ROFECOXIB-ORAL SUSPENSION, Vioxx (cont.)
HOW TO USE: Take by mouth, generally once daily, or as directed by your doctor. To decrease the chance of stomach upset, this drug is best taken with food. Shake the suspension well just before use. Dosage is based on your medical condition and response to therapy. Take this medication with a full glass of water (8 oz or 240 ml) unless your doctor directs you otherwise. Do not lie down for 30 minutes after taking this medication. In certain conditions (e.g., arthritis), it may take up to two weeks, taken regularly, before significant benefits of this drug take effect. If you are taking this drug on an "as needed" basis (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has significantly worsened, the medicine may not work as well. Read the Patient Information Leaflet available from your pharmacist. Review the leaflet with each refill in case there is any new information.
SIDE EFFECTS: Stomach upset or tiredness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur: unexplained weight gain, swelling of the hands or feet, change in amount of urine. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: severe headache, very stiff neck, mental/mood changes. This drug may rarely cause serious (possibly fatal) bleeding from the stomach or intestines. If you notice any of the following highly unlikely but very serious side effects, stop taking rofecoxib and consult your doctor or pharmacist immediately: black stools, vomit that looks like coffee grounds, persistent stomach/abdominal pain. This drug may rarely cause serious (possibly fatal) liver disease. If you notice any of the following highly unlikely but very serious side effects, stop taking rofecoxib and consult your doctor or pharmacist immediately: yellowing eyes or skin, dark urine, persistent stomach/abdominal pain, unusual fatigue. In the unlikely event you have a serious allergic reaction to this drug, seek immediate medical attention. Symptoms of a serious allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.
Report Problems to the Food and Drug Administration
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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