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 this medication.
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.
A previous advisory on non-steroidal anti-inflammatory drugs (NSAIDs) was issued on October 30, 2020.
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; swelling of the face, tongue, or throat), get immediate medical attention.
Aseptic Meningitis: Teva Flurbiprofen 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 Teva Flurbiprofen and get immediate medical attention.
Bladder problems: Teva Flurbiprofen 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 Teva Flurbiprofen and contact your doctor.
Drowsiness/reduced alertness: Headache, dizziness, lightheadedness, and mental confusion have been reported by some people taking Teva Flurbiprofen. Do not drive vehicles or perform other potentially hazardous activities until you have determined that Teva Flurbiprofen does not affect you in this way.
Fluid and electrolyte balance: NSAIDs such as flurbiprofen 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 Teva Flurbiprofen may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Teva Flurbiprofen, and whether any special monitoring is needed. If you have severe, uncontrolled heart failure, you should not take Teva Flurbiprofen.
Flurbiprofen 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 Teva Flurbiprofen.
Heart attack and Stroke: Like other NSAID medications, flurbiprofen may increase the risk of heart attacks, strokes, and Blood Clots. The risk is greater with higher doses and long-term use. People at risk of heart problems, such as those with high blood pressure, High Cholesterol, diabetes, peripheral arterial disease, heart failure, or Coronary Artery Disease, should discuss with their doctor how Teva Flurbiprofen may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Teva Flurbiprofen, and whether any special monitoring is needed.
Kidney Disease: Like other NSAIDs, flurbiprofen is not recommended for people with advanced kidney disease. If you have kidney disease, discuss with your doctor how Teva Flurbiprofen 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.
If you experience signs of kidney problems, such as blood in your urine or decreased urine production, contact your doctor as soon as possible.
Liver function: Flurbiprofen may worsen liver disease. If you have liver disease or severely impaired liver function, discuss with your doctor how Teva Flurbiprofen may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Teva Flurbiprofen, and whether any special monitoring is needed.
If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Sun sensitivity: Teva Flurbiprofen may make your skin more sensitive to the sun. While you are using Teva Flurbiprofen, avoid excessive sun exposure, including tanning beds and sun lamps. If you experience Sunburn with itching, swelling, and blistering, stop taking Teva Flurbiprofen and contact your doctor.
Ulcers: Flurbiprofen may increase the risk of ulcers in the stomach and intestines. People prone to irritation of the stomach and intestines, and particularly those who have had a stomach ulcer, blood in the stools, or diverticulosis or other inflammatory disease of the stomach or intestines (such as Ulcerative Colitis or Crohn's Disease) should only take Teva Flurbiprofen if they are under close medical supervision. In such cases, the doctor must weigh the benefits of treatment against the possible risks. Stop taking the medication and seek immediate medical attention if you develop symptoms of a bleeding ulcer, such as dark tarry stools, blood in the stools, or vomiting up of blood or material that looks like coffee grounds.
Pregnancy: The safety and effectiveness of Teva Flurbiprofen have not been established for pregnant women. Teva Flurbiprofen should not be used during pregnancy unless the benefits outweigh the risks, and it should be avoided during the last trimester of pregnancy (after 28 weeks of pregnancy). If you become pregnant while taking Teva Flurbiprofen, contact your doctor immediately.
Teva Flurbiprofen may reduce fertility. If you are trying to get pregnant or are having difficulty getting pregnant, you should not take Teva Flurbiprofen.
Breast-feeding: Flurbiprofen passes into breast milk. If you are a breast-feeding mother and are taking flurbiprofen, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of Teva Flurbiprofen have not been established for children. For this reason, flurbiprofen is not recommended for use by children.
Seniors: Seniors should be closely monitored by their doctors while they are taking Teva Flurbiprofen. They may be more prone to side effects and may require a lower dose.
