Lansoprazole/naproxen (By mouth)

Treats symptoms of arthritis or ankylosing spondylitis. Used for patients with stomach ulcers who cannot take regular nonsteroidal anti-inflammatory drugs (NSAIDs) for joint disease.

Brand Name(s):

Prevacid NapraPAC 375, Prevacid NapraPAC 500

When This Medicine Should Not Be Used:

How to Use This Medicine:

Delayed Release Capsule, Tablet

• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information.
• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine is usually taken two times per day. The usual dose is one Prevacid® capsule plus one Naprosyn® tablet in the morning before eating, and one Naprosyn® tablet in the evening. Unless your doctor tells you otherwise, you will not take a Prevacid® capsule in the evening.
• It is best to take this medicine on an empty stomach. Take your medicine with a glass of water.
• Swallow the Prevacid® capsule whole. Do not break, crush, or chew it. If you are also taking sucralfate, take the Prevacid® capsule 30 minutes before sucralfate.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Leave the tablets and capsules in their blister pack until you are ready to use the medicine.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using aspirin, a blood thinner (such as warfarin, Coumadin®), a steroid medicine (such as cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, or Orapred®), or a diuretic or "water pill" (such as furosemide, hydrochlorothiazide [HCTZ], torsemide, Demadex®, or Lasix®).
• Do not use any other NSAID medicine unless your doctor says it is okay. Some other NSAIDs are aspirin, diclofenac, ibuprofen, Advil®, Aleve®, Celebrex®, Ecotrin®, Motrin®, Naprosyn®, or Voltaren®.
• Make sure your doctor knows if you are also using digoxin (Lanoxin®), ketoconazole (Nizoral®), lithium (Eskalith®), methotrexate (Rheumatrex®), sucralfate (Carafate®), theophylline (Theo-Dur®), medicine to treat an infection (ampicillin, trimethoprim/sulfamethoxazole, Bactrim®, Cotrim®, Omnipen®, or Septra®), or diabetes medicine that you take by mouth (such as glyburide, Glucotrol®, or Glucovance®). Tell your doctor if you are also using a blood pressure medicine (such as atenolol, lisinopril, metoprolol, propranolol, Accupril®, Inderal®, Lotensin®, Monopril®, Prinivil®, Toprol®, or Zestril®) or medicine for seizures (such as phenytoin, Dilantin®).

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding. You should not use this medicine during the later part of pregnancy, unless your doctor tells you to.
• Make sure your doctor knows if you have a history of ulcers or other stomach problems. Tell your doctor if you have kidney disease, liver disease (especially cirrhosis), aspirin-sensitive asthma, bleeding problems, high blood pressure, congestive heart failure (CHF), or other heart or circulation problems.
• Naproxen may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.
• Naproxen may cause bleeding in your stomach or intestines. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain medicines (a steroid medicine or a blood thinner).
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.
• Bleeding, peeling, or red skin rash.
• Bloody, black or tarry stools.
• Blurred vision or changes in vision.
• Change in how much or how often you urinate.
• Chest pain, shortness of breath, or coughing up blood.
• Dark-colored urine or pale stools.
• Flu-like symptoms.
• Nausea, vomiting, loss of appetite, or pain in your upper stomach.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Pain in your lower leg (calf).
• Problems with vision, speech, or walking.
• Rapid weight gain.
• Severe stomach pain.
• Shortness of breath, cold sweat, and bluish-colored skin.
• Skin rash or blisters with fever.
• Sudden or severe headache.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding, bruising, or weakness.
• Vomiting of blood or something that looks like coffee grounds.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, nausea, vomiting, or stomach pain.
• Feeling very sad or depressed.
• Headache, ringing in your ears.
• Mild skin rash or itching.
• Mild stomach upset, heartburn, gas, or indigestion.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 6/12/2013