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IMPORTANT: PLEASE READ

 Current pregnancy (after 28 weeks of pregnancy) PART III CONSUMER INFORMATION  Currently breastfeeding (or planning to breastfeed) Pr Sandoz-  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  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 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

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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), , diclofenac, following conditions, see your health care , , , , provider to discuss treatment options other , indomethacin, , , than Sandoz-Diclofenac or Sandoz-Diclofenac , , , SR: , , , , • Heart Attack or Angina , , , , or • Stroke or Mini-stroke (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

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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 such changed. as metformin)  Phenytoin (a medicine used to treat seizures). If, at any time while taking Sandoz-Diclofenac or  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 )  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 care provider and pharmacist if you you took Sandoz-Diclofenac or Sandoz-Diclofenac SR are taking any other medication (prescription or non- alone. prescription) such as any of the following (NOT a complete list): PROPER USE OF THIS MEDICATION  Acetaminophen  Acetylsalicylic Acid (ASA) or other NSAIDs Sandoz-Diclofenac or Sandoz-Diclofenac SR is used e.g. ASA, celecoxib, diclofenac, ibuprofen, for maintenance therapy only. indomethacin, ketorolac, meloxicam, naproxen  Alcohol Usual Dose for patients 16 years of age and older:  Antacids  Anti-depressants Medical Maintenance Maximum Dose

 Selective Serotonin Reuptake Inhibitors (SSRIs) Condition Dose (per day) e.g. citalopram, fluoxetine, paroxetine, sertraline  Blood pressure medications Sandoz-Diclofenac 50 mg enteric-coated tablets - ACE (angiotensin converting enzyme) Rheumatoid 50 mg twice 100 mg inhibitors e.g. enalapril, lisinopril, perindopril, Arthritis daily ramipril - ARBs (angiotensin II receptor blockers) e.g. Osteoarthritis 50 mg twice 100 mg candesartan, irbesartan, , valsartan daily - Beta-blockers e.g. metoprolol Sandoz-Diclofenac SR 75 & 100 mg slow-release  Blood thinners (medicine used to prevent blood- tablets clotting) e.g. warfarin, ASA, clopidogrel Rheumatoid 75 mg once 100 mg  Corticosteroids (including glucocorticoids) Arthritis daily (medicines used to provide relief for inflamed areas of the body) e.g. prednisone Osteoarthritis 75 mg once 100 mg  Cyclosporine (a medicine primarily used in daily patients who have received organ transplants) Sandoz-Diclofenac 50 mg and 100 mg suppositories  Digoxin (a medicine used for heart problems)

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Rheumatoid 50 mg once 100 mg Arthritis daily If you forget to take your scheduled dose, you should

not double the next scheduled dose to make up for the 50 mg once 100 mg Osteoarthritis missed dose. daily

Overdose: Take Sandoz-Diclofenac or Sandoz-Diclofenac SR only as directed by your health care provider. Do NOT take more of it, do NOT take it more often and do If you have accidentally taken more than the NOT take it for a longer period of time than your prescribed dose of Sandoz-Diclofenac tablets, health care provider recommended. If possible, you suppositories or Sandoz-Diclofenac SR tablets, should take the lowest dose of this medication for contact your doctor, pharmacist or poison the shortest time period. Taking too much Sandoz- control centre immediately or go to the hospital Diclofenac or Sandoz-Diclofenac SR may increase emergency unit at once. You may require medical your chances of unwanted and sometimes dangerous attention. side effects, especially if you are elderly and frail or if you have a low body weight, have other diseases or SIDE EFFECTS AND WHAT TO DO ABOUT take other medications. THEM

If you will be using Sandoz-Diclofenac or Sandoz- Sandoz-Diclofenac or Sandoz-Diclofenac SR may Diclofenac SR for more than 7 days, see your health cause some side effects, especially when used for a care provider regularly to discuss whether this long time or in large doses. When these side effects medicine is working for you and if it is causing you occur, you may require medical attention. Report all any unwanted effects. symptoms or side effects to your health care provider.

Swallow the tablet whole with water, do not chew or Sandoz-Diclofenac or Sandoz-Diclofenac SR may divide the tablet. It is best to take your dose at the same cause you to become drowsy or tired. Be careful about time each day. driving or participating in activities that require you to

be alert. If you become drowsy, dizzy or light-headed To help reduce the possibility of stomach upset you after taking Sandoz-Diclofenac or Sandoz-Diclofenac should take Sandoz-Diclofenac or Sandoz-Diclofenac SR, do NOT drive or operate machinery. SR tablets immediately after a meal or with food or milk. Also, you should remain standing or sitting Sandoz-Diclofenac or Sandoz-Diclofenac SR may upright (i.e. do not lie down) for about 15-30 minutes cause you to become more sensitive to sunlight. Any after taking the medicine. This helps to prevent exposure to sunlight or sunlamps may cause sunburn, irritation that may lead to trouble swallowing. If skin blisters, skin rash, redness, itching or stomach upset (indigestion, nausea, vomiting, stomach discolouration, or vision changes. If you have a pain or diarrhea) occurs and continues, contact your reaction from the sun, check with your health care doctor. provider.

Using Suppositories Check with your health care provider Sandoz-Diclofenac suppositories (50 and 100 mg) are IMMEDIATELY if you develop chills, fever, muscle wrapped in a plastic film. Make sure that the plastic aches or pains, or other flu-like symptoms, especially wrapping is fully removed before inserting the if they occur before or together with a skin rash. These suppository into the rectum. It is best to take the symptoms may be the first signs of a SERIOUS suppositories after emptying your bowels. ALLERGIC REACTION to this medication.

Do not take suppositories by mouth.

This medication has been prescribed specifically for you. Do NOT give it to anyone else. It may harm them, even if their symptoms seem to be similar to yours.

Missed dose:

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SERIOUS SIDE EFFECTS AND WHAT TO DO SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM ABOUT THEM Symptom STOP taking STOP taking Symptom STOP taking STOP taking Sandoz-Diclofenac Sandoz- Sandoz-Diclofenac Sandoz- or Sandoz- Diclofenac or or Sandoz- Diclofenac or Diclofenac SR and Sandoz- Diclofenac SR and Sandoz- get emergency Diclofenac get emergency Diclofenac medical attention SR and talk medical attention SR and talk IMMEDIATELY to your IMMEDIATELY to your physician physician or or pharmacist pharmacist Bloody or black √ and/or extremities tarry stools, (signs of vomiting blood angioedema) Spontaneous √ Vomiting or √ bleeding or persistent bruising (signs of indigestion, thrombocytopenia nausea, ) stomach pain or Shortness of √ diarrhea breath, wheezing, Chest pain and √ any trouble allergic reactions breathing or chest happening at the tightness same time (signs Skin rash, hives, √ of Kounis swelling or syndrome) itching Yellow √ Skin rash with √ discolouration of

flacking or the skin or eyes peeling (signs of (signs of liver dermatitis failure), with exfoliative). or without itchy Purple skin √ skin patches (signs of Malaise, fatigue, √ purpura or loss of appetite or Henoch- « flu-like » Schonlein purpura symptoms if caused by an Headaches, stiff √ allergy). neck, fever, Blurred vision, or √ nausea, vomiting any visual (signs of aseptic disturbance meningitis) Any change in the √ Mental confusion, √ amount or colour depression of your Dizziness, √ urine (red or lightheadedness brown) Hearing problems √ Any pain or √ Rectal itching or √ difficulty bleeding experienced while Right upper √ urinating abdominal Swelling of the √ discomfort or pain feet, lower legs; weight gain Swelling mainly √ This is NOT a complete list of side effects. If you of the face, throat, develop any other symptoms while taking Sandoz- lips, tongue,

Sandoz-Diclofenac and Sandoz-Diclofenac SR Page 39 of 40 IMPORTANT: PLEASE READ

Diclofenac and/or Sandoz-Diclofenac SR, see your Or by written request at: health care provider. 110 rue de Lauzon Boucherville QC HOW TO STORE IT J4B 1E6

Protect tablets from heat (i.e., store at temperatures Or by e-mail at: between 15°C-30°C) and humidity. [email protected]

Protect suppositories from heat (i.e., store at This leaflet was prepared by Sandoz Canada Inc, temperatures between 15°C-30°C).

Do NOT keep outdated medicine or medicine no Last revised: January 06, 2020 longer needed. Any outdated or unused medicine should be returned to your pharmacist.

Keep this and all medication out of the reach of children.

REPORTING SUSPECTED SIDE EFFECTS

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

 Visiting the Web page on Adverse Reaction Reporting ( https://www.canada.ca/en/health- canada/services/drugs-health- products/medeffect-canada/adverse- reaction-reporting.html ) for information on how to report online, by mail or by fax; or  Calling toll-free at 1-866-234-2345.

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- Diclofenac or Sandoz-Diclofenac SR:

 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 (https://www.canada.ca/en/health- canada.html); the manufacturer’s website www.sandoz.ca, or by calling 1-800-361- 3062

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