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 Vaseretic.
HEALTH CANADA ADVISORY
January 31, 2019
Health Canada has issued new restrictions concerning the use of hydrochlorothiazide. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Allergic reaction: Some people who are allergic to sulfonamide medications also experience allergic reactions to hydrochlorothiazide. Before you take Vaseretic, 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 Vaseretic, although it is not common. If you experience swelling of the face, tongue, or throat, stop taking Vaseretic 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 like the one contained in Vaseretic.
Blood disorders: In rare cases, a low white blood cell count has been reported by people taking Vaseretic. 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 Vaseretic.
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: Vaseretic may make it more difficult for people who have diabetes to control their blood sugar. If you have diabetes, discuss with your doctor how Vaseretic may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Vaseretic, 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:
- confusion
- drowsiness
- dry mouth
- lethargy
- low blood pressure
- muscle pains or cramps
- muscular fatigue
- nausea and vomiting
- racing heartbeat
- restlessness
- seizures
- thirst
- weakness
Gout: Hydrochlorothiazide may increase the level of uric acid in the body, causing symptoms of gout. If you have a history of gout, discuss with your doctor how Vaseretic may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Vaseretic, 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 Vaseretic, contact your doctor immediately. This may be more likely to happen to people who have previously had sulfonamide or penicillin allergies.
Kidney function: Decreased kidney function or kidney disease can cause Vaseretic to build up in the body, causing side effects.
Vaseretic may also 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.
Changes in kidney function have been seen in certain people who take Vaseretic. The use of other diuretics (water pills), nonsteroidal anti-inflammatory drugs (NSAIDs), or aliskiren may further increase risk of kidney problems for those at risk for this problem. If you have kidney disease, renal artery stenosis (narrowing of blood vessels in the kidneys), or Congestive Heart Failure, discuss with your doctor how Vaseretic may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Vaseretic, and whether any special monitoring is needed.
Liver function: Liver disease or reduced liver function may cause Vaseretic to build up in the body, causing side effects. Vaseretic can also worsen liver function. If you have liver problems, discuss with your doctor how Vaseretic may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Vaseretic, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Vaseretic. If you notice any signs of liver problems (e.g., abdominal pain, itching of skin, 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, such as aliskiren, 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.
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.
Lupus: Hydrochlorothiazide can cause the symptoms of systemic lupus erythematosus (SLE) to worsen. If you have SLE, discuss with your doctor how Vaseretic may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Vaseretic, and whether any special monitoring is needed.
Potassium levels: Increases in blood levels of potassium occur for some people who take Vaseretic or other ACE inhibitors. This rarely causes problems, but your doctor will likely want to monitor your potassium levels through blood tests. Avoid using salt substitutes that contain potassium while you are taking enalapril.
Skin Cancer: Long-term use of hydrochlorothiazide may increase the risk of developing certain types of skin cancer. Hydrochlorothiazide is also known to increase sensitivity of the skin to the sun and increase the risk of severe sunburn. While you are taking Vaseretic, protect your skin from the sun by using sunscreen with at least 30 SPF and covering exposed skin during peak hours of sunlight. Notify your doctor as soon as possible if you notice any new skin lesions or moles, or changes to existing skin lesions.
Surgery: It is important that your physician and anesthesiologist know that you are taking Vaseretic before you undergo any surgical procedures requiring general anesthesia.
Pregnancy: ACE inhibitors such as enalapril may cause severe harm or death to the developing baby if taken by the mother during pregnancy and should not be taken by pregnant women. If you become pregnant while taking Vaseretic, stop taking Vaseretic 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 Vaseretic have not been established for children. Children should not take Vaseretic.