IMPORTANT: PLEASE READ

PART III: CONSUMER INFORMATION  Are already taking a blood pressure-lowering medicine that contains aliskiren (such as Rasilez) and Pr Sandoz Olmesartan HCTZ you have diabetes or kidney disease.

Olmesartan medoxomil and Hydrochlorothiazide  Have one of the following rare hereditary diseases Tablets - Galactose intolerance 20 mg / 12.5 mg, 40 mg / 12.5 mg, and 40 mg / 25 mg - Lapp lactase deficiency - Glucose-galactose malabsorption Read this carefully before you start taking Sandoz Because lactose is a non-medicinal ingredient in Sandoz Olmesartan HCTZ and each time you get a refill. Olmesartan HCTZ.

This leaflet is a summary and will not tell you What the medicinal ingredients are: everything about Sandoz Olmesartan HCTZ. Talk to Olmesartan medoxomil and hydrochlorothiazide your doctor, nurse or pharmacist about your medical condition and treatment and ask if there is any new What the non-medicinal ingredients are: information about Sandoz Olmesartan HCTZ. Hydroxypropylcellulose, lactose monohydrate,

microcrystalline cellulose, low-substituted ABOUT THIS MEDICATION hydroxypropylcellulose, magnesium stearate,

hydroxypropyl methylcellulose, polyethylene glycol, What the medication is used for: titanium dioxide, talc, iron oxide yellow and iron oxide

Sandoz Olmesartan HCTZ lowers high blood pressure. red.

What it does: What dosage forms it comes in: Sandoz Olmesartan HCTZ contains a combination of Tablets: 20 mg/12.5 mg, 40 mg/12.5 mg and 40 mg/25 two drugs, olmesartan medoxomil and mg. hydrochlorothiazide:  Olmesartan medoxomil is an angiotensin receptor WARNINGS AND PRECAUTIONS blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”. It Serious Warnings and Precautions –Pregnancy lowers blood pressure. Sandoz Olmesartan HCTZ should not be used during  Hydrochlorothiazide is a diuretic or “water pill” that pregnancy. If you discover that you are pregnant while increases urination. This lowers blood pressure. taking Sandoz Olmesartan HCTZ, stop the medication and contact your doctor, nurse or pharmacist as soon as This medicine does not cure high blood pressure. It possible. helps to control it. Therefore, it is important to continue taking Sandoz Olmesartan HCTZ regularly even if you BEFORE you use Sandoz Olmesartan HCTZ talk to feel fine. your doctor, nurse or pharmacist if you:  Have had skin cancer or have a family history of skin When it should not be used: cancer. Do not take Sandoz Olmesartan HCTZ if you:  Have a greater chance of developing skin cancer  Are allergic to olmesartan medoxomil, because you have light-coloured skin, get sunburned hydrochlorothiazide or to any non-medicinal easily, or are taking drugs to suppress your immune ingredient in the formulation or components of the system. container.  Are allergic to any drug used to lower blood  Are allergic to any sulphonamide-derived drugs pressure, including angiotensin converting enzyme (sulfa drugs): most of them have a medicinal (ACE) inhibitors, or penicillin. ingredient that ends in “-MIDE”.  Have narrowing of an artery or a heart valve.  Have experienced an allergic reaction (angioedema)  Have had a heart attack or stroke. with swelling of the hands, feet, or ankles, face, lips,  Have heart failure. tongue, throat, or sudden difficulty breathing or  Have diabetes, liver or kidney disease. swallowing to any ARB (any drug in the same class  Are taking a medicine that contains aliskirin, such as as olmesartan medoxomil). Be sure to tell your Rasilez, used to lower high blood pressure. The doctor, nurse, or pharmacist that this has happened to combination with Sandoz Olmesartan HCTZ is not you. recommended.  Have difficulty urinating or produce no urine.  Are taking an angiotensin converting enzyme  Are pregnant or intend to become pregnant. Taking inhibitor (ACEI). You can recognize ACEIs because Sandoz Olmesartan HCTZ during pregnancy can their medicinal ingredient ends in “-PRIL”. cause injury and even death to your baby.  Have lupus or gout.  Are breastfeeding. Sandoz Olmesartan HCTZ passes  Are on dialysis. into breast milk. Sandoz Olmesartan HCTZ Product Monograph Page 33 of 37 IMPORTANT: PLEASE READ

 Are dehydrated or suffer from excessive vomiting, their use with your physician. Alcohol consumption may diarrhea, or sweating. alter your blood pressure.  Are taking a salt substitute that contains potassium, potassium supplements, or a potassium-sparing If Sandoz Olmesartan HCTZ is taken with medicines to diuretic (a specific kind of “water pill”). reduce pain and swelling (called Non-steroidal anti-  Are on a low-salt diet. inflammatory drugs (NSAIDs) or with COX-2  Are less than 18 years old. inhibitors), you may experience:  Are taking any medication including non-  Decreased kidney function or sudden kidney failure. prescription or herbal products. If you notice a decrease in the amount of urine you  You have to undergo any kind of surgery and general produce, generalized swelling, weakness, shortness anesthesia. of breath, or irregular heartbeats, loss of appetite, lethargy, and fatigue, contact your doctor or go to the Risk of skin cancer: emergency department of the hospital right away.  A decreased ability of Sandoz Olmesartan HCTZ to Sandoz Olmesartan HCTZ contains hydrochlorothiazide. lower your blood pressure. This means that Sandoz Treatment with hydrochlorothiazide may increase the Olmesartan HCTZ may not be able to lower your risk of developing non- melanoma skin cancer. The risk blood pressure as it is expected to do. If this happens, is higher if you have been taking Sandoz Olmesartan speak with your doctor or pharmacist. HCTZ for many years (more than 3) or at a high dose. INTERACTIONS WITH THIS MEDICATION While taking Sandoz Olmesartan HCTZ: As with most medications, interaction with other drugs  Make sure to regularly check your skin for any new are possible. Tell your doctor, nurse, or pharmacist lesions. Check areas that are most exposed to the about all the medicines you take, including drugs sun, such as the face, ears, hands, shoulders, upper prescribed by other doctors, vitamins, minerals, natural chest and back. supplements, or alternative medicines.  Limit your exposure to the sun and to indoor tanning. Always use sunscreen (SPF-30 or higher) and wear The following may interact with Sandoz Olmesartan protective clothing when going outside. HCTZ:  Talk to your doctor immediately if you get more  Adrenocorticotropic hormone (ACTH) used to treat sensitive to the sun or UV light or if you develop an West Syndrome unexpected skin lesion (such as a lump, bump, sore,  Alcohol, barbiturates (sleeping pills), or narcotics or patch) during the treatment. (strong pain medications). They may cause low blood pressure and dizziness when you go from lying Sandoz Olmesartan HCTZ can cause severe chronic or sitting to standing up. diarrhea with substantial weight loss (sprue-like  Amphotericin B, an antifungal drug. enteropathy). It can take months to years for symptoms  Anticancer drugs, including cyclophosphamide and to develop. methotrexate.  Antidepressants, in particular selective serotonin Hydrochlorothiazide in Sandoz Olmesartan HCTZ reuptake inhibitors (SSRIs), including citalopram, can cause Sudden Eye Disorders: escitalopram, and sertraline.  Myopia: sudden nearsightedness or blurred vision.  Antidiabetic drugs, including insulin and oral  Glaucoma: an increased pressure in your eyes, eye medicines. pain. Untreated, it may lead to permanent vision loss.  Bile acid resins used to lower cholesterol. These eye disorders are related and can develop  Other blood pressure lowering drugs. When taken in within hours to weeks of starting Sandoz Olmesartan combination with Sandoz Olmesartan HCTZ, they HCTZ. may cause excessively low blood pressure.  Calcium or vitamin D supplements. You may become sensitive to the sun while taking  Corticosteroids used to treat joint pain and swelling. Sandoz Olmesartan HCTZ. Exposure to sunlight should  Digoxin, a heart medicine. be minimized until you know how you respond.  Drugs that slow down or speed up bowel function, including atropine, metoclopramide and Driving and using machines: Before you perform tasks domperidone. which may require special attention, wait until you  Drugs used to treat epilepsy, including know how you respond to Sandoz Olmesartan HCTZ. carbamazepine and topiramate. Dizziness, lightheadedness, or fainting can especially  Gout medications, including allopurinol and occur after the first dose and when the dose is increased. probenecid.

 Lithium used to treat bipolar disease. Avoid alcoholic beverages until you have discussed Sandoz Olmesartan HCTZ Product Monograph Page 34 of 37 IMPORTANT: PLEASE READ

 Nonsteroidal anti-inflammatory drugs (NSAIDs),  bleeding under the skin, rash, red patches on the skin used for arthritis and to reduce pain and swelling.  fatigue, drowsiness, insomnia Examples include ibuprofen, naproxen, and  reduced libido celecoxib.  Skeletal muscle relaxants used to relieve muscle If any of these affects you severely, tell your doctor, spasms, including tubocurare. nurse or pharmacist.  Pressor amines such as norepinephrine.  Sympathomimetics Sandoz Olmesartan HCTZ can cause abnormal blood  Anesthetics test results. Your doctor will decide when to perform  Amantadine blood tests and will interpret the results.  Anticholonergic agents  Cyclosporine SERIOUS SIDE EFFECTS, HOW OFTEN THEY  Blood pressure-lowering drugs, including diuretics HAPPEN AND WHAT TO DO ABOUT THEM ("water pills"), aliskiren-containing products (e.g. Symptom / effect Talk to your Stop taking Rasilez), or angiotensin converting enzyme doctor, nurse drug and or pharmacist seek inhibitors (ACEIs). Only In all immediate if cases medical PROPER USE OF THIS MEDICATION severe help Non-melanoma skin √ Take Sandoz Olmesartan HCTZ exactly as prescribed. It cancer: lump or is recommended to take your dose at about the same discoloured patch on the time everyday. skin that stays after a few weeks and slowly Dosage must be individualized. Sandoz Olmesartan changes. Cancerous lumps are red/pink and HCTZ is not for initial therapy. firm and sometimes turn into ulcers. Cancerous Sandoz Olmesartan HCTZ may be taken with or without patches are usually flat food. If Sandoz Olmesartan HCTZ causes upset and scaly. stomach, take it with food or milk. Low Blood Pressure:

dizziness, fainting, √ Usual Adult dose: lightheadedness. One tablet daily. May occur when you go Common from lying or sitting to Overdose: standing up. Decreased or increased levels of potassium in √ If you think you have taken too much Sandoz the blood: irregular Olmesartan HCTZ contact your healthcare professional, heartbeats, muscle hospital emergency department or regional Poison weakness and generally Control Centre immediately, even if there are no feeling unwell. symptoms. Chest Pain: √ Edema: Swelling of the √ hands, ankles or feet. Missed Dose: Allergic Reaction: rash, hives, swelling of the √ If you have forgotten to take your dose during the day, lips, face, tongue or carry on with the next one at the usual time. Do not throat difficulty double dose. swallowing or breathing. Kidney Disorder:

SIDE EFFECTS AND WHAT TO DO ABOUT n change in frequency of √ THEM o urination, nausea,

m

m vomiting, swelling of

co extremities, fatigue. Side effects may include: n  upper respiratory tract infection, cough. U Liver Disorder:  back or leg pain, muscle cramps, spasms and pain, yellowing of the skin or √ eyes, dark urine, weakness, restlessness abdominal pain, nausea,  dizziness, pins and needles in your fingers, headache vomiting, loss of  constipation, diarrhea, nausea, vomiting, decreased appetite. appetite, upset stomach, enlargement of the glands in your mouth Sandoz Olmesartan HCTZ Product Monograph Page 35 of 37

IMPORTANT: PLEASE READ

SERIOUS SIDE EFFECTS, HOW OFTEN THEY SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM HAPPEN AND WHAT TO DO ABOUT THEM Symptom / effect Talk to your Stop taking Symptom / effect Talk to your Stop taking doctor, nurse drug and doctor, nurse drug and or pharmacist seek or pharmacist seek Only In all immediate Only In all immediate if cases medical if cases medical severe help severe help Increased blood sugar: Sprue-like enteropathy: √ frequent urination, thirst, √ severe chronic diarrhea and hunger. with substantial weight loss. Electrolyte Imbalance: weakness, drowsiness, √ muscle pain or cramps, This is not a complete list of side effects. For any irregular heartbeat. unexpected effects while taking Sandoz Olmesartan Bronchitis: HCTZ, contact your doctor or pharmacist. shortness of breath, √ weakness, high fever, HOW TO STORE IT coughing and fatigue. Sudden Kidney Failure Store at 15°C - 30°C. (sudden decrease or absence of urine, √ Keep out of reach and sight of children. generalized swelling, weakness, shortness of breath, or irregular REPORTING SIDE EFFECTS heartbeats, loss of appetite, lethargy and You can report any suspected side effects associated fatigue). with the use of health products to Health Canada by: Rhabdomyolysis √

e

r muscle pain that you  Visiting the Web page on Adverse Reaction

a

R cannot explain, muscle Reporting (https://www.canada.ca/en/health- tenderness or weakness, canada/services/drugs-health-products/medeffect- dark brown urine. canada/adverse-reaction-reporting.html) for Decreased White Blood √ Cells: infections, fatigue, information on how to report online, by mail or by fever, aches, pains, and fax; or flu-like symptoms. Decreased Platelets: √  Calling toll-free at 1-866-234-2345. bruising, bleeding, fatigue and weakness. NOTE: Contact your health professional if you need Toxic Epidermal e √ information about how to manage your side effects.

r

a Necrolysis:

R The Canada Vigilance Program does not provide severe skin peeling,

y

r medical advice.

e especially in mouth and

V eyes. Eye disorders: √ MORE INFORMATION - Myopia: sudden near sightedness or blurred If you want more information about Sandoz Olmesartan vision HCTZ: -Glaucoma: increased pressure in your eyes,  Talk to your healthcare professional eye pain.  Find the full Product Monograph that is prepared for

n Anemia: √ healthcare professionals and includes this Consumer

w

o fatigue, loss of energy,

n Information by visiting the Health Canada website

k weakness, shortness of (https://www.canada.ca/en/health-

Un breath. canada/services/drugs-health-products/drug- Inflammation of the √ Pancreas: abdominal products/drug-product-database.html), the pain that lasts and gets manufacturer’s website (www.sandoz.ca), or by worse when you lie calling the manufacturer, Sandoz Canada Inc., at 1- down, nausea, vomiting. 800-361-3062. Palpitations: √ Irregular heartbeats. or by written request at:

Sandoz Olmesartan HCTZ Product Monograph Page 36 of 37 IMPORTANT: PLEASE READ

110 Rue de Lauzon Boucherville Québec J4B 1E6

or by e-mail at: [email protected]

This leaflet was prepared by Sandoz Canada Inc.

Last revised: January 17, 2020

Sandoz Olmesartan HCTZ Product Monograph Page 37 of 37