Ansaid Tablets 50 mg: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Ansaid, which has been prescribed to you by your doctor, is used to treat the symptoms of certain types of arthritis (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis); dysmenorrhea (menstrual pain); and mild to moderate pain accompanied by inflammation (bursitis, tendinitis, soft tissue trauma,).

What it does:

Ansaid (flurbiprofen), as a nonsteroidal anti-inflammatory drug (NSAID), can reduce the chemicals produced by your body which cause pain and swelling. It helps to relieve joint pain, swelling, stiffness and fever by reducing the production of certain substances (prostaglandins) and by helping to control inflammation.

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

When it should not be used:

DO NOT TAKE Ansaid if you have any of the following medical 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 to other NSAIDs (Nonsteroidal Anti-

  Inflammatory Drugs) or to ASA (Acetylsalicylic Acid), or to any component of the formulation

• Active peptic ulcers or active intestinal disease
• 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

• If you are already taking another NSAID

  Patients who took a drug in the same class as Ansaid 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.

  Ansaid should NOT be used in patients under 18 years of age since the safety and effectiveness have NOT been established.

What the medicinal ingredient is:

Flurbiprofen

What the important nonmedicinal ingredients are: Non-medicinal ingredients present in Ansaid (both strengths) include carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, propylene glycol, and titanium dioxide. In addition, the 100 mg tablet contains FD&C Blue No. 2.

What dosage forms it comes in:

Tablet 50 mg, 100 mg

WARNINGS AND PRECAUTIONS

Serious 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 Ansaid:

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

BEFORE you use Ansaid talk to your doctor or pharmacist 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 chronic urticaria (hives);

• you are on any special diet, such as a low-sodium

  or low-sugar diet.

• Breast feeding or intend to breast feed while taking

  this medication;

• Any other medical problem(s) such as alcohol

  abuse, bleeding problems, etc.

Also, before taking this medication, tell your health care provider if you are planning to get pregnant.

WHILE taking Ansaid:

• Tell any other doctor, dentist or pharmacist or any

  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 Ansaid is

  not recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping Ansaid should be considered;

• Some NSAIDs may cause drowsiness or fatigue in

  some people taking them; be cautious about driving or participating in activities that require alertness if you are drowsy, dizzy or lightheaded after taking this medication;

• Check with your doctor if you are not getting any

  relief of your arthritis or if any problems develop;

• Report any untoward reactions to your doctor; this

  is very important as it will aid in the early detection and prevention of potential complications;

• See your physician for regular medical checkups as

  these are essential.

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 (ASA) or other NSAIDs (e.g.

  ASA, celecoxib, diclofenac, ibuprofen, indomethacin, ketorolac, meloxicam, naproxen

• Antacids

• Antidepressants

  • 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)

• Blood thinners (e.g. warfarin, ASA, clopidogrel)

• Corticosteroids (including glucocorticoids) (e.g.

  prednisone)

  • Cyclosporin
  • Digoxin
  • Diuretics (e.g. furosemide, hydrochlorothiazide)
  • Lithium
  • Methotrexate
  • Oral contraceptives
  • Oral hypoglycemics (diabetes medications)
  • Tacrolimus
  • Cimetidine/Ranitidine
  • Sulfonamides
  • Phenytoin

Do not take ASA (acetylsalicylic acid), ASA-containing compounds, or other drugs used to relieve symptoms of arthritis while taking Ansaid unless directed to do so by your physician.

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 Ansaid. 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 Ansaid and ASA than if you took Ansaid alone.

PROPER USE OF THIS MEDICATION

Usual Dose:

Medical Condition Starting Dose Maximum Dose

(per day)

Rheumatoid arthritis,

Osteoarthritis,

Ankylosing Spondylitis

100 mg every 12 hours

100 mg every 8 hours

Dysmenorrhoea 50 mg every 6

hours

50 mg every 6 hours

Mild to Moderately

Severe Pain

50 mg every 6 hours

50 mg every 4 hours

To lessen stomach upset, take this medicine 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.

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

Be sure to take Ansaid regularly as prescribed. In some types of arthritis, up to two weeks may pass before you feel the full effects of this medicine. If you will be using Ansaid 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. Your doctor may set upper and lower dosage limits and tell you to adjust the dose within these limits, according to your pain and inflammation. It is important, however, not to go beyond the upper limits your doctor has set.

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.

Ansaid is NOT recommended for use in patients under 18 years of age since safety and effectiveness have NOT been established.

Missed Dose:

Take as soon as you remember. If your next dose is due within 2 hours, take a single dose now and skip the next dose.

Overdose:

The symptoms of overdose may include confusion, coma, diminished muscle tone, headache, double vision, slow breathing, nausea, and abdominal pain. Seek immediate medical attention if you think that you or anyone else may have taken too much Ansaid. Do this even if there are no signs of discomfort or poisoning.

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

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Ansaid may cause some undesirable reactions 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.

Ansaid 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 Ansaid, do NOT drive or operate machinery.

Ansaid 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 doctor immediately if you experience unexpected weakness while taking this medication, or if you vomit any blood or have dark or bloody stools;

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.

Elderly, frail, or debilitated patients often seem to experience more frequent or more severe side effects.

TO DO ABOUT THEM

Symptom STOP taking

Ansaid and get emergency medical attention

IMMEDIATELY

STOP taking Ansaid and talk to your physician or pharmacist

Bloody or black

tarry stools

Shortness of breath,

wheezing, any

trouble breathing or

chest tightness

Skin rash, hives,

swelling or itching

Blurred vision, or

any visual

disturbance

Any change in the

amount or colour of

your urine (red or

brown)

Any pain or

difficulty

experienced while

urinating

Swelling of the feet,

lower legs; weight

gain

Vomiting or

persistent

indigestion, nausea,

stomach pain or

diarrhea

Yellow

discolouration of

the skin or eyes,

with or without

itchy skin

Malaise, fatigue,

loss of appetite

Headaches, stiff

neck

Mental confusion,

depression

Dizziness,

lightheadedness

Hearing problems This is NOT a complete list of side effects. If you develop any other symptoms while taking Ansaid, see your health care provider.

HOW TO STORE IT

Store at controlled room temperature (15-30°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 the reach of children.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345 toll-free fax: 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals, may be obtained by contacting the sponsor, Pfizer Canada Inc., at:

1-800-463-6001

Pfizer Canada Inc.

Last revised: November 22, 2007