Ava-Diclofenac: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the Medication is used for:

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

What it does:

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

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

  DICLOFENAC or AVA-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 AVA-DICLOFENAC and AVA-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.

AVA-DICLOFENAC and AVA-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 mg and 50 mg tablets (AVA-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 (AVA-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:

AVA-DICLOFENAC 25 mg (enteric-coated) tablet: yellow, round, S on one side and 25 on the other.

AVA-DICLOFENAC 50 mg (enteric-coated) tablet: light brown, round, S on one side and 50 on the other.

AVA-DICLOFENAC 75 mg Slow Release (SR) tablet: light pink, triangular, S on one side and SR 75 on the other.

AVA-DICLOFENAC 100 mg Slow Release (SR) tablet: pink, round, S on one side and SR100 on the other.

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

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 AVA-DICLOFENAC or AVA-DICLOFENAC SR:

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

Use of NSAIDs, such as AVA-DICLOFENAC and AVA-DICLOFENAC SR, may cause gastrointestinal problems (such as peptic/duodenal ulceration, perforation, obstruction and gastrointestinal bleeding).

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 AVA-

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

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

AVA-DICLOFENAC or AVA-DICLOFENAC 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

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 (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)
• Phenytoin (a medicine used to treat seizures).
• Probenecid
• Quinolone antibacterials (medicines used against infection)
• Sulfinpyrazone (a medicine used to treat gout)
• Tacrolimus (a medicine primarily used in patients who have received organ transplants)
• 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 AVA-DICLOFENAC or AVA-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 AVA-DICLOFENAC or AVA-DICLOFENAC SR and ASA than if you took AVA-DICLOFENAC or AVA-DICLOFENAC SR alone.

PROPER USE OF THIS MEDICATION

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

Usual Dose for patients 16 years of age and older:

^Δ If required, the maximum daily dose of 150 mg may be prescribed by your doctor in divided doses for a short period of time and under 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 AVA-DICLOFENAC (50 mg twice a day).

Take AVA-DICLOFENAC or AVA-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 AVA-DICLOFENAC or AVA-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 AVA-DICLOFENAC or AVA-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.

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 AVA-DICLOFENAC or AVA-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.

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.

Overdose:

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

AVA-DICLOFENAC or AVA-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.

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

AVA-DICLOFENAC or AVA-DICLOFENAC SR may cause you to become more sensitive to sunlight. Any If you have accidentally taken more than the prescribed dose of AVA-DICLOFENAC tablets or AVA-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.

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

This is NOT a complete list of side effects. If you develop any other symptoms while taking AVA-DICLOFENAC and/or AVA-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

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:

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• 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 0701E Ottawa, Ontario

    K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ 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.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor,Avanstra Inc., at:

1-855-708-36-78

Or by e-mail at :

medinfo@avanstra.com