In the U.S.—

In Canada—

• Antirheumatic (nonsteroidal anti-inflammatory)

Diclofenac and misoprostol (dye-KLOE-fen-ak and mye-soe-PROST-ole ) combination is used for patients with arthritis who may develop stomach ulcers from taking nonsteroidal anti-inflammatory drugs (NSAIDs) alone.

Diclofenac is a NSAID used in this combination medicine to help relieve some symptoms of arthritis, such as inflammation, swelling, stiffness, and joint pain.

Misoprostol is used in this combination medicine to prevent stomach ulcers.

This medicine is available only with your doctor's prescription, in the following dosage form(s):

Oral
• Tablets (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For diclofenac and misoprostol combination, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to diclofenac or other nonsteroidal anti-inflammatory drugs (NSAIDs), to misoprostol, or to any of the following medicines:

• Aspirin or other salicylates
• Prostaglandin analogs

Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Diclofenac and misoprostol combination must not be used during pregnancy.

Before starting to take diclofenac and misoprostol combination, you must have had a negative pregnancy test within the previous 2 weeks. Also, you must start taking this combination only on the second or third day of your next normal menstrual period. In addition, it will be necessary that you use an effective form of birth control while taking this medicine. Be sure that you have discussed this with your doctor before taking diclofenac and misoprostol combination.

Studies on birth defects with the diclofenac and misoprostol combination have not been done. However, there is a chance that diclofenac may cause unwanted effects on the heart or blood flow of the fetus or newborn baby if taken regularly during the last few months of pregnancy. Also, studies in animals have shown that diclofenac, if taken late in pregnancy, may increase the length of pregnancy, prolong labor, or cause other problems during delivery. Diclofenac caused unwanted effects on the formation of bones in animals.

Misoprostol has been shown to cause contractions and bleeding of the uterus. It may also cause miscarriage.

Breast-feeding—It is not known whether diclofenac and misoprostol combination passes into breast milk. Diclofenac passes into breast milk. Diclofenac and misoprostol combination is not recommended for use during breast-feeding.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of diclofenac and misoprostol combination in children with use in other age groups.

Older adults—Certain side effects, such as confusion, swelling of the face, feet, or lower legs, or sudden decrease in the amount of urine, may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of nonsteroidal anti-inflammatory drugs. Also, elderly people are more likely than younger adults to get sick if this medicine causes stomach problems.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking diclofenac and misoprostol combination, it is especially important that your health care professional know if you are taking any of the following:

• Anticoagulants (blood thinners) or
• Corticosteroids (e.g., prednisone or other cortisone-like medicines)—The chance of bleeding may be increased

• Aspirin—The chance of serious side effects may be increased if aspirin is used together with diclofenac and misoprostol combination on a regular basis

• Cyclosporine (e.g., Sandimmune) or
• Digitalis glycosides (heart medicine) or
• Lithium (e.g., Lithane) or
• Methotrexate (e.g., Mexate)—Higher blood levels of these medicines and an increased chance of side effects may occur

• Amiloride (e.g., Midamor) or
• Spironolactone (e.g., Aldactone) or
• Triamterene (e.g., Dyrenium)—May cause high blood levels of potassium, which may increase the chance of side effects

• Alcohol abuse or
• Bleeding problems or
• Hepatitis or other liver disease or
• Kidney disease (or history of) or
• Tobacco use (or recent history of) or
• Stomach ulcer, or other stomach or intestinal problems or
• Systemic lupus erythematosus—The chance of side effects may be increased

• Anemia or
• Asthma or
• Dehydration or
• Fluid retention (swelling of feet or lower legs) or
• Heart disease or
• High blood pressure or
• Low platelet count or
• Low white blood cell count or
• Porphyria (liver) or
• Volume depletion—Diclofenac and misoprostol combination may make these conditions worse

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your health care professional. Taking too much of this medicine may increase the chance of unwanted effects.

Do not take diclofenac and misoprostol combination with magnesium-containing antacids. Antacids may be taken with diclofenac and misoprostol combination, if needed, to help relieve stomach pain, unless you are otherwise directed by your doctor. However, do not take magnesium-containing antacids, since they may cause diarrhea or worsen the diarrhea that is sometimes caused by the diclofenac and misoprostol combination.

Do not chew, crush, or dissolve tablets.

Do not give this medication to another person.

Diclofenac and misoprostol combination should be taken with meals.

Dosing—

The dose of diclofenac and misoprostol combination will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of diclofenac and misoprostol combination. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking diclofenac and misoprostol combination.

• For oral dosage form (tablets):
  • For osteoarthritis:
    • Adults—1 tablet of Arthrotec 50 three times a day.
    • Children—Use and dose must be determined by your doctor.
  • For rheumatoid arthritis:
    • Adults—1 tablet of Arthrotec 50 three or four times a day.
    • Children—Use and dose must be determined by your doctor.
  • For osteoarthritis or rheumatoid arthritis (for patients who are unable to tolerate other doses):
    • Adults—1 tablet of Arthrotec 50 two times a day or 1 tablet of Arthrotec 75 two times a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Misoprostol may cause miscarriage if taken during pregnancy. Therefore, if you suspect that you may have become pregnant, stop taking this medicine immediately and check with your doctor.

This medicine may cause diarrhea in some people. The diarrhea will usually disappear within a few days as your body adjusts to the medicine. However, check with your doctor if the diarrhea is severe and/or does not stop after a week.

If you will be taking this medicine for a long time, your doctor should check your progress at regular visits. Your doctor may want to do certain tests to find out if unwanted effects are occurring. The tests are very important because serious side effects, including ulcers, bleeding, blood, or liver problems, can occur without any warning.

Stomach problems may be more likely to occur if you drink alcoholic beverages while being treated with this medicine. Therefore, do not regularly drink alcoholic beverages while taking this medicine, unless otherwise directed by your doctor.

Taking nonsteroidal anti-inflammatory drugs together with this medicine on a regular basis may increase the chance of unwanted effects. Also, taking acetaminophen, aspirin or other salicylates, or ketorolac (e.g.,Toradol) regularly while you are taking a diclofenac and misoprostol combination may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicine together. If your health care professional directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take acetaminophen or aspirin or other salicylates together with this medicine for more than a few days, and do not take any ketorolac (e.g., Toradol) while you are taking this medicine, unless your doctor has directed you to do so and is following your progress.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Less common
  • Black, tarry stools;  bleeding or crusting sores on lips;  blood in urine or stools;  bruises and/or red spots on the skin;  chest pain;  chills;  confusion ;  continuing thirst;  convulsions (seizures);  cough or hoarseness;  disorientation;  drowsiness;  fainting;  fever with or without chills;  fluid retention;  general feeling of illness;  heartburn and/or indigestion;  increased blood pressure;  increased heart rate;  increased weight gain;  itching of the skin;  irregular heartbeat;  large, flat, blue or purplish patches on the skin;  light-headedness or dizziness;  lower back or side pain;  mental depression;  muscle cramps;  nausea;  painful or difficult urination;  pounding heartbeat;  psychotic reaction;  rectal bleeding;  seeing, hearing, or feeling things that are not there;  severe headache;  severe hepatic reactions;  severe stomach pain, cramping or burning;  shortness of breath, troubled breathing, tightness in chest, and/or wheezing;  skin rash;  sores, ulcers, or white spots on lips or in mouth;  sore throat;  stiff neck and/or back;  sudden decrease in the amount of urine;  swelling and/or tenderness in upper stomach ;  swelling of face, fingers, feet, and/or lower legs ;  unusual bleeding or bruising;  unusual tiredness or weakness;  vomiting of material that looks like coffee grounds;  yellow eyes or skin  
  
  

• Rare
  • Changes in facial skin color;  fast or irregular breathing;  puffiness or swelling of the eyelids or around the eyes 
  
  

• Symptoms of overdose
  • Confusion;  diarrhea;  drowsiness;  fever;  nausea and/or vomiting;  pounding heartbeat;  convulsions (seizures);  shortness of breath;  slow heartbeat;  stomach pain;  trembling or shaking 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Diarrhea;  gas;  heartburn 
  
  

• Less common
  • Abnormal vision;  acne;  change in sense of taste;  decreased appetite;  dry mouth;  irritability or nervousness;  loss of hair;  muscle pain;  decrease in sexual ability;  tingling, burning, or prickling sensations;  trembling or shaking;  trouble swallowing;  vaginal bleeding 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.