IMPORTANT: PLEASE READ PART III: CONSUMER INFORMATION • Inflammatory bowel disease (Crohn’s Disease or Pr ® Ulcerative Colitis) CELEBREX • Liver disease (active or severe) (Celecoxib) • Kidney disease (severe or worsening) • High potassium in the blood Read this information each time you refill your prescription in case new information has been added. CELEBREX is NOT recommended for use in patients This leaflet is a summary designed specifically for you to under 18 years of age since the safety and effectiveness read. It will NOT tell you everything about CELEBREX. of CELEBREX have NOT been established in these See your health care provider and pharmacist regularly and patients. ask them questions about your health and any medications you take. Patients who took a drug in the same class as CELEBREX after a type of heart surgery (coronary artery bypass grafting (CABG) were more likely to have heart attacks, ABOUT THIS MEDICATION strokes, blood clots in the leg(s) or lung(s), and infections or other complications than those who did NOT take that What the medication is used for: drug. Your health care provider has prescribed CELEBREX for you for one or more of the following medical conditions: What the medicinal ingredient is: Celecoxib • Osteoarthritis – relieve pain • Rheumatoid Arthritis – relieve joint pain and swelling What nonmedicinal ingredients are: • Ankylosing Spondylitis – relieve pain Croscarmellose sodium, Ferric oxide edible ink (E172) (200 • Sprains, After orthopaedic (bone and joint) surgery (NOT mg capsules), Gelatin, Indigotine edible ink (E132) (100 mg open heart surgery), dental extraction – to relieve short-term capsules), Lactose monohydrate, Magnesium stearate, pain (maximum use of 7 days) Povidone, Sodium lauryl sulphate, Titanium dioxide (E171) What it does: What dosage forms it comes in: CELEBREX (celecoxib), as a nonsteroidal anti-inflammatory Capsules, 100 mg and 200 mg drug (NSAID), can reduce the type of prostaglandins (chemicals), produced by your body which cause joint WARNINGS AND PRECAUTIONS swelling, redness and pain. At prescribed doses, CELEBREX does not affect the type of prostaglandins that helps maintain the protective layer of the stomach, and reduces the chances of Serious Warnings and Precautions bleeding from the stomach. If you have, or previously had, any of the following medical conditions, see your health care provider to CELEBREX, as a nonsteroidal anti-inflammatory drug discuss treatment options to consider before taking (NSAID), does NOT cure your illness or prevent it from CELEBREX: getting worse. CELEBREX can only relieve pain and reduce swelling as long as you continue to take it. • Heart Attack or Angina • Stroke or Mini-stroke When it should not be used: • Loss of Vision Do not take CELEBREX if you have any of the • Congestive Heart Failure following medical conditions: • Current Pregnancy (less than 28 weeks) • Heart bypass surgery (planning to have or recently • Ulcer or bleeding from the gut had) • Severe, uncontrolled heart failure Also consult your healthcare provider if you are • Allergy to celecoxib or any of the other ingredients in taking a dose of CELEBREX which is higher than CELEBREX 200mg per day or if you have been taking • Allergy to sulfonamide drugs CELEBREX regularly for over 18 months. Patients in this situation have an increased risk of a serious • Allergy to ASA (Acetylsalicylic Acid) or other NSAIDs cardiovascular side effect such as the ones described (Nonsteroidal Anti-Inflammatory Drugs) above. • Pregnancy of more than 28 weeks (in your third trimester) • Currently breastfeeding (or planning to breastfeed) BEFORE you use CELEBREX talk to your doctor or • Ulcer (active) pharmacist if you have any of the following: • Bleeding from the stomach or gut (active) • Disease of the heart or blood vessels (also called • Bleeding in the brain or other bleeding disorders cardiovascular disease, including uncontrolled high CELEBREX (celecoxib) – Product Monograph Page 54 of 57 IMPORTANT: PLEASE READ blood pressure, congestive heart failure, established INTERACTIONS WITH THIS MEDICATION ischemic heart disease, or peripheral arterial disease) • Risk factors for cardiovascular disease (see above) such as high blood pressure, abnormally high levels of fat Talk to your health care provider and pharmacist if you are (cholesterol, triglycerides) in your blood taking any other medication (prescription or non-prescription) such as any of the following (NOT a complete list): • Diabetes mellitus or on a low sugar diet • Atherosclerosis • Acetylsalicylic acid (ASA) or other NSAIDs (e.g. • Poor circulation to your extremities diclofenac, ibuprofen, indomethacin, ketorolac, • Smoker or ex-smoker meloxicam, naproxen) • Kidney disease or urine problems • Antacids or proton pump inhibitors (omeprazole) • Previous ulcer or bleeding from the stomach or gut • Antidepressants [Selective serotonine receptor uptake • Previous bleeding in the brain inhibitor (SSRIs) (e.g. citalopram, paroxetine, fluoxetine, • Bleeding problems sertraline)] • Family history of allergy to sulfonamide drugs • Blood pressure medications, such as ACE (angiotensin • Family history of allergy to NSAIDs, such as converting enzyme) inhibitors (e.g. enalapril, lisinopril, acetylsalicylic acid (ASA), celecoxib, diclofenac, perindopril, ramipril), ARBs (angiotensin II receptor diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen, blockers) (e.g. candesartan, irbesartan, losartan, indomethacin, ketoprofen, ketorolac, mefenamic acid, valsartan), beta blockers (e.g. metoprolol) meloxicam, nabumetone, naproxen, oxaprozin, • Blood thinners (to prevent blood clots), such as warfarin, piroxicam, rofecoxib, sulindac, tenoxicam, tiaprofenic apixaban, rivaroxaban, dabigatran, ASA, clopidogrel acid, tolmetin, or valdecoxib (NOT a complete list) • Corticosteroids (including glucocorticoids) e.g. • Family history of asthma, nasal polyp, long-term prednisone swelling of the sinus (chronic sinusitis) or hives • Cyclosporin • Gastrointestinal problems (problems with your stomach • Digoxin and/or intestine) • Diuretics such as furosemide, hydrochlorothiazide • History of a severe drug hypersensitivity reaction • Fluconazole including skin problems • Lithium • Current pregnancy • Dextromethorphan (found in some cough medications) • Any other medical problem • Tacrolimus Fertility may be decreased. The use of CELEBREX is not Using CELEBREX with a blood thinner such as warfarin recommended in women who have difficulty conceiving. increases the risk of bleeding, which can be fatal, especially in older patients. Also, before taking this medication, tell your health care provider if you are planning to get pregnant. Your health care provider may prescribe low dose ASA (acetylsalicylic acid) as a blood thinner for the prevention of While taking this medication: having a heart attack or stroke while you are taking CELEBREX. Take only the amount of ASA prescribed by • tell any other doctor, dentist, pharmacist or other health your health care provider. You are more likely to upset or care professional that you see, that you are taking this damage your stomach if you take both CELEBREX and ASA medication, especially if you are planning to have heart than if you take CELEBREX alone. surgery; • do NOT drink alcoholic beverages while taking this medication because you would be more likely to develop PROPER USE OF THIS MEDICATION stomach problems; • If you have cardiovascular disease or risks for Dose: 18 years of age and older only cardiovascular disease, your doctor will periodically re- evaluate whether you should continue treatment with Medical Starting Maximum Maximum CELEBREX. Patients with these conditions should not Condition Dose Dose Duration of receive doses of CELEBREX higher than 200 mg per (per day) Treatment day. (days) Osteoarthritis 200 mg once 200 mg not If, at any time while taking CELEBREX you experience any (18 years of a day or 100 specified signs or symptoms of problems with your heart or blood age and older) mg twice a vessels such as chest pain, shortness of breath, weakness, or day slurring of speech, seek emergency medical treatment Rheumatoid 100 mg twice 400 mg not immediately. Arthritis a day specified CELEBREX (celecoxib) – Product Monograph Page 55 of 57 IMPORTANT: PLEASE READ (18 years of CELEBREX may cause you to become more sensitive to age and older) sunlight. Any exposure to sunlight or sunlamps may cause Ankylosing 200 mg once 200 mg not sunburn, skin blisters, skin rash, redness, itching or Spondylitis a day or 100 specified discolouration, or vision changes. If you have a reaction from (18 years of mg twice a the sun, check with your health care provider. age and older) day Pain 400 mg on 400 mg 7 days CELEBREX can cause abnormal laboratory test results. Your (18 years of first day, then doctor will decide when to perform laboratory tests and will age and older) 200 mg once interpret the results. They may check kidney function, liver a day function, amount of blood cells and other functions. Take CELEBREX only as directed by your health care Your doctor will decide when to measure the amount of your provider. Do NOT take more of it, do NOT take it more amniotic fluid during pregnancy. often and do NOT take it for a longer period of time than your health care provider recommended. If possible, you Check with your health care provider IMMEDIATELY if you should take the lowest dose of this medication for the develop chills, fever, muscle aches or pains, or other flu-like shortest time period.