pravastatin/buffered aspirin-oral, Pravigard PAC (cont.)
SIDE EFFECTS: Heartburn, headache, dizziness, or stomach upset may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. This drug may infrequently cause muscle damage (which can rarely lead to a very serious, possibly fatal, condition called rhabdomyolysis). Seek immediate medical attention if you develop: muscle pain/tenderness/weakness (especially with fever or unusual tiredness). Tell your doctor immediately if any of these unlikely but serious side effects occur: difficulty hearing/ringing in the ears, easy bruising or bleeding. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: yellowing eyes and skin, dark urine, severe fatigue, persistent nausea, severe stomach/abdominal pain, black stool, change in the amount of urine. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: Before taking pravastatin/buffered aspirin, tell your doctor or pharmacist if you are allergic to it; or to other "statins" or other NSAIDs (nonsteroidal anti-inflammatory drugs such as ibuprofen, celecoxib); or if you have any other allergies. These medications should not be used if you have certain medical conditions. Before using these medicines, consult your doctor or pharmacist if you have: active liver disease. Before using these medications, tell your doctor or pharmacist your medical history, especially of: heart disease, history of liver disease, kidney disease, underactive thyroid (hypothyroidism), diabetes (poorly controlled), alcohol use, blood disorders, bleeding problems, ulcers. The rare development of severe muscle damage (see Side Effects) infrequently can lead to serious kidney problems. This medication is usually temporarily stopped if you have any condition which can increase your risk of developing kidney problems. Before stopping your medication, notify your doctor immediately if you have any of the following conditions: major surgery, trauma, serious illness (e.g., sepsis, severe metabolic/endocrine/electrolyte disorders), very low blood pressure, uncontrolled seizures. Limit alcoholic beverages. Aspirin or daily use of alcohol may increase your risk for stomach bleeding or other serious side effects (e.g., liver damage). Check with your doctor or pharmacist for more information. Aspirin that has a very strong vinegar-like odor is too old and should not be used. Pravastatin may make you dizzy; use caution engaging in activities requiring alertness such as driving or using machinery. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially muscle damage. These medications must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. It is recommended that women of child-bearing age use effective birth control measures while taking these drugs since this product may cause fetal harm. These medications pass into breast milk and may have undesirable effects on a nursing infant. Breast-feeding is not recommended while using these drugs. 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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