Before Using This Medicine

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

Other medical problems—The presence of other medical problems may affect the use of diclofenac and misoprostol combination. Make sure you tell your doctor if you have any other medical problems, especially:

• 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