Naprelan 500

Naprelan 500 is a nonsteroidal anti-inflammatory drug (NSAID).

Naprelan 500 is used to relieve pain or swelling from conditions like arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps.

The delayed-release or extended-release tablets are slower-acting versions of naproxen and are meant only for managing long-term conditions such as arthritis or ankylosing spondylitis. These forms of naproxen will not work quickly enough for sudden pain.

Naprelan 500 may also be used for reasons not mentioned in this medication guide.

Use exactly as directed on the label, or as prescribed by your doctor. Use the lowest dose that works for your condition.

Shake the oral suspension (liquid) before measuring a dose. Measure a dose with the provided measuring device (not a kitchen spoon).

Take Naprelan 500 with food or milk if it bothers your stomach.

Always follow the instructions on the medicine label for giving this medicine to a child. Naprelan 500 doses for children depend on their weight. Your child's dose may need to change if they gain or lose weight.

If you take Naprelan 500 for a long time, you may need regular medical tests.

This medicine can change the results of some medical tests. Inform any doctor who treats you that you are using Naprelan 500.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Naprelan 500 can raise your chances of having a fatal heart attack or stroke. Do not use Naprelan 500 right before or after heart bypass surgery (coronary artery bypass graft, or CABG). This medicine may also cause stomach or intestinal bleeding, which can be deadly.

Naprelan 500 can raise your chances of having a fatal heart attack or stroke, even if you do not have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Naprelan 500 can also lead to stomach or intestinal bleeding, which can be fatal. These issues can happen without warning while you are using this medicine, especially in older adults.

You should not use Naprelan 500 if you are allergic to it, or if you have ever experienced an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Ask a doctor before giving Naprelan 500 to a child younger than 12 years old.

Ask a doctor or pharmacist if this medicine is safe for you if you have:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a history of heart attack, stroke, or blood clot;
• stomach ulcers or bleeding;
• asthma;
• liver or kidney disease;
• fluid retention; or
• if you take aspirin to prevent heart attack or stroke.

If you are pregnant, you should not take Naprelan 500 unless your doctor advises you to. Taking an NSAID during the last 20 weeks of pregnancy can lead to serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

It may not be safe to breastfeed while using this medicine. Consult your doctor about any risks.

Get emergency medical help if you notice signs of an allergic reaction, such as a runny or stuffy nose, wheezing or trouble breathing, hives, or swelling in your face or throat. Also, seek immediate help for a severe skin reaction, which may include fever, sore throat, burning eyes, skin pain, or a red or purple rash that blisters and peels.

Stop using Naprelan 500 and get medical help if you experience a serious drug reaction that affects multiple parts of your body. Symptoms can include a skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Get emergency medical help if you notice signs of a heart attack or stroke, such as chest pain that spreads to your jaw or shoulder, sudden numbness or weakness on one side of your body, slurred speech, leg swelling, or feeling short of breath.

Naprelan 500 may cause serious side effects. Stop using Naprelan 500 and call your doctor immediately if you experience:

• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• the first sign of any skin rash or blister, no matter how mild;
• signs of stomach bleeding, such as bloody or tarry stools, coughing up blood, or vomit that looks like coffee grounds;
• liver problems, which may include nausea, upper stomach pain, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes);
• kidney problems, including little or no urination, painful urination, or swelling in your feet or ankles; or
• low red blood cells (anemia), which may present as pale skin, unusual tiredness, feeling light-headed or short of breath, or cold hands and feet.

Common side effects of Naprelan 500 may include:

• headache;
• indigestion, heartburn, or stomach pain; or
• flu symptoms;

This is not a complete list of side effects. Others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Since Naprelan 500 is taken as needed, you may not have a regular dosing schedule. If you miss a dose and it's almost time for your next dose, just skip the missed dose. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Avoid drinking alcohol. It may increase your risk of stomach bleeding.

• Avoid taking aspirin or other NSAIDs unless your doctor tells you to.

• Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to Naprelan 500 (such as aspirin, ibuprofen, or ketoprofen).

• Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb Naprelan 500.

Ask your doctor before using Naprelan 500 if you take an antidepressant. Taking certain antidepressants with an NSAID may make you bruise or bleed easily.

Ask a doctor or pharmacist before using Naprelan 500 with any other medications, especially:

• other NSAIDs or salicylates (diflunisal, salsalate);
• antacids and sucralfate;
• cholestyramine;
• cyclosporine;
• digoxin;
• lithium;
• methotrexate;
• pemetrexed;
• probenecid;
• warfarin (Coumadin, Jantoven) or similar blood thinners;
• a diuretic or "water pill"; or
• heart or blood pressure medication.

This list is not complete. Other drugs may affect Naprelan 500, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.