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 Floctafenine.
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.
Drowsiness/reduced awareness: Some people have reported headache, dizziness, lightheadedness, and confusion while taking Floctafenine. Do not drive vehicles or undertake other potentially hazardous activties until you have determined that Floctafenine does not affect you in this way.
Fluid and electrolyte balance: Fluid retention and edema have been reported with use of Floctafenine. People with the following medical conditions should be closely monitored by their doctor while taking floctafenine:
- any other condition that might lead to fluid retention
- certain heart conditions (e.g., Congestive Heart Failure)
- high blood pressure
- Kidney Disease or reduced kidney function
- recovering from a surgical operation under general anesthesia
There is a risk of high blood potassium with NSAID treatment. Those most at risk include seniors, those with conditions such as Diabetes or kidney failure, and those taking beta-adrenergic blockers, angiotensin converting enzyme (ACE) inhibitors, or some diuretics (water pills).
Heart problems: NSAID medications 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 Floctafenine may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Floctafenine, and whether any special monitoring is needed.
Infection: Floctafenine may mask the signs of an infection, such as a fever.
Kidney function: Long-term use of floctafenine may lead to a higher risk of reduced kidney function. This is most common for people who already have kidney disease, liver disease, or heart failure; for people who are take diuretics (water pills); and for seniors.
Liver function: Floctafenine may cause liver problems. If you have a liver condition, you may need more frequent checkups with your doctor. If you develop signs of a liver problem (such as yellow skin or eyes, dark urine, pale stools, abdominal pain, or itchy skin), stop taking the medication and see your doctor as soon as possible.
Stomach problems: Stomach ulcers, perforation, and bleeding from the stomach have been known to occur during therapy with floctafenine. These complications can occur at any time, and are sometimes severe enough to require immediate medical attention. The risk of ulcers and bleeding are increased for people taking higher doses of NSAIDs for longer periods of time.
Floctafenine should be taken under close medical supervision by people prone to irritation of the stomach and intestines, particularly those who have had a stomach ulcer, bloody stools, or diverticulosis or other inflammatory disease of the stomach or intestines (such as ulcerative colitis or Crohn's Disease). In these cases, your doctor must weigh the benefits of treatment against the possible risks.
Stop taking the medication and contact your doctor immediately if you experience symptoms or signs suggestive of stomach ulcers or bleeding in the stomach (black, tarry stools). These reactions can occur at any time during treatment without warning.
Sun sensitivity: Floctafenine may make your skin more sensitive to the sun. While you are using Floctafenine, avoid excessive sun exposure, including tanning beds and sun lamps. If you experience Sunburn with itching, swelling, and blistering, stop taking Floctafenine and contact your doctor.
Pregnancy: Floctafenine should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Floctafenine, contact your doctor immediately.
Breast-feeding: Floctafenine passes into breast milk and should not be used by breast-feeding mothers.
Children: The safety and effectiveness of using Floctafenine have not been established for children.
Seniors: Seniors appear to have a higher risk of side effects with Floctafenine. The lowest effective dosage should be used under close medical supervision.
