IMPORTANT: PLEASE READ Current pregnancy (after 28 weeks of pregnancy) PART III CONSUMER INFORMATION Currently breastfeeding (or planning to breastfeed) Pr Sandoz-Diclofenac Allergy (hypersensitivity) to diclofenac Pr Sandoz-Diclofenac SR sodium, or ASA (Acetylsalicylic Acid) or other (diclofenac sodium) NSAIDs (Nonsteroidal Anti- Inflammatory Drugs), or any of the nonmedicinal ingredients Read this information each time you refill your in Sandoz-Diclofenac or Sandoz-Diclofenac prescription in case new information has been SR added. Ulcer (active) Bleeding or perforation from the stomach or This leaflet is Part III of a three-part "Product gut (active) Monograph" published when PrSandoz-Diclofenac Inflammatory bowel disease (Crohn’s Disease and PrSandoz-Diclofenac SR were approved for or Ulcerative Colitis) sale in Canada and is designed specifically for Liver disease (active or severe) Consumers. This leaflet is a summary and will Kidney problems (severe or worsening) NOT tell you everything about Sandoz-Diclofenac High potassium in the blood or Sandoz-Diclofenac SR. Contact your doctor or pharmacist if you have any questions about the Do not use Sandoz-Diclofenac suppositories if you drug. have inflammation of the rectum or anus or have a recent history of bleeding from the rectum or anus. ABOUT THIS MEDICATION Patients who took a drug in the same class as What the Medication is used for: Sandoz-Diclofenac and Sandoz-Diclofenac SR after a type of heart surgery (coronary artery bypass Your health care provider has prescribed Sandoz- grafting (CABG)) were more likely to have heart Diclofenac or Sandoz-Diclofenac SR for you to relieve attacks, strokes, blood clots in the leg(s) or lung(s), pain and swelling in rheumatoid arthritis and and infections or other complications than those osteoarthritis, including degenerative joint disease of who did NOT take that drug. the hip. Sandoz-Diclofenac and Sandoz-Diclofenac SR should What it does: NOT be used in patients under 16 years of age since the safety and effectiveness have NOT been Sandoz-Diclofenac and Sandoz-Diclofenac SR established. (diclofenac sodium), as nonsteroidal anti- inflammatory drugs (NSAIDs), can reduce the What the medicinal ingredient is: chemicals prostaglandins produced by your body which cause pain and swelling. diclofenac sodium. Sandoz-Diclofenac and Sandoz-Diclofenac SR, as What the non-medicinal ingredients are: nonsteroidal anti-inflammatory drugs (NSAIDs) do NOT cure your illness or prevent it from getting worse. The enteric coated 50 mg tablets (Sandoz Diclofenac) Sandoz-Diclofenac or Sandoz-Diclofenac SR can only contain black ink, castor oil derivatives, colloidal relieve pain and reduce swelling as long as you silicon dioxide, corn starch, hypromellose, iron continue to take it. oxides, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium When it should not be used: starch glycolate, talc, titanium dioxide. DO NOT TAKE Sandoz-Diclofenac or Sandoz- The slow-release 75 mg and 100 mg tablets (Sandoz- Diclofenac SR if you have any of the following Diclofenac SR) contain black ink, carnauba wax, conditions: cellulose compounds, cetyl alcohol, colloidal silicon Heart bypass surgery (planning to have or dioxide, hypromellose magnesium stearate, recently had) polysorbate 80, povidone, red iron oxide, sucrose, talc, Severe, uncontrolled heart failure titanium dioxide. Bleeding in the brain or other bleeding disorders Sandoz-Diclofenac and Sandoz-Diclofenac SR Page 35 of 40 IMPORTANT: PLEASE READ The 50 mg and 100 mg suppositories contain semi- Before taking this medication, tell your health care synthetic glycerides. provider if you have any of the following: What dosage forms it comes in: Disease of the heart or blood vessels (also called cardiovascular disease, including uncontrolled Sandoz-Diclofenac 50 mg (enteric-coated) tablet: light high blood pressure, congestive heart failure, brown, round, S on one side and 50 on the other. established ischemic heart disease, or peripheral arterial disease), as treatment with Sandoz- Sandoz Diclofenac 75 mg Slow Release (SR) tablet: Diclofenac and Sandoz-Diclofenac SR in these light pink, triangular, SR 75 on one side and plain on cases is not recommended. the other. Risk factors for cardiovascular disease (see above) such as high blood pressure, abnormally high Sandoz-Diclofenac 100 mg Slow Release (SR) tablet: levels of fat (cholesterol, triglycerides) in your pink, round, SR 100 on one side and plain on the other. blood, diabetes, or if you smoke. Diabetes mellitus or on a low sugar diet Sandoz-Diclofenac 50 mg and 100 mg Suppositories: Atherosclerosis Bullet shaped, white to yellowish-white colour, with a Poor circulation to your extremities smooth surface with a fat like odour. Kidney disease or urine problems Previous ulcer or bleeding from the stomach or gut Check with your pharmacist if the identifying If you recently had a surgery of the stomach or markings or colour appear different. intestinal tract (intestines, colon, rectum, anus) Previous bleeding in the brain WARNINGS AND PRECAUTIONS Bleeding problems Family history of allergy to NSAIDs, such as If you have, or previously had, any of the acetylsalicylic acid (ASA), celecoxib, diclofenac, following conditions, see your health care diflunisal, etodolac, fenoprofen, flurbiprofen, provider to discuss treatment options other ibuprofen, indomethacin, ketoprofen, ketorolac, than Sandoz-Diclofenac or Sandoz-Diclofenac mefenamic acid, meloxicam, nabumetone, SR: naproxen, oxaprozin, piroxicam, rofecoxib, • Heart Attack or Angina sulindac, tenoxicam, tiaprofenic acid, tolmetin, or • Stroke or Mini-stroke valdecoxib (NOT a complete list) • Loss of Vision Family history of asthma, nasal polyps, long-term • Current Pregnancy (less than 28 weeks) swelling of the sinus (chronic sinusitis) or hives • Congestive Heart Failure High blood pressure Also, before taking this medication, tell your health Diabetes care provider if you are pregnant or you are planning High levels of fats in your blood to get pregnant. Smoking While taking this medication: It is important to take the lowest dose of Tell any other doctor, dentist, pharmacist or other Sandoz-Diclofenac and Sandoz-Diclofenac SR health care professional that you see, that you are that relieves your pain and/or swelling and for taking this medication, especially if you are the shortest time possible in order to keep your planning to have heart surgery, or surgery of the risk of side effects on the heart and blood stomach or intestinal tract; vessels as small as possible. Do NOT drink alcoholic beverages while taking this medication because you would be more likely Use of NSAIDS, such as Sandoz-Diclofenac and to develop stomach problems; Sandoz-Diclofenac SR can result in increased Fertility may be decreased. The use of Sandoz- blood pressure and /or worsening of congestive Diclofenac or Sandoz-Diclofenac SR is not heart failure. recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping Use of NSAIDs, such as Sandoz-Diclofenac and Sandoz-Diclofenac or Sandoz-Diclofenac SR Sandoz-Diclofenac SR, may cause stomach and should be considered. bowel problems (such as ulceration, If you have cardiovascular disease or risks for perforation, obstruction and bleeding). cardiovascular disease, your doctor will periodically re-evaluate whether you should Sandoz-Diclofenac and Sandoz-Diclofenac SR Page 36 of 40 IMPORTANT: PLEASE READ continue treatment with Sandoz-Diclofenac or Diuretics (medicines used to increase the amount Sandoz-Diclofenac SR. of urine) e.g. furosemide, hydrochlorothiazide Your doctor will monitor your kidney function, Lithium your liver function and your blood count to decide Methotrexate (a medicine used to treat some if Sandoz-Diclofenac or Sandoz-Diclofenac SR kinds of cancer or arthritis) needs to be discontinued or if the dose needs to be Oral hypoglycemics (diabetes medications such changed. as metformin) Phenytoin (a medicine used to treat seizures). If, at any time while taking Sandoz-Diclofenac or Probenecid Sandoz-Diclofenac SR you experience any signs or Quinolone antibacterials (medicines used against symptoms of problems with your heart or blood infection) vessels such as chest pain, shortness of breath, Rifampin (an antibiotic medicine used to treat weakness, or slurring of speech, contact your doctor bacterial infections) immediately. Sulfinpyrazone (a medicine used to treat gout) Tacrolimus (a medicine primarily used in patients Long-term use of Sandoz-Diclofenac or Sandoz- who have received organ transplants) Diclofenac SR might increase the risk of heart Trimethoprim (a medicine used to prevent or treat attacks or strokes. urinary tract infection) Voriconazole (a medicine used to treat fungal Sandoz-Diclofenac or Sandoz-Diclofenac SR is infections) NOT recommended for use in patients under 16 years of age since safety and effectiveness have Your health care provider may prescribe low dose NOT been established. ASA (acetylsalicylic acid) as a blood thinner to reduce your risk of having a heart attack or stroke while you INTERACTIONS WITH THIS MEDICATION are taking Sandoz-Diclofenac or Sandoz-Diclofenac SR. Take only the amount of ASA prescribed by your What About Taking Other Drugs At The Same health care provider. You are more likely to upset or Time? damage your stomach if you take both Sandoz- Diclofenac or Sandoz-Diclofenac SR and ASA than if See your health