Prevacid NapraPAC contains a combination of naproxen and lansoprazole. Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing substances in the body that cause inflammation, pain, and fever. Lansoprazole is a proton pump inhibitor. It decreases the amount of acid produced in the stomach.

Prevacid NapraPAC is used to treat symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The lansoprazole in Prevacid NapraPAC helps reduce the risk of stomach ulcers in people who may be at risk for them while receiving treatment with an NSAID.

Prevacid NapraPAC may also be used for purposes not listed in this medication guide.

The naproxen in Prevacid NapraPAC may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use Prevacid NapraPAC just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

Naproxen may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking Prevacid NapraPAC, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds. Ask a doctor or pharmacist before using any other pain or arthritis medicine. Many medicines available over the counter contain naproxen or similar medicines (such as aspirin, ibuprofen, or ketoprofen). Taking naproxen during the last 3 months of pregnancy may result in birth defects. Do not take Prevacid NapraPAC during pregnancy unless your doctor has told you to.

Take Prevacid NapraPAC exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Each package of Prevacid NapraPAC contains pills for 7 days of treatment (one lansoprazole capsule and two naproxen tablets per day). In most cases, you will take one lansoprazole (Prevacid) capsule and one naproxen (Naprosyn) tablet each morning before eating. The second naproxen tablet is then taken 12 hours later, without lansoprazole. Follow your doctor's instructions.

Do not crush, chew, break, or open the lansoprazole capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

To be sure Prevacid NapraPAC is not causing harmful effects, your blood may need to be tested often. Your kidney or liver function may also need to be tested. You may also need eye exams if you have any changes in your vision. Visit your doctor regularly.

Prevacid NapraPAC can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Prevacid NapraPAC.

Store Prevacid NapraPAC at room temperature away from moisture, heat, and light.

You should not use Prevacid NapraPAC if you are allergic to lansoprazole (Prevacid) or naproxen (Aleve, Anaprox, Naprosyn, and others), or if you have ever had a severe allergic reaction to aspirin or other NSAIDs. Do not use Prevacid NapraPAC just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

The naproxen in Prevacid NapraPAC may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

Naproxen may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking Prevacid NapraPAC, especially in older adults.

To make sure you can safely take Prevacid NapraPAC, tell your doctor if you have any of these other conditions:

• liver or kidney disease;

• heart disease, high blood pressure, fluid retention, or a history of stroke, heart attack, or congestive heart failure;

• low levels of magnesium in your blood;

• a bleeding or blood clotting disorder, such as hemophilia;

• a history of stomach ulcers or bleeding;

• asthma, or a history of allergic reaction to aspirin, especially aspirin triad syndrome; or

• if you smoke.

FDA pregnancy category C. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking naproxen during the last 3 months of pregnancy may result in birth defects. Do not take Prevacid NapraPAC during pregnancy unless your doctor has told you to. Naproxen can pass into breast milk and may harm a nursing baby. You should not breast-feed while taking Prevacid NapraPAC.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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

Overdose symptoms may include nausea, vomiting, stomach pain or discomfort, severe dizziness or drowsiness, confusion, weak or shallow breathing, and urinating less than usual or not at all.

Avoid taking sucralfate (Carafate) or antacids that contain magnesium or aluminum (such as Maalox, Mylanta, or Rolaids) at the same time you take Prevacid NapraPAC. These other medications can make it harder for your body to absorb naproxen.

Ask a doctor or pharmacist before using any other pain or arthritis medicine. Many medicines available over the counter contain naproxen or similar medicines (such as aspirin, ibuprofen, or ketoprofen). Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains naproxen or another NSAID.

Ask your doctor before taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with an NSAID may increase your risk of stomach bleeding.

Avoid drinking alcohol while takine Prevacid NapraPAC. It may increase your risk of stomach bleeding.

Get emergency medical help if you have any of these signs of an allergic reaction to Prevacid NapraPAC: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Prevacid NapraPAC and call your doctor at once if you have a serious side effect such as:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• sudden numbness or weakness, especially on one side of the body;

• sudden headache, confusion, problems with vision, speech, or balance;

• urinating less than usual or not at all;

• swelling, rapid weight gain, feeling short of breath, even with mild exertion;

• low magnesium (dizziness, confusion, fast or uneven heart rate, jerking muscle movements, jittery feeling, muscle cramps, muscle weakness or limp feeling, cough or choking feeling, seizure);

• black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;

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

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

• pale skin, easy bruising, feeling very weak or tired.

Less serious Prevacid NapraPAC side effects may include:

• mild stomach pain, heartburn, constipation, diarrhea;

• headache, dizziness or drowsiness;

• sweating, mild skin rash or itching; or

• ringing in your ears.

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

Tell your doctor about all other medicines you use, especially:

• atazanavir (Reyataz);

• cholestyramine (Prevalite);

• digoxin (Lanoxin, Lanoxicaps);

• lithium (Eskalith, Lithobid, others);

• methotrexate (Rheumatrex, Trexall);

• phenytoin (Dilantin);

• probenecid (Benemid);

• theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl);

• an iron supplement;

• a blood thinner such as warfarin (Coumadin, Jantoven);

• steroids (prednisone and others);

• sulfa drugs (Bactrim, Septra, Sulfatrim, SMX-TMP, and others);

• medication used to prevent blood clots such as ticlopidine (Ticlid), and others;

• an oral diabetes medication such as glipizide (Glucotrol, Metaglip), glimepiride (Amaryl, Avandaryl, Duetact), or glyburide (DiaBeta, Micronase, Glucovance);

• a diuretic (water pill) such as furosemide (Lasix);

• an antibiotic such as ampicillin (Principen, Unasyn);

• antifungal medication such as ketoconazole (Nizoral);

• aspirin or other NSAIDs such as ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), meloxicam (Mobic), nabumetone (Relafen), or piroxicam (Feldene);

• an ACE inhibitor such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), or ramipril (Altace); or

• a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), or sotalol (Betapace).

This list is not complete and other drugs may interact with Prevacid NapraPAC. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.