Nu-Diclo Rapide: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the Medication is used for:

Your health care provider has prescribed NU-DICLO RAPIDE 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 dysmenorrhea (painful menstrual periods).

What it does:

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

NU-DICLO RAPIDE, as a nonsteroidal anti-inflammatory drug (NSAID) does NOT cure your illness or prevent it from getting worse. NU-DICLO RAPIDE can only relieve pain and reduce swelling as long as you continue to take it.

When it should not be used:

DO NOT TAKE NU-DICLO RAPIDE 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 NU-DICL0

  RAPIDE.

  • 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 NU-DICLO RAPIDE 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.

NU-DICLO RAPIDE 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:

NU-DICLO RAPIDE contains the active ingredient diclofenac potassium.

What the important non-medicinal ingredients are: Each NU-DICLO RAPIDE tablet contains the following inactive ingredients: tribasic calcium phosphate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, colloidal silicon dioxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyethylene glycol, titanium dioxide, and red ferric oxide.

What dosage form it comes in:

NU-DICLO RAPIDE 50 mg Tablets: reddish-brown, round, biconvex, coated tablet, engraved “50” on one side and plain on the other side.

Check with your pharmacist if the identifying markings or color 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 NU-DICLO RAPIDE:

• 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 NU-

  DICLO RAPIDE is not recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping NU-DICLO RAPIDE should be considered.

  Long-term use of NU-DICLO RAPIDE 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 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 NU-DICLO RAPIDE. 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 NU-DICLO RAPIDE and ASA than if you took NU-DICLO RAPIDE alone.

PROPER USE OF THIS MEDICATION

Usual dose:

Take NU-DICLO RAPIDE 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 NU-DICLO RAPIDE 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.

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

Take the NU-DICLO RAPIDE with a meal or food to reduce the possibility of stomach upset.

NU-DICLO RAPIDE (diclofenac potassium): NU- DICLO RAPIDE 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 NU-DICLO RAPIDE (diclofenac potassium), you should not increase the dose of NU-DICLO RAPIDE 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 NU-DICLO RAPIDE, 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

NU-DICLO RAPIDE 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.

NU-DICLO RAPIDE 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 NU-DICLO RAPIDE, do NOT drive or operate machinery.

NU-DICLO RAPIDE 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 NU-DICLO RAPIDE, see your health care provider.

HOW TO STORE IT

Protect from heat (store at 15 to 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 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:

• Report on line 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 leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Nu-Pharm, Inc. at:

1-800-267-1438

If you have any additional question about your individual condition, you should contact your healthcare professional.

Date of revision: April 28, 2010