Diclofenac and misoprostol

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). Misoprostol helps lower stomach acid and restores protective substances in the stomach that NSAIDs can decrease.

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

Diclofenac and misoprostol may also be used for other reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides. Use the lowest dose that works for your condition.

Take diclofenac and misoprostol with food to reduce 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 as you.

If you use diclofenac and misoprostol for a long time, you may need regular medical tests at your doctor's office.

Store at room temperature, away from moisture and heat.

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.

Diclofenac can raise your chances of having a fatal heart attack or stroke, even if you do not have any risk factors. Do not use diclofenac and misoprostol right before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Diclofenac may also lead to bleeding in the stomach or intestines, which can be deadly. These issues can happen 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 begin 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.

Get emergency medical help if you notice signs of an allergic reaction such as sneezing, runny or stuffy nose, hives, wheezing or trouble breathing, or swelling in your face or throat. Also seek help if you have a severe skin reaction, which may include fever, sore throat, burning eyes, skin pain, or a red or purple skin rash that blisters and peels.

Stop using diclofenac and misoprostol and get medical treatment if you experience a serious drug reaction that can affect multiple 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 experience signs of a heart attack or stroke, such as chest pain that spreads to your jaw or shoulder, sudden numbness or weakness on one side of your body, slurred speech, or difficulty breathing.

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

• any skin rash, even if it seems mild;
• shortness of breath (even during mild activity);
• swelling or rapid weight gain;
• signs of stomach bleeding, such as bloody or tarry stools, coughing up blood, or vomit that looks like coffee grounds;
• liver problems, which may include loss of appetite, stomach pain (in the upper right side), tiredness, itching, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes);
• kidney problems, such as little or no urination, swelling in your feet or ankles, or feeling tired or short of breath; or
• low red blood cells (anemia), which may cause pale skin, unusual tiredness, feeling light-headed or short of breath, or cold hands and feet.

Common side effects of diclofenac and misoprostol may include:

• abnormal vaginal bleeding;
• heartburn, indigestion, stomach pain, or gas;
• nausea or vomiting;
• diarrhea or 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 can report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Osteoarthritis:

One tablet (diclofenac 50 mg-misoprostol 200 mcg) orally 3 times a dayMaximum 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 dayMaximum 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

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

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

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).

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.