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 Naproxen Gels.
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 this medication. If you experience symptoms of a severe allergic reaction (e.g., hives; difficulty breathing; wheezing; or swelling of the face, tongue, or throat), get immediate medical attention.
Blood clotting: Naproxen Gels 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 Naproxen Gels may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Naproxen Gels, and whether any special monitoring is needed. If you have a bleeding disorder, do not take Naproxen Gels.
Blood pressure: Naproxen Gels can cause fluid to build up in the body, increasing the amount of effort it takes for the heart to pump blood through the body. As a result, blood pressure can increase when taking naproxen/naproxen sodium. If you have high blood pressure, discuss with your doctor how Naproxen Gels may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Naproxen Gels, and whether any special monitoring is needed.
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 Naproxen Gels has on you.
Heart function: Naproxen Gels can cause fluid to build up in the body. This may decrease the effectiveness of the heart and contribute to heart failure. If you have heart disease, discuss with your doctor how Naproxen Gels may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Heart Attack and Stroke: Naproxen Gels 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 Naproxen Gels may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Naproxen Gels, and whether any special monitoring is needed.
Skin reactions: Naproxen Gels 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 this medication and contact your doctor.
Naproxen Gels may make your skin more sensitive to sunlight (including sunlamps) and may cause Sunburn, skin blisters, and skin redness, itching, or discoloration. If you have a reaction from the sun while taking Naproxen Gels, contact your doctor.
Ulcers or bleeding in the stomach or intestines: Naproxen Gels can cause stomach ulcers, perforation (holes), and bleeding from the stomach, or can make these conditions worse.
The risk of ulcers and bleeding is increased if you are taking higher doses of Naproxen Gels for longer periods of time.
If you currently have bleeding ulcers in the stomach or intestines, or have an inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), you should not take this medication. If you have a history of these conditions, discuss with your doctor how Naproxen Gels may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Naproxen Gels, 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 without warning at any time during treatment.
Pregnancy: Naproxen Gels should not be used during the third trimester (last 3 months) of pregnancy. Naproxen Gels 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 Naproxen Gels, contact your doctor immediately.
Naproxen Gels may reduce your ability to become pregnant. Taking Naproxen Gels while trying to become pregnant is not recommended.
Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking naproxen/naproxen sodium, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using Naproxen Gels have not been established for children less than 12 years of age.
Seniors: If you are a senior, you may have a higher risk of experiencing side effects from Naproxen Gels. You should use the lowest effective dose under close medical supervision.
