Diclofenac Sodium (dye-KLOE-fen-ak SOE-dee-um), Misoprostol (mye-soe-PROST-ol)

Treats arthritis pain and swelling. This medicine contains an NSAID.

Brand Name(s):

Arthrotec

When This Medicine Should Not Be Used:

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 this medicine together with an antacid that contains magnesium. Ask your doctor or pharmacist if you are not sure which antacid you can use.
• Some medicines can affect how diclofenac/misoprostol works. Tell your doctor if you are using any of the following:
  • Cyclosporine, digoxin, lithium, methotrexate, pemetrexed, phenobarbital, rifampin, tacrolimus, voriconazole
  • Blood pressure medicine (including ACE inhibitors, ARBs, beta blocker)
  • Blood thinner (including warfarin)
  • Diuretic (water pill)
  • Insulin or oral diabetes medicine
  • Medicine to treat depression (including SNRIs, SSRIs)
  • Other NSAID medicine (including aspirin, celecoxib, diflunisal, salsalate)
  • Steroid medicine

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, birth defects, or tearing of the uterus if taken during pregnancy, especially during the later part of pregnancy. If you are a woman who can bear children, your doctor may give you a pregnancy test within 2 weeks before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment with this medicine. Tell your doctor right away if you think you have become pregnant.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, heart or blood vessel disease, anemia, asthma, diabetes, inflammatory bowel disease, high blood pressure, heart failure, a recent heart attack, lupus, porphyria, bleeding problems, 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, stroke, or worsening of heart failure
  • Stomach or bowel problems (including bleeding, perforation, ulcers)
  • Liver problems
  • High blood pressure
  • Kidney problems
  • Serious skin reactions, including Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS)
  • Increased risk of bleeding
• This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.
• 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, difficult or painful urination
• 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, 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 bowel movements, 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:

• Bloating or feeling of fullness, heartburn
• Mild nausea or stomach pain, constipation, diarrhea, upset stomach, passing gas

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