MEDICATION GUIDE

Lansoprazole (lan soe′ pra zole)
Delayed-Release Orally Disintegrating Tablets

What is the most important information that I should know about lansoprazole delayed-release orally disintegrating tablets?

You should take lansoprazole delayed-release orally disintegrating tablets exactly as prescribed, at the lowest dose possible and for the shortest time needed.

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

Lansoprazole delayed-release orally disintegrating tablets can cause serious side effects, including:

• A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including lansoprazole delayed-release orally disintegrating tablets, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with PPI medicines including lansoprazole delayed-release orally disintegrating tablets. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine.
• 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.
• 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.
• 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 delayed-release orally disintegrating tablets, 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 delayed-release orally disintegrating tablets can have other serious side effects. See “What are the possible side effects of lansoprazole delayed-release orally disintegrating tablets?”.

What are lansoprazole delayed-release orally disintegrating tablets?

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

In adults, lansoprazole delayed-release orally disintegrating tablets are used for:

• 4 weeks for the healing and symptom relief of duodenal ulcers.
• 10 to 14 days with certain antibiotics to treat an infection caused by bacteria called H. pylori.
• maintaining healing of duodenal ulcers. Lansoprazole has not been studied beyond 12 months for this purpose.
• up to 8 weeks for the healing and symptom relief of stomach ulcers.
• 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.
• 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.
• 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.
• 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 delayed-release orally disintegrating tablets for patients whose EE does not improve or whose symptoms return.
• maintaining healing of EE. Lansoprazole has not been studied beyond 12 months for this purpose.
• 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 delayed-release orally disintegrating tablets exactly as prescribed by your child’s doctor. Do not increase the dose of lansoprazole delayed-release orally disintegrating tablets or give your child lansoprazole delayed-release orally disintegrating tablets longer than the amount of time your doctor tells you to.

In children 1 to 11 years of age, lansoprazole delayed-release orally disintegrating tablets are used for:

• up to 12 weeks to treat heartburn and other symptoms that can happen with GERD.
• up to 12 weeks for the healing and symptom relief of EE.

In children 12 to 17 years of age, lansoprazole delayed-release orally disintegrating tablets are used for:

• up to 8 weeks to treat heartburn and other symptoms that can happen with GERD.
• up to 8 weeks for the healing and symptom relief of EE.

Lansoprazole delayed-release orally disintegrating tablets are not recommended for treating the symptoms of GERD in children less than 1 year of age and may harm them.

Do not take lansoprazole delayed-release orally disintegrating tablets if you are:

• allergic to lansoprazole, any other PPI medicine, or any of the ingredients in lansoprazole delayed-release orally disintegrating tablets. See the end of this Medication Guide for a complete list of ingredients in lansoprazole delayed-release orally disintegrating tablets.
• taking a medicine that contains rilpivirine (EDURANT, COMPLERA, ODEFSEY, JULUCA) used to treat HIV-1 (Human Immunodeficiency Virus).                                                                                               

Before you take lansoprazole delayed-release orally disintegrating tablets, tell your doctor about all of your medical conditions, including if you:

• have low magnesium, calcium, potassium or sodium levels in your blood or you are taking a diuretic.
• have liver problems.
• have phenylketonuria. Lansoprazole delayed-release orally disintegrating tablets contains aspartame.
• are pregnant, think you may be pregnant or plan to become pregnant. Lansoprazole delayed-release orally disintegrating tablets may harm your unborn baby. Talk to your doctor about the possible risks to an unborn baby if lansoprazole delayed-release orally disintegrating tablets are taken during pregnancy.
• 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 delayed-release orally disintegrating tablets.

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 delayed-release orally disintegrating tablets?

• Take lansoprazole delayed-release orally disintegrating tablets exactly as prescribed by your doctor.
• Do not change your dose or stop taking lansoprazole delayed-release orally disintegrating tablets without talking to your doctor.
• Take lansoprazole delayed-release orally disintegrating tablets before meals.

Lansoprazole delayed-release orally disintegrating tablets:

• Lansoprazole delayed-release orally disintegrating tablet is a tablet that melts in your mouth with or without water.
• Do not break, cut, crush or chew the tablets.
• See the “Instructions for Use” at the end of this Medication Guide for instructions on how to mix and give lansoprazole delayed-release orally disintegrating tablets through a syringe and NG tube.
• If you miss a dose of lansoprazole delayed-release orally disintegrating tablets, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take your next dose at your regular time. Do not take 2 doses at the same time.
• If you take too much lansoprazole delayed-release orally disintegrating tablets, call your doctor or your poison control center at 1-800-222-1222 right away or go to the nearest hospital emergency room.

What are the possible side effects of lansoprazole delayed-release orally disintegrating tablets?

Lansoprazole delayed-release orally disintegrating tablets can cause serious side effects, including:

• See “What is the most important information that I should know about lansoprazole delayed-release orally disintegrating tablets?”.
• 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.
• 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.
• Low magnesium levels in the body can happen in people who have taken lansoprazole delayed-release orally disintegrating tablets for at least 3 months. Tell your doctor right away 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.
• Severe skin reactions. Lansoprazole can cause rare but severe skin reactions that may affect any part of your body. These serious skin reactions may need to be treated in a hospital and may be life threatening:
  • Skin rash which may have blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet).
  • You may also have fever, chills, body aches, shortness of breath, or enlarged lymph nodes.

        Stop taking lansoprazole and call your doctor right away. These symptoms may be the first sign of a severe skin reaction.

The most common side effects of lansoprazole delayed-release orally disintegrating tablets include: diarrhea, stomach-area (abdomen) pain, nausea and constipation.

These are not all the possible side effects of lansoprazole delayed-release orally disintegrating tablets.

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 delayed-release orally disintegrating tablets?

Store lansoprazole delayed-release orally disintegrating tablets at room temperature between 20° to 25°C (68° to 77°F).

Keep lansoprazole delayed-release orally disintegrating tablets and all medicines out of the reach of children.

General information about the safe and effective use of lansoprazole delayed-release orally disintegrating tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lansoprazole delayed-release orally disintegrating tablets for conditions for which it was not prescribed. Do not give lansoprazole delayed-release orally disintegrating tablets 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 delayed-release orally disintegrating tablets that is written for health professionals.

What are the ingredients in lansoprazole delayed-release orally disintegrating tablets?

Active ingredient: lansoprazole.

Inactive ingredients in lansoprazole delayed-release orally disintegrating tablets:
 

artificial strawberry flavor, aspartame, citric acid anhydrous, crospovidone, ethyl acrylate and methyl methacrylate copolymer dispersion, ferric oxide red, glyceryl monostearate, hydroxy propyl cellulose, hypromellose, magnesium carbonate, magnesium stearate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, nonoxynol, polyethylene glycol, polysorbate 80,  silicified microcrystalline cellulose, sodium lauryl sulphate, sugar spheres (which contains liquid glucose, starch (maize) and sucrose), talc, titanium dioxide, and tri ethyl citrate.

Lansoprazole delayed-release orally disintegrating tablets contains 2.44 mg of phenylalanine in each 15 mg tablet and 4.88 mg of phenylalanine in each 30 mg tablet.

Manufactured for: Northstar Rx LLC
Memphis, TN 38141.

Manufactured by: Aurobindo Pharma Limited
Unit-VII (SEZ)
Mahabubnagar (Dt)-509302
India.

M.L.No.: 22/MN/AP/2009/F/R

For more information, call Northstar Rx LLC at 1-800-206-7821.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Issued: 06/2024