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 Novo Profen (Ibuprofen).
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 other anti-inflammatory medications also experience allergic reactions to Novo Profen (Ibuprofen). Before you take Novo Profen (Ibuprofen), inform your doctor or pharmacist about any previous adverse reactions you have had to medications, especially ASA or naproxen. 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.
Bladder problems: Novo Profen (Ibuprofen) 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 Novo Profen (Ibuprofen) and contact your doctor.
Blood clotting: Novo Profen (Ibuprofen) 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 Novo Profen (Ibuprofen) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Novo Profen (Ibuprofen), and whether any special monitoring is needed.
Blood pressure: Novo Profen (Ibuprofen) may cause an increase in blood pressure, particularly for people who already have high blood pressure. If you are taking medications for blood pressure or are at risk of developing high blood pressure, discuss with your doctor how Novo Profen (Ibuprofen) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Novo Profen (Ibuprofen), and whether any special monitoring is needed.
Fluid and electrolyte balance: Fluid retention and edema have been reported with use of Novo Profen (Ibuprofen). Use Novo Profen (Ibuprofen) with caution if you:
- are recovering from a surgical operation under general anesthesia
- have certain heart conditions (e.g., Congestive Heart Failure)
- have high blood pressure
- have kidney disease or reduced kidney function
- have any other condition that might lead to fluid retention
Gastrointestinal problems: Stomach ulcers, perforation, and bleeding from the stomach have been known to occur during therapy with Novo Profen (Ibuprofen). These complications can occur at any time and are sometimes severe enough to require immediate medical attention.
The risk of ulcers and bleeding increases for people taking higher doses of Novo Profen (Ibuprofen) for longer periods of time. Stomach problems are also more likely to occur with alcohol use. Do not drink alcohol while taking Novo Profen (Ibuprofen).
If you are prone to irritation of the stomach and intestines, particularly if you have had a stomach ulcer, bloody stools, diverticulosis, or other inflammatory disease of the stomach or intestines (such as ulcerative colitis or Crohn's disease), discuss with your doctor how Novo Profen (Ibuprofen) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Novo Profen (Ibuprofen), and whether any special monitoring is needed.
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 without warning during treatment.
Heart attack and stroke: High doses of Novo Profen (Ibuprofen) (2,400 mg or more per day) have been linked to increased risk of heart attack and stroke. The risk is increased with higher total daily doses and taking the medication over long periods of time. If you have had a heart attack or stroke, or are at risk of a heart attack or stroke, discuss with your doctor how Novo Profen (Ibuprofen) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Novo Profen (Ibuprofen), and whether any special monitoring is needed.
Heart disease: Novo Profen (Ibuprofen) can cause fluid retention, which may make symptoms of congestive heart failure worse. If you have been diagnosed with congestive heart failure, discuss with your doctor how Novo Profen (Ibuprofen) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Novo Profen (Ibuprofen), and whether any special monitoring is needed.
If you are taking low-dose ASA for heart health, discuss with your doctor whether you should use Novo Profen (Ibuprofen).
Kidney function: Long-term use of Novo Profen (Ibuprofen) 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.
If you have reduced kidney function or kidney disease, discuss with your doctor how Novo Profen (Ibuprofen) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Novo Profen (Ibuprofen), and whether any special monitoring is needed.
People with severely reduced kidney function and kidney disease should not take Novo Profen (Ibuprofen).
Potassium levels: There is a risk of high levels of potassium in the blood for people who take NSAIDs, including Novo Profen (Ibuprofen). People most at risk are seniors; those who have conditions such as Diabetes or kidney failure; and those taking beta-blockers (e.g., Metoprolol), angiotensin converting enzyme (ACE) inhibitors (e.g., Ramipril), or some diuretics (water pills). If you experience unexplained nausea, fatigue, muscle weakness or tingling sensations, contact your doctor as these are possible symptoms of too much potassium in the blood.
Reduced alertness/dizziness: Novo Profen (Ibuprofen) may cause drowsiness, dizziness or a sensation of spinning, any of which can affect your ability to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how Novo Profen (Ibuprofen) affects you.
Pregnancy: Novo Profen (Ibuprofen) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Novo Profen (Ibuprofen), contact your doctor immediately. Novo Profen (Ibuprofen), like other NSAIDs, must not be taken in the last 3 months of pregnancy.
Novo Profen (Ibuprofen) may reduce your ability to become pregnant. Taking Novo Profen (Ibuprofen) while trying to become pregnant is not recommended.
Breast-feeding: Novo Profen (Ibuprofen) may pass into breast milk in small quantities. If you are a breast-feeding mother and are taking Novo Profen (Ibuprofen), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Seniors: Seniors appear to have a higher risk of side effects with Novo Profen (Ibuprofen). The lowest effective dosage should be used under close medical supervision.
