IMPORTANT: PLEASE READ PART III: CONSUMER INFORMATION increased risk of getting an allergic reaction that is passed down through families. This can be triggered by different PrSandoz Trandolapril factors, such as surgery, flu, or dental procedures. Trandolapril Capsules  You have diabetes or kidney disease and are already taking a blood pressure-lowering medicine that contains aliskiren Read this carefully before you start taking Sandoz (such as Rasilez®) or an angiotensin II receptor blocker Trandolapril and each time you get a refill. This leaflet is a (ARB). You can recognize ARBs because the name of their summary and will not tell you everything about Sandoz medicinal ingredient ends in “-sartan”. Trandolapril. Talk to your doctor, nurse, or pharmacist  Are pregnant or intend to become pregnant. Taking Sandoz about your medical condition and treatment and ask if Trandolapril during pregnancy can cause injury and even there is any new information about Sandoz Trandolapril. death to your baby.  Are breastfeeding. Sandoz Trandolapril passes into breast milk. ABOUT THIS MEDICATION  Have one of the following rare hereditary diseases: o Galactose intolerance What the medication is used for: o Lapp lactase deficiency Sandoz Trandolapril is used to treat; o Glucose-galactose malabsorption  High blood pressure. Because lactose is a non-medicinal ingredient in Sandoz  Patients after a heart attack. Trandolapril.

Managing your lifestyle What the medicinal ingredient is: The “lifestyle” part of your treatment is as important as Trandolapril your medication. In collaboration with your doctor, you can help reduce the risk of high blood pressure complications to What the non-medicinal ingredients are: maintain the lifestyle you are accustomed to. To do this, your Colloidal silicon dioxide, dimeticone, erythrosine, gelatin, doctor may discuss changes to your alcohol consumption and lactose monohydrate, magnesium stearate, microcrystalline your diet. Your doctor will also probably recommend regular cellulose, quinoline yellow, red iron oxide, starch exercise and to completely avoid smoking. pregelatinised, sunset yellow, titanium dioxide and yellow iron oxide. What it does: Sandoz Trandolapril is an angiotensin converting enzyme (ACE) What dosage forms it comes in: inhibitor. You can recognize ACE inhibitors because their Capsules: 0.5 mg, 1 mg, 2 mg and 4 mg. medicinal ingredient ends in ‘-PRIL’.

This medicine does not cure your disease. It helps to control it. WARNINGS AND PRECAUTIONS Therefore, it is important to continue taking Sandoz Trandolapril regularly even if you feel fine. Serious Warnings and Precautions-Pregnancy Sandoz Trandolapril should not be used during pregnancy. If Although you may not feel any symptoms for years, high you discover that you are pregnant or you are planning to blood pressure can lead to stroke, heart attack, kidney disease become pregnant while taking Sandoz Trandolapril, stop the and other serious conditions. medication and contact your doctor, nurse, or pharmacist as soon as possible. Hypertension is the medical term for high blood pressure.

When blood flows through the blood vessels it pushes against their walls, almost like water pushing against the sides of a BEFORE you use Sandoz Trandolapril talk to your doctor, hose. Blood pressure is like that “push”. When blood pressure nurse or pharmacist if you: is high (like the water pressure in a hose when the nozzle is partially shut), damage can occur to the heart and blood vessels.  You are taking salt substitutes or foods containing potassium, potassium supplements, or a potassium-sparing When it should not be used: diuretic (a specific kind of “water pill”). Do not take Sandoz Trandolapril if you:  Have diabetes, liver or kidney disease.  Are allergic to trandolapril or any non-medicinal  Have narrowing of an artery or heart valve disease. ingredients  Have had a heart attack or stroke.  Have experienced an allergic reaction (angioedema) with  Have heart failure. swelling of the hands, feet, or ankles, face, lips, tongue,  Are on dialysis. throat) or sudden difficulty breathing or swallowing, to any  Are dehydrated or suffer from excessive vomiting, diarrhea, ACE inhibitor or without a known cause. Be sure to tell or sweating. your doctor, nurse, or pharmacist that this has happened to  Are possibly allergic to Sandoz Trandolapril (or any drug you. used to lower blood pressure), including any of its non-  Have been diagnosed with hereditary angioedema: an medicinal ingredients. (Refer to the subheading “What the non-medicinal ingredients are” for a complete listing). Sandoz Trandolapril Page 35 of 38

IMPORTANT: PLEASE READ  Have recently received or are planning to get allergy shots transplanted organ or treat autoimmune diseases; for bee or wasp stings.  Inhalation anesthetics;  Are on a low-salt diet.  mTOR (mammalian target of rapamycin) inhibitor (e.g.,  Are taking a medicine that contains aliskiren, such as temsirolimus, sirolimus, everolimus) therapy; Rasilez®, used to lower high blood pressure. The  Lithium used to treat bipolar disease; combination with Sandoz Trandolapril is not recommended.  Nifedipine SR used to treat chest pain or lower blood  Are taking an angiotensin receptor blocker (ARB). You can pressure; recognize an ARB because its medicinal ingredient ends in “-  Non-steroidal anti-inflammatory drugs (NSAIDs) used to SARTAN”. reduce pain and swelling. Examples include ibuprofen,  Are receiving gold (sodium aurothiomalate) injections. naproxen, celecoxib, and acetylsalicylic acid (aspirin) used  Are less than 18 years old. in higher doses;  Have lupus or scleroderma.  Procainamide used to treat irregular heartbeats;  Systemic corticosteroids used to treat joint pain and swelling You may become sensitive to the sun while taking Sandoz Trandolapril. Exposure to sunlight should be minimized until you know how you respond. PROPER USE OF THIS MEDICATION

If you are going to have surgery and will be given an anesthetic, Usual Adult Dose: be sure to tell your doctor or dentist that you are taking Sandoz Take Sandoz Trandolapril exactly as prescribed. Dosage Trandolapril. must be individualized The recommended initial dose of Sandoz Trandolapril is 1 mg once daily. The dose can be Driving and using machines: Before you perform tasks which increased over time by your doctor, up to a maximum may require special attention, wait until you know how you dose of 4 mg once daily. For patients with kidney or liver respond to Sandoz Trandolapril. Dizziness, lightheadedness, or impairment, the recommended initial dose is 0.5 mg once fainting can especially occur after the first dose and when the daily. dose is increased. It is recommended to take your dose at about the same time every day. You can take Sandoz Trandolapril with a INTERACTIONS WITH THIS MEDICATION meal, or if you prefer, on an empty stomach.

As with most medicines, interactions with other drugs are With your first dose of Sandoz Trandolapril your blood possible. Tell your doctor, nurse, or pharmacist about all the pressure may drop too low and you may experience a medicines you take, including drugs prescribed by other doctors, sensation of lightheadedness. This effect should disappear vitamins, minerals, natural supplements, or alternative once your system becomes used to Sandoz Trandolapril. If medicines. they persist, discuss this with your doctor. Your medication may need to have the dose reduced or changed. The following may interact with Sandoz Trandolapril:  Agents increasing serum potassium, such as a salt substitute Overdose: that contains potassium, potassium supplements, or a potassium-sparing diuretic (a specific kind of “water pill”; If you think you (or someone you know) may have examples include spironolactone, triamterene or amiloride); taken too much Sandoz Trandolapril, contact your  Alcohol. It may cause low blood pressure, dizziness and doctor, nurse, pharmacist, hospital emergency fainting; department or regional Poison Control Centre  Allopurinol, used to treat gout; immediately, even if there are no symptoms. Tell  Antacids; them how much you have taken and show them the  Antidepressants, used to control your depression; capsules  Antidiabetic agents, including insulin and oral medicines used to control your blood glucose; Overdose symptoms expected with drugs like Sandoz  Bee or wasp venom found in allergy shots for bee or wasp Trandolapril include a severe drop in blood pressure, shock, stings; stupor, and an abnormally slow heart beat.  Blood pressure-lowering drugs, including diuretics (“water pills”,e.g., hydrochlorothiazide), aliskiren-containing Missed dose: products (e.g. Rasilez®), or angiotensin receptor blockers If you forget to take your dose of Sandoz Trandolapril, take it (ARBs); as soon as you remember, if you remember on the same day. If not, do not take your missed dose at all. Simply wait until it is  Cytostatic agents used to treat cancers; time for your next dose. Do not double dose.  Dextran sulphate used in low density lipoprotein apheresis to remove cholesterol from the blood;  Digoxin used to treat irregular heartbeats; SIDE EFFECTS AND WHAT TO DO ABOUT THEM  Gold for the treatment of rheumatoid arthritis;  Immunosuppressive agents used to prevent rejection of a Like all medicines, Sandoz Trandolapril can cause side Sandoz Trandolapril Page 36 of 38

IMPORTANT: PLEASE READ effects. After you have started taking Sandoz Trandolapril it is SERIOUS SIDE EFFECTS, HOW OFTEN THEY important that you tell your doctor at once about any HAPPEN AND WHAT TO DO ABOUT THEM unexplained symptom you might experience.

Symptoms / effects Talk with your Stop taking Frequent side effects include coughing and dizziness. Other doctor or drug and occasional side effects include: pharmacist seek immediate  Headache Only if In all emergency severe cases medical  Flu-like symptoms such as sore throat, fever, attention malaise, muscle pain or weakness Intestinal   Rash angioedema   Nausea, vomiting, diarrhea, abdominal pain, loss Abdominal pain that may become more of appetite (anorexia) severe after eating,  Fatigue nausea, vomiting,  Sensation of lightheadedness, confusion intestinal cramps  Sad mood (depression) Kidney Disorder:  change in frequency of   Blurred vision urination, nausea,  Confusion vomiting, swelling of  Dermatitis extremities, fatigue Jaundice (Liver   Sinusitis and rhinitis Disorder)  Yellowing of the eyes If any of these affects you severely, tell your doctor, nurse or and skin, dark urine, pharmacist. abdominal pain, nausea, vomiting, loss of appetite Sandoz Trandolapril can cause abnormal blood test results. Your Electrolyte  doctor will decide when to perform blood tests and will interpret Imbalance: weakness,  the results. drowsiness, muscle pain or cramps, irregular heartbeat

SERIOUS SIDE EFFECTS, HOW OFTEN THEY Rare Decreased Platelets:  bruising, bleeding,  HAPPEN AND WHAT TO DO ABOUT THEM fatigue and weakness

Decreased White  Symptoms / effects Talk with your Stop taking  doctor or drug and Blood Cells: pharmacist seek infections, fatigue, immediate fever, aches, pains, and Only if In all emergency flu-like symptoms severe cases Unknown Toxic Epidermal  medical  attention Necrolysis: Severe skin peeling, Common Hypersensitivity  especially in mouth reactions and eyes Skin rash, skin eruption or other effect Stevens-Johnson  of the skin or eyes, Syndrome:  itching or fever Blistering of the mucous membranes of Low blood pressure  Fainting, dizziness,  the skin including lightheadedness, may mouth, lips, eyelids, occur when you go and genitals from lying or sitting to standing up. This is not a complete list of side effects. For any unexpected Increased levels of  potassium in the effects while taking Sandoz Trandolapril, contact your doctor, blood: nurse, or pharmacist. Irregular or skipped heart beats, muscle weakness and HOW TO STORE IT generally feeling unwell

Uncommon Allergic Reactions  Store Sandoz Trandolapril between 15 and 25ºC in original  (angioedema) container. Sandoz Trandolapril should not be stored beyond Swollen mouth, lips, tongue, eyes, the date indicated on the container. Keep this drug out of extremities, throat or reach and sight of children. difficulty swallowing or breathing

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IMPORTANT: PLEASE READ Reporting Side Effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report Online at MedEffect; . By calling1-866-234-2345 (toll-free); . By completing a Consumer Side Effect . Reporting Form and sending it by: - Fax to 1-866-678-6789 (toll-free), or - Mail to: Canada Vigilance Program Health Canada Postal Locator 1908C Ottawa, Ontario K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

If you want more information about Sandoz Trandolapril:  Talk to your healthcare professional  Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website www.sandoz.ca, by calling 1-800-361-3062 or by email to [email protected].

This leaflet was prepared by Sandoz Canada.

Last Revised: June 5, 2017.

Rasilez® is a trademark of its respective owner and is not a trademark of Sandoz Canada Inc.

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