October 20, 2014
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Inhibace

(cilazapril)

DIN (Drug Identification Number)

01911473 INHIBACE 2.5MG TABLET
01911481 INHIBACE 5MG TABLET

What side effects are possible with Inhibace?

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)
  • diarrhea
  • headache
  • nausea
  • unusual tiredness
  • weakness (loss of energy)

Although most of the 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:

  • dizziness, lightheadedness, or fainting (signs of low blood pressure)
  • signs of anemia (low red blood cells; e.g., pale skin, unusual tiredness or weakness)
  • signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • signs of kidney or urinary tract problems (e.g., difficulty urinating, pain when urinating, decreased amount of urine passed)
  • 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)
  • 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:

  • difficulty swallowing or breathing (sudden)
  • 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





Are there any other precautions or warnings for Inhibace?

HEALTH CANADA ADVISORY

February 4, 2014

Health Canada has issued new restrictions concerning the use of cilazapril. 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 is a serious allergic reaction that causes the area around the face, throat, and tongue to swell. It may occur with use of cilazapril. If you experience swelling of the face, tongue, or throat, stop taking cilazapril at once and get immediate medical attention. Do not take other ACE inhibitors in the future. If you have had angioedema caused by other substances may be at increased risk of angioedema while receiving cilazapril.

Cough: ACE inhibitors such as this medication may cause you to develop a dry, persistent cough within hours of the first dose to weeks or months after starting therapy. The cough usually resolves within 4 weeks of stopping this medication. Talk to your doctor if you develop a persistent, intolerable cough.

Diabetes: Cilazapril may cause a decrease in blood sugar levels and increased effects from medications used to reduce blood glucose. You may find it necessary to monitor your blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing 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.

Fluid and electrolyte balance: Increases in blood levels of potassium occur for some people who take this medication. This rarely causes problems, but potassium levels should be monitored by your doctor. If you have kidney disease or diabetes there is a higher risk of having increased blood potassium while taking cilazapril. 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.

Infection: Cilazapril can reduce the number of cells that fight infection in the body (white blood cells). This makes you more likely to experience infections.

Tell your doctor if you notice signs of an infection such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor should do blood tests periodically, to monitor the number of specific types of blood cells in your blood.

Kidney function: Changes in kidney function have been noticed in people with narrowed blood vessels in their kidneys, or those with severe congestive heart failure. The use of diuretics (water pills) may further increase risk of kidney problems in those at risk for this problem. Let your doctor know if you notice any decreases in urine output or increases in the swelling of lower limbs, suggesting accumulation of fluid due to decreased urination.

Liver function: This medication may worsen liver disease or cause reduced liver function. If you have liver disease or decreased liver function, 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.

Low blood pressure: Occasionally, blood pressure drops too low after taking cilazapril. This usually happens after the first or second dose, or when the dose is increased. It is more likely to occur for people who take water pills, have a salt-restricted diet, are on dialysis, are suffering from diarrhea or vomiting, or have been sweating excessively and not drinking enough liquids. If low blood pressure causes you to faint or feel lightheaded, contact your doctor.

Surgery: Cilazapril may interact with medications used during surgery. If you are scheduled for surgery, let your doctor know that you are taking this medication.

Pregnancy: Like other ACE inhibitors, cilazapril may cause harm to an unborn fetus and should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking cilazapril, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

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

Seniors: People over the age of 65 are more likely to experience the side effects of cilazapril. Lower doses may be appropriate for this population.

What other drugs could interact with Inhibace?

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

  • allopurinol
  • amifostine
  • amiloride
  • antacids (e.g., aluminum hydroxide, calcium carbonate, sodium bicarbonate)
  • beta-blockers (e.g., propranolol, metoprolol)
  • calcium channel blockers (e.g., amlodipine, nifedipine, verapamil)
  • cyclosporine
  • diabetes medications (e.g., glyburide, rosiglitazone)
  • diuretics (e.g., hydrochlorothiazide, furosemide)
  • insulin
  • iron dextran complex
  • lithium
  • nonsteroidal anti-inflammatory medications (NSAIDs; e.g., ibuprofen, indomethacin, naproxen)
  • potassium supplements
  • rituximab
  • salt substitutes that contain potassium
  • sodium phosphates
  • spironolactone
  • triamterene

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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