeks of stopping Mylan Cilazapril. Talk to your doctor if you develop a persistent, intolerable cough.
Diabetes: Cilazapril may cause a decrease in blood sugar levels and increased effects from medications used to reduce blood glucose. You may find it necessary to monitor your blood sugar more frequently while using Mylan Cilazapril.
If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Mylan Cilazapril may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mylan Cilazapril, and whether any special monitoring is needed.
Drowsiness/reduced alertness: Cilazapril 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 Mylan Cilazapril affects you.
Fluid and electrolyte balance: Increases in blood levels of potassium occur for some people who take Mylan Cilazapril. This rarely causes problems, but potassium levels should be monitored by your doctor. If you have kidney disease or diabetes, there is a higher risk of having increased blood potassium while taking cilazapril. Discuss with your doctor how Mylan Cilazapril 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.
Infection: Cilazapril can reduce the number of cells that fight infection in the body (white blood cells). This makes you more likely to experience infections.
Tell your doctor if you notice frequent signs of infection such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor should do blood tests periodically, to monitor the number of specific types of blood cells in your blood.
Kidney function: Changes in kidney function have been noticed in people with narrowed blood vessels in their kidneys, or those with severe congestive heart failure. The use of diuretics (water pills), non-steroidal anti-inflammatory drugs (NSAIDs), or aliskiren, may further increase risk of kidney problems in those at risk for this problem. If you have reduced kidney function or kidney disease, discuss with your doctor how Mylan Cilazapril 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 Mylan Cilazapril.
Let your doctor know if you notice any decreases in urine output or increases in the swelling of lower limbs, suggesting accumulation of fluid due to decreased urination.
Liver function: This medication may worsen liver disease or cause reduced liver function. 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 disease or decreased liver function, discuss with your doctor how Mylan Cilazapril 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.
Low blood pressure: Occasionally, blood pressure drops too low after taking cilazapril. This usually happens after the first or second dose, or when the dose is increased. It is more likely to occur for people 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.
Surgery: Cilazapril may interact with medications used during surgery. If you are scheduled for surgery, let your doctor know that you are taking Mylan Cilazapril.
Pregnancy: Like other ACE inhibitors, cilazapril may cause severe harm or death to an unborn baby and should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if cilazapril passes into breast milk. If you are a breast-feeding mother and are taking Mylan Cilazapril, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of cilazapril have not been established for children. Its use by this age group is not recommended.
Seniors: People over the age of 65 are more likely to experience the side effects of cilazapril. If you are over the age of 65, your doctor may prescribe a lower dose of Mylan Cilazapril.
