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 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 acetylsalicylic acid or other anti-inflammatory medications also experience allergic reactions to diclofenac. Before you take diclofenac – misoprostol, inform your doctor about any previous adverse reactions you have had to medications, especially anti-inflammatory pain relievers. 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: Arthrotec 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 Arthrotec and contact your doctor.
Blood clotting: Arthrotec 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 Arthrotec may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Arthrotec, and whether any special monitoring is needed. If you have a bleeding disorder, do not take Arthrotec.
Drowsiness/reduced alertness: Headache, dizziness, lightheadedness, and confusion have been reported by some people who take Arthrotec. Avoid activities requiring mental alertness, such as driving, operating machinery, or performing hazardous work, while taking Arthrotec until you are certain that your ability to perform these tasks is not impaired.
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 and electrolyte balance: Fluid retention and edema have been reported with use of diclofenac sodium – misoprostol. Taking Arthrotec is more likely to cause fluid retention for people who:
- are recovering from a surgical operation under general anesthesia
- have any other condition that might lead to fluid retention
- have certain heart conditions (e.g., Congestive Heart Failure)
- have high blood pressure
- have Kidney Disease or reduced kidney function
There is a risk of high blood potassium with use of Arthrotec. People most at risk are seniors, those who have conditions such as Diabetes or kidney failure, and those taking beta-adrenergic blockers, angiotensin converting enzyme (ACE) inhibitors, or some diuretics (water pills).
Contact your doctor as soon as possible if you experience symptoms of fluid and electrolyte imbalance such as muscle pains or cramps; dry mouth; numb hands, feet, or lips; or racing heartbeat.
Gastrointestinal problems: The presence of misoprostol in this medication is intended to protect against the damaging effects of diclofenac on the inside lining of the stomach wall. Serious problems such as stomach ulcers, perforation, and stomach bleeding (with or without symptoms) may still occur in patients treated with diclofenac sodium – misoprostol. These complications can occur at any time, and are sometimes severe enough to require immediate medical attention. Taking higher doses of Arthrotec for longer periods of time increases your risk for ulcers and bleeding.
Minor stomach problems such as heartburn are common, and usually develop early in therapy. Take diclofenac sodium – misoprostol under close medical supervision if your stomach and intestines are easily irritated, especially 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). If you have a history of any of these conditions, discuss with your doctor how Arthrotec 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.
Stop taking the medication and contact your doctor immediately if you experience symptoms or signs suggestive of stomach ulcers or bleeding in the stomach, such as black, tarry stools, or spitting up blood. There may not be any pain associated with bleeding in the stomach and these reactions can occur at any time during treatment, without warning.
Heart disease: As with other NSAIDs, diclofenac sodium – misoprostol may lead to an increased risk of heart failure, heart attack, or stroke which can be fatal. The risk of this occurring appears to increase with higher doses, the length of time Arthrotec is used, and is also increased for people who have already had a heart attack or have heart disease. The lowest effective dose of Arthrotec should be used for the shortest period of time. If you have a history of heart problems, or are at risk of developing heart problems, discuss the risks and benefits of using Arthrotec with your doctor.
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 Arthrotec. 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: Arthrotec may mask signs of infection such as fever or muscle aches. If you notice other symptoms of infection (e.g., painful or frequent urination, sore throat, cough), contact your doctor.
Kidney function: Decreased kidney function and kidney disease may cause diclofenac to build up in the body, causing side effects. Long-term use of diclofenac sodium – misoprostol may lead to a higher risk of reduced kidney function. This is most common for people who already have kidney disease, diabetes or heart failure; people who take diuretics (water pills); and seniors. 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 Arthrotec, and whether any special monitoring is needed. Contact your doctor as soon as possible if you experience signs of decreasing kidney function while you are taking Arthrotec.
Liver function: Decreased liver function or liver disease may cause diclofenac sodium – misoprostol to build up in the body and lead to side effects. It may also reduce liver function and can cause liver failure. If you have liver problems, discuss with your doctor how Arthrotec may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Arthrotec, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Arthrotec.
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.
Stroke: As with other NSAIDs, diclofenac sodium – misoprostol may lead to an increased risk of "mini-strokes" or strokes, which can be fatal. If you experience signs of stroke while taking Arthrotec, seek immediate medical attention. Signs of stroke may include sudden headache, weakness or numbness in an arm or leg, difficulty speaking or understanding, or sudden change in vision.
Pregnancy: Misoprostol is known to cause miscarriage when taken during pregnancy. It is not recommended for a woman to become pregnant while taking diclofenac sodium – misoprostol. Stop using Arthrotec and contact your doctor immediately if you suspect you are pregnant.
Breast-feeding: Misoprostol passes into breast milk and may cause infants to have severe diarrhea. If you are a breast-feeding mother and are taking diclofenac sodium – misoprostol, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using Arthrotec have not been established for children. Arthrotec is not recommended for children under 18 years of age.
Seniors: Seniors appear to have a higher risk of side effects and should use the lowest effective dosage under close medical supervision.
