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 Teva Sulindac.
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 alertness: Some people have reported headache, dizziness, lightheadedness, and confusion while taking Teva Sulindac. Avoid operating motor vehicles and doing other potentially hazardous activities until you have determined the effect Teva Sulindac has on you.
Fluid and electrolyte balance: As with many other nonsteroidal anti-inflammatory drugs (NSAIDs), fluid retention and edema have been reported with use of Teva Sulindac. People with the following medical conditions should be closely monitored by their doctor while taking sulindac:
- any other condition that might lead to fluid retention
- certain heart conditions
- high blood pressure
- Kidney Disease
- recovering from surgical operations under general anesthesia
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 Teva Sulindac may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Teva Sulindac, and whether any special monitoring is needed.
Infection: Teva Sulindac may mask the signs of an infection, such as a fever.
Kidney function: Long-term use of sulindac 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: Teva Sulindac may cause liver problems. If you have a liver condition, you may need more frequent check-ups 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.
Potassium: There is a risk of high blood potassium with the use of sulindac. People most at risk are seniors, those having conditions such as diabetes, or kidney failure, or those taking beta-blockers (e.g., Metoprolol, Atenolol), angiotensin converting enzyme inhibitors (ACE inhibitors; e.g., Ramipril, Enalapril), or some diuretics (water pills; e.g., Hydrochlorothiazide).
Stomach problems: Stomach ulcers, perforation, and bleeding from the stomach have been known to occur during therapy with sulindac. 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.
Sulindac 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.
Surgery: If you are going to have any kind of surgery (including dental surgery), tell your doctor or dentist that you are taking Teva Sulindac.
Pregnancy: Teva Sulindac is not recommended for pregnant women because its safety during pregnancy has not been established. If you become pregnant while taking Teva Sulindac, contact your doctor immediately.
Breast-feeding: It is not known if sulindac passes into breast milk. If you are a breast-feeding mother and are taking Teva Sulindac, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using Teva Sulindac have not been established for children.
Seniors: Seniors, as well as those who are frail or debilitated, appear to have a higher risk of side effects with Teva Sulindac. The lowest effective dose should be used, and seniors should be closely followed by their doctors while taking Teva Sulindac.
