HEALTH CANADA ADVISORY
February 4, 2014
Health Canada has issued new restrictions concerning the use of azilsartan. 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.
Allergy: Some people who are allergic to sulfa antibiotics (sulfonamides) also experience allergic reactions to chlorthalidone. Before you take azilsartan-chlorthalidone, inform your doctor about any previous adverse reactions you have had to medications, especially sulfa antibiotics. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing or swelling of the face and throat.
Drowsiness/reduced alertness: Azilsartan-chlorthalidone may cause drowsiness or dizziness, affecting mental and physical abilities needed to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how this medication affects you.
Fluid and electrolyte balance: Azilsartan-chlorthalidone may cause the levels of electrolytes such as potassium, sodium, magnesium, chloride, and calcium in the blood to change while taking this medication. 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. Your doctor will do blood tests regularly to monitor the levels of these electrolytes in your blood while you are taking this medication.
Kidney function: Azilsartan may affect kidney function, especially for those people who already have kidney problems. Taking the medication aliskiren may further increase the risk of kidney problems. If you have kidney disease or reduced kidney function, 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: If you have liver disease or reduced liver function, 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.
Systemic lupus erythematosus: People with systemic lupus erythematosus should be monitored by their doctor while taking chlorthalidone as it may worsen this condition.
Vision problems: Chlorthalidone can cause sudden changes in vision, possibly leading to blindness. If you experience blurred vision, eye pain or sudden nearsightedness, contact your doctor immediately.
Pregnancy: Azilsartan, like other medications in this class, can cause severe harm and possibly death of the developing baby if it is taken during pregnancy. This medication 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 azilsartan-chlorthalidone 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 using this medication have not been established for children.
Seniors: Seniors may be more sensitive to the effects of this medication. It may be necessary to take a lower dose.