Naprelan 500

Naprelan 500

What is Naprelan 500?

Naprelan 500 is used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendonitis, bursitis, gout, or menstrual problems.

Delayed-release or extended-release tablets are slower-acting forms of naproxen that are only used to treat chronic conditions such as arthritis or ankylosing spondylitis. These forms of naproxen do not work quickly enough to treat acute pain.

Naprelan 500 can also be used for purposes not listed in this medication guide.

Side effects of Naprelan 500

If necessary, get emergency medical helpSigns of an allergic reaction(runny or stuffy nose, wheezing or difficulty breathing, hives, swelling of the face or throat)or a severe skin reaction(Fever, sore throat, burning eyes, skin pain, red or purple rash with blistering and peeling).

Stop using Naprelan 500 and seek medical attention if you experience a serious drug reaction that may affect many parts of your body.Symptoms may include rash, fever, swollen glands, muscle pain, severe weakness, unusual bruising, or yellowing of your skin or eyes.

If necessary, get emergency medical helpSigns of a heart attack or stroke:Chest pain spreading to the jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, swollen leg, shortness of breath.

Naprelan 500 can have serious side effects. Stop using Naprelan 500 and call your doctor immediately if you have:

• shortness of breath (even with slight exertion);

• swelling or rapid weight gain;

• the first sign of a rash or blister, no matter how mild;

• Signs of stomach bleeding - bloody or tarry stools, coughing up blood, or vomit that looks like coffee grounds;

• Liver problems - nausea, upper abdominal pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• Kidney problems – little or no urination, pain when urinating, swelling of the feet or ankles; or

• low red blood cells (anemia) – pale skin, unusual tiredness, lightheadedness or shortness of breath, cold hands and feet.

Common side effects of Naprelan 500 may include:

• Headache;

• indigestion, heartburn, stomach pain; or

• flu symptoms;

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

Warnings

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

Before you take this medicine

Naprelan 500 may increase your risk of a fatal heart attack or stroke, even if you have no risk factors. Do not use this medicine immediately before or after heart bypass surgery (coronary artery bypass grafting, or CABG).

Naprelan 500 can also cause stomach or intestinal bleeding, which can be fatal. These conditions may occur without warning while using this medication, especially in older adults.

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

Ask a doctor before giving Naprelan 500 to a child under 12 years of age.

Ask a doctor or pharmacist if it is safe to use this medicine if you have:

• heart disease, high blood pressure, high cholesterol, diabetes or if you smoke;

• a heart attack, stroke, or blood clot;

• stomach ulcers or bleeding;

• Asthma;

• liver or kidney disease;

• fluid retention; or

• if you are taking aspirin to prevent heart attack or stroke.

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

Breastfeeding may not be safe while using this medication. Ask your doctor about any risks.

How should I take Naprelan 500?

Use exactly as directed on the label or as prescribed by your doctor. Use the lowest dose that is effective to treat your condition.

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

Take Naprelan 500 with food or milk if stomach upset occurs.

Always follow the drug label instructions when giving this medication to a child. The dosage of Naprelan 500 depends on the weight of children. Your child's dosage needs may change if the child gains or loses weight.

If you use Naprelan 500 long-term, frequent medical examinations may be necessary.

This medicine may affect the results of certain medical tests. Tell any doctor who treats you that you are using Naprelan 500.

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

What happens if I miss a dose?

Because Naprelan 500 is only used when needed, you may not be required to follow a dosing schedule. Skip the missed dose if it is almost time for the next dose. Do not use two doses at the same time.

What happens if I overdose?

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

What should I avoid while taking Naprelan 500?

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

Avoid taking aspirin or other NSAIDs unless directed to do so by your doctor.

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

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

What other medications affect Naprelan 500?

Before using Naprelan 500, ask your doctor if you are taking an antidepressant.Taking certain antidepressants with an NSAID may cause easy bruising or bleeding.

Ask a doctor or pharmacist before using Naprelan 500 together with other medicines, especially:

• other NSAIDs or salicylates (Diflunisal, Salsalat);

• 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 medications.

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