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.
Allergy: Some people who are allergic to sulfonamide medications such as certain antibiotics also experience allergic reactions to celecoxib. Before you take celecoxib, inform your doctor about any previous adverse reactions you have had to medications, especially sulfonamides and acetylsalicylic acid (ASA) or other anti-inflammatories. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing, or swelling of the face and throat.
Blood counts: Mylan Celecoxib can decrease the number of neutrophils (a type of white blood cell that helps fight infection), red blood cells (which carry oxygen), and platelets (which help your blood to clot). Your doctor will do blood tests to monitor this. Contact your doctor immediately if you notice an increased occurrence of signs of infection (e.g., fever, chills, or sore throat), feel unusually tired, lack energy, or experience unusual bleeding or bruising.
Drowsiness/reduced alertness: Celecoxib may cause drowsiness, dizziness or, sometimes, blurred vision. Avoid driving, operating machinery, or engaging in other activities that require alertness and coordination if you find that celecoxib affects you in this way.
Fertility: As with other NSAIDs, Mylan Celecoxib may make it more difficult for a couple to conceive if the woman is taking celecoxib. Stopping the medication allows the body's chemistry to return to normal which often resolves this issue.
Fluid retention: Celecoxib may cause fluid retention and swelling, possibly worsening high blood pressure, Congestive Heart Failure, or decreased heart function. If you have any of these conditions, discuss with your doctor how Mylan Celecoxib may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mylan Celecoxib, and whether any special monitoring is needed. Consult your doctor immediately if you develop shortness of breath, fatigue, excessive weight gain, chest pain, or swelling of the legs, feet, or ankles while taking Mylan Celecoxib.
Heart Attack and Stroke: The use of selective COX-2 inhibitor NSAIDs, including celecoxib, is associated with an increased risk of cardiovascular events such as heart attack and stroke, similar to the risk associated with most traditional NSAIDs (e.g., ibuprofen, diclofenac, naproxen). The risk is increased with higher total daily doses and when taking the medication over long periods of time. Due to this increased risk, people with the following conditions or risk factors should be closely monitored by their doctor if they use celecoxib:
- congestive heart failure
- Diabetes
- heart attack
- heart disease
- high blood pressure
- High Cholesterol
- impaired kidney function
- poor circulation
- smoking
- stroke
Kidney Disease: Like other NSAIDs, celecoxib may cause decreased kidney function and is not recommended for people with advanced kidney disease. If you have kidney disease, discuss with your doctor how Mylan Celecoxib may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mylan Celecoxib, 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: Celecoxib may worsen liver disease. If you have liver disease or decreased liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mylan Celecoxib, and whether any special monitoring is needed.
Contact your doctor immediately 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.
Meningitis: On rare occasions, people taking NSAIDs such as celecoxib experience symptoms of inflammation of the tissues surrounding the brain (meningitis). This appears to be more likely for people who have an autoimmune disorder. If you experience symptoms of meningitis not caused by infection, such as stiff neck, severe headache, nausea, vomiting, or changes in consciousness and awareness, contact your doctor immediately.
Potassium levels: Celecoxib may increase the risk of high potassium levels in the blood, especially for seniors, people who have conditions such as diabetes or kidney failure, or people taking certain other types of medications. Your doctor may order blood tests periodically during long-term treatment to monitor the amount of potassium in your blood. People who have been diagnosed with having high potassium levels in their blood should not take Mylan Celecoxib.
Stomach problems: Celecoxib may cause stomach problems such as ulcers or bleeding. If you have stomach problems, discuss with your doctor how Mylan Celecoxib may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mylan Celecoxib, and whether any special monitoring is needed. Call your doctor immediately if you notice signs such as stomach or abdominal pain, black tarry stools, or vomiting blood. Using acetylsalicylic acid (ASA) at the same time as celecoxib increases the risk of stomach ulcers and bleeding.
Urinary tract problems: Some people experience ongoing symptoms of urinary problems. If you experience bladder pain, pain when urinating, or increased frequency of urination, stop taking Mylan Celecoxib and contact your doctor.
Pregnancy: The safety of using Mylan Celecoxib during pregnancy has not been established. Mylan Celecoxib 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). Using celecoxib, as with any NSAID, late in pregnancy may cause labour to be prolonged. If you become pregnant while taking Mylan Celecoxib, contact your doctor immediately.
Breast-feeding: Mylan Celecoxib may pass into breast milk. If you are a breast-feeding mother and are taking celecoxib, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using Mylan Celecoxib have not been established for children and adolescents under 18 years old.
Seniors: Seniors are more likely to experience side effects of celecoxib. Discuss the risks and benefits of using Mylan Celecoxib with your doctor.
