HEALTH CANADA ADVISORY
February 4, 2014
Health Canada has issued new restrictions concerning the use of enalapril. 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.
Allergic reaction: Some people who are allergic to sulfonamide medications also experience allergic reactions to hydrochlorothiazide. Before you take this medication, tell your doctor about any previous adverse reactions you have had to medications, especially to sulfonamide antibiotics or diabetes medications. 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.
Angioedema: Angioedema (a serious allergic reaction that causes the area around the throat and tongue to swell) may occur with ACE inhibitors, including this medication, although uncommonly. If you experience swelling of the face, tongue, or throat, you should stop taking this medication at once and get immediate medical attention.
People who have had angioedema caused by other substances may be at increased risk of angioedema while receiving an ACE inhibitor such as contained in this medication.
Blood disorders: In rare cases, a low white blood cell count has been reported by 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.
Cholesterol: An increase 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 enalapril may develop a dry, persistent cough that usually disappears only after stopping or lowering their dose of enalapril. Inform your doctor of any cough that does not seem to be related to a usual cause.
Diabetes: This medication may make it more difficult for people who have diabetes to control their blood sugar. 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. An adjustment to doses of antidiabetic medications may be required.
Fluid and electrolyte balance: The levels of electrolytes such as potassium, sodium, magnesium, and chloride can be reduced by the use of hydrochlorothiazide. Your doctor will periodically check to see whether these are in balance, and a potassium supplement may be necessary. Warning signs or symptoms of fluid and electrolyte imbalance include:
- dry mouth
- low blood pressure
- muscle pains or cramps
- muscular fatigue
- nausea and vomiting
- racing heartbeat
Gout: Hydrochlorothiazide may increase the level of uric acid in the body. 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. If you develop painful, warm, and swollen joints, contact your doctor.
Glaucoma: Rarely, hydrochlorothiazide can cause an increase in the pressure in the eyes (glaucoma). If you experience decreased sharpness of vision or eye pain shortly after starting to take this medication, contact your doctor immediately. This may be more likely to happen to people who have previously had sulfonamide or penicillin allergies.
Kidneys: This medication may affect kidney function for certain people. Let your doctor know if you notice any decrease in urine output or increased swelling of the lower limbs, which suggests 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, which may cause side effects. This medication can also worsen liver function. 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. If you notice any signs of liver problems (e.g., abdominal pain, itching of skin, or yellow eyes or skin, loss of appetite, vomiting), contact your doctor immediately.
Low blood pressure: Occasionally, blood pressure drops too low after taking enalapril. This usually happens after the first or second dose or when the dose is increased. It is more likely to occur if you take water pills, have a salt-restricted diet, are on dialysis, are sweating excessively and not drinking enough fluids, or are suffering from diarrhea or vomiting. If low blood pressure causes you to faint or feel lightheaded, contact a doctor.
Lupus: Hydrochlorothiazide can cause the symptoms of systemic lupus erythematosus (SLE) to worsen. If you have SLE, 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.
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.
Pregnancy: ACE inhibitors should not be taken by pregnant women. If you become pregnant while taking this medication, stop taking this medication at once and contact your doctor immediately.
Breast-feeding: These medications pass into breast milk. If you are a breast-feeding mother and are taking enalapril and hydrochlorothiazide, 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. Its use by them is not recommended.