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 Vasotec (Enalapril). If you are concerned about side effects, discuss the risks and benefits of Vasotec (Enalapril) 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.

• abdominal pain
• cough (dry, persistent)
• Diarrhea
• fatigue
• headache
• loss of appetite
• nausea
• rash
• sore throat
• vomiting

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not 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)
• flu-like symptoms (sudden lack of energy, Fever, cough, sore throat)
• shortness of breath
• signs of  liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• 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)
• symptoms of low blood sugar (e.g., cold sweat, cool pale skin, headache, fast heart beat, weakness

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)

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 Vasotec (Enalapril).

Tablets
2.5 mg
Each white, oval-shaped, tablet engraved "MSD 14" on one side and scored on both sides contains 2.5 mg of Vasotec (Enalapril) maleate. Nonmedicinal ingredients: cornstarch, lactose, magnesium stearate, pregelatinized starch, and sodium bicarbonate. The splitting of VASOTEC tablets is not advised.

5 mg
Each white, rounded, triangle-shaped tablet engraved "MSD 712" on one side and scored on the other contains 5 mg of Vasotec (Enalapril) maleate. Nonmedicinal ingredients: cornstarch, lactose, magnesium stearate, pregelatinized starch, and sodium bicarbonate. The splitting of VASOTEC tablets is not advised.

10 mg
Each rust red, rounded, triangle-shaped tablet engraved "MSD 713" on one side and scored on the other contains 10 mg of Vasotec (Enalapril) maleate. Nonmedicinal ingredients: cornstarch, lactose, magnesium stearate, pregelatinized starch, red or yellow iron oxides, and sodium bicarbonate. The splitting of VASOTEC tablets is not advised.

20 mg
Each peach-coloured, rounded, triangle-shaped tablet engraved "MSD 714" on one side and scored on the other contains 20 mg of Vasotec (Enalapril) maleate. Nonmedicinal ingredients: cornstarch, lactose, magnesium stearate, pregelatinized starch, red and/or yellow iron oxides, and sodium bicarbonate. The splitting of VASOTEC tablets is not advised.

Vasotec I.V.
Each mL of clear, colourless solution contains 1.25 mg of enalaprilat (anhydrous equivalent), 6.2 mg of sodium chloride to adjust tonicity, sodium hydroxide to adjust pH (to approximately 7.0), water for injection, with 9 mg of benzyl alcohol as preservative.

Do not take Vasotec (Enalapril) if you:

• are allergic to Vasotec (Enalapril) or any ingredients of the medication
• are pregnant or planning to get pregnant
• have been diagnosed with hereditary angioedema
• have had angioedema (a serious allergic reaction which causes the area around the throat and tongue to swell) after taking any other ACE inhibitors (e.g., Captopril, Vasotec (Enalapril), Ramipril)
• have Diabetes or Kidney Disease and are taking Aliskiren

There may be an interaction between Vasotec (Enalapril) and any of the following:

• acetylsalicylic acid (Asa)
• Aldesleukin
• aliskiren
• Allopurinol
• alpha blockers (e.g., Alfuzosin, Doxazosin, Tamsulosin)
• alpha agonists (e.g., Clonidine, methyldopa)
• amifostine
• Amiodarone
• amphetamines (e.g., Dextroamphetamine, lisdexamphetamine)
• angiotensin II receptor blockers (ARBs; e.g., Candesartan, Losartan)
• antidiabetes medications (e.g., insulin, Metformin, Glyburide)
• atypical anti-psychotics (e.g., Clozapine, Olanzapine, Quetiapine, Risperidone)
• Azathioprine
• barbiturates (e.g., butalbital, pentobarbital Phenobarbital)
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, Sotalol)
• brimonidine
• Bromocriptine
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Canagliflozin
• ciprofloxacin
• conivaptan
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• drospirenone
• Duloxetine
• Eplerenone
• Everolimus
• "gliptin" diabetes medications (e.g., Linagliptin, Saxagliptin, Sitagliptin)
• grass pollen allergen extract
• Guanfacine
• Heparin
• iron dextran complex
• iron gluconate
• levodopa
• lithium
• low-molecular-weight heparins (e.g., Dalteparin, Enoxaparin, Tinzaparin)
• medications that increase potassium levels (e.g., potassium supplements, Spironolactone, Amiloride, and salt substitutes containing potassium)
• metformin
• Methylphenidate
• Minoxidil
• nitrates (e.g., Nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)
• nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., Ibuprofen, Indomethacin, Naproxen)
• other angiotensin-converting-enzyme inhibitors (ACEIs; e.g., captopril,  ramipril)
• Pentoxifylline
• phosphodiesterase-5 inhibitors (e.g., Sildenafil, Tadalafil, Vardenafil)
• Pregabalin
• quinine
• Ropinirole
• sacubitril
• Selegiline
• Sirolimus
• sodium phosphates
• Temsirolimus
• Tizanidine
• tolcapone
• Tolvaptan
• Trimethoprim
• Yohimbine

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.

HEALTH CANADA ADVISORY

February 4, 2014

Health Canada has issued new restrictions concerning the use of Vasotec (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 Vasotec (Enalapril), although uncommonly. If you experience swelling of the face, tongue, or throat, you should stop taking Vasotec (Enalapril) 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 Vasotec (Enalapril).

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

Diabetes: Vasotec (Enalapril) may cause a loss of blood glucose control, and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Vasotec (Enalapril). If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Vasotec (Enalapril) 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.

Kidney function: Changes in kidney function have been seen in certain people taking Vasotec (Enalapril). The use of diuretics (water pills) or aliskiren may further increase the risk of kidney problems for those already at risk for this problem. If you have kidney disease, discuss with your doctor how Vasotec (Enalapril) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Vasotec (Enalapril), and whether any special monitoring is needed.

Liver function: Changes in liver function have occurred in people with or without preexisting liver problems during treatment with Vasotec (Enalapril). In most cases, the changes were reversed when the medication was stopped. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Low blood pressure: Occasionally, blood pressure drops too low after taking Vasotec (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 take aliskiren, are on dialysis, are experiencing diarrhea or vomiting, are sweating excessively and not drinking enough fluids, have a salt-restricted diet, or are taking water pills. People with these conditions 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 down or sitting position. 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.

Potassium levels: Increases in blood levels of potassium occur for a small percentage of people taking Vasotec (Enalapril). This rarely causes problems, but potassium levels should be monitored by your doctor. Avoid using salt substitutes that contain potassium while you are taking Vasotec (Enalapril).

Pregnancy: ACE inhibitors such as Vasotec (Enalapril) may cause severe harm or death to the developing fetus if taken by the mother during pregnancy. Vasotec (Enalapril) should not be used during pregnancy. If you become pregnant while taking Vasotec (Enalapril), contact your doctor immediately.

Breast-feeding: Vasotec (Enalapril) passes into breast milk in small amounts. If you are a breast-feeding mother and are taking Vasotec (Enalapril), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of Vasotec (Enalapril) have not been established for infants and children with decreased kidney function.

Seniors: Seniors have an increased risk of experiencing side effects when taking enalalpril due to reduced kidney function. Lower doses may be necessary to minimize side effects.