Details for: TEVA-PIROXICAM
Company: TEVA CANADA LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 00695718 | TEVA-PIROXICAM | PIROXICAM | 10 MG | CAPSULE | ORAL |
| 00695696 | TEVA-PIROXICAM | PIROXICAM | 20 MG | CAPSULE | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Your health care provider has prescribed TEVA-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
TEVA-PIROXICAM (piroxicam) a nonsteroidal antiinflammatory drug (NSAID), can reduce the chemicals produced by your body, which cause pain and swelling.
TEVA-PIROXICAM does NOT cure your illness or prevent it from getting worse. TEVA-PIROXICAM can only relieve the pain and reduce swelling as long as you continue to take it.
When it should not be used
DO NOT TAKE TEVA-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 disorders
- 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 to any ingredient in the formulation (see nonmedicinal ingredients below).
Patients who took a drug in the same class as TEVAPIROXICAM 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.
TEVA-PIROXICAM should NOT be used in patients under 16years of age since the safety and effectiveness have NOT been established.
What the medicinal ingredient is
Piroxicam
What the non-medicinal ingredients are
Magnesium stearate, sodium lauryl sulphate, sodium starch glycolate and starch.
10mg and 20mg capsules: FD&C blue#1, FD&C red #3 and titanium dioxide.
What dosage form it comes in
TEVA-PIROXICAM is available in 10 mg and 20 mg capsules.
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 TEVA-PIROXICAM:
- Heart Attack or Angina
- Stroke or Mini-stroke
- Loss of Vision
- Current Pregnancy (less than 28 weeks)
- Congestive Heart Failure
- Gastrointestinal conditions such as ulcers, stomach bleeding, obstructions
- Kidney problems (i.e. sodium retention) leading to increase blood pressure
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 asthma, nasal polyps, long-term swelling of the sinus (chronic sinusitis) or hives
- Family history of allergy to piroxicam or other 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)
- Any other medical problem.
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 TEVAPIROXICAM is not recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping TEVA-PIROXICAM should be considered.
- Check with your doctor if you are not getting any relief or if any problems develop.
- Your regular medical checkups 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
- 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
- Beta-adrenergic blockers e.g. propranolol
- Blood thinners e.g. warfarin, ASA, clopidogrel
- Cimetidine
- Cholestyramine
- Corticosteroids (including glucocorticoids) e.g. prednisone
- Cyclosporin
- Digoxin
- 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 TEVAPIROXICAM. 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 TEVA-PIROXICAM and ASA than if you took TEVA-PIROXICAM alone.
Proper use of this medication
Usual Dose
| Medical Condition | Starting Dose | Maximum Dose ( per day) |
| Rheumatoid arthritis | 20 mg once daily or 10 mg twice daily. According to therapeutic response, the dose may be reduced to 10 mg once daily | 20 mg |
| Ankylosing spondylitis | 20 mg once daily or 10 mg twice daily. According to therapeutic response, the dose may be reduced to 10 mg once daily | 20 mg |
| Osteoarthritis | 0 mg once daily or 10 mg twice daily. According to therapeutic response, the dose may be reduced to 10 mg once daily | 20 mg |
Take TEVA-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 TEVA-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.
TEVA-PIROXICAM is NOT recommended for use in patients under 16 years of age since safety and effectiveness have NOT been established.
TEVA-PIROXICAM must be taken immediately after a meal or with food or milk.
Missed Dose
If you take TEVA-PIROXICAM (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 TEVAPIROXICAM (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.
Overdose
Side effects and what to do about them
TEVA-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.
TEVA-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 TEVA-PIROXICAM, do NOT drive or operate machinery.
TEVA-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.
| Symptom | STOP taking TEVAPIROXICAM and get emergency medical attention IMMEDIATELY | STOP taking TEVAPIROXICAM and talk to your physician or pharmacist |
|---|---|---|
| Bloody or black tarry stools | ✔ | |
| Shortness of breath, wheezing, and 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 TEVA-PIROXICAM see your health care provider.
How to store
TEVA-PIROXICAM capsules should be protected from light and stored at room temperature (15 - 30ºC). The unit dose boxes should be stored at a temperature not exceeding 25ºC and protected from light and high 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 the Reach of Children.
Reporting 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 three 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 ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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. 1255005 (English); 1-877-777-9117 (French)
or druginfo@tevacanada.com
This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Last revised: July 14, 2015