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 take Sandoz Indomethacine.
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 Sandoz Indomethacine. If you experience symptoms of a Anaphylaxis (severe allergic reaction) (e.g., hives; difficulty breathing; wheezing; swelling of the face, tongue, or throat), get immediate medical attention.
Aseptic Meningitis: Sandoz Indomethacine 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 Sandoz Indomethacine and get immediate medical attention.
Bladder problems: Sandoz Indomethacine 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 this medication and contact your doctor.
Blood clotting: Sandoz Indomethacine may reduce the ability of the blood to clot. If you are taking anticoagulants (e.g., Warfarin, Heparin) or have Hemophilia or other blood disorders (e.g., low platelets), discuss with your doctor how Sandoz Indomethacine may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sandoz Indomethacine, and whether any special monitoring is needed. If you have a bleeding disorder, do not take Sandoz Indomethacine.
Drowsiness and reduced alertness: Headaches, sometimes combined with dizziness or lightheadedness, may occur during treatment with indomethacin. (These headaches usually occur early in the treatment.) Avoid operating motor vehicles and doing other activities that require alertness until you determine how this medication affects you.
Heart problems and stroke: Indomethacin may increase the risk of heart attacks, strokes, and high blood pressure, and may also make existing high blood pressure worse. As well, it can cause fluid buildup, especially in the feet and legs.
If you have or have had a heart condition (such as Congestive Heart Failure), high blood pressure, High Cholesterol, stroke, kidney disease, or if you have had recent surgery, discuss with your doctor how Sandoz Indomethacine 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.
High blood potassium: There is a risk of high blood potassium with NSAID treatment. People most at risk are seniors, people with conditions such as Diabetes or kidney failure, and people who are taking beta-adrenergic blockers, angiotensin converting enzyme (ACE) inhibitors, or some diuretics (water pills). Ask your doctor whether you need to have your potassium levels checked while you are taking Sandoz Indomethacine.
Kidney function: Long-term use of indomethacin may lead to a higher risk of reduced kidney function. This is most common for those who already have kidney disease, liver disease, or heart failure; for those who take diuretics (water pills); and for seniors. If you fit into one of these groups, discuss with your doctor how Sandoz Indomethacine may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sandoz Indomethacine, and whether any special monitoring is needed.
Liver function: Indomethacin may reduce liver function and can cause liver failure. If you have liver problems, discuss with your doctor how Sandoz Indomethacine may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sandoz Indomethacine, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Sandoz Indomethacine.
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.
Stomach ulcers: Stomach ulcers, perforation, and bleeding from the stomach have been known to occur during therapy with indomethacin. These problems can happen even to people who have never had stomach problems before. These complications can occur at any time, and are sometimes severe enough to require immediate medical attention. The risk of ulcers and bleeding increase for people taking higher doses of NSAIDs for longer periods of time.
If you have ever had a stomach ulcer, bloody stools, diverticulosis or other conditions affecting the stomach or intestines (such as ulcerative colitis or Crohn's Disease), discuss with your doctor how Sandoz Indomethacine may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sandoz Indomethacine, and whether any special monitoring is needed.
Pregnancy: Do not use Sandoz Indomethacine if you are in the third trimester of pregnancy. For the first and second trimesters, this medication should not be used unless the benefits outweigh the risks. If you become pregnant while taking Sandoz Indomethacine, contact your doctor immediately.
Sandoz Indomethacine may reduce fertility. If you are trying to get pregnant or are having difficulty getting pregnant, you should not use Sandoz Indomethacine.
Breast-feeding: Sandoz Indomethacine passes into breast milk. If you are a breast-feeding mother and are taking indomethacin, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.
Seniors: Seniors appear to have a higher risk of side effects. They should use the lowest effective dosage under close medical supervision.
