Dom-Diclofenac: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the Medication is used for:

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

Dom-DICLOFENAC and Dom-DICLOFENAC-SR is used for maintenance therapy only.

What it does:

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

Dom-DICLOFENAC and Dom-DICLOFENAC-SR, as nonsteroidal anti-inflammatory drugs (NSAIDs) do NOT cure your illness or prevent it from getting worse. Dom-DICLOFENAC or Dom-DICLOFENAC-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 Dom-DICLOFENAC or Dom-DICLOFENAC-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 Dom-DICLOFENAC or Dom-DICLOFENAC-SR

• Ulcer (active)

• Bleeding from the stomach or gut (active)

  • Inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis)
  • Liver disease (active or severe)
  • Kidney disease (severe or worsening)
  • High potassium in the blood

Patients who took a drug in the same class as Dom-DICLOFENAC and Dom-DICLOFENAC-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.

Dom-DICLOFENAC and Dom-DICLOFENAC-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:

The enteric coated 25 and 50 mg tablets (Dom-DICLOFENAC) contain black ink, castor oil derivatives, colloidal silicon dioxide, corn starch, hypromellose, iron oxides, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, talc, titanium dioxide.

The slow-release 75 mg and 100 mg tablets (Dom-DICLOFENAC-SR) contain black ink, carnauba wax, cellulose compounds, cetyl alcohol, colloidal silicon dioxide, hypromellose magnesium stearate, polysorbate 80, povidone, red iron oxide, sucrose talc, titanium dioxide.

What dosage forms it comes in:

Dom-DICLOFENAC

• 25 and 50 mg tablets (enteric coated)

Dom-DICLOFENAC-SR

• 75 and 100 mg slow release tablets

WARNINGS AND PRECAUTIONS

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

• Heart Attack or Angina
• Stroke or Mini-stroke
• Loss of Vision
• Current Pregnancy (less than 28 weeks)
• Congestive Heart Failure

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

• High blood pressure
• High cholesterol
• Diabetes mellitus or on a low sugar diet
• Atherosclerosis
• Poor circulation to your extremities
• Smoker or ex-smoker
• Kidney disease or urine problems
• Previous ulcer or bleeding from the stomach or gut
• 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;

• 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 Dom-DICLOFENAC

  or Dom-DICLOFENAC-SR is not recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping Dom-DICLOFENAC or Dom-DICLOFENAC-SR should be considered.

Long-term use of Dom-DICLOFENAC or Dom-DICLOFENAC-SR might increase the risk of heart attacks or strokes.

INTERACTIONS WITH THIS MEDICATION

What About Taking Other Drugs At The Same Time?

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

• Cyclosporin or tacrolimus (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)
• Probenecid
• Quinolone antibacterials (medicines used against infection)

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 Dom-DICLOFENAC or Dom-DICLOFENAC-SR. Take only the amount of ASA prescribed by your health care provider. You are more likely to upset or damage you stomach if you take both Dom-DICLOFENAC or Dom-DICLOFENAC-SR and ASA than if you took Dom-DICLOFENAC or Dom-DICLOFENAC-SR alone.

PROPER USE OF THIS MEDICATION

Usual Dose:

^Δ If your symptoms are not adequately controlled, you should contact your doctor, who may increase the total daily dose to a maximum of 150 mg in divided doses for a short period and with close monitoring. If you are older than 65 years, have liver

problems, kidney problems, or heart problems, the maximum total dose per day should not exceed 100 mg of Dom-DICLOFENAC (50 mg twice a day).

Take Dom-DICLOFENAC or Dom-DICLOFENAC-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 Dom-DICLOFENAC or Dom-DICLOFENAC-SR may increase your chances of unwanted and sometimes dangerous side effects, especially if you are elderly, have other diseases or take other medications.

If you will be using Dom-DICLOFENAC or Dom-DICLOFENAC-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.

Dom-DICLOFENAC (enteric coated tablets): Dom-DICLOFENAC tablets are an extended release product. The tablets should be swallowed whole with water, and must not be divided or chewed.

Taking Dom-DICLOFENAC-SR Tablets Once A Day If you are taking Dom-DICLOFENAC-SR 100 mg tablet or Dom-DICLOFENAC-SR 75 mg tablet once a day, it is best to take this tablet at the same time each day unless your doctor has told you differently.

Taking Dom-DICLOFENAC-SR Tablets Twice A Day If your doctor has prescribed 150 mg of Dom-DICLOFENAC-SR for a short period of time, you should take Dom-DICLOFENAC-SR 75 mg tablet twice a day, in the morning and evening.

To help reduce the possibility of stomach upset you should take Dom-DICLOFENAC or Dom-DICLOFENAC-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 15-30 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.

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

Missed dose:

If you forget to take one or more doses of Dom-DICLOFENAC (diclofenac sodium) 25 or 50 mg tablets or Dom-DICLOFENAC-SR (diclofenac sodium) 75 and 100 mg tablets, you should not increase the dose of Dom-DICLOFENAC (diclofenac sodium) or

Dom-DICLOFENAC-SR to make up for the missed dose or doses, but you should continue taking your tablet or suppository at the next prescribed or regular time.

Overdose:

If you have accidentally taken more than the prescribed dose of Dom-DICLOFENAC tablets or Dom-DICLOFENAC-SR tablets, contact your doctor, pharmacist or poison control centre immediately or go to the hospital emergency unit at once. You may require medical attention.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Dom-DICLOFENAC or Dom-DICLOFENAC-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.

Dom-DICLOFENAC or Dom-DICLOFENAC-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 Dom-DICLOFENAC or Dom-DICLOFENAC-SR, do NOT drive or operate machinery.

Dom-DICLOFENAC or Dom-DICLOFENAC-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.

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

HOW TO STORE IT

Protect tablets from heat (i.e., store at temperatures between 15°C-30°C) and 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 SUSPECTED SIDE EFFECTS

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Dominion Pharmacal. at, 1-888-550-6060.

Dominion Pharmacal Inc.

Montreal Quebec

H4P 2T4

Last revised: April 19, 2010

REPORTING SUSPECTED SIDE-EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program

    Health Canada

    Postal Locator 0701C

    Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect ^TM Canada Web site at www.healthcanada.gc.ca/medeffect .

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.