Lansoprazole is a proton pump inhibitor. Lansoprazole decreases the amount of acid produced in the stomach.

Lansoprazole is used to treat and prevent stomach and intestinal ulcers, erosive esophagitis (damage to the esophagus from stomach acid), and other conditions involving excessive stomach acid such as Zollinger-Ellison syndrome.

Over-the-counter lansoprazole (Prevacid OTC) is used to treat frequent heartburn that happens 2 or more days per week. This medicine is not for the immediate relief of heartburn symptoms.

Lansoprazole can cause kidney problems. Tell your doctor if you are urinating less than usual, or if you have blood in your urine.

This medicine can cause diarrhea, which may be a sign of a new infection. Call your doctor if you have diarrhea that is watery or has blood in it.

Lansoprazole may cause new or worsening symptoms of lupus. Tell your doctor if you have joint pain and a skin rash on your cheeks or arms that worsens in sunlight.

You may be more likely to have a broken bone while taking this medicine long term or more than once per day.

If you also take sucralfate (Carafate), avoid taking it at the same time you take this medicine. Sucralfate can make it harder for your body to absorb lansoprazole. Wait at least 30 minutes after taking this medicine before you take sucralfate.

Prescription lansoprazole comes as a delayed-release (releases the medication in the intestine to prevent break-down of the medication by stomach acids) capsule and as a delayed-release orally disintegrating (dissolving) tablet to take by mouth. Nonprescription lansoprazole comes as a delayed-release capsule to take by mouth. Prescription lansoprazole is usually taken once a day, before a meal. When taken in combination with other medications to eliminate H. pylori, prescription lansoprazole is taken twice a day (every 12 hours) or three times a day (every 8 hours), before a meal, for 10 to 14 days. Nonprescription lansoprazole is usually taken once a day, in the morning before eating for 14 days. If needed, additional 14-day treatments may be repeated, not more often than once every 4 months. Take lansoprazole at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take lansoprazole exactly as directed. Do not take more or less of it or take it more often or for a longer time than prescribed by your doctor or stated on the package. Tell your doctor if you have taken nonprescription lansoprazole for a longer period of time than stated on the package.

Swallow the prescription capsules whole; do not split, chew, or crush them. If you have difficulty swallowing capsules, you may open the capsule, sprinkle the granules on 1 tablespoon of applesauce, Ensure^® pudding, cottage cheese, yogurt, or strained pears and swallow the mixture immediately without chewing. You can also open a capsule and pour the contents into 2 ounces (60 milliliters) of orange juice, apple juice or tomato juice, mix briefly, and swallow immediately. After you swallow the mixture, rinse the glass with some additional juice and drink immediately. Then rinse the glass with juice at least two more times and drink the juice to be sure that you wash all the medication out of the glass.

Swallow the nonprescription capsules whole with a glass of water. Do not split, chew, or crush them.

Do not break, cut or chew the orally disintegrating tablets. Place a tablet on your tongue and wait up to one minute for it to dissolve. After the tablet dissolves, swallow it with or without water. If you cannot swallow the tablet, you may place it in an oral syringe, draw up 4 mL of water for a 15 mg tablet or 10 mL of water for a 30-mg tablet, shake the syringe gently to dissolve the tablet, and squirt the contents into your mouth immediately. Then draw an additional 2 mL of water into the syringe, shake gently, and squirt that water into your mouth. Do not swallow the mixture more than 15 minutes after you dissolve the tablet.

The capsule contents and orally disintegrating tablets can both be given through a feeding tube. If you have a feeding tube, ask your doctor how you should take the medication. Follow these directions carefully.

Do not take nonprescription lansoprazole for immediate relief of heartburn symptoms. It may take 1 to 4 days for you to feel the full benefit of the medication. Call your doctor if your symptoms get worse or do not improve after 14 days or if your symptoms return sooner than 4 months after you finish your treatment. Do not take nonprescription lansoprazole for longer than 14 days or treat yourself with lansoprazole more often than once every 4 months without talking to your doctor.

Continue to take lansoprazole even if you feel well. Do not stop taking prescription lansoprazole without talking to your doctor. If your condition does not improve or gets worse, call your doctor.

Ask your doctor or pharmacist for a copy of the manufacturer's information for the patient.

Use lansoprazole exactly as directed on the label, or as prescribed by your doctor and read all medication guides or instruction sheets.

Lansoprazole is usually taken before eating. Prevacid OTC should be taken in the morning before you eat breakfast.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Shake the lansoprazole oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Swallow the lansoprazole capsule whole and do not crush, chew, break, or open it.

Remove an orally disintegrating tablet from the package only when you are ready to take the medicine. Place the tablet in your mouth and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves.

Use lansoprazole for the full prescribed length of time, even if your symptoms quickly improve.

Prevacid OTC should be taken only once daily for 14 days. It may take up to 4 days for full effect. Allow at least 4 months to pass before you start another 14-day treatment with Prevacid OTC.

Call your doctor if your symptoms do not improve or if they get worse while you are taking lansoprazole. If you take Prevacid OTC, call your doctor if your heartburn gets worse over the 14-day treatment, or if you need treatment more than once every 4 months.

Some conditions are treated with a combination of lansoprazole and antibiotics. Use all medications as directed.

If you use lansoprazole for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Store at room temperature away from moisture, heat, and light. Do not freeze the liquid medicine.

You should not use lansoprazole if you are allergic to it, or if you take any medicine that contains rilpivirine (Edurant, Complera, Odefsey).

Heartburn can mimic early symptoms of a heart attack. Get emergency medical help if you have chest pain that spreads to your jaw or shoulder and you feel anxious or light-headed.

Tell your doctor if you have ever had:

• liver disease;

• lupus;

• low levels of magnesium in your blood; or

• osteoporosis or low bone mineral density (osteopenia).

Do not use over-the-counter lansoprazole (Prevacid OTC) without the advice of a doctor if you have:

• trouble or pain with swallowing;

• bloody or black stools; vomit that looks like blood or coffee grounds;

• heartburn that has lasted for over 3 months;

• frequent chest pain, heartburn with wheezing;

• unexplained weight loss;

• nausea or vomiting, stomach pain; or

• an electrolyte imbalance or metabolic disorder.

Some forms of lansoprazole may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

You may be more likely to have a broken bone in your hip, wrist, or spine while taking a proton pump inhibitor long-term or more than once per day. Talk with your doctor about ways to keep your bones healthy.

Some conditions are treated with a combination of lansoprazole and antibiotics. Use all medications as directed by your doctor

Do not give lansoprazole to a child younger than 1 year old. Prevacid OTC is not approved for use by anyone younger than 18 years old.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

This medicine can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Get emergency medical help if you have signs of an allergic reaction ro lansoprazole: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;

• new or unusual pain in your wrist, back, hip, or thigh;

• a seizure (convulsions);

• kidney problems - fever, nausea, little or no urination, blood in your urine, swelling, rapid weight gain;

• low magnesium - dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling; or

• new or worsening symptoms of lupus - joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Taking lansoprazole long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use lansoprazole for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common lansoprazole side effects may include:

• nausea, stomach pain;

• diarrhea, constipation; or

• headache.

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.

Sucralfate (Carafate) can make it harder for your body to absorb lansoprazole. Wait at least 30 minutes after taking lansoprazole before you take sucralfate.

Tell your doctor if you use methotrexate.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect lansoprazole, and some drugs should not be used at the same time. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain laboratory tests before and during your treatment.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking lansoprazole.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Prevacid® NapraPAC® (containing Lansoprazole, Naproxen)