For female patients:

Do not take diclofenac and misoprostol if you are pregnant or plan to become pregnant. If you become pregnant while taking diclofenac and misoprostol, stop taking the medication and call your doctor immediately. Diclofenac and misoprostol may cause miscarriage (pregnancy loss), serious bleeding, or premature birth (baby is born too early) if taken during pregnancy.

Women who can become pregnant generally should not take diclofenac and misoprostol. However, you and your doctor may decide that diclofenac and misoprostol combination is needed to treat your condition. In that case you must:

• agree to use a reliable method of birth control during your treatment and for at least 1 month or one menstrual cycle after your treatment;
• have a negative blood test for pregnancy no longer than 2 weeks before you start taking diclofenac and misoprostol;
• begin taking the medication only on the second or third day of the next normal menstrual period.

For all patients:

People who take nonsteroidal anti-inflammatory medications (NSAIDs) (other than aspirin) such as diclofenac and misoprostol combination may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, or a stroke, if you smoke, and if you have or have ever had high cholesterol, high blood pressure, or diabetes. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of the body, or slurred speech.

If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not take diclofenac and misoprostol right before or right after the surgery.

NSAIDs such as diclofenac may cause ulcers, bleeding, or holes in the stomach or intestine. Misoprostol is taken in combination with diclofenac to protect the stomach and intestine, but may not prevent all damage to these parts of the body. Problems with the stomach and intestine may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time, are older in age, have poor health, or drink large amounts of alcohol while taking diclofenac and misoprostol. Tell your doctor if you take any of the following medications: anticoagulants ('blood thinners') such as warfarin (Coumadin); aspirin; other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); or oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone). Also tell your doctor if you have or have ever had ulcers, bleeding in your stomach or intestines, or other bleeding disorders. If you experience any of the following symptoms, stop taking diclofenac and misoprostol and call your doctor: stomach pain, heartburn, vomiting a substance that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools.

Keep all appointments with your doctor and the laboratory. Your doctor will monitor your symptoms carefully and will probably order certain tests to check your body's response to diclofenac and misoprostol. Be sure to tell your doctor how you are feeling so that your doctor can prescribe the right amount of medication to treat your condition with the lowest risk of serious side effects.

Do not give this medication to anyone else, especially a woman who is or could become pregnant.

Your doctor or pharmacist will give you the manufacturer's patient information sheet sheet for diclofenac and misoprostol and the general Medication Guide for NSAIDs when you begin your treatment and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/cder) or the manufacturer's website to obtain the patient information sheet and Medication Guide.