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.
HEALTH CANADA ADVISORY
February 4, 2014
Health Canada has issued new restrictions concerning the use of ramipril. 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 this medication, inform 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: This medication may cause a serious allergic reaction called angioedema, which may be fatal if not treated promptly. If you have difficulty breathing or notice hives or swelling of the face, lips, tongue, or throat, stop taking this medication and get emergency medical help at once. 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 receiving 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: Increases in cholesterol and triglyceride levels may occur when taking hydrochlorothiazide. Your doctor may monitor for this with blood tests.
Cough: People taking ramipril may develop a dry, persistent cough that usually disappears only after stopping ramipril. 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 with 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.
Drowsiness/reduced alertness: This medication may reduce alertness, especially at the beginning of treatment. Exercise caution when driving or performing tasks that require alertness.
Electrolytes: The use of hydrochlorothiazide can reduce the levels of electrolytes such as potassium, sodium, magnesium, and chloride and increase the levels of calcium. Your doctor will periodically check to see if these levels are in balance, and a potassium supplement may be recommended. Warning signs or symptoms of fluid and electrolyte imbalance include:
- dryness of 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.
Kidney function: This medication may change the kidney function in 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, causing 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 experience any signs of liver problems such as yellowing of the skin or eyes, fever, generally feeling unwell, abdominal pain, nausea, vomiting, loss of appetite, itching, muscle pain, rash, or swollen glands, contact your doctor immediately. People who have preexisting liver problems will need to be closely monitored by their doctor while taking this medication.
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 diuretics, have a salt-restricted diet, are on dialysis, or are suffering from diarrhea or vomiting. These individuals should be monitored closely by their doctor for the first weeks of treatment and whenever the dose of the medication is increased. 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 a doctor. If low blood pressure causes you to faint or feel lightheaded, contact your doctor.
Excessive sweating and lack of fluid intake may lead to an excessive fall in blood pressure because of reduced fluid in your blood vessels. Vomiting or diarrhea may also lead to a fall in blood pressure. Consult your doctor if you feel your blood pressure is too low.
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. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.
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 such as ramipril have the potential to cause harm or death to a developing fetus 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: It is not known if ramipril passes into breast milk. Hydrochlorothiazide 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. Its use by this age group is not recommended.
Seniors: Seniors may be more sensitive to the effects of this medication.