Lansoprazole Oral gastro-resistant sprinkle capsule; Naproxen Oral tablet

What is this medicine?

NAPROXEN; LANSOPRAZOLE (na PROX en; lan SOE pra zole) is a combination of two medicines. The naproxen is a non-steroidal anti-inflammatory drug (NSAID). It is used to reduce swelling and to treat pain. This medicine may be used for painful joint problems such as arthritis. The lansoprazole is a proton pump inhibitor (PPI) that is used to prevent stomach ulcers that may be caused by the naproxen.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not crush or chew. Take your medicine at regular intervals. Do not take it more often than directed. Long term, continuous use may increase the risk of heart attack or stroke.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• black or bloody stools, blood in the urine or vomit

• blurred vision

• bone, muscle or joint pain

• chest pain

• dark yellow or brown urine

• difficulty breathing or wheezing

• dizziness

• fast, irregular heartbeat

• feeling faint or lightheaded

• fever or sore throat

• muscle spasms

• nausea or vomiting

• palpitations

• rash on cheeks or arms that gets worse in the sun

• redness, blistering, peeling, or loosening of the skin, including inside the mouth

• seizures

• slurred speech or weakness on one side of the body

• stomach pain

• tremors

• unexplained weight gain or swelling

• unusual bleeding or bruising

• unusually weak or tired

• yellowing of eyes or skin

• vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation

• diarrhea

• dry mouth

• headache

• heartburn

• nausea

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• atazanavir

• nelfinavir

This medicine may also interact with the following medications:

• alcohol

• ampicillin

• antacids

• aspirin and aspirin-like medicines

• cidofovir

• delavirdine

• digoxin

• diuretics

• iron salts

• lithium

• medicines for fungal infections like ketoconazole and itraconazole

• medicines for stomach, or intestine problems, like acid reflux or GERD

• medicines that treat or prevent blood clots like warfarin

• methotrexate

• pemetrexed

• probenecid

• steroid medicines like prednisone or cortisone

• sucralfate

• theophylline

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light and moisture. Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• cigarette smoker

• coronary artery bypass graft (CABG) surgery within the past 2 weeks

• drink more than 3 alcohol-containing beverages a day

• heart disease

• high blood pressure

• history of stomach bleeding

• kidney disease

• liver disease

• lung or breathing disease, like asthma

• an unusual or allergic reaction to naproxen, aspirin, other NSAIDs, lansoprazole or other proton pump inhibitors, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Tell your doctor or healthcare provider if your pain does not get better. Talk to your doctor before taking another medicine for pain. Do not treat yourself.

You may need blood work done while you are taking this medicine.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your healthcare provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

This medicine does not prevent heart attack or stroke. In fact, this medicine may increase the chance of a heart attack or stroke. The chance may increase with longer use of this medicine and in people who have heart disease. If you take aspirin to prevent heart attack or stroke, talk with your doctor or healthcare provider.

Do not take other medicines that contain aspirin, ibuprofen, or naproxen with this medicine. Side effects such as stomach upset, nausea, or ulcers may be more likely to occur. Many medicines available without a prescription should not be taken with this medicine.

This medicine can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Do not smoke cigarettes or drink alcohol. These increase irritation to your stomach and can make it more susceptible to damage from this medicine. Ulcers and bleeding can happen without warning symptoms and can cause death.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

This medicine can cause you to bleed more easily. Try to avoid damage to your teeth and gums when you brush or floss your teeth.

This medicine may cause a decrease in vitamin B12. You should make sure that you get enough vitamin B12 while you are taking this medicine. Discuss the foods you eat and the vitamins you take with your healthcare provider.