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 use Apo Naproxen Sr.
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.
Allergy: Some people who are allergic to other NSAIDs or ASA also experience allergic reactions to naproxen controlled-release. Before you take naproxen controlled-release, inform your doctor about any previous adverse reactions you have had to medications, especially NSAIDs. People who have experienced difficulty breathing after taking ASA or other NSAIDs should not take naproxen controlled-release.
Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing, or swelling of the face and throat.
Anemia: Apo Naproxen Sr may cause anemia (low red blood cells). If you take Apo Naproxen Sr for a long period of time, your doctor will periodically monitor your red blood cell levels. If you experience symptoms of anemia (e.g., shortness of breath, fatigue, pallor, fast heartbeat), contact your doctor as soon as possible.
Asthma: People with asthma are at increased risk of severe and even fatal allergic reactions (Anaphylaxis (severe allergic reaction)) when taking Apo Naproxen Sr. People with asthma or other breathing problems should discuss with their doctor how Apo Naproxen Sr may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Apo Naproxen Sr, and whether any special monitoring is needed.
Bleeding disorders: Naproxen controlled-release may increase bruising and bleeding from cuts may take longer to stop. People with bleeding disorders, a history of bleeding problems, or those who are taking medications to prevent clotting, should discuss with their doctor how Apo Naproxen Sr may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Apo Naproxen Sr, and whether any special monitoring is needed.
Blood pressure: Naproxen controlled-release may cause an increase in blood pressure, even when there have been no blood pressure problems in the past. People with high blood pressure should discuss with their doctor how Apo Naproxen Sr may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Apo Naproxen Sr and whether any special monitoring is needed. Report any ongoing increase in blood pressure to your doctor as soon as possible.
Drowsiness/reduced alertness: Apo Naproxen Sr may cause drowsiness. Do not drive, operate machinery, or perform other potentially hazardous tasks until you have determined how Apo Naproxen Sr affects you.
Fluid and electrolyte balance: Apo Naproxen Sr can cause fluid retention and edema. People with conditions that might be affected by fluid retention or contribute to fluid retention (e.g., Congestive Heart Failure, high blood pressure, kidney disease, or reduced kidney function) should be closely monitored by their doctor while taking Apo Naproxen Sr.
Apo Naproxen Sr may cause high blood potassium levels. People most at risk are seniors; people with conditions such as Diabetes or kidney failure; and those taking beta-adrenergic blockers, angiotensin converting enzyme (ACE) inhibitors, angiotensin-II receptor antagonists, Cyclosporine, or some diuretics (water pills).
Heart problems: Naproxen controlled-release may increase the risk of heart-related problems such as Heart Attack, Stroke, or Blood Clots. The risk may increase with the length of treatment and for people who already have heart disease (e.g., a history of heart attack or Angina, stroke, transient ischemic attacks, or congestive heart failure), or risk factors for heart disease (e.g., high blood pressure, High Cholesterol, diabetes, smoking, impaired kidney function). Talk to your doctor about the risks and benefits of using Apo Naproxen Sr. To minimize heart-related problems, the lowest dose of naproxen controlled-release should be used for the shortest time possible.
Kidney function: Long-term use of naproxen controlled-release may increase the risk of developing reduced kidney function. This risk is increased for people who already have kidney disease, liver disease, or heart failure; for people who are taking certain medications (e.g., beta-adrenergic blockers, angiotensin converting enzyme [ACE] inhibitors, angiotensin-II receptor antagonists, cyclosporine, or some diuretics [water pills]; and for seniors. Your doctor will monitor your kidney function with blood tests during long-term therapy with naproxen controlled-release.
Liver function: Rarely, this medication can cause decreased liver function. If you experience yellowing of the skin or whites of the eyes, nausea, vomiting, or loss of appetite, contact your doctor immediately. If you take Apo Naproxen Sr for a long period of time, your doctor will periodically check your liver function with blood tests.
Stomach problems: Stomach or duodenal ulcers, perforation, and bleeding from the stomach have occurred with Apo Naproxen Sr. These complications can occur at any time. The risk for ulcers and bleeding increases with higher doses and longer treatment periods. The risk also increases for people with a history of ulcers, for people who smoke or drink large amounts of alcohol, or for people taking certain medications (e.g., Warfarin, ASA, Clopidogrel, Prednisone, Citalopram, Fluoxetine, Paroxetine, Sertraline). Stop taking Apo Naproxen Sr and contact your doctor immediately if you experience symptoms of stomach ulcers or bleeding in the stomach (e.g., bloody or black, tarry stools).
Pregnancy: Apo Naproxen Sr should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Apo Naproxen Sr, contact your doctor immediately.
The use of naproxen controlled-release during the last 3 months of pregnancy may result in harm to the baby or longer labour for the mother. Naproxen controlled-release should not be used during this time.
Apo Naproxen Sr may reduce your ability to become pregnant. Taking Apo Naproxen Sr 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 controlled-release, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: Naproxen controlled-release is not recommended for children under the age of 18 years. The safety and effectiveness of using Apo Naproxen Sr have not been established for children.
Seniors: Seniors appear to have a higher risk of side effects, such as bleeding and kidney problems. They should use the lowest effective dosage for the shortest time period possible.
