Riva-Celecoxib: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Your health care provider has prescribed RIVA-CELECOXIB for you for one or more of the following medical conditions:

• Osteoarthritis - relieve pain
• Rheumatoid Arthritis - relieve joint pain and swelling
• Ankylosing Spondylitis - relieve pain

• Sprains, After orthopaedic (bone and joint) surgery (NOT

  open heart surgery), dental extraction - to relieve short-term pain (maximum use of 7 days)

What it does:

RIVA-CELECOXIB (celecoxib), as a nonsteroidal anti-inflammatory drug (NSAID), can reduce the type of prostaglandins (chemicals), produced by your body which cause joint swelling, redness and pain. At prescribed doses, RIVA-CELECOXIB does not affect the type of prostaglandins that helps maintain the protective layer of the stomach, and reduces the chances of bleeding from the stomach.

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

When it should not be used:

Do not take RIVA-CELECOXIB if you have any of the following medical conditions:

• Heart bypass surgery (planning to have or recently had)
• Severe, uncontrolled heart failure
• Allergy to celecoxib or any of the other ingredients in RIVA-CELECOXIB
• Allergy to Sulfonamide drugs

• Allergy to ASA (Acetylsalicylic Acid) or other NSAIDs

  (Nonsteroidal Anti-Inflammatory Drugs)

• Current Pregnancy (after 28 weeks of pregnancy)
• Currently Breastfeeding (or planning to breastfeed)
• Ulcer (active)
• Bleeding from the stomach or gut (active)

• Bleeding in the brain

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

Safety and effectiveness of RIVA-CELECOXIB have NOT been established in children under 18 years of age.

Patients who took a drug in the same class as RIVA-CELECOXIB 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.

What the medicinal ingredient is:

Celecoxib

What the nonmedicinal ingredients are:

Croscarmellose sodium, lactose, magnesium stearate, povidone, sodium lauryl sulfate and talc. Capsule contains gelatin, sodium lauryl sulphate and titanium dioxide.

100 mg ink: ammonia, FD&C blue aluminum lake, propylene glycol and shellac.

200 mg ink: ammonia, propylene glycol, shellac and yellow iron oxide.

What dosage forms it comes in:

Capsules: 100 mg and 200 mg

WARNINGS AND PRECAUTIONS

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 sulfonamide drugs

• 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 polyp, long-term swelling

  of the sinus (chronic sinusitis) or hives

• Gastrointestinal problems (problems with your stomach

  and/or intestine)

• Any other medical problem

Fertility may be decreased. The use of RIVA-CELECOXIB is not recommended in women who have difficulty conceiving.

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;

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):

• Acetylsalicylic acid or other NSAIDs (e.g. ASA,

  diclofenac, ibuprofen, indomethacin, ketorolac, meloxicam, naproxen)

• Antacids

• Antidepressants [Selective serotonin receptor uptake

  inhibitor (SSRIs) (e.g. citalopram, paroxetine, fluoxetine, 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)

• Blood thinners e.g. warfarin (to prevent blood clots), ASA,

  clopidogrel

• Corticosteroids (including glucocorticoids) e.g. prednisone
• Cyclosporin
• Digoxin
• Diuretics Furosemide, hydrochlorothiazide
• Fluconazole
• Lithium
• Methotrexate
• Oral contraceptives

• Oral hypoglycemics (diabetes medications)

  • Tacrolimus

Your health care provider may prescribe low dose ASA (acetylsalicylic acid) as a blood thinner for the prevention of having a heart attack or stroke while you are taking RIVA-CELECOXIB. Take only the amount of ASA prescribed by your health care provider. You are more likely to upset or damage your stomach if you take both RIVA-CELECOXIB and ASA than if you take RIVA-CELECOXIB alone.

PROPER USE OF THIS MEDICATION

Capsules should be swallowed whole. DO NOT open, divide, crush, or chew the capsules.

Dose: 18 years of age and older only

Take RIVA-CELECOXIB 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 RIVA-CELECOXIB 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 RIVA-CELECOXIB 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.

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.

RIVA-CELECOXIB is NOT recommended for patients under 18 year of age since safety and effectiveness have NOT been established.

RIVA-CELECOXIB can be taken with or without food.

Missed Dose:

Take the dose you missed as soon as you remember, then take the next dose at the scheduled time.

Overdose:

If you take more than the prescribed dose, contact your health care provider immediately.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

RIVA-CELECOXIB may cause some side effects, especially if 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.

RIVA-CELECOXIB 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 RIVA-CELECOXIB, do NOT drive or operate machinery.

RIVA-CELECOXIB 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 occur, 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 RIVA-CELECOXIB, see your health care provider.

HOW TO STORE IT

Store between 15 and 30°C.

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 and pets.

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 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 obtained by contacting the sponsor Laboratoire Riva Inc., at 1-800-363-7988.

Laboratoire Riva Inc.

Blainville Québec

J7C 3V4

www.labriva.com

Last revised: January 15, 2015