Nu-Meloxicam: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

NU-MELOXICAM (meloxicam) belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs) and is used to treat the symptoms of adult rheumatoid arthritis and 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:

NSAIDS do not cure arthritis, but they promote suppression of the inflammation and the tissue damaging effects resulting from this inflammation. NU-MELOXICAM will help you only as long as you continue to take it. It cannot prevent the disease from getting worse.

NU-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, NU-MELOXICAM reduces the type that causes pain and swelling.

What the medicinal ingredient is:

Meloxicam

What the important nonmedicinal ingredients are:

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

What dosage forms it comes in:

Tablets, 7.5 and 15 mg.

WHEN NOT TO USE THIS MEDICATION

WHEN SHOULD I NOT TAKE NU-MELOXICAM? DO NOT TAKE NU-MELOXICAM if you have, or previously had:

• Open Heart Surgery (planning to have or recently had)

Or are:

• Currently pregnant

• Currently Breastfeeding (or planning to breastfeed)

In addition, DO NOT TAKE NU-MELOXICAM if you have, or previously had any of the following medical conditions;

• Known or suspected allergy to meloxicam or any other component of NU-MELOXICAM;

• Known or suspected allergy to ASA

  (Acetylsalicylic Acid) or other NSAIDs (Nonsteroidal Anti-Inflammatory Drugs);

• Congestive heart failure;
• Ulcer;
• Bleeding from the stomach, gut or any other bleeding;
• Bleeding in the brain or other bleeding disorders;

• Inflammatory Bowel Disease (Crohn’s

  Disease or Ulcerative Colitis);

• Liver Disease (active or severe);
• Kidney Disease (severe or worsening);
• High potassium in the blood.

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

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

Patients who took a drug in the same class as NU-MELOXICAM after any type of heart surgery (coronary artery bypass grafting (CABG)) were more likely to have heart attacks, strokes, blood clots in the leg(s) or lungs(s), and infections or other complication than those who did NOT take that drug.

It is not known whether long-term use of NU-MELOXICAM will increase the risk of heart attacks or strokes.

WARNINGS AND PRECAUTIONS

Before starting NU-MELOXICAM and to get the best possible treatment, be sure to tell your doctor if you:

• Have angina;
• Have heart problems (e.g. congestive heart failure);
• Have had a heart attack, stroke or mini-stroke, loss of vision;
• Intend to become pregnant while taking this medication;
• Intend to breast feed while taking this medication;

In addition, BEFORE TAKING THIS MEDICATION TELL YOUR DOCTOR AND PHARMACISTS IF YOU:

• or a family member are allergic to or have

  had a reaction to NU-MELOXICAM or other anti-inflammatory drugs (such as acetylsalicylic acid (ASA), celecoxib, diclofenac, diflunisal, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, mefenamic acid, piroxicam, rofecoxib, tiaprofenic acid, tolmetin, nabumetone or tenoxicam, 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, chronic sinusitis or chronic urticaria (hives);
  • have a history of stomach upset, ulcers, liver or kidney diseases;
  • have blood or urine abnormalities;
  • have high cholesterol;
  • have high blood pressure;
  • have atherosclerosis;

  • have poor circulation to your extremities

    (hands and feet);

  • have diabetes
  • are a smoker or ex-smoker;
  • are on any special diet, such as a low-sodium or low-sugar diet.
  • Are taking any other medication (either prescription or non-prescription) including ASA or other NSAIDs, high blood pressure medication, blood thinners, corticosteroids, methotrexate, cyclosporin, lithium, phenytoin, cholestyramine (NOT a complete list);
  • Have any other medical problem(s) such as alcohol abuse, bleeding problems, etc.

While taking this medication:

• tell any other physician, dentist 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;
• Your regular medical checkups are essential.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with NU-MELOXICAM include (NOT a complete list):

• ACE (Angiotensin Converting Enzyme)

  Inhibitors

  • e.g. enalapril, lisinopril, perindopril, ramipril

• Acetylsalicyclic Acid (ASA) or Other NSAIDs

  • e.g. ASA, diclofenac, ibuprofen, indomethacin, ketorolac, meloxicam, Naproxen, celecoxib
• Anti-platelet agents
• Angiotensin receptor blockers (ARBs)
• Cholestyramine

• Corticosteroids (including Glucocorticoids)

  • e.g. prednisone
• Cyclosporine
• Diuretics

• e.g. hydrochlorothiazide,

  furosemide

• Fluconazole
• Lithium
• Methotrexate
• Anticoagulants
• e.g. warfarin
• Intrauterine Devices

Your health care provider may prescribe low dose ASA (acetylsalicylic acid) as a blood thinner to help prevent heart and blood vessel disease while you are taking NU-MELOXICAM. Take only the amount of ASA prescribed by your healthcare provider. Taking NU-MELOXICAM and ASA has a greater potential to upset or damage your stomach than if you took NU-MELOXICAM alone.

PROPER USE OF THIS MEDICATION

Usual dose:

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

Take NU-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 ordered. You should take the lowest dose of this medication for the shortest time period. Taking too much NU-MELOXICAM increases your chances of unwanted and sometimes dangerous side effects, especially if you are elderly, have other disease or take other medications.

If you will be using NU-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 seems to be similar to yours.

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

NU-MELOXICAM tablets may be taken with or without food.

Overdose:

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

Missed Dose:

You should take NU-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.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Along with its beneficial effects, NU-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;

• NU-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 NU-MELOXICAM, do NOT drive or operate machinery;

• NU-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;

• The use of meloxicam, as with any NSAID,

  may decrease fertility and is not

  recommended in women trying to get pregnant. Therefore, in women who have difficulties conceiving, stopping meloxicam should be considered.

• Check with your doctor if you are not getting

  any relief of your arthritis or if any problems develop.

This is not a complete list of side effects. For any unexpected effects while taking NU-MELOXICAM, contact your doctor or pharmacist.

HOW TO STORE IT

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.

Keep out of reach of children.

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

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

REPORTING SUSPECTED 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 0701C Ottawa, ON K1A 0K9 Postage paid labels, Canada Vigilance Form and the adverse reaction reporting guidelines are available on the MedEffect^TM Canada Web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you should 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 the sponsor, Nu-Pharm Inc. at:

1-800-267-1438

Last Revised: October 7, 2009