Precautions and Warnings With Naprelan (Cont.)

• There are certain other medications that can interact with Naprelan (see Naprelan Drug Interactions).
   
• All NSAIDs, including Naprelan, have been reported to cause cardiovascular events such as a heart attack or stroke, both of which can result in loss of life. People with cardiovascular disease or who have risk factors for cardiovascular disease appear to be at greater risk.

To decrease the chances of these problems occurring, it is recommended that people take the smallest effective dose for the shortest period of time. Also, call 911 or an ambulance if you notice things such as chest pain, shortness of breath, weakness, and slurring of speech.

• All NSAIDs, including Naprelan, may worsen high blood pressure or cause high blood pressure. Naprelan should be used with caution in people with known high blood pressure.
   
• All NSAIDs, including Naprelan, may cause congestive heart failure or swelling. Make sure to contact your healthcare provider if you notice unexplained weight gain or swelling. Also, Naprelan should be used with caution in people with heart failure.
   
• All NSAIDs, including Naprelan, have been reported to cause problems in the stomach and intestines, including bleeding (known as gastrointestinal bleeding), stomach ulcers, or holes in the stomach or intestines. These problems can lead to serious complications or even loss of life. Extreme caution should be used if Naprelan is prescribed to people with a history of ulcers or gastrointestinal bleeding.

To decrease the chances of these problems occurring, it is recommended that people take the smallest effective dose for the shortest period of time. Make sure to contact your healthcare provider immediately if you experience any signs or symptoms of stomach ulcers or bleeding, including:

• Stomach pain
• Indigestion
• Black, tarry stools
• Vomiting blood.

• People taking NSAIDs, including Naprelan, can experience kidney damage. It is more common in the elderly and people with kidney disease, heart failure, or liver problems. It is also more common in those taking diuretics or ACE inhibitors.
   

• People taking Naprelan can experience liver damage. Contact your healthcare provider immediately if you notice things such as nausea, tiredness, lethargy, itchy or yellowing skin, abdominal pain, or flu-like symptoms.

   
• NSAIDs, including Naprelan, have been reported to cause allergic reactions. Seek emergency medical attention immediately if you notice things such as difficulty breathing and swelling of the face and throat.
   
• In rare cases, people taking Naprelan can develop a very serious rash. If you notice an unexplained rash or blisters, fever, or itchy skin, stop taking the Naprelan and call your healthcare provider.
   
• If you are an alcoholic or drink alcohol frequently, discuss this with your healthcare provider prior to starting Naprelan. Alcohol can affect the way the liver works, indirectly affecting the Naprelan.
   
• NSAIDS have been known to cause an increase in liver enzymes. Therefore, it is recommended that you have a blood test that looks at your liver function before starting Naprelan and 12 weeks after treatment has started.
   
• Naprelan had been known to cause anemia. If you are taking Naprelan for an extended amount of time and show signs of anemia, talk with your healthcare provider.
   
• You should not take Naprelan with any other NSAID, as this may increase your risk of any of the problems discussed above. There are many NSAIDs available with or without a prescription; make sure to read labels carefully. Some examples of NSAIDs are ibuprofen (Advil^®, Motrin^®), diclofenac (Cataflam^®, Voltaren^®), indomethacin (Indocin^®), nabumetone (Relafen^®), oxaprozin (Daypro^®), celecoxib (Celebrex^®), meloxicam (Mobic^®), etodolac (Lodine^®), ketoprofen, ketorolac (Toradol^®), and others. You can ask your doctor or pharmacist for a complete list of these medications.
   
• Naprelan is a pregnancy Category C medicine, meaning that Naprelan could potentially cause harm to your unborn child. If you are pregnant, you should take Naprelan only if the benefit outweighs the possible risk to your unborn child. Naprelan is not recommended for women in the third trimester of pregnancy because it can cause injury (and even death) to the developing fetus. If you become pregnant while taking Naprelan, contact your healthcare provider immediately (see Naprelan and Pregnancy for more information).
   
• You are recommended not to take Naprelan while nursing. Therefore, if you are nursing and taking Naprelan, discuss with your healthcare provider whether to stop nursing or stop taking Naprelan.