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
[October 6, 2014]
Health Canada has issued new restrictions concerning the use of diclofenac. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
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.
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 this medication 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.
Drowsiness/reduced awareness: Some people have reported headache, dizziness, lightheadedness, and confusion while taking this medication. Avoid operating motor vehicles and doing other potentially hazardous activities until you have determined how this medication affects you.
Fertility: As with other NSAIDs, this medication 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 this medication 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. If you develop shortness of breath; fatigue; excessive weight gain; chest pain; or swelling of the legs, feet, or ankles while taking this medication, consult your doctor immediately.
Heart problems: Like other NSAID medications, diclofenac may increase the risk of heart attacks, strokes, and blood clots. 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
- heart attack
- heart disease
- high blood pressure
- high cholesterol
- impaired kidney function
- poor circulation
If you have any of these conditions, discuss with your doctor how this medication 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.
Infection: This medication may hide the signs of an infection, such as a fever or generalized achiness.
Kidney function: 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 take 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: This medication 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 this medication.
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: This medication may make your skin more sensitive to the sun. While you are using this medication, avoid excessive sun exposure, including tanning beds and sun lamps. If you experience sunburn with itching, swelling, and blistering, stop using this medication 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, this medication is not recommended for use during pregnancy.
Breast-feeding: It is not known if diclofenac passes into breast milk. Due to the potential for harm to a baby if they are exposed to this medication, breast-feeding must be stopped before starting this medication.
Children: Diclofenac is not recommended for children under 16 years of age. The safety, effectiveness, and dosage of this medication for this age group have not been established.
Seniors: Seniors appear to have a higher risk of side effects with this medication. The lowest effective dosage should be used under close medical supervision.