Uses

This medication is used alone or with other medications to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. It is also used with other drugs to treat heart failure.

Cilazapril belongs to a group of drugs called ACE inhibitors. It works by relaxing the blood vessels so that blood can flow through the body more easily.

Other Uses

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used for kidney disease and to help protect the kidneys from harm due to diabetes.

How To Use

Take this medication by mouth with or without food as directed by your doctor, usually once or twice daily.

The dosage is based on your medical condition and response to treatment.

Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Keep taking this medication even if you feel well. Most people with high blood pressure do not feel sick.

For the treatment of high blood pressure, it may take 2 weeks before the full benefit of this drug takes effect.

Tell your doctor if your condition worsens (such as your routine blood pressure readings increase).

Side Effects

Dizziness or lightheadedness may occur as your body adjusts to the medication. Nausea or dry cough may also occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• fast/irregular heartbeat
• swelling of the hands/feet
• mental/mood changes
• numbness/tingling of the hands/feet
• muscle/joint aches
• fainting
• decreased sexual ability/interest
• easy bruising/bleeding
• symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat)

Although cilazapril may be used to prevent kidney problems or treat people who have kidney problems, it may also rarely cause serious kidney problems or make them worse. Your doctor will check your kidney function while you are taking cilazapril. Tell your doctor right away if you have any signs of kidney problems such as a change in the amount of urine.

This drug may rarely cause serious (possibly fatal) liver problems. Tell your doctor right away if you notice any of the following serious side effects:

• nausea/vomiting that doesn't stop
• yellowing eyes/skin
• dark urine
• stomach/abdominal pain
• unusual tiredness

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat/neck)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking cilazapril, tell your doctor or pharmacist if you are allergic it; or to other ACE inhibitors (such as captopril, lisinopril); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• a history of an allergic reaction that included swelling of the face/lips/tongue/throat (angioedema)
• fluid/swelling of the stomach/abdomen (ascites)
• blood exchange procedures (such as apheresis, dialysis)
• dehydration
• untreated salt imbalances (such as high potassium, low sodium)
• liver disease

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Severe sweating, diarrhea, or vomiting may cause dehydration and cause you to feel lightheaded. Tell your doctor if you have severe diarrhea or vomiting. To prevent dehydration, drink plenty of fluids unless your doctor tells you not to.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug may increase your potassium levels. Before using potassium supplements or salt substitutes containing potassium, consult your doctor or pharmacist.

Older adults may be more sensitive to the side effects of this drug, including dizziness and increases in potassium level.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using cilazapril . Cilazapril may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. (See also Warning section.)

This drug may pass into breast milk and could have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this drug. Consult your doctor before breastfeeding.

Drug Interactions

See also Precautions section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• aliskiren
• alpha blockers (such as prazosin, terazosin)
• drugs that may increase the level of potassium in the blood (such as ARBs including losartan/valsartan, birth control pills containing drospirenone)
• certain drugs that weaken the immune system/increase the risk of infection (such as everolimus, sirolimus)
• lithium
• gold injections
• sacubitril

A very serious reaction may occur if you are getting injections for bee/wasp sting allergy (desensitization) and are also taking cilazapril. Make sure all your doctors know which medicines you are using.

Some products have ingredients that could raise your blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen).

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness.

Notes

Do not share this medication with others. Lifestyle changes such as stress reduction programs, exercise, and dietary changes may increase the effectiveness of this medicine. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.

Lab and/or medical tests (such as complete blood count, blood sodium and potassium levels, kidney/liver function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Check your blood pressure regularly while taking this medication, especially when you first start this drug or when your dose is changed. Learn how to monitor your own blood pressure at home, and share the results with your doctor.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.