July 22, 2014
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Vasotec

(enalapril)

DIN (Drug Identification Number)

00670901 VASOTEC 10MG TABLET
00851795 VASOTEC 2.5MG TABLET
00670928 VASOTEC 20MG TABLET
00708879 VASOTEC 5MG TABLET
01923846 VASOTEC IV 1.25 MG/ML SOLUTION

What side effects are possible with Vasotec?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • cough (dry, persistent)
  • fatigue
  • headache
  • rash
  • unusual tiredness

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • chest pain
  • dizziness, lightheadedness, or fainting (signs of low blood pressure)
  • shortness of breath
  • signs of too much potassium in the body (e.g., confusion; irregular heartbeat; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath or difficulty breathing; weakness or heaviness of legs)
  • skin rash with or without itching, fever, or joint pain

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of angioedema (e.g., swelling of face, mouth, hands, or feet)
  • stomach pain, itching of skin, or yellow eyes or skin
  • trouble in swallowing or breathing (sudden)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.





Are there any other precautions or warnings for Vasotec?

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.

Angioedema: Angioedema (a serious allergic reaction that causes the area around the throat and tongue to swell) may occur with ACE inhibitors, including enalapril, 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 enalapril.

Cough: People taking enalapril may develop a dry, persistent cough that usually disappears only after stopping or lowering the enalapril dose. Be sure to tell your doctor of any cough that does not seem to be related to a usual cause.

Kidney function: Changes in kidney function have been seen in certain people taking this medication.

Liver function: Changes in liver function have occurred in people with or without preexisting liver problems during treatment with this medication. In most cases, the changes were reversed when the medication was stopped.

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 in those who are on dialysis, are suffering from diarrhea or vomiting, are sweating excessively and not drinking enough fluids, have a salt-restricted diet, or are taking water pills. If low blood pressure causes you to faint or feel lightheaded, contact a doctor.

Potassium levels: Increases in blood levels of potassium occur for a small percentage of people taking enalapril. This rarely causes problems, but potassium levels should be monitored by your doctor.

Pregnancy: ACE inhibitors should not be taken by pregnant women. If you discover you are pregnant, you should stop taking enalapril at once.

Breast-feeding: Enalapril passes into breast milk in trace amounts. This medication should not be used by breast-feeding women.

Children: The safety and effectiveness of this medication have not been established for children. Its use by children is not recommended.

What other drugs could interact with Vasotec?

There may be an interaction between enalapril and any of the following:

  • angiotensin II receptor blockers (e.g., candesartan, losartan)
  • antidiabetes medications (e.g., insulin, metformin, glyburide)
  • blood pressure lowering medications (e.g., beta-blockers)
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide)
  • lithium
  • medications that increase potassium levels (e.g., potassium supplements, spironolactone, amiloride, and salt substitutes containing potassium)
  • nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, indomethacin, naproxen)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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