When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to diclofenac, misoprostol, or another NSAID medicine, or if you are pregnant.

How to Use This Medicine:
Tablet, Coated Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. It is best to take this medicine with food to prevent diarrhea and stomach upset.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Swallow the tablet whole with a full glass of water. Do not crush, break, or chew it.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use an antacid that contains magnesium. Ask your doctor or pharmacist if you are not sure which antacid you can use.
• Some foods and medicines can affect how diclofenac/misoprostol works. Tell your doctor if you are using any of the following:
  
  • Cyclosporine, digoxin, lithium, methotrexate, phenobarbital, rifampin, tacrolimus, or voriconazole
  • Other pain or arthritis medicine (such as aspirin, celecoxib, ibuprofen, naproxen)
  • Insulin or diabetes medicine that you take by mouth
  • A steroid medicine (such as hydrocortisone, methylprednisolone, prednisone, prednisolone, dexamethasone)
  • Blood pressure medicine
  • A diuretic (water pill)
  • A blood thinner (such as warfarin)

Warnings While Using This Medicine:

• Do not use this medicine if you are pregnant or planning to become pregnant. This medicine can cause miscarriage, premature birth, or birth defects if taken during pregnancy. You will need to have a negative pregnancy test before you start using this medicine. Continue to use birth control for at least 1 month after you stop using this medicine. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, anemia, asthma, diabetes, inflammatory bowel disease, high blood pressure, heart failure or other heart problems, lupus, porphyria, or a history of stomach ulcers or bleeding problems. Tell your doctor if you drink alcohol regularly.
• This medicine may cause the following problems:
  
  • Increased risk for blood clots, heart attack, or stroke
  • Stomach or bowel bleeding
  • Liver problems
  • Serious skin reactions
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Change in how much or how often you urinate
• Chest pain, trouble breathing, slurred speech, sudden or severe headache
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fast, slow, or uneven heartbeat, lightheadedness or fainting
• Numbness or weakness in your arm or leg, or on one side of your body
• Rapid weight gain, swelling in your hands, ankles, or feet
• Severe neck pain and stiffness, fever
• Severe stomach pain or diarrhea, red or black stools, vomiting blood or material that looks like coffee grounds
• Unusual bleeding or bruising, including heavy vaginal bleeding

If you notice these less serious side effects, talk with your doctor:

• Mild nausea or stomach pain, diarrhea, or upset stomach that lasts longer than 7 days

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088