PMS-Piroxicam Suppositories -20mg: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Your health care provider has prescribed pms-PIROXICAM Capsules or Suppositories for you for symptomatic relief of one or more of the following medical conditions:

C rheumatoid arthritis;

C osteoarthritis (degenerative joint disease); C ankylosing spondylitis.

What it does:

pms-PIROXICAM (piroxicam) Capsules or Suppositories a nonsteroidal anti-inflammatory drug (NSAID), can reduce the chemicals produced by your body, which cause pain and swelling.

pms-PIROXICAM Capsules or Suppositories does NOT cure your illness or prevent it from getting worse. pms-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 pms-PIROXICAM Capsules or Suppositories 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).

DO NOT TAKE pms-PIROXICAM suppositories if you have any of the following medical conditions:

• Inflammation of the rectum or anus or a recent history of bleeding from the rectum or anus

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

pms-PIROXICAM Capsules or Suppositories 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:

In alphabetical order:

Capsules: Corn starch, D&C Red #28, FD&C Blue #1, FD&C Red #40, gelatin, lactose, magnesium stearate, sodium lauryl sulphate and titanium dioxide.

Suppositories: microcrystalline wax, propyl gallate, suppocire.

What dosage forms it comes in:

Capsule: 10 mg and 20 mg.

Suppository: 10 mg and 20 mg

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 pms-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, 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 pms-

  PIROXICAM Capsules or Suppositories is not recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping pms-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 ③ ARBs (angiotensin II receptor blockers)
      • e.g. candesartan, irbesartan, losartan, valsartan P Beta-adrenergic blokers

" e.g. propranolol

• Blood thinners

  • e.g warfarin, ASA, clopidogrel
• Cimetidine
• Cholestyramine

• 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 pms-PIROXICAM Capsules or Suppositories. 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 pms-PIROXICAM and ASA than if you took pms-PIROXICAM alone.

PROPER USE OF THIS MEDICATION

Usual dose:

Take pms-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 pms-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.

pms-PIROXICAM Capsules or Suppositories is NOT recommended for use in patients under 16 years of age since safety and effectiveness have NOT been established.

Using Capsules

pms-PIROXICAM capsules (10 and 20 mg) should be taken immediately after a meal or with food or milk.

Using Suppositories

pms-PIROXICAM suppositories (10 and 20 mg) are wrapped in a plastic film. Make sure that the plastic wrapping is fully removed before inserting the suppository into the rectum.

Do not take suppositories by mouth.

Missed Dose:

If you take pms-PIROXICAM Capsules or Suppositories 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 pms-PIROXICAM Capsules or Suppositories 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

pms-PIROXICAM Capsules or Suppositories 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.

pms-PIROXICAM Capsules or Suppositories 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 pms-PIROXICAM, do NOT drive or operate machinery.

pms-Piroxicam Capsules or Suppositories 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.

If you take more than the prescribed dose, contact a health care practitioner, hospital emergency department or regional Poison Control Center immediately, even if there are no symptoms.

This is NOT a complete list of side effects. If you develop any other symptoms while taking pms-PIROXICAM Capsules or Suppositories, see your health care provider.

HOW TO STORE IT

Capsules: Protect from moisture and store at room temperature (15°C - 30°C).

Suppositories: store at 15°C - 25°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.

MORE INFORMATION T

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Pharmascience Inc., at:

1-888-550-6060

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:

C Report online at www.healthcanada.gc.ca/medeffect C Call toll-free at 1-866-234-2345

C 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 0701D

  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, contact your health professional. The Canada Vigilance Program does not provide medical advice.