NTP-Diclofenac Sodium: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the Medication is used for:

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

NTP-DICLOFENAC SODIUM and NTP-DICLOFENAC SODIUM SR are used for maintenance therapy only.

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

NTP-DICLOFENAC SODIUM and NTP-DICLOFENAC SODIUM SR, as a nonsteroidal anti-inflammatory drug (NSAID) does NOT cure your illness or prevent it from getting worse. NTP-DICLOFENAC SODIUM or NTP-DICLOFENAC SODIUM 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 NTP-DICLOFENAC SODIUM or NTP-DICLOFENAC SODIUM 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 NTP-DICLOFENAC SODIUM or NTP-DICLOFENAC SODIUM 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 NTP-DICLOFENAC SODIUM and NTP-DICLOFENAC SODIUM 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.

NTP-DICLOFENAC SODIUM and NTP-DICLOFENAC SODIUM 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 nonmedicinal ingredients are:

NTP-DICLOFENAC SODIUM (diclofenac sodium) 50 mg enteric coated tablets:

Each tablet contains the medicinal ingredient diclofenac sodium and non-medicinal ingredients: magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide, sodium lauryl sulfate and sodium starch glycolate.

The film coating contains: D&C Yellow # 10, hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, maltodextrin, methacrylic acid, polyethylene glycol, talc, titanium dioxide, triethyl citrate,

NTP-DICLOFENAC SODIUM SR (diclofenac sodium) 75 slow release tablets:

Each tablet contains the medicinal ingredient diclofenac sodium and non-medicinal ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and povidone.

The film coating contains: aquacoat ECD-30, cetyl alcohol, dibutyl sebacate, FD&C Blue #2, FD&C Red #6, FD&C Yellow #40, hydroxypropyl methylcellulose, polyethylene glycol, polysorbate and titanium dioxide.

What dosage forms it comes in:

50 mg enteric coated tablets

75 mg SR (slow release) 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 SODIUM or NTP-DICLOFENAC SODIUM 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 NTP-

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

Long-term use of NTP-DICLOFENAC SODIUM or NTP-DICLOFENAC SODIUM 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 NTP-DICLOFENAC SODIUM or NTP-DICLOFENAC SODIUM 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 NTP-DICLOFENAC SODIUM or NTP-DICLOFENAC SODIUM SR and ASA than if you took NTP-DICLOFENAC SODIUM or NTP-DICLOFENAC SODIUM SR alone.

PROPER USE OF THIS MEDICATION

Usual Dose:

* 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 NTP-DICLOFENAC SODIUM (50 mg twice a day).

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

Make sure that you do not take more than a total of 100 mg per day, unless directed by your doctor.

If you will be using NTP-DICLOFENAC SODIUM or NTP-DICLOFENAC SODIUM 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.

NTP-DICLOFENAC SODIUM (enteric coated tablets): NTP-DICLOFENAC SODIUM tablets are a delayed-release product. Tablets should be taken with food and the tablets should be swallowed whole with water, and must not be divided or chewed.

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

To help reduce the possibility of stomach upset you should take NTP-DICLOFENAC SODIUM or NTP-DICLOFENAC SODIUM 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.

NTP-DICLOFENAC SODIUM or NTP-DICLOFENAC SODIUM 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 NTP-DICLOFENAC SODIUM (diclofenac sodium), 50 mg tablets or NTP-DICLOFENAC SODIUM SR (diclofenac sodium) 75 mg slow release tablets, you should not increase the dose of NTP-DICLOFENAC SODIUM (diclofenac sodium) or NTP-DICLOFENAC SODIUM 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 NTP-DICLOFENAC SODIUM tablets or NTP-DICLOFENAC SODIUM SR tablets tell your doctor or pharmacist or contact your regional Poison Control Centre or go to the hospital emergency unit at once. You may require medical attention.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

NTP-DICLOFENAC SODIUM or NTP-DICLOFENAC SODIUM 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.

NTP-DICLOFENAC SODIUM or NTP-DICLOFENAC SODIUM 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 NTP-DICLOFENAC SODIUM or NTP-DICLOFENAC SODIUM SR, do NOT drive or operate machinery.

NTP-DICLOFENAC SODIUM or NTP-DICLOFENAC SODIUM 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 NTP-DICLOFENAC

SODIUM or NTP-DICLOFENAC SODIUM SR, see your health care provider.

HOW TO STORE IT

Store between 15°-30°C. Unit dose strips should be stored between 15°-25°C and protected 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 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^™ 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 druginfo@tevacanada.com

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: July 22, 2013