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 Diclofenac Sodium.
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 diclofenac. Before you take diclofenac, inform your doctor about any previous adverse reactions you have had to medications, especially Ketorolac or Ibuprofen. 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 symptoms: Diclofenac Sodium can cause bladder symptoms such as frequent or painful urination and blood in urine. If you develop these symptoms, stop taking Diclofenac Sodium and contact your doctor immediately.
Bleeding: Like other NSAIDs, diclofenac may increase bruising, and bleeding from cuts may take longer to stop. If you have a condition where your blood does not clot easily, or if you are taking medications to prevent your blood from clotting, discuss with your doctor how Diclofenac Sodium may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Diclofenac Sodium, and whether any special monitoring is needed.
If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible.
Breathing problems: People who have Asthma, long term breathing problems, or allergic conditions such as hay fever or nasal polyps are more likely to experience difficulty breathing and allergic reactions caused by NSAIDs. If you have a history of allergic reactions to other substances, or respiratory illness, discuss with your doctor how Diclofenac Sodium may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Diclofenac Sodium, and whether any special monitoring is needed.
Drowsiness/reduced awareness: Some people have reported headache, dizziness, lightheadedness, and confusion while taking Diclofenac Sodium. Avoid operating motor vehicles and doing other potentially hazardous activities until you have determined how Diclofenac Sodium affects you.
Fertility: As with other NSAIDs, Diclofenac Sodium may make it more difficult for a couple to conceive if the woman is taking diclofenac. Stopping the medication allows the body's chemistry to return to normal which often resolves this issue.
Fluid retention: Diclofenac 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 Diclofenac Sodium may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Diclofenac Sodium, and whether any special monitoring is needed. If you develop shortness of breath; fatigue; excessive weight gain; chest pain; or swelling of the legs, feet, or ankles while taking Diclofenac Sodium, consult your doctor immediately.
Heart problems: Like other NSAID medications, diclofenac may increase the risk of heart attacks, strokes, and Blood Clots, which may be fatal. The risk is greater with higher total daily doses and taking the medication for a long period 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 diclofenac:
- congestive heart failure
- Diabetes
- heart attack
- heart disease
- high blood pressure
- High Cholesterol
- impaired kidney function
- poor circulation
- smoking
- Stroke
If you have any of these conditions, discuss with your doctor how Diclofenac Sodium may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Diclofenac Sodium, and whether any special monitoring is needed.
Contact your doctor as soon as possible if you experience signs of decreasing heart function, such as swelling in the hands and feet, difficulty breathing when lying down, or easily becoming short of breath.
Seek medical help immediately if you experience signs of heart attack while taking Diclofenac Sodium. Signs of heart attack may include a crushing sensation or pain in the chest, difficulty breathing, becoming pale and sweating, or sudden development of nausea and vomiting.
Infection: Diclofenac Sodium may hide the signs of an infection, such as a fever or generalized achiness.
Kidney function: Decreased kidney function and Kidney Disease may cause diclofenac to build up in the body, causing side effects. If you have decreased kidney function, discuss with your doctor how Diclofenac Sodium may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Diclofenac Sodium, and whether any special monitoring is needed.
Long-term use of diclofenac 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 taking diuretics (water pills); and for seniors. If you experience signs of decreasing kidney function, such as increased fluid retention or decreased amounts of urine being produced, see your doctor as soon as possible.
Liver function: Diclofenac Sodium 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.
Potassium levels: Diclofenac 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 those 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 Diclofenac Sodium.
Stomach problems: Stomach ulcers, perforation, and bleeding from the stomach have been known to occur during treatment with diclofenac. 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.
Diclofenac 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.
Sun sensitivity: Diclofenac Sodium may make your skin more sensitive to the sun. While you are using Diclofenac Sodium, avoid excessive sun exposure, including tanning beds and sun lamps. If you experience Sunburn with itching, swelling, and blistering, stop using Diclofenac Sodium and contact your doctor.
Pregnancy: When diclofenac is taken during the last 3 months of pregnancy, there is an increased risk of the child developing heart problems and the mother having a longer labour to deliver the baby. If diclofenac is taken during the earlier stages of pregnancy, there is an increased risk of miscarriage. For these reasons, Diclofenac Sodium is not recommended for use during pregnancy.
Breast-feeding: It is not known if diclofenac passes into breast milk. If you are a breast-feeding mother and are taking diclofenac, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: Diclofenac is not recommended for children under 16 years of age. The safety, effectiveness, and dosage of Diclofenac Sodium for this age group have not been established.
Seniors: Seniors appear to have a higher risk of side effects with Diclofenac Sodium. The lowest effective dosage should be used under close medical supervision.
