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Diclofenac-MisoprostolWarningThis medication is a combination of 2 drugs: diclofenac and misoprostol. Do not take this medication if you are pregnant or think that you may be pregnant. Misoprostol may cause loss of pregnancy, premature birth, or birth defects. In rare cases, serious problems (such as uterine rupture) have occurred when misoprostol was used to start labor or to end a pregnancy. These problems have caused harm to the mother and unborn baby. The risk for uterine rupture increases as your pregnancy advances and if you had prior uterine surgery (including Cesarean delivery) or if you had five or more previous pregnancies. Avoid pregnancy while taking this medication and for at least one month or one complete menstrual cycle after you have stopped treatment. If you become pregnant while taking this medication, contact your doctor right away. If you are of a woman of childbearing age, do not use this medication unless you need a nonsteroidal anti-inflammatory drug (NSAID) such as diclofenac and you are at high risk of having an ulcer or ulcer complications from NSAID treatment. Female patients must meet the following four requirements in order to use this drug: 1) test negative for pregnancy within 2 weeks before starting treatment; 2) use effective birth control to prevent pregnancy; 3) receive oral and written warnings on the dangers of using misoprostol while of childbearing age and the risks of possible birth control failure; 4) start taking this medication only on the second or third day of the next normal menstrual period. This medication must not be shared with others. Nonsteroidal anti-inflammatory drugs (including diclofenac) may rarely increase the risk for a heart attack or stroke. This effect can happen at any time while taking this drug but is more likely if you take it for a long time. The risk may be greater in older adults or if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes). Do not take this drug right before or after heart bypass surgery (CABG). Also, diclofenac may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. This effect can occur without warning symptoms at any time while taking this drug. Older adults may be at higher risk for this effect. Stop taking this medication and get medical help right away if you notice any of these rare but serious side effects: stomach/abdominal pain that doesn't go away, black/tarry stools, vomit that looks like coffee grounds, chest/jaw/left arm pain, shortness of breath, unusual sweating, confusion, weakness on one side of the body, trouble speaking, sudden vision changes. Talk to your doctor or pharmacist about the benefits and risks of taking this drug. PrecautionsSee also Warning section. Before taking this medication, tell your doctor or pharmacist if you are allergic to diclofenac or misoprostol; or to aspirin or other NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, stomach/intestinal/esophagus problems (such as bleeding, heartburn, ulcers), heart disease (such as previous heart attack), high blood pressure, stroke, swelling (edema, fluid retention), blood disorders (such as anemia), bleeding/clotting problems, aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), growths in the nose (nasal polyps). Kidney problems can sometimes occur with the use of NSAID medications, including diclofenac. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have a change in the amount of urine. This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Talk to your doctor if you are using marijuana (cannabis). Diclofenac may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Ask your doctor or pharmacist about how much alcohol you may safely drink. This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be at greater risk for stomach/intestinal bleeding, kidney problems, heart attack, and stroke while using this drug. This medication must not be used during pregnancy. It may harm the mother and unborn baby. Use reliable forms of birth control to prevent pregnancy while taking this medication and for at least one month or one completed menstrual cycle after stopping treatment. If you become pregnant or think you may be pregnant, tell your doctor right away. This medication passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breastfeeding. Side EffectsSee also Warning section. Diarrhea and stomach/abdominal pain may occur within a few weeks after you start taking this medication, and usually last for about one week. Nausea, heartburn, gas, upset stomach, drowsiness, and dizziness may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Diarrhea that is severe or doesn't stop may result in dehydration. Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness. Tell your doctor right away if you have any serious side effects, including: difficult/painful swallowing, hearing changes (such as ringing in the ears), mental/mood changes (such as depression), easy bruising/bleeding, unusual/heavy vaginal bleeding, menstrual problems/irregular periods, signs of kidney problems (such as change in the amount of urine), symptoms of heart failure (such as swelling ankles/feet, unusual tiredness, unusual/sudden weight gain). This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn't stop, loss of appetite, severe stomach/abdominal pain, yellowing eyes/skin, dark urine. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. |