Meloxicam (Cobalt Pharmaceuticals): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

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 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 anti-inflammatory 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 can only 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 compenent 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 BP

What the important nonmedicinal ingredients are:

Colloidal Silicon Dioxide, Crospovidone, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Povidone, and Sodium Citrate.

What dosage forms it comes in:

7.5 mg and 15 mg tablets.

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 anti-inflammatory 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 low-sodium or low-

  sugar diet;

• have been told by a physician that you have 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 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, 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

(acetylsalicyclic acid) as blood thinner to reduce your risk of having a heart attack or stroke while you are taking MELOXCIAM. 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 MELOXCIAM and ASA than if you took MELOXCIAM alone.

PROPER USE OF THIS MEDICATION

DOSE:

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

Take MELOXCIAM 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 MELOXCIAM 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 MELOXCIAM 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.

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

MELOXCIAM 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:

For management of a suspected drug overdose, contact your regional Poison Control Center.

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.

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 IT

Store at room temperature (15-30°C). 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 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 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 at:

http://www.cobaltpharma.com

or by contacting the sponsor, Cobalt Pharmaceuticals Inc., at: 1-866-254-6111.

Cobalt Pharmaceuticals Inc.

Mississauga, ON

Canada, L5N 2B8

Last revised: February 3, 2010