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Details for: APO-DICLO SR

Company: APOTEX INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02162814APO-DICLO SRDICLOFENAC SODIUM75 MGTABLET (EXTENDED-RELEASE)ORAL
02091194APO-DICLO SRDICLOFENAC SODIUM100 MG / SRTTABLET (EXTENDED-RELEASE)ORAL
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

Your health care provider has prescribed APO-DICLO or APO-DICLO SR for you to relieve pain and swelling in rheumatoid arthritis and osteoarthritis, including degenerative joint disease of the hip.

What it does

APO-DICLO and APO-DICLO SR (diclofenac sodium), as nonsteroidal anti-inflammatory drugs (NSAIDs), can reduce the chemicals prostaglandins produced by your body which cause pain and swelling.

APO-DICLO and APO-DICLO SR, as nonsteroidal anti-inflammatory drugs (NSAIDs) do NOT cure your illness or prevent it from getting worse. APO-DICLO or APO-DICLO SR can only relieve pain and reduce swelling as long as you continue to take it.

When it should not be used

DO NOT TAKE APO-DICLO or APO-DICLO SR if you have any of the following conditions:

  • Heart bypass surgery (planning to have or recently had)
  • Severe, uncontrolled heart failure
  • Bleeding in the brain or other bleeding disorders
  • Current pregnancy (after 28 weeks of pregnancy)
  • Currently breastfeeding (or planning to breastfeed)
  • Allergy (hypersensitivity) to diclofenac sodium, or ASA (Acetylsalicylic Acid) or other NSAIDs (Nonsteroidal Anti- Inflammatory Drugs), or any of the nonmedicinal ingredients in APO-DICLO or APO-DICLO SR.
  • Ulcer (active)
  • Bleeding or perforation from the stomach or gut (active)
  • Inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis)
  • Liver disease (active or severe)
  • Kidney problems (severe or worsening)
  • High potassium in the blood

Patients who took a drug in the same class as APO-DICLO and APO-DICLO SR after a type of heart surgery (coronary artery bypass grafting (CABG)) were more likely to have heart attacks, strokes, blood clots in the leg(s) or lung(s), and infections or other complications than those who did NOT take that drug.

APO-DICLO and APO-DICLO SR should NOT be used in patients under 16 years of age since the safety and effectiveness have NOT been established.

What the medicinal ingredient is

diclofenac sodium

What the non-medicinal ingredients are

Each enteric coated tablet contains the non-medicinal ingredients colloidal silicon dioxide, dextrates, D&C yellow #10 (25 mg tablet) FD & C yellow #6, ferric oxide yellow, hydroxypropyl methylcellulose, methanol, magnesium stearate, methylcellulose, polyethylene glycol, polyvinylacetate phthalate stearic acid, titanium dioxide and triethyl citrate.

Each slow release tablet contains the non-medicinal ingredients dextrates, ferric oxide red, hydroxyethyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide.

What dosage form it comes in

APO-DICLO 25 mg (enteric coated): yellow, round, identified ‘25’ on one side.

APO-DICLO 50 mg (enteric coated): light brown, round, identified ‘50’ on one side.

APO-DICLO SR (slow release) 75 mg: light pink, triangular, identified ‘APO’ over ‘75’ on one side.

APO-DICLO SR (slow release) 100 mg: pink, round, identified ‘APO’ over ‘100’ on one side.

Check with your pharmacist if the identifying markings or color appear different.

Warnings and precautions

Serious Warnings and Precautions

If you have, or previously had, any of the following conditions, see your health care provider to discuss treatment options other than APO-DICLO or APO-DICLO SR:

  • Heart Attack or Angina
  • Stroke or Mini-stroke
  • Loss of Vision
  • Current Pregnancy (less than 28 weeks)
  • Congestive Heart Failure
  • High blood pressure
  • Diabetes
  • High levels of fats in your blood
  • Smoking

It is important to take the lowest dose of APO- DICLO and APO-DICLO SR that relieves your pain and/or swelling and for the shortest time possible in order to keep your risk of side effects on the heart and blood vessels as small as possible.

Use of NSAIDS, such as APO-DICLO and/or APO- DICLO SR can result in increased blood pressure and /or worsening of congestive heart failure.

Use of NSAIDs, such as APO-DICLO and APO- DICLO SR, may cause stomach and bowel problems (such as ulceration, perforation, obstruction and bleeding).

Before taking this medication, tell your health care provider if you have any of the following:

  • Disease of the heart or blood vessels (also called cardiovascular disease, including uncontrolled high blood pressure, congestive heart failure, established ischemic heart disease, or peripheral arterial disease), as treatment with APO-DICLO and APO-DICLO SR in these cases is not recommended.
  • Risk factors for cardiovascular disease (see above) such as high blood pressure, abnormally high levels of fat (cholesterol, triglycerides) in your blood, diabetes, or if you smoke.
  • Diabetes mellitus or on a low sugar diet
  • Atherosclerosis
  • Poor circulation to your extremities
  • Kidney disease or urine problems
  • Previous ulcer or bleeding from the stomach or gut
  • If you recently had a surgery of the stomach or intestinal tract (intestines, colon, rectum, anus)
  • Previous bleeding in the brain
  • Bleeding problems
  • Family history of allergy to NSAIDs, such as acetylsalicylic acid (ASA), celecoxib, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, meloxicam, nabumetone, naproxen, oxaprozin, piroxicam, rofecoxib, sulindac, tenoxicam, tiaprofenic acid, tolmetin, or valdecoxib (NOT a complete list)
  • Family history of asthma, nasal polyps, long-term swelling of the sinus (chronic sinusitis) or hives

Also, before taking this medication, tell your health care provider if you are planning to get pregnant.

While taking this medication:

  • Tell any other doctor, dentist, pharmacist or other health care professional that you see, that you are taking this medication, especially if you are planning to have heart surgery, or surgery of the stomach or intestinal tract;
  • Do NOT drink alcoholic beverages while taking this medication because you would be more likely to develop stomach problems;
  • Fertility may be decreased. The use of APO- DICLO or APO-DICLO SR is not recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping APO-DICLO or APO-DICLO SR should be considered.
  • If you have cardiovascular disease or risks for cardiovascular disease, your doctor will periodically re-evaluate whether you should continue treatment with APO-DICLO or APO- DICLO SR.
  • Your doctor will monitor your kidney function, your liver function and your blood count to decide if APO-DICLO or APO-DICLO SR needs to be discontinued or if the dose needs to be changed.

If, at any time while taking APO-DICLO or APO- DICLO SR you experience any signs or symptoms of problems with your heart or blood vessels such as chest pain, shortness of breath, weakness, or slurring of speech, contact your doctor immediately.

Long-term use of APO-DICLO or APO-DICLO SR might increase the risk of heart attacks or strokes.

APO-DICLO or APO-DICLO SR is NOT recommended for use in patients under 16 years of age since safety and effectiveness have NOT been established.

Interactions with this medication

See your health care provider and pharmacist if you are taking any other medication (prescription or non- prescription) such as any of the following (NOT a complete list):

  • Acetaminophen
  • Acetylsalicylic Acid (ASA) or other NSAIDs e.g. ASA, celecoxib, diclofenac, ibuprofen, indomethacin, ketorolac, meloxicam, naproxen
  • Alcohol
  • Antacids
  • Anti-depressants
  • Selective Serotonin Reuptake Inhibitors (SSRIs) e.g. citalopram, fluoxetine, paroxetine, sertraline
  • Blood pressure medications
    • ACE (angiotensin converting enzyme) inhibitors e.g. enalapril, lisinopril, perindopril,ramipril ARBs (angiotensin II receptor blockers) e.g. candesartan, irbesartan, losartan, valsartan
    • Beta-blockers e.g. metoprolol
  • Blood thinners (medicine used to prevent blood clotting) e.g.warfarin, ASA, clopidogrel
  • Corticosteroids (including glucocorticoids) (medicines used to provide relief for inflamed areas of the body) e.g. prednisone
  • Cyclosporine (a medicine primarily used in patients who have received organ transplants)
  • Digoxin (a medicine used for heart problems)
  • Diuretics (medicines used to increase the amount of urine) e.g.furosemide, hydrochlorothiazide
  • Lithium
  • Methotrexate (a medicine used to treat some kinds of cancer or arthritis)
  • Oral hypoglycemics (diabetes medications such as metformin)
  • Phenytoin (a medicine used to treat seizures).
  • Probenecid
  • Quinolone antibacterials (medicines used against infection)
  • Rifampin (an antibiotic medicine used to treat bacterial infections)
  • Sulfinpyrazone (a medicine used to treat gout)
  • Tacrolimus (a medicine primarily used in patients who have received organ transplants)
  • Trimethoprim (a medicine used to prevent or treat urinary tract infection)
  • Voriconazole (a medicine used to treat fungal infections)

Your health care provider may prescribe low dose ASA (acetylsalicylic acid) as a blood thinner to reduce your risk of having a heart attack or stroke while you are taking APO-DICLO or APO-DICLO SR. Take only the amount of ASA prescribed by your health care provider. You are more likely to upset or damage your stomach if you take both APO-DICLO or APO-DICLO SR and ASA than if you took APO-DICLO or APO- DICLO SR alone.

Proper use of this medication

APO-DICLO and APO-DICLO S is used for maintenance therapy only.

Usual Dose

Medical Condition Maintenance Dose Maximum Dose (per day)
APO-DICLO 25 mg and 50 mg enteric coated tablets
Rheumatoid Arthritis 50 mg twice daily 100 mg
Osteoarthritis 50 mg twice daily 100 mg
APO-DICLO SR 75 mg and 100 mg slow release tablets
Rheumatoid Arthritis 75 mg once daily 100 mg
Osteoarthritis 75 mg once daily 100 mg

Take APO-DICLO or APO-DICLO SR only as directed by your health care provider. Do NOT take more of it, do NOT take it more often and do NOT take it for a longer period of time than your health care provider recommended. If possible, you should take the lowest dose of this medication for the shortest time period. Taking too much APO-DICLO or APO-DICLO SR may increase your chances of unwanted and sometimes dangerous side effects, especially if you are elderly and frail or if you have a low body weight, have other diseases or take other medications.

If you will be using APO-DICLO or APO-DICLO SR for more than 7 days, see your health care provider regularly to discuss whether this medicine is working for you and if it is causing you any unwanted effects.

Swallow the tablet whole with water, do not chew or divide the tablet. It is best to take your dose at the same time each day.

To help reduce the possibility of stomach upset you should take APO-DICLO or APO-DICLO SR tablets immediately after a meal or with food or milk. Also, you should remain standing or sitting upright (i.e. do not lie down) for about 15 to 30 minutes after taking the medicine. This helps to prevent irritation that may lead to trouble swallowing. If stomach upset (indigestion, nausea, vomiting, stomach pain or diarrhea) occurs and continues, contact your doctor.

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.

Overdose

If you think you have taken too much APO-DICLO TABLETS or APO-DICLO SR, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose

If you forget to take your scheduled dose, you should not double the next scheduled dose to make up for the missed dose.

Side effects and what to do about them

APO-DICLO or APO-DICLO SR may cause some side effects, especially when used for a long time or in large doses. When these side effects occur, you may require medical attention. Report all symptoms or side effects to your health care provider.

APO-DICLO or APO-DICLO SR may cause you to become drowsy or tired. Be careful about driving or participating in activities that require you to be alert. If you become drowsy, dizzy or light-headed after taking APO-DICLO or APO-DICLO SR, do NOT drive or operate machinery.

APO-DICLO or APO-DICLO SR may cause you to become more sensitive to sunlight. Any exposure to sunlight or sunlamps may cause sunburn, skin blisters, skin rash, redness, itching or discolouration, or vision changes. If you have a reaction from the sun, check with your health care provider.

Check with your health care provider IMMEDIATELY if you develop chills, fever, muscle aches or pains, or other flu-like symptoms, especially if they occur before or together with a skin rash. These symptoms may be the first signs of a SERIOUS ALLERGIC REACTION to this medication.

Serious side effects and what to do about them
Symptom / effect STOP taking APO-DICLO or APO-DICLO SR and get emergency medical attention IMMEDIATELY STOP taking APO-DICLO or APO-DICLO SR and talk to your physician or pharmacist
Bloody or black tarry stools, vomiting blood  
Spontaneous bleeding or bruising (signs of thrombocytopenia)  
Shortness of breath, wheezing, any trouble breathing or chest tightness  
Skin rash, hives, swelling or itching  
Skin rash with flacking or peeling (signs of dermatitis exfoliative).  
Purple skin patches (signs of purpura or Henoch-Schonlein purpura if caused by an allergy).  
Blurred vision, or any visual disturbance  
Any change in the amount or colour of your urine (red or brown)  
Any pain or difficulty experienced while urinating  
Swelling of the feet, lower legs; weight gain  
Swelling mainly of the face, throat, lips, tongue, and/or extremities (signs of angioedema)  
Vomiting or persistent indigestion, nausea, stomach pain or diarrhea  
Chest pain and allergic reactions happening at the same time (signs of Kounis syndrome)  
Yellow discolouration of the skin or eyes (signs of liver failure), with or without itchy skin  
Malaise, fatigue, loss of appetite or « flu-like » symptoms  
Headaches, stiff neck, fever, nausea, vomiting (signs of aseptic meningitis)  
Mental confusion, depression  
Dizziness, lightheadedness  
Hearing problems  
Rectal itching or bleeding  
Right upper abdominal discomfort or pain  

This is NOT a complete list of side effects. If you develop any other symptoms while taking APO- DICLO and/or APO-DICLO SR, see your health care provider.

How to store

Store at room temperature between (15°C to 30°C) and protect from high humidity.

Do NOT keep outdated medicine or medicine no 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 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 for information on how to report online, by mail or by fax; or
  • Call 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 APO-DICLO or APO-DICLO SR:

  • Talk to your doctor or pharmacist.
  • Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website. Find the Consumer Information on the manufacturer’s website or by calling 1-800-667-4708.

This leaflet was prepared by Apotex Inc., Toronto,
Ontario, M9L 1T9.

Date of revision: January 28, 2020

Date modified: