Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Mylan Nabumetone.
HEALTH CANADA ADVISORY
June 8, 2021
Health Canada has issued new information concerning the use of non-steroidal anti-inflammatory drugs (NSAIDs). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Allergic reactions: If you have had a reaction to acetylsalicylic acid (ASA) or other NSAIDs (e.g., ibuprofen, Ketoprofen, Diclofenac) that included a runny nose, itchy skin rash, nasal polyps, or shortness of breath and wheezing, you should not take Mylan Nabumetone. If you experience symptoms of a Anaphylaxis (severe allergic reaction) (e.g., hives; difficulty breathing; wheezing; swelling of the face, tongue, or throat), get immediate medical attention.
Bladder symptoms: Mylan Nabumetone can cause bladder symptoms such as frequent or painful urination and blood in urine. If you develop these symptoms, stop taking Mylan Nabumetone and contact your doctor immediately.
Drowsiness and dizziness: Mylan Nabumetone can cause drowsiness or dizziness. Do not drive or operate machinery until you are sure that Mylan Nabumetone does not affect your ability to do these safely.
Fluid and electrolyte balance: Mylan Nabumetone can cause fluid retention. If you have heart failure, high blood pressure, or other medical conditions that increase your risk of fluid retention (e.g., kidney problems), discuss with your doctor how Mylan Nabumetone may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mylan Nabumetone, and whether any special monitoring is needed.
Nabumetone may also cause high blood potassium levels. If you are a senior; have Diabetes or kidney failure; or are taking beta-blockers (e.g., Metoprolol, Atenolol), angiotensin converting enzyme (ACE) inhibitors (e.g., Ramipril, Enalapril), or some diuretics (e.g., triamterene, Amiloride), you are more at risk of high blood potassium.
Infection: As with other anti-inflammatory medications, nabumetone may mask the usual signs of infection.
Kidney function: Mylan Nabumetone can affect kidney function. You have a higher risk of developing kidney problems if you are a senior; take diuretics (water pills; e.g., Hydrochlorothiazide, Furosemide); or already have Kidney Disease, liver disease, or heart failure.
Your doctor may monitor your kidney function with blood tests if you take Mylan Nabumetone. If you have kidney disease or reduced kidney function, discuss with your doctor how Mylan Nabumetone may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mylan Nabumetone, and whether any special monitoring is needed.
Liver problems: Mylan Nabumetone may affect your liver function or cause liver problems. If you experience symptoms of liver problems (e.g., nausea, vomiting, feeling tired, yellowing of the skin or eyes), contact your doctor immediately. If you have liver problems, discuss with your doctor how Mylan Nabumetone may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mylan Nabumetone, and whether any special monitoring is needed.
Sun sensitivity: Mylan Nabumetone may make your skin more sensitive to sunlight (including sunlamps) and may cause Sunburn; skin blisters; and skin redness, itching, or discolouration. If you have a reaction from the sun while taking Mylan Nabumetone, contact your doctor.
Ulcers and bleeding in the stomach and intestines: Mylan Nabumetone can cause stomach ulcers, perforation (holes), and bleeding from the stomach. These complications can occur at any time without warning, and are sometimes severe enough to require immediate medical attention. The risk of ulcers and bleeding increases if you are taking higher doses of nabumetone for longer periods of time.
Other factors that increase the risk of these complications include drinking excessive amounts of alcohol, increased age, smoking, poor health, H. pylori infection, and taking certain medications (e.g., Warfarin, ASA, Clopidogrel, Prednisone, Citalopram, Fluoxetine, Paroxetine, Sertraline).
If you currently have ulcers in the stomach or intestines that are bleeding, or have an inflammatory bowel disease (e.g., Crohn's Disease, ulcerative colitis), you should not take Mylan Nabumetone. If you have a history of these conditions, discuss with your doctor how Mylan Nabumetone may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mylan Nabumetone, and whether any special monitoring is needed.
Stop taking the medication and get immediate medical attention if you experience symptoms or signs of stomach ulcers or bleeding in the stomach (black, tarry stools; blood in stools; stomach pain; vomiting blood or coffee grind material). These reactions can occur at any time during treatment without warning.
Vision: Blurred vision has occasionally been reported with the use of Mylan Nabumetone. If this symptom develops, stop taking nabumetone and contact your doctor.
Pregnancy: Mylan Nabumetone should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Mylan Nabumetone, stop taking it immediately and call your doctor. Mylan Nabumetone must not be used during the last 3 months of pregnancy, as it may cause heart and kidney problems for the developing baby and prolonged labour with excessive bleeding during delivery.
Breast-feeding: Taking Mylan Nabumetone while breast-feeding is not recommended since the safety of doing so has not been established.
Children: The safety and effectiveness of using Mylan Nabumetone have not been established for children.
Seniors: Seniors appear to have a higher risk of developing side effects from Mylan Nabumetone. The lowest effective dosage should be used under close medical supervision.
