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 Diflunisal.
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: Headache, dizziness, lightheadedness, and confusion have been reported by some people using Teva Diflunisal. Avoid operating machinery or motor vehicles or doing other potentially hazardous tasks until you determine how Teva Diflunisal affects you.
Fluid and electrolyte balance: Fluid retention and edema have been reported with use of Teva Diflunisal. People who have the following conditions should be monitored by their doctor while taking Teva Diflunisal:
- certain heart conditions (e.g., Congestive Heart Failure)
- high blood pressure
- Kidney Disease or impaired kidney function
- liver disease
- recovering from surgical operations under general anesthesia
- other conditions that might lead to fluid retention
There is a risk of high blood potassium with treatment with diflunisal. People most at risk are seniors, those having 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 Teva Diflunisal may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Teva Diflunisal, and whether any special monitoring is needed.
Infection: Teva Diflunisal may mask the signs of an infection, such as a fever.
Kidney function: Long-term use of diflunisal 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 take diuretics (water pills); and for seniors.
Liver function: Teva Diflunisal 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 while taking diflunisal. 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 in people taking higher doses of diflunisal for longer periods of time.
Diflunisal 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.
Pregnancy: Teva Diflunisal should not be used during the third trimester (last 3 months) of pregnancy. Teva Diflunisal 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 Teva Diflunisal, contact your doctor immediately.
Breast-feeding: Teva Diflunisal passes into breast milk. If you are a breast-feeding mother and are taking Teva Diflunisal, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children:. Diflunisal is not recommended for children under 12 years of age. The safety, effectiveness, and dosages of Teva Diflunisal for this age group have not been established.
Seniors: Seniors appear to have a higher risk of side effects. They should use the lowest effective dosage under close medical supervision.
