Gen-Piroxicam - Cap 20mg: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

Your health care provider has prescribed Gen-Piroxicam for you for symptomatic relief of one or more of the following medical conditions:

• rheumatoid arthritis;
• osteoarthritis (degenerative joint disease);
• ankylosing spondylitis

What it does:

Gen-Piroxicam (piroxicam), as a nonsteroidal anti-inflammatory drug (NSAID), can reduce the chemicals produced by your body, which cause pain and swelling.

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

When it should not be used:

DO NOT TAKE Gen-Piroxicam 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 disorder

• Current pregnancy (after 28 weeks of pregnancy)

• Currently breastfeeding (or planning to breastfeed)

• Allergy to ASA (Acetylsalicylic Acid) or other NSAIDs

  (Nonsteroidal Anti-Inflammatory Drugs)

• 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
• Allergy to piroxicam or any other component of Gen-Piroxicam capsules.

Patients who took a drug in the same class as Gen-Piroxicam 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.

Gen-Piroxicam 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:

Piroxicam

What the important nonmedicinal ingredients are:

Gen-Piroxicam Capsules contain 10 or 20 mg of Gen-Piroxicam, USP. In addition, they contain cornstarch, D&C Red #28, FD&C Blue #1, FD&C Red #40, gelatin, lactose, magnesium stearate, sodium lauryl sulphate and titanium dioxide.

What dosage forms it comes in:

Gen-Piroxicam is available as capsules of 10 mg and 20 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 Gen-Piroxicam:

• 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 Gen-Piroxicam is not

  recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping Gen-Piroxicam should be considered.

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
• Cholestyramine
• Cimetidine

• Corticosteroids (including glucocorticoids)

  • e.g. prednisone
• Cyclosporin

• Diuretics

  • e.g. furosemide, hydrochlorothiazide
• Lithium
• Methotrexate
• Oral contraceptives
• Oral hypoglycemics (diabetes medications)
• Tacrolimus

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 Gen-Piroxicam. 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 Gen-Piroxicam and ASA than if you took Gen-Piroxicam alone.

PROPER USE OF THIS MEDICATION

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

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.

Gen-Piroxicam is NOT recommended for use in patients under 16 years of age since safety and effectiveness have NOT been esetablished.

Gen-Piroxicam should be taken immediately after a meal or with food or milk. You should remain standing or sitting upright for about 15-30 minutes after taking this medicine

Missed Dose:

If you take Gen-Piroxicam once a day and if you miss a dose of this medicine and remember within 8 hours of the missed dose, take it right away. If you take Gen-Piroxicam twice a day and if you miss a dose and remember within 2 hours of the missed dose, take it right away. Then go back to your regular dosing schedule. If you have any question, check with your doctor or pharmacist.

Overdose:

If you have taken too much Gen-Piroxicam (more than prescribed by your doctor), contact your doctor, nearest Emergency Department, or Poison Control Centre.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Gen-Piroxicam 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.

Gen-Piroxicam 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 Gen-Piroxicam, do NOT drive or operate machinery. Gen-Piroxicam 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 Gen-Piroxicam, see your health care provider.

HOW TO STORE IT

Store between 15 and 30°C. Protect from moisture.

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

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 the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be requested by contacting the sponsor Genpharm ULC at:

1-888-575-1375

Email: customerservice@genpharm.ca

Last revised: December 01, 2009