IMPORTANT: PLEASE READ PART III: CONSUMER INFORMATION Pr APO-CILAZAPRIL Cilazapril Tablets This leaflet is part III of a three-part “Product Monograph” published when APO-CILAZAPRIL was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about APO-CILAZAPRIL. Contact your doctor or pharmacist if you have any questions about the drug. ABOUT THIS MEDICATION What the medication is used for: APO-CILAZAPRIL is used to treat raised blood pressure. What it does: APO-CILAZAPRIL blocks natural chemicals produced by the body which cause raised blood pressure. This inhibition leads to reduction of blood pressure. When it should not be used: Do not take APO-CILAZAPRIL if you have had an allergic reaction to APO-CILAZAPRIL or any of the ingredients listed at the end of this information. APO-CILAZAPRIL is also contraindicated in patients with history of angioedema related to previous treatment with an ACE inhibitor and in patients with ascites. What the medicinal ingredient is: APO-CILAZAPRIL tablets contain the active ingredient called cilazapril. What the important nonmedicinal ingredients are: APO-CILAZAPRIL tablets contain the following inactive ingredients: microcrystalline cellulose, starch, sodium stearyl fumarate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyethylene glycol, titanium dioxide (1 mg and 2.5 mg only), yellow ferric oxide (1 mg only) and red ferric oxide (2.5 mg and 5 mg only). What dosage forms it comes in: APO-CILAZAPRIL tablets are available in 1 mg, 2.5 mg and 5 mg strengths. WARNINGS AND PRECAUTIONS Pregnancy: Since the use of ACE inhibitors during pregnancy can cause injury and even death of the developing fetus, patients should be advised to stop the medication and report promptly to their physician if they become pregnant. Before starting APO-CILAZAPRIL and to get the best possible treatment, be sure to tell your doctor if you: • are on a salt restricted diet • have a heart, liver or kidney condition • are undergoing dialysis • are pregnant or plan to become pregnant • are breast-feeding or plan to breast-feed • are taking other medicines • plan to have surgery that requires anesthetic • are using desensitization therapy Angioedema: Angioedema, including laryngeal edema, may occur especially following the first dose of cilazapril. Patients should be so advised and told to report immediately any signs or symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, tongue, difficulty in breathing) and to take no more drug until they have consulted with the prescribing physician. Should the tongue and/or larynx be involved, the physician should be consulted immediately. Hypotension: Patients should be cautioned to report light-headedness, especially during the first few days of APO-CILAZAPRIL therapy. If actual syncope occurs, the patients should be told to discontinue the drug until they have consulted with the prescribing physician. All patients should be cautioned that excessive perspiration and dehydration may lead to an excessive fall in blood pressure because of reduction in fluid volume. Other causes of volume depletion such as vomiting or diarrhea may also lead to a fall in blood pressure; patients should be advised to consult with their physician. Neutropenia: Patients should be advised to report promptly any indication of infection (e.g., sore throat, fever) since this may be an early sign of neutropenia. Impaired Liver Function: Patients should be advised to return to the physician if he/she experiences any symptoms possibly related to liver dysfunction. This would include “viral-like symptoms” in the first weeks to months of therapy (such as fever, malaise, muscle pain, rash or adenopathy which are possible indicators Page 1 of 7 of hypersensitivity reactions), or if abdominal pain, nausea or vomiting, loss of appetite, jaundice, itching or any other unexplained symptoms occur during therapy. Hyperkalemia: Patients should be advised not to use potassium supplements or salt substitutes containing potassium without consulting their physician. Surgery: Patients planning to undergo surgery and/or anesthesia should be told to inform their physician that they are taking an ACE inhibitor. Monotherapy: The recommended initial dose of APOCILAZAPRIL is 2.5 mg once daily. Dosage should be adjusted according to the blood pressure response, generally at intervals of at least two weeks. The usual dose range for APO-CILAZAPRIL is 2.5 to 5 mg once daily. A dose of 10 mg should not be exceeded. Overdose: If you take too much, immediately contact your doctor or go to your nearest hospital emergency department. Nursing Mothers: Patients should be advised not to breast feed if they are taking APO-CILAZAPRIL. Missed Dose: The dose should always be taken at about the same time each day. If you miss a dose, wait until your next scheduled dose. Do not take 2 doses at once. In case of doubt contact your doctor or pharmacist. INTERACTIONS WITH THIS MEDICATION SIDE EFFECTS AND WHAT TO DO ABOUT THEM Tell all doctors, dentists and pharmacists who are treating you that you are taking APO-CILAZAPRIL. Tell your doctor or pharmacist that you are taking APO-CILAZAPRIL before you start taking any new medicines. The medicines may interfere with APO-CILAZAPRIL: • ACE inhibitors and diuretics • lithium salts • digoxin • non-steroidal anti-inflammatory drugs • agents increasing serum potassium Only take other medicines while you are on APOCILAZAPRIL if your doctor tells you that you can. DO NOT give APO-CILAZAPRIL to anyone else. Your doctor has prescribed it for you and your condition. Like other medicines, APO-CILAZAPRIL can cause some side effects. The most common side effects of APO-CILAZAPRIL are: • • • • • • • headache dizziness fatigue cough nausea asthenia palpitation This is not a complete list of side effects. For any unexpected effects while taking APO-CILAZAPRIL, contact your doctor or pharmacist. Elevation of liver enzymes and/or serum bilirubin have been reported for APO-CILAZAPRIL. PROPER USE OF THIS MEDICATION Usual dose: Dose must be individualized. Page 2 of 7 HOW TO STORE IT MORE INFORMATION All medicines should be kept out of the reach of children. APO-CILAZAPRIL should be stored in its original package at room temperature (15-30°C), in a dry place. Keep container tightly closed and protect from moisture. The expiry date of this medicine is printed on the package label. Do not use the medicine after this date. For more information, please contact your doctor, pharmacist or other healthcare professional. This document, plus the full product monograph, prepared for health professional can be found at http://www.apotex.ca/products. This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9. Date of Revision: January 23, 2007 REPORTING SUSPECTED SIDE EFFECTS To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by: toll-free telephone: 866-234-2345 toll-free fax 866-678-6789 By email: [email protected] By regular mail: Canadian Adverse Drug Reaction Monitoring Program (CADRMP) Health Canada Address Locator: 0201C2 Ottawa, ON K1A 1B9 Health Canada Address Locator: 0201C2 Ottawa, ON K1A 1B9 NOTE: Before contacting Health Canada, you should contact your physician or pharmacist. Page 3 of 7