Before you begin taking 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 take Naprelan (Naproxen-sodium).
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 Naprelan (Naproxen-sodium). 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.
Aseptic meningitis: Naprelan (Naproxen-sodium) 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 Naprelan (Naproxen-sodium) can get immediate medical attention.
Bladder problems: Naprelan (Naproxen-sodium) 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 Naprelan (Naproxen-sodium) and contact your doctor.
Blood clotting: Naprelan (Naproxen-sodium) 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 Naprelan (Naproxen-sodium) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Naprelan (Naproxen-sodium), and whether any special monitoring is needed. If you have a bleeding disorder, do not take Naprelan (Naproxen-sodium).
Drowsiness/reduced alertness: As with other NSAIDs, naproxen sodium can cause drowsiness, dizziness, and blurred vision. Avoid driving and other activities that require alertness and concentration until you determine the effect Naprelan (Naproxen-sodium) has on you.
Fluid and electrolyte balance: NSAIDs such as naproxen sodium 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 Naprelan (Naproxen-sodium) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Naprelan (Naproxen-sodium), and whether any special monitoring is needed. If you have severe, uncontrolled heart failure, you should not take Naprelan (Naproxen-sodium).
Naproxen sodium 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 Naprelan (Naproxen-sodium).
Heart Attack and Stroke: Naprelan (Naproxen-sodium) may be associated with an increased risk of heart attack and stroke. The risk is increased with higher total daily doses and taking the medication over long periods of time. 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 Naprelan (Naproxen-sodium) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Naprelan (Naproxen-sodium), and whether any special monitoring is needed.
Kidney function: Long-term use of naproxen sodium may lead to kidney problems. If you have kidney problems, liver disease, or heart failure; or are dehydrated, on a salt restricted diet, or are a senior, you have an increased risk for kidney problems while taking Naprelan (Naproxen-sodium). 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 Naprelan (Naproxen-sodium) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Naprelan (Naproxen-sodium), and whether any special monitoring is needed. If you have severe kidney problems, you should not take Naprelan (Naproxen-sodium).
Liver problems: Rarely, Naprelan (Naproxen-sodium) causes liver problems. If you have reduced liver function, discuss with your doctor how Naprelan (Naproxen-sodium) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Naprelan (Naproxen-sodium), 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 Naprelan (Naproxen-sodium), contact your doctor immediately. If you have liver disease or severely reduced liver function, you should not take Naprelan (Naproxen-sodium).
Skin reactions: Naprelan (Naproxen-sodium) 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 Naprelan (Naproxen-sodium) and contact your doctor.
Naprelan (Naproxen-sodium) 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 Naprelan (Naproxen-sodium), contact your doctor.
Ulcers or bleeding in the stomach or intestines: Naproxen sodium 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 are increased if you are taking higher doses of Naprelan (Naproxen-sodium) 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 Naprelan (Naproxen-sodium). If you have a history of these conditions, discuss with your doctor how Naprelan (Naproxen-sodium) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Naprelan (Naproxen-sodium), 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 and tarry stools, vomit that looks like coffee grounds, stomach pain). These reactions can occur at any time during treatment without warning.
Pregnancy: Naprelan (Naproxen-sodium) should not be used during the third trimester (last 3 months) of pregnancy. Naprelan (Naproxen-sodium) should not be used during the first and second trimester (first 6 months) of pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Naprelan (Naproxen-sodium), contact your doctor immediately.
Naprelan (Naproxen-sodium) may reduce your ability to become pregnant. Taking Naprelan (Naproxen-sodium) while trying to become pregnant is not recommended.
Breast-feeding: You should not use Naprelan (Naproxen-sodium) if you are breast-feeding.
Children: The safety and effectiveness of using Naprelan (Naproxen-sodium) have not been established for children.
Seniors: If you are a senior, you may have a higher risk of experiencing side effects from Naprelan (Naproxen-sodium). You should use the lowest effective dose for the shortest period of time under close medical supervision.
