Dom-Cilazapril: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Dom-CILAZAPRIL is used to treat the following:

• Mild to moderate essential high blood pressure

  (hypertension). The cause of essential high blood pressure is unknown.

• Heart failure. This is a condition where the heart

  cannot pump adequate amounts of blood to satisfy the needs of the body.

What it does:

Dom-CILAZAPRIL is an angiotensin converting enzyme (ACE) inhibitor. You can recognize ACE inhibitors because their medicinal ingredient ends in ‘-PRIL’.

It works by making your blood vessels relax and widen. This helps to lower your blood pressure. It also makes it easier for your heart to pump blood around your body if you have chronic heart failure.

This medicine does not cure your disease. It helps to control it. Therefore, it is important to continue taking Dom-CILAZAPRIL regularly even if you feel fine.

When it should not be used:

Do not take Dom-CILAZAPRIL if you:

• Are allergic (hypersensitive) to other ACE inhibitor

  medicines. These include captopril, enalapril, lisinopril and ramipril.

• Are allergic to cilazapril or to any non-

  medicinal ingredient in the formulation.

• Have experienced an allergic reaction (angioedema)

  with swelling of the hands, feet, or ankles, face, lips, tongue, throat, or sudden difficulty breathing or swallowing, to any ACE inhibitor or without a known cause. Be sure to tell your doctor, nurse, or pharmacist that this has happened to you.

• Have been diagnosed with hereditary angioedema: an

  increased risk of getting an allergic reaction that is passed down through families. This can be triggered by different factors, such as surgery, flu, or dental procedures.

• Are pregnant or intend to become pregnant. Taking

  Dom-CILAZAPRIL during pregnancy can cause injury and even death to your baby.

  • Are breastfeeding. Cilazapril passes into breast milk.
  • Have a build up of fluid in your abdomen (ascites).

What the medicinal ingredient is:

Cilazapril

What the nonmedicinal ingredients are:

Colloidal Silicon Dioxide, Crospovidone, FD&C Blue#1 Aluminum Lake (5 mg), FD&C Red #40 Aluminum Lake (5 mg), FD&C Yellow# 6 Aluminum Lake (5 mg), Iron Oxide Yellow (1 mg), Iron Oxide Red (2.5 mg), Lactose Spray Dried, Polyethylene glycol, Magnesium Stearate, Microcrystalline Cellulose, Polyvinyl Alcohol-part Hydrolyzed, Titanium Dioxide, and Talc.

What dosage forms it comes in:

Tablets: 1 mg, 2.5 mg & 5 mg.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions - Pregnancy Dom-CILAZAPRIL should not be used during pregnancy. If you discover that you are pregnant while taking Dom-CILAZAPRIL, stop the medication and contact your doctor, nurse, or pharmacist as soon as possible.

BEFORE you use Dom-CILAZAPRIL talk to your doctor or pharmacist if you:

• have diabetes, liver or kidney problems are on kidney dialysis.
• have recently been vomiting or have had diarrhea.
• are on a diet to control how much salt (sodium) you take in.
• are planning to have treatment to reduce your allergy to bee or wasp stings (desensitization).
• are planning to have an operation (including dental surgery). This is because some anesthetics can lower your blood pressure, and it may become too low.
• have a build up of fluid in your abdomen (ascites).
• have a collagen vascular disease (collagen vascular disease occurs when problems with the immune system affect collagen; symptoms of collagen vascular disease vary, but may include back pain, chest pain and shortness of breath, fatigue and weakness, fever, painful, swollen joints, rashes).
• undergo low density lipoprotein (LDL) apheresis with dextrane sulphate (procedure used to lower LDL cholesterol).
• are less than 18 years old.

If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Dom-CILAZAPRIL

Dom-CILAZAPRIL is not recommended for use in children.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast- feeding. Dom-CILAZAPRIL is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed.

Driving and using machines

You may feel dizzy while taking Dom-CILAZAPRIL. This is more likely to happen when you first start treatment. If you feel dizzy, do not drive or use any tools or machines.

INTERACTIONS WITH THIS MEDICATION

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Dom-CILAZAPRIL can affect the way some medicines work. Also some medicines can affect the way Dom-CILAZAPRIL works.

Drugs that may interact with Dom-CILAZAPRIL include:

• Other blood pressure lowering drugs, including

  diuretics (water pills).When taken in combination with Dom-CILAZAPRIL, they may cause excessively low blood pressure.

• Allopurinol used to treat gout.

• Medicines called ‘non-steroidal anti-inflammatory

  drugs’ (NSAIDs) for pain and inflammation. These include aspirin, indometacin and ibuprofen.

• Digoxin
• Insulin or other medicines used to treat diabetes.
• Lithium (used to treat depression).

• Steroide medicines (such as hydrocortisone,

  prednisolone and dexamethasone) or other medication which suppress the immune system.

• Potassium supplements (including salt substitutes)

  or potassium-sparing diuretics.

• Aldosterone antagonists (aldosterone blockers).

• Sympathomimetics (substances that imitate the

  activated sympathetic nervous system).

• Anesthetics, narcotics.
• Tricyclic antidepressants, antipsychotics.
• Gold compounds (used to treat rheumatoid arthritis).
• Iron

Taking Dom-CILAZAPRIL with food and drink Tell your doctor or pharmacist if you are taking food supplements that contain potassium.

PROPER USE OF THIS MEDICATION

Take Dom-CILAZAPRIL exactly as prescribed. It is recommended to take your dose at about the same time every day.

Usual Adult Dose:

Follow your doctor’s instructions about how much medicine you should take. If you have any questions, you should consult your doctor or pharmacist.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Center immediately, even if there are no symptoms.

If you take more Dom-CILAZAPRIL than you should, the following effects may happen: feeling dizzy or light-headed, shallow breathing, cold clammy skin, being unable to move or speak and a slow heart beat.

Missed Dose:

If you forget to take a dose, skip the missed dose. Then take the next dose when it is due.

Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

• Common: feeling dizzy, coughing, nausea, feeling tired headache, drowsiness, weakness, rash, abdominal pain.

• Uncommon: a runny or blocked nose and sneezing

  (rhinitis), dry or swollen mouth, lack of appetite, change in the way things taste, diarrhoea and vomiting, muscle cramps or pain in your muscles or joints, impotence, sweating more than usual, flushing, sleeping problems.

• Rare: interstitial lung disease (a group of lung diseases affecting the tissue and space around the air sacs of the lungs), pins and needles or numbness in the hands or feet, wheezing, a feeling of fullness or a throbbing pain behind the nose, cheeks and eyes (sinusitis), soreness of your tongue, increased sensitivity to light, hair loss (which may be temporary), loosening or separation of a nail from its bed, breast enlargement in men.

If any of these affects you severely, tell your doctor, nurse or pharmacist.

Dom-CILAZAPRIL can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

This is not a complete list of side effects. If you have any unexpected effects while taking this Dom-CILAZAPRIL, contact your doctor or pharmacist.

If you have any further questions, ask your doctor or pharmacist.

HOW TO STORE IT

• Do not use this product after the expiry date written on the package.
• Store between 15°C and 30°C in a tightly closed container.
• Keep this and all medicines in a safe place away from children.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

$ Report online at www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345

$ Complete a Canada Vigilance Reporting Form and:

• Fax toll-free to 1-866-678-6789, or

• Mail to: Canada Vigilance Program Health Canada

  Postal Locator 0701E

  Ottawa, Ontario

  K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting Dominion Pharmacal, at

1-888-550-6060

Dominion Pharmacal

Montreal, Canada

H4P 2T4

Last revised: April 5, 2013