MEDICATION GUIDE

What is the most important information that I should know about Lansoprazole?

You should take Lansoprazole exactly as prescribed, at the lowest dose possible and for the shortest time needed.

Lansoprazole may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.

Lansoprazole can cause serious side effects, including:

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A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including Lansoprazole, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with PPI medicines including Lansoprazole. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine.

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Diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever.

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Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine.

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Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take PPI medicines, including Lansoprazole, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun.

Talk to your doctor about your risk of these serious side effects.

Lansoprazole can have other serious side effects. See “What are the possible side effects of Lansoprazole?”.

What is Lansoprazole?

A prescription medicine called a proton pump inhibitor (PPI) used to reduce  the amount of acid in your stomach.

In adults, Lansoprazole is used for:

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4 weeks for the healing and symptom relief of duodenal ulcers.

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10 to 14 days with certain antibiotics to treat an infection caused by bacteria called  H. pylori.

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maintaining healing of duodenal ulcers. Lansoprazole has not been studied beyond 12 months for this purpose.

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up to 8 weeks for the healing and symptom relief of stomach ulcers.

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up to 8 weeks for the healing of stomach ulcers in people taking pain medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Lansoprazole has not been studied beyond 8 weeks for this purpose.

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reducing the risk of stomach ulcers in people who are at risk of developing stomach ulcers with NSAIDs. Lansoprazole has not been studied beyond 12 weeks for this purpose.

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up to 8 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD). GERD happens when acid in your stomach backs up into the tube (esophagus) that connects your mouth to your stomach. This may cause a burning feeling in your chest or throat, sour taste or burping.

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up to 8 weeks for the healing and symptom relief of acid-related damage to the lining of the esophagus (called erosive esophagitis or EE). Your doctor may prescribe another 8 to 16 weeks of Lansoprazole for patients whose EE does not improve or whose symptoms return.

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maintaining healing of EE. Lansoprazole has not been studied beyond 12 months for this purpose.

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the long-term treatment of conditions where your stomach makes too much acid. This includes a rare condition called Zollinger-Ellison syndrome.

Children:

Give Lansoprazole exactly as prescribed by your child’s doctor. Do not increase the dose of Lansoprazole or give your child Lansoprazole longer than the amount of time your doctor tells you to.

In children 1 to 11 years of age, Lansoprazole is used for:

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up to 12 weeks to treat heartburn and other symptoms that can happen with GERD.

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up to 12 weeks for the healing and symptom relief of EE.

In children 12 to 17 years of age, Lansoprazole is used for:

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up to 8 weeks to treat heartburn and other symptoms that can happen with GERD.

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up to 8 weeks for the healing and symptom relief of EE.

Lansoprazole is not recommended for treating the symptoms of GERD in children less than 1 year of age and may harm them.

Do not take Lansoprazole if you are:

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allergic to lansoprazole, any other PPI medicine, or any of the ingredients in Lansoprazole. See the end of this Medication Guide for a complete list of ingredients in Lansoprazole.

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taking a medicine that contains rilpivirine (EDURANT, COMPLERA, ODEFSEY, JULUCA) used to treat HIV-1 (Human Immunodeficiency Virus).

Before you take Lansoprazole, tell your doctor about all of your medical conditions, including if you:

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have low magnesium levels in your blood.

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have liver problems.

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are pregnant, think you may be pregnant or plan to become pregnant. Lansoprazole may harm your unborn baby. Talk to your doctor about the possible risks to an unborn baby if Lansoprazole is taken during pregnancy.

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are breastfeeding or plan to breastfeed. It is not known if Lansoprazole passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take Lansoprazole.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take methotrexate (OTREXUP, RASUVO, TREXALL, REDITREX, XATMEP).

How should I take Lansoprazole?

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Take Lansoprazole exactly as prescribed by your doctor.

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Do not change your dose or stop taking Lansoprazole without talking to your doctor.

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Take Lansoprazole before meals.

 

Lansoprazole capsules:

What are the possible side effects of Lansoprazole?

Lansoprazole can cause serious side effects, including:

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See “What is the most important information that I should know about Lansoprazole?”.

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Low vitamin B12 levels in the body can happen in people who have taken Lansoprazole for a long time (more than 3 years). Tell your doctor if you have symptoms of low vitamin B12 levels, including shortness of breath, lightheadedness, irregular heartbeat, muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness in the arms and legs.

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Low magnesium levels in the body can happen in people who have taken Lansoprazole for at least 3 months. Tell your doctor if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice.

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Stomach growths (fundic gland polyps). People who take PPI medicines for a long time have an increased risk of developing a certain type of stomach growth called fundic gland polyps, especially after taking PPI medicines for more than 1 year.

The most common side effects of Lansoprazole include: diarrhea, stomach-area (abdomen) pain, nausea and constipation.

These are not all the possible side effects of Lansoprazole.

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

How should I store Lansoprazole?

Store Lansoprazole at room temperature between 68°F to 77°F (20°C to 25°C).

Keep Lansoprazole and all medicines out of the reach of children.

General information about the safe and effective use of Lansoprazole.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Lansoprazole for conditions for which it was not prescribed. Do not give Lansoprazole to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information about Lansoprazole that is written for health professionals.