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 Apo Naproxen.
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, ketorolac) that included a runny nose, itchy skin rash, nasal polyps, or shortness of breath and wheezing, you should not take Apo Naproxen. If you experience symptoms of a severe allergic reaction (e.g., hives; difficulty breathing; wheezing; swelling of the face, tongue, or throat), get immediate medical attention.
Anemia: Naproxen may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.
Aseptic meningitis: Apo Naproxen can rarely cause symptoms of aseptic meningitis (inflammation or swelling of the membranes around the brain and spinal cord that is not caused by bacteria). If you have an autoimmune condition (e.g., systemic Lupus erythematosus, mixed connective tissue disease), you are more at risk for developing this. If you experience symptoms such as stiff neck, severe headache, nausea, vomiting, Fever, or changes in consciousness, stop taking Apo Naproxen can get immediate medical attention.
Bladder problems: Apo Naproxen may cause bladder pain, painful or difficult urination, or increased frequency of urination. If these symptoms occur without an explanation (e.g., infection), stop taking Apo Naproxen and contact your doctor.
Blood clotting: Apo Naproxen may reduce the ability of the blood to clot. If you are taking anticoagulants (e.g., Warfarin, Heparin) or have Hemophilia or other blood disorders (e.g., low platelets), discuss with your doctor how Apo Naproxen may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Apo Naproxen, and whether any special monitoring is needed. If you have a bleeding disorder, do not take Apo Naproxen.
Drowsiness/reduced alertness: Do not drive a car or perform hazardous tasks until you determine that Apo Naproxen does not impair your ability to perform these tasks safely.
Fluid and electrolyte balance: NSAIDs such as naproxen can cause fluid retention and edema (swelling). This can lead to high blood pressure or worsening of heart failure. If you have heart failure or high blood pressure, discuss with your doctor how Apo Naproxen may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Apo Naproxen, and whether any special monitoring is needed. If you have severe, uncontrolled heart failure, you should not take Apo Naproxen.
Naproxen 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. If you have high blood potassium levels, you should not take Apo Naproxen.
Heart Attack and Stroke: Apo Naproxen may be associated with an increased risk of heart attack or stroke. The risk is higher with larger total daily doses and longer treatment periods. If you have a history of heart disease (e.g., heart attack, stroke, heart failure) or have risk factors for heart disease (e.g., high blood pressure, High Cholesterol, diabetes, smoking, Kidney Disease) discuss with your doctor how Apo Naproxen may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Apo Naproxen, and whether any special monitoring is needed.
Kidney function: Long-term use of naproxen may lead to a higher risk of reduced kidney function. If you have kidney disease, liver disease, or heart failure; take diuretics (water pills); or are a senior, you have an increased risk for kidney problems while taking Apo Naproxen. If you are taking medications such as diuretics (e.g., Hydrochlorothiazide, triamterene, Indapamide), ACE inhibitors (e.g., enalapril, ramipril), angiotensin receptor blockers (e.g., Valsartan, Candesartan), or Cyclosporine, you are also at an increased risk.
If you have these conditions or are taking these medications, discuss with your doctor how Apo Naproxen may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Apo Naproxen, and whether any special monitoring is needed. If you have severe kidney problems, you should not take Apo Naproxen.
Liver function: Rarely, Apo Naproxen causes liver problems. If you have reduced liver function, discuss with your doctor how Apo Naproxen may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Apo Naproxen, and whether any special monitoring is needed.
If you experience unexplained tiredness, loss of appetite, itchy skin or yellowing of the skin or eyes while taking Apo Naproxen, contact your doctor immediately. If you have liver disease or severely reduced liver function, you should not take Apo Naproxen.
Skin reactions: Apo Naproxen can cause skin reactions, some of which may be severe. If you experience a skin rash, especially where the skin is blistering or peeling, stop taking Apo Naproxen and contact your doctor.
Apo Naproxen 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 Apo Naproxen, contact your doctor.
Ulcers or bleeding in the stomach or intestines: Naproxen 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 increase if you are taking higher doses of naproxen 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 Apo Naproxen. If you have a history of these conditions, discuss with your doctor how Apo Naproxen may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Apo Naproxen, 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 changes: Occasionally, naproxen is related to changes in vision. If you experience blurred or decreased vision while taking Apo Naproxen, contact your doctor.
Pregnancy: Apo Naproxen should not be used during pregnancy, especially during the third trimester. If you become pregnant while taking Apo Naproxen, contact your doctor immediately.
Apo Naproxen may reduce fertility. If you are trying to get pregnant or are having difficulty getting pregnant, you should not take Apo Naproxen.
Breast-feeding: Apo Naproxen is not recommended for women who are breast-feeding.
Children: The safety and effectiveness of naproxen suspension have not been established for children less than 2 years of age. Naproxen tablets or suppositories should not be used by children under 18 years of age, unless recommended by your doctor.Seniors: If you are a senior, you may have a higher risk of experiencing side effects from Apo Naproxen. You should use the lowest effective dose under close medical supervision.
