Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). Misoprostol reduces stomach acid and replaces protective substances in the stomach that are reduced by NSAIDs.

Diclofenac and misoprostol is a combination medicine used to treat osteoarthritis and rheumatoid arthritis in people at high risk for developing stomach or intestinal ulcers.

Diclofenac and misoprostol may also be used for purposes not listed in this medication guide.

Do not use if you are pregnant. Misoprostol can cause birth defects, miscarriage, premature labor, or rupture of the uterus. You must have a negative pregnancy test within 2 weeks before you start taking diclofenac and misoprostol. You may need to start taking this medicine only on the 2nd or 3rd day of a normal menstrual period. Use effective birth control while you are using diclofenac and misoprostol.

Diclofenac can increase your risk of fatal heart attack or stroke. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Diclofenac may also cause stomach or intestinal bleeding, which can be fatal.

Follow all directions on your prescription label and read all medication guides. Use the lowest dose that is effective in treating your condition.

Take diclofenac and misoprostol with food to lessen stomach upset.

Swallow the tablet whole and do not crush, chew, or break it.

Do not share this medicine with anyone else, even if they have the same symptoms you have.

If you use diclofenac and misoprostol long-term, you may need frequent medical tests at your doctor's office.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Osteoarthritis:

One tablet (diclofenac 50 mg-misoprostol 200 mcg) orally 3 times a day
Maximum doses: diclofenac 150 mg/day; misoprostol 200 mcg/dose and 800 mcg/day

Comments:
-Monitor response to initial therapy and adjust dose and frequency to fit individual needs; consider titration of individual components if appropriate.
-For patients who experience intolerance, diclofenac 75 mg-misoprostol 200 mcg or diclofenac 50 mg-misoprostol 200 mcg orally twice a day may be used, however these regimens are less effective in preventing ulcers.
-For gastric ulcer prevention, misoprostol 200 mcg 3 times a day is therapeutically equivalent to 200 mcg 4 times a day and both are more protective than 200 mcg 2 times a day.
-For duodenal ulcer prevention, misoprostol 200 mcg 4 times a day is more protective than 200 mcg 2 or 3 times a day, but may not be well tolerated.

Use: For the treatment of signs and symptoms of osteoarthritis in patients at high risk of developing nonsteroidal anti-inflammatory drug (NSAID) induced gastric and duodenal ulcers and their complications

Usual Adult Dose for Rheumatoid Arthritis:

One tablet (diclofenac 50 mg-misoprostol 200 mcg) orally 3 to 4 times a day
Maximum doses: diclofenac 225 mg/day; misoprostol 200 mcg/dose and 800 mcg/day

Comments:
-For patients who experience intolerance, diclofenac 75 mg-misoprostol 200 mcg or diclofenac 50 mg-misoprostol 200 mcg orally twice a day may be used, however these regimens are less effective in preventing ulcers.
-Monitor response to initial therapy and adjust dose and frequency to fit individual needs; consider titration of individual components if appropriate.
-For gastric ulcer prevention, misoprostol 200 mcg 3 times a day is therapeutically equivalent to 200 mcg 4 times a day and both are more protective than 200 mcg 2 times a day.
-For duodenal ulcer prevention, misoprostol 200 mcg 4 times a day is more protective than 200 mcg 2 or 3 times a day, but may not be well tolerated.

Use: For the treatment of signs and symptoms of rheumatoid arthritis in patients at high risk of developing NSAID induced gastric and duodenal ulcers and their complications

Diclofenac can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use diclofenac and misoprostol just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Diclofenac may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using diclofenac and misoprostol, especially in older adults.

You should not use this medicine if you are allergic to diclofenac or misoprostol, or:

• if you have active bleeding in your stomach or intestines;

• if you are pregnant; or

• if you have a history of asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Tell your doctor if you have ever had:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;

• a heart attack, stroke, or blood clot;

• stomach ulcers or bleeding;

• asthma;

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

• liver or kidney disease; or

• fluid retention.

Do not use this medicine if you are pregnant. Diclofenac and misoprostol can cause birth defects, miscarriage, premature labor, or rupture of the uterus. Use an effective form of birth control to prevent pregnancy while you are using this medicine. Tell your doctor right away if you become pregnant during treatment.

You will need to have a pregnancy test within 2 weeks before you start taking diclofenac and misoprostol. You may need to start taking this medicine only on the 2nd or 3rd day of a normal menstrual period.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Avoid exposure to sunlight or tanning beds. diclofenac and misoprostol can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb diclofenac and misoprostol.

Avoid drinking alcohol. It may increase your risk of stomach bleeding caused by diclofenac.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to diclofenac (such as aspirin, ibuprofen, ketoprofen, or naproxen).

Get emergency medical help if you have signs of an allergic reaction (sneezing, runny or stuffy nose, hives, wheezing or trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using diclofenac and misoprostol and seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

diclofenac and misoprostol may cause serious side effects. Stop using diclofenac and misoprostol and call your doctor at once if you have:

• the first sign of any skin rash, no matter how mild;

• shortness of breath (even with mild exertion);

• swelling or rapid weight gain;

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or

• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects of diclofenac and misoprostol may include:

• abnormal vaginal bleeding;

• heartburn, indigestion stomach pain, gas;

• nausea, vomiting;

• diarrhea, constipation; or

• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ask your doctor before using this medicine if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all your other medicines, especially:

• cyclosporine;

• lithium;

• methotrexate;

• heart or blood pressure medication, including a diuretic or "water pill";

• oral diabetes medicine;

• a blood thinner--warfarin (Coumadin, Jantoven);

• other forms of diclofenac--Cambia, Cataflam, Flector, Voltaren, Zipsor, Zorvolex;

• other NSAIDs--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), indomethacin, meloxicam, and others; or

• steroid medicine--prednisone, dexamethasone, and others.

This list is not complete. Other drugs may affect diclofenac and misoprostol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking diclofenac and misoprostol.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Arthrotec® (containing Diclofenac, Misoprostol)