Consumer Information for: MELOXICAM

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

MELOXICAM (meloxicam) belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs).

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

  • adult rheumatoid arthritis;
  • painful osteoarthritis (arthrosis, degenerative joint disease) in adults.

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases:

  • with longer use of NSAID medicines
  • in people who have heart disease or cardiovascular disease
  • in people with risk factors for heart disease or cardiovascular disease

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleedings:

  • can happen without warning symptoms
  • may cause death

The chance of a person getting an ulcer or bleeding increases with:

  • taking medicines called “corticosteroids” and “anticoagulants”
  • longer use
  • smoking
  • drinking alcohol
  • older age
  • having poor health

NSAID medicines should only be used:

  • exactly as prescribed
  • at the lowest dose possible for your treatment for the shortest time needed
What it does

MELOXICAM (meloxicam), as a nonsteroidal antiinflammatory drug (NSAID), can reduce the chemicals produced by your body which can cause pain and swelling.

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

MELOXICAM helps to relieve joint swelling, redness and pain of arthritis. Your body produces chemicals called prostaglandins. Some of these prostaglandins help line the stomach with a protective layer. In arthritis, other prostaglandins cause pain and swelling. At the dose prescribed by your doctor, MELOXICAM reduces the type that causes pain and swelling.

When it should not be used

DO NOT TAKE MELOXICAM if you have, or previously had any of the following medical conditions:

  • Heart bypass surgery (planning to have or recently had);
  • Severe, uncontrolled heart failure;
  • Congestive heart failure;
  • Bleeding in the brain or other bleeding disorders;
  • Current pregnancy;
  • Currently breastfeeding (or planning to breastfeed);
  • Allergy to meloxicam or any other component of MELOXICAM;
  • 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;
  • Rare hereditary conditions that may be incompatible with the non-medicinal ingredient, lactose

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

Patients who took a drug in the same class as MELOXICAM 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. MELOXICAM should NOT be used in patients under 18 years of age since safety and effectiveness have NOT been established.

What the medicinal ingredient is

Meloxicam

What the non-medicinal ingredients are

Lactose monohydrate, microcrystalline cellulose, sodium bicarbonate, croscarmellose sodium, magnesium stearate and colloidal silicon dioxide.

What dosage form it comes in

Tablets, 7.5 mg and 15 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 MELOXICAM:

  • Heart Attack or Angina
  • Stroke or Mini-Stroke
  • Loss of Vision
  • Current pregnancy
  • Congestive Heart Failure

Before taking this medication, tell your health care provider if you:

  • or a family member are allergic to or have had a reaction to MELOXICAM or other antiinflammatory drugs (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)). Allergic reactions may appear as increased sinus symptoms, hives (rash), new or worsened asthma or anaphylaxis (sudden collapse);
  • or a family member has had asthma, nasal polyps, long-term swelling of the sinus (chronic sinusitis) or chronic urticaria (hives);
  • have a history of stomach upset, ulcers, or bleeding from the stomach or gut;
  • have liver disease;
  • had bleeding in the brain;
  • have kidney disease or urine problems;
  • have bleeding problems;
  • have high cholesterol;
  • have high blood pressure;
  • have atherosclerosis;
  • have poor circulation to your extremities (hands and feet);
  • have diabetes mellitus;
  • are a smoker or ex-smoker;
  • are on any special diet, such as a lowsodium or low-sugar diet;
  • have been told by a physician that you have an intolerance to some sugars;
  • have any other medical problem(s) such as alcohol abuse etc.

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

While taking this medication:

  • Tell any other physician, 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 MELOXICAM is not recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping MELOXICAM should be considered;
  • Your regular medical checkups are essential
Interactions with this medication

Talk to you 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, naproxen
  • Anti-depressants
    • Selective Serotonin Reuptake Inhibitors (SSRIs)
      • e.g. citalopram, fluoxetine, paroxetine, sertraline
  • Blood pressure medications
    • Angiotensin Converting Enzyme (ACE) Inhibitors
      • e.g. enalapril, lisinopril, perindopril, ramipril
  • Angiotensin II receptor blockers (ARBs)
    • e.g. candesartan, irbesartan, losartan, valsartan
  • Blood thinners
    • e.g. warfarin, ASA, clopidogrel
  • Cholestyramine
  • Cimetidine
  • Corticosteroids (including Glucocorticoids)
    • e.g. prednisone
  • Cyclosporine
  • Digoxin
  • Diuretics
    • e.g. furosemide, hydrochlorothiazide
  • Intrauterine Devices
  • 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 MELOXICAM.

Take only the amount of ASA prescribed by your health care provider. You are more likely to upset or damage your stomach than if you take both MELOXICAM and ASA than if you took MELOXICAM alone.

Proper use of this medication

Dose

MELOXICAM is intended for use in patients greater than 18 years of age for the shortest possible duration.

Medical Condition Starting Dose Maximum Dose (per day)
Symptomatic treatment of rheumatoid arthritis in adults 15 mg once daily. According to therapeutic response, the dose may be reduced to 7.5 mg once daily 15 mg once daily.

In dialysis patients with severe renal failure, the dose should not exceed 7.5 mg/day.
Painful
osteoarthritis
(arthrosis,
degenerative joint disease in adults)		 7.5 mg once daily. If necessary the dose may be increased to 15 mg once daily.

In patients with increased risks of adverse reactions, treatment should be started at the dose of 7.5 mg once daily.		 15 mg once daily.

In dialysis patients with severe renal failure, the dose should not exceed 7.5 mg/day

Take MELOXICAM 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 MELOXICAM increases 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 MELOXICAM 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. In some types of arthritis, up to two weeks may pass before you feel the full effects of this medicine.

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.

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

MELOXICAM tablets may be taken with or without food.

Missed Dose

You should take MELOXICAM as your doctor has prescribed. However, if you miss a dose, just resume your usual schedule the following day. Do not take an extra dose.

Overdose

In the event of overdosage, contact your doctor, hospital emergency department of regional Poison Control Center Immediately.
Side effects and what to do about them

Along with its beneficial effects, MELOXICAM, like other NSAID drugs, may cause some undesirable reactions especially when used for a long time or in large doses. Elderly, frail or debilitated patients often seem to experience more frequent or more severe side effects. Although not all of these side effects are common, when they do occur, they may require medical attention. Report all symptoms or side effects to your health care provider.

MELOXICAM 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 MELOXICAM, do NOT drive or operate machinery;

MELOXICAM 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 if you are not getting any relief of your arthritis or if any problems develop.

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.

Serious side effects, how often they happen and what to do about them
Symptom / effect STOP taking MELOXICAM and talk to your physician or pharmacist IMMEDIATELY STOP taking MELOXICAM and talk to your physician or pharmacist
Bloody or black tarry stools ✔  
Shortness of breath, wheezing, any trouble in breathing, or tightness in the chest ✔  
Allergic reactions, such as: skin rash, hives or swelling, itching, chills, fever, muscle aches and pains, or other flulike symptoms ✔  
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. For any unexpected effects while taking MELOXICAM, contact your health care provider or pharmacist immediately, so that these effects may be properly addressed.

How to store

Store at controlled room temperature (15 – 30°C), safely out of the reach of children. Store in a dry place.

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.
This medication has been prescribed for your medical problem. Do not give it to anyone else.

If you require more information on this drug, consult your doctor or pharmacist.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health product to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free to 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 0701D
                  Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance 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

For more information, please contact your doctor, pharmacist or other healthcare professional.

This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting Pro Doc Ltée at 1-800-361-8559, http://www.prodoc.qc.ca or [email protected].

This leaflet was prepared by
Pro Doc Ltée, Laval, Québec, H7L 3W9

Last revised: September 4, 2013

Date modified: