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DICLOFENAC W/MISOPROSTOL-ORAL TABLET (cont.)

SIDE EFFECTS: Stomach upset, stomach pain, diarrhea or gas may occur the first few days as your body adjusts to the medication. Other side effects reported include headache, dizziness. If any of these effects continue or become bothersome, inform your doctor. Notify your doctor if you develop: dark urine, vomiting, chest pain, ringing in the ears, unusual bruising or bleeding, increased menstrual bleeding, vision changes, lightheadedness, yellowing of the eyes or skin, mental confusion or depression. If you notice any of the following unlikely but very serious side effects, stop taking this drug and consult your doctor or pharmacist immediately: black stools, persistent stomach/ abdominal pain, vomit that looks like coffee grounds. In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Tell your doctor your medical history especially: liver disease, kidney disease, blood disorders, ulcers, heart disease, alcohol use, high blood pressure, eye disease, prior Cesarean births or uterus surgery, five or more previous pregnancies, asthma, nasal polyps, any allergies - especially aspirin/NSAID allergy (e.g., ibuprofen, celecoxib). Use caution when performing tasks requiring alertness. Limit alcohol intake as it may intensify the drowsiness effect of this medication. This medicine may cause stomach bleeding. Daily use of alcohol, especially when combined with this medicine, may increase your risk for stomach bleeding. Check with your doctor or pharmacist for more information. To minimize dizziness and lightheadedness when rising from a seated or lying position, get up slowly. Infrequently, this medication may increase the skin's sensitivity to sunlight. If this happens to you: avoid prolonged sun exposure, wear protective clothing, use a sunscreen, avoid sunlamps. Caution is advised when this drug is used in the elderly. This medication should not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. This drug is excreted into breast milk. Consult your doctor before breast-feeding.




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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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