How does this medication work? What will it do for me?
This combination product contains two medications: diclofenac sodium and misoprostol.
Diclofenac sodium belongs to the class of medications known as nonsteroidal anti-inflammatories (NSAIDs). It reduces pain and inflammation.
Misoprostol helps to protect the stomach from irritation and stomach ulcers that can be caused by diclofenac.
Diclofenac sodium – misoprostol is used to treat the pain and swelling of rheumatoid arthritis and osteoarthritis.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each white-to-off-white, round, biconvex tablet, plain on one side and debossed with "0397" on the other, contains an enteric-coated core of diclofenac sodium 50 mg surrounded by an outer layer containing misoprostol 200 µg. Nonmedicinal ingredients: colloidal silicon dioxide, corn starch, crospovidone, hydrogenated castor oil, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K-30, sodium hydroxide, talc, triethyl citrate; film coating: methacrylic acid-ethyl acrylate, sodium lauryl sulfate, and polysorbate 80.
Each white-to-off-white, round, biconvex tablet, plain on one side and debossed with "0398" on the other, contains an enteric-coated core of diclofenac sodum 75 mg surrounded by an outer layer containing misoprostol 200 µg. Nonmedicinal ingredients: colloidal silicon dioxide, corn starch, crospovidone, hydrogenated castor oil, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K-30, sodium hydroxide, talc, triethyl citrate; film coating: methacrylic acid-ethyl acrylate, sodium lauryl sulfate, and polysorbate 80.
How should I use this medication?
The recommended adult dose of diclofenac sodium – misoprostol contains 50 mg of diclofenac taken 2 times a day. The maximum total daily dose of diclofenac is 100 mg.
Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
To reduce the chance of this medication causing stomach upset, take diclofenac sodium – misoprostol immediately after a meal or with food or milk. Swallow the tablets whole. Do not crush or chew them. You should remain sitting or standing upright for 15 to 30 minutes after taking this medication in order to avoid irritation that can lead to trouble swallowing.
It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature and keep out of reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take this medication if you:
- are allergic to diclofenac sodium, misoprostol, or any ingredients of the medication
- are allergic to medications similar to misoprostol (prostaglandins and their analogues)
- have had an allergic reaction to ASA or other non-steroidal anti-inflammatory medications (NSAIDs)
- are currently taking other NSAIDs
- are pregnant or may be pregnant
- are breast-feeding or planning to breast-feed
- have, or have recently had, inflammatory diseases of the stomach and intestines, such as Crohn's disease or ulcerative colitis
- have an active stomach or intestinal ulcer
- have bleeding from the stomach
- have a known electrolyte imbalance, particularly high potassium
- have a history of asthma after taking ASA or other NSAIDs have bleeding in or around the brain or any other diseases involving bleeding
- have recently had or are planning to have heart bypass surgery
- have severe, uncontrolled heart failure
- have severely impaired or deteriorating kidney function
- have significant liver impairment or liver disease
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- decreased appetite
- difficulty sleeping
- stomach pain
- upset stomach
Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- general feeling of being unwell
- increased sensitivity of the skin to sunlight
- hearing problems
- lightheadedness or dizziness
- signs of acid reflux (e.g., cough or hoarseness, heartburn or indigestion)
- signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, cuts that don't stop bleeding, blood in stools)
- signs of decreased blood sugar control (e.g., continuing thirst, increased urination at night, increased frequency of urination)
- signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
- signs of fluid and electrolyte imbalance (e.g., muscle pain, cramps, dry mouth, numb hands and feet)
- signs of heart problems (e.g., swelling of face, fingers, feet, or lower legs, irregular heartbeat, fluid retention, increased blood pressure, increased heart rate, chest pain, rapid weight gain)
- signs of kidney problems (e.g., lower back or side pain, painful or difficult urination, sudden decrease in the amount of urine)
- signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools, itching of the skin)
- unusual infections (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, listlessness)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- blurred vision or any visual disturbances
- signs of gastrointestinal bleeding (e.g., black, tarry stools, vomiting of material that looks like coffee grounds, rectal bleeding)
- signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
- signs of meningitis not caused by infection (e.g., headache [severe], throbbing, or with stiff neck or back)
- signs of a serious allergic reaction (i.e., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
- signs of stroke (e.g., sudden headache, weakness or numbness in an arm or leg, difficulty speaking or understanding, sudden vision difficulty, dizziness)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
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.
What other drugs could interact with this medication?
There may be an interaction between diclofenac sodium - misoprostol and any of the following:
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.