Cilazapril (Cobalt Pharmaceuticals): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

CILAZAPRIL is used for the treatment of raised blood pressure and when used with digitalis (a medicine which increases the strength of the heart) and/or diuretics (water tablets), it is used for the treatment of heart failure.

What it does:

CILAZAPRIL works by inhibiting (blocking) natural chemicals produced by the body which cause raised blood pressure. This inhibition leads to a reduction in the blood pressure. When given together with digitalis, a medicine which increases the strength of the heart, and/or diuretics (water tablets), this medication will also reduce the strain on your heart and enable it to work more efficiently, thus easing the symptoms of heart failure.

When it should not be used:

• If you are allergic to this drug or to any ingredient in the

  medication or component of the container. (See the “What the important nonmedicinal ingredients are” section below).

• If you have previously suffered from angioedema (swelling

  of the skin, particularly of the face and around the lips) when taking other angiotensin converting enzyme (ACE) inhibitors.

• If you are suffering from ascites (fluid in the abdominal

  cavity).

What the medicinal ingredient is:

This medication contains the medicinal ingredient cilazapril, which belongs to a group of medicines known as ACE inhibitors.

What the important nonmedicinal ingredients are: Corn starch, hypromellose, lactose monohydrate, sodium stearyl fumarate, and talc. The tablets also contain the following film- coating ingredients:

1 mg tablet: polyvinyl alcohol, PEG 3350, titanium dioxide, talc and iron oxide yellow.

2.5 mg tablet: polyvinyl alcohol, PEG 3350, titanium dioxide, talc, iron oxide red and iron oxide yellow.

5 mg tablet: polyvinyl alcohol, iron oxide red, PEG 3350 and talc

What dosage forms it comes in:

CILAZAPRIL is available as 1 mg, 2.5 mg and 5 mg tablets.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Pregnancy: Since the use of ACE inhibitors during pregnancy can cause injury or even death of the developing fetus, patients should stop taking CILAZAPRIL and report promptly to their physician if they become pregnant.

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

• You are pregnant, breast-feeding or thinking of becoming pregnant? Taking CILAZAPRIL during pregnancy can cause injury and even death to your baby. This medicine should not be used during pregnancy. If you become pregnant while taking CILAZAPRIL, stop the medication and report to your doctor as soon as possible. It is possible that CILAZAPRIL passes into breast milk. You should not breast-feed while taking CILAZAPRIL.
• You are on a salt restricted diet
• You have recently suffered from vomiting or diarrhea
• You have a heart, blood, liver or kidney condition
• You are undergoing dialysis or apheresis
• You are taking any other medications, including those not prescribed by your doctor, especially if you have been treated with a diuretic for a long time before starting treatment with CILAZAPRIL.
• You are about to have any form of operation that requires an anesthetic.

WHILE you are using CILAZAPRIL, talk to your doctor if any of the following occurs:

• You experience symptoms of an infection (e.g. sore throat, fever). This may be an early sign of neutropenia (a blood condition).
• You experience any symptoms of liver dysfunction. This would include “viral-like symptoms” in the first weeks to months of therapy (such as fever, general body discomfort, muscle pain, or rash), or if stomach pain, nausea or vomiting, loss of appetite, jaundice (yellowing of the skin or eyes), itching or any other unexplained symptoms occur during therapy.
• Surgery: If you are planning to undergo surgery and/or anesthesia, tell your doctor that you are taking an ACE inhibitor.

STOP using CILAZAPRIL, and talk to your doctor if you experience any of the following during your treatment:

• Angioedema (swelling of face, extremities, eyes, lips, tongue, difficulty in breathing) may occur especially after the first dose of cilazapril. If you experience angioedema in your tongue or throat, consult with your doctor immediately.
• Hypotension (low blood pressure). Report any symptoms of light-headedness, especially during the first few days of cilazapril therapy. If you faint while taking cilazapril, do not take any more drug until you have consulted with your doctor. Please note that excessive sweating and dehydration (lack of water/liquids) while taking cilazapril may lead to a greater than usual fall in blood pressure because of a reduction in blood fluid volume. Vomiting or diarrhea may also lead to a fall in blood pressure; consult with your doctor if this occurs while you are talking CILAZAPRIL.
• You become pregnant.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor about all the medications you are taking, including those not prescribed by your doctor.

Drugs that may interact with CILAZAPRIL include:

• Potassium supplements or potassium-containing salt

  substitutes

• Diuretics (water pills)
• NSAIDS (for relief of pain e.g., aspirin)
• lithium (for depression)

Interactions with herbal products, homeopathic preparations and laboratory tests have not been established.

PROPER USE OF THIS MEDICATION

Always take your medication exactly as your doctor tells you to and do not stop treatment unless he/she tells you to do so.

Take your medication before or after meals, and swallow the tablets whole with water or another non-alcoholic drink. The medication should be taken at about the same time each day.

Usual dose:

• If you have high blood pressure, your normal starting dose

  will be 2.5 mg once daily. In some cases your doctor may feel that you should start on a lower dose. Your doctor may change the dose to suit your needs throughout your treatment. The full effect of your medication is not usually seen until after two to four weeks of treatment and the effect then remains constant. If your blood pressure is not adequately controlled with CILAZAPRIL, your doctor may prescribe a diuretic (water tablet), which will work together with your medication to further control your blood pressure.

• If you are elderly, your doctor will probably start you on 1.25

  mg once daily or less if you are suffering from hypertension and 0.5 mg if you suffer from heart failure. After starting therapy your doctor may adjust your dose, depending on your response.

• If you have kidney or liver problems, your doctor may start

  you on a lower dose than normal before adjusting your dose depending on your response.

• If you have heart failure, treatment usually starts with a daily

  dose of 0.5 mg in addition to digitalis and/or diuretics. Depending on your individual response to the treatment your doctor may decide to increase the daily dose.

• If you are already taking diuretics your doctor may reduce the

  dose of the diuretic, or even stop you from taking the diuretic at all before you start talking CILAZAPRIL.

Overdose:

If you take too many tablets or someone else accidentally takes your medicine, contact your doctor, pharmacist, nearest hospital, or your regional poison control centre immediately.

Missed Dose:

If a dose of this medication is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not double doses.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these effects may occur, if they do occur they may need medical attention. Please contact your doctor if the side effects continue or cause you any concern.

Common side effects: The most commonly reported side effects include:

• headache
• dizziness
• fatigue (feeling extremely tired)
• nausea
• cough
• palpitation (awareness of the beating of the heart)
• asthenia (weakness)

This is not a complete list of side effects. For any unexpected effects while taking CILAZAPRIL, contact your doctor or pharmacist.

HOW TO STORE IT

Store at 15 – 30°C. Protect from moisture. Keep container tightly closed. Keep out of reach of children.

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 0701C

  Ottawa, ON 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 found by contacting the sponsor, Cobalt Pharmaceuticals Inc., at: 1-866-254-6111

Mississauga, Ontario L5N 2B8 Canada

Last revised: March 3, 2010