NTP-Diclofenac Potassium: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the Medication is used for:

Your health care provider has prescribed NTP-DICLOFENAC POTASSIUM for short term treatment of acute, mild to moderate severe pain that may be accompanied with swelling (inflammation) in conditions such as sprains, tooth extraction, episiotomy (a surgical cut made just before delivery to enlarge vaginal opening), and dysmenorhea (painful menstrual periods).

What it does:

NTP-DICLOFENAC POTASSIUM (diclofenac potassium), as a nonsteroidal anti-inflammatory drug (NSAID), can reduce the chemicals prostaglandins produced by your body which cause pain and swelling.

NTP-DICLOFENAC POTASSIUM, as a nonsteroidal antiinflammatory drug (NSAID) does NOT cure your illness or prevent it from getting worse. NTP-DICLOFENAC POTASSIUM can only relieve pain and reduce swelling as long as you continue to take it.

When it should not be used:

DO NOT TAKE NTP-DICLOFENAC POTASSIUM 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 potassium,

  or ASA (Acetylsalicylic Acid) or other NSAIDs (Nonsteroidal Anti-Inflammatory Drugs), or any of the nonmedicinal ingredients in NTP-DICLOFENAC POTASSIUM

• 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 NTP-DICLOFENAC POTASSIUM 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.

NTP-DICLOFENAC POTASSIUM 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 Potassium

What the nonmedicinal ingredients are:

Each 50 mg tablet contains: calcium phosphate, corn starch, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate.

The film coating contains: hydroxypropyl methylcellulose, maltodextrin, polydextrose, polyethylene glycol, synthetic red iron oxide, synthetic yellow iron oxide, titanium dioxide, triacetin.

What dosage forms it comes in:

50 mg Tablets

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 NTP-DICLOFENAC POTASSIUM.

• 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

• Any other medical problem such as alcohol abuse

• Any side effects from medicines for arthritis,

  rheumatism or sore joints that you have taken in the past

• A history of stomach upset
• Are on any special diet, such as a low-sodium diet

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 NTP-

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

Long-term use of NTP-DICLOFENAC POTASSIUM might increase the risk of heart attacks or strokes

INTERACTIONS WITH THIS MEDICATION

Talk to 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 enzymes) 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 (medicines 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 NTP-DICLOFENAC POTASSIUM. 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 NTP-DICLOFENAC POTASSIUM and ASA than if you took NTP-DICLOFENAC POTASSIUM alone.

PROPER USE OF THIS MEDICATION

Usual dose:

Take NTP-DICLOFENAC POTASSIUM 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 NTP-DICLOFENAC POTASSIUM 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 are not getting adequate relief from your medication, speak to your doctor before you stop taking it.

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.

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

Take the NTP-DICLOFENAC POTASSIUM tablet with a meal or food to reduce the possibility of stomach upset.

NTP-DICLOFENAC POTASSIUM: NTP-DICLOFENAC POTASSIUM are immediate release tablets. The tablets should be swallowed whole with water, and must not be divided or chewed.

Missed dose:

If you forget to take one or more doses of NTP-DICLOFENAC POTASSIUM (diclofenac potassium), you should not increase the dose of NTP-DICLOFENAC POTASSIUM to make up for the missed dose or doses, but you should continue taking your tablet at the next prescribed or regular time.

Overdose:

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

In the event of overdosage, contact your doctor, hospital emergency department or regional Poison Control Centre.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

NTP-DICLOFENAC POTASSIUM 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.

NTP-DICLOFENAC POTASSIUM 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 NTP-DICLOFENAC POTASSIUM, do NOT drive or operate machinery.

NTP-DICLOFENAC POTASSIUM 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

This is NOT a complete list of side effects. If you develop any other symptoms while taking NTP-DICLOFENAC POTASSIUM, see your health care provider.

HOW TO STORE IT

Store bottles between 15EC and 30EC.

Do NOT keep outdated medicine or medicine no longer needed. Any outdated or unused medicine should be returned to your pharmacist.

Keep Out of 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 0701C Ottawa, ON 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 Teva Canada Limited at:

1-800-268-4127 ext. 5005 (English Canada) or 1-877-777-9117 (French Canada)

or druginfo@tevacanada.com

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: July 19, 2013