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
[October 6, 2014]
Health Canada has issued new restrictions concerning the use of diclofenac sodium – misoprostol. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Drowsiness/reduced alertness: Headache, dizziness, lightheadedness, and confusion have been reported by some people who take this medication. Avoid activities requiring mental alertness, such as driving, operating machinery, or performing hazardous work, while taking this medication until you are certain that your ability to perform these tasks is not impaired.
Fluid and electrolyte balance: Fluid retention and edema have been reported with use of diclofenac sodium – misoprostol. Taking this medication 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 this medication. People most at risk are seniors, those having 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 this medication 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 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.
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 this medication is used, and is also increased for people who have already had a heart attack or have heart disease. If you have a history of heart problems, or are at risk of developing heart problems, discuss the risks and benefits of using this medication 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 this medication. 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.
Kidney function: 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 this medication, 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 this medication.
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 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. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.
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 this medication, 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 this medication 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 this medication have not been established for children. This medication 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.