MEDICATION GUIDE
LANSOPRAZOLE DELAYED-RELEASE CAPSULES, USP
(lan soe′ pra zole)
15 mg and 30 mg

Read this Medication Guide before you start taking lansoprazole and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

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

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:

• Diarrhea. Lansoprazole may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away.
• Bone fractures. People who take multiple daily doses of proton pump inhibitor medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist or spine. You should take lansoprazole exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take lansoprazole.

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

What is lansoprazole?

Lansoprazole is a prescription medicine called a proton pump inhibitor (PPI). Lansoprazole reduces the amount of acid in your stomach.

Lansoprazole is used in adults:

• for 4 weeks for the healing and symptom relief of duodenal ulcers. The duodenal area is the area where food passes when it leaves the stomach.
• with certain antibiotics to treat an infection called H. pylori. Sometimes H. pylori bacteria can cause duodenal ulcers. The infection needs to be treated to prevent ulcers from coming back.
• for continued healing of duodenal ulcers.
• for up to 8 weeks to heal stomach ulcers.
• for up to 8 weeks to heal stomach ulcers in some people taking pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
• for reducing the risk of stomach ulcers in some people taking NSAIDs.
• for up to 8 weeks for the relief of heartburn and other symptoms of 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.

• for 8 weeks to heal the acid-related damage to the lining of the esophagus (called erosive esophagitis) and to relieve symptoms. If needed, your doctor may prescribe another 8 weeks of lansoprazole.
• for continued healing of erosive esophagitis.
• for the long-term treatment of conditions where your stomach makes too much acid. This includes a condition called Zollinger-Ellison syndrome.

Lansoprazole is used in children and adolescents (ages 1 to 17):

• for up to 12 weeks to treat GERD and erosive esophagitis in children 1 to 11 years old.
• for up to 8 weeks to treat GERD and erosive esophagitis in adolescents 12 to 17 years old.

Lansoprazole is not effective for symptoms of GERD in children under the age of 1 year.

Who should not take lansoprazole?

• Do not take lansoprazole delayed-release capsules if you are allergic to lansoprazole or any of the other ingredients in lansoprazole delayed-release capsules. See the end of this Medication Guide for a complete list of ingredients in lansoprazole delayed-release capsules.

What should I tell my doctor before taking lansoprazole?

Before you take lansoprazole, tell your doctor if you:

• have been told that you have low magnesium levels in your blood.
• have liver problems
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if lansoprazole will harm your unborn baby.
• are breast-feeding or plan to breastfeed. It is not known if lansoprazole passes into your breast milk. You and your doctor should decide if you will take lansoprazole or breast-feed. You should not do both. 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 non-prescription medicines, vitamins, and herbal supplements. Lansoprazole may affect how other medicines work, and other medicines may affect how lansoprazole works.

Especially tell your doctor if you take:

• atazanavir (Reyataz)
• digoxin (Lanoxin)
• a product that contains iron
• ketoconazole (Nizoral)
• warfarin (Coumadin, Jantoven)
• tacrolimus (Prograf)
• theophylline (Theo-24, Elixophyllin, Theochron, Theolair)
• an antibiotic that contains ampicillin or clarithromycin
• methotrexate

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take lansoprazole?

• Take lansoprazole exactly as prescribed by your doctor.
• Do not change your dose or stop taking lansoprazole without talking to your doctor.
• You should take lansoprazole before eating.
• Lansoprazole Delayed-Release Capsules:
  • You should swallow lansoprazole delayed-release capsules whole.
  • Do not crush or chew lansoprazole delayed-release capsules.
  • If you have trouble swallowing a whole capsule, you can open the capsule and take the contents with certain foods or juices. See the “Instructions for Use” at the end of this Medication Guide for instructions on how to take lansoprazole delayed-release capsules with certain foods and juices.
  • See the “Instructions for Use” at the end of this Medication Guide for instructions on how to mix and give lansoprazole delayed-release capsules through a nasogastric tube.
• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Just take the next dose at your regular time. Do not take two doses at the same time.
• If you take too much lansoprazole, call your doctor right away.

What are the possible side effects of lansoprazole?

Lansoprazole can cause serious side effects, including:

• See “What is the most important information that I should know about lansoprazole?”
• Low magnesium levels in your body. This problem can be serious. Low magnesium can happen in some people who take a proton pump inhibitor medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment. You may or may not have symptoms of low magnesium.

Tell your doctor right away if you develop any of these symptoms:

• seizures
• dizziness
• abnormal or fast heartbeat
• jitteriness
• jerking movements or shaking (tremors)
• muscle weakness
• spasms of the hands and feet
• cramps or muscle aches
• spasm of the voice box

Your doctor may check the level of magnesium in your body before you start taking lansoprazole, or during treatment; if you will be taking lansoprazole for a long period of time.

The most common side effects of lansoprazole in adults and children include:

• diarrhea
• stomach pain
• nausea
• constipation
• headache

Other side effects:

• Serious allergic reactions. Tell your doctor if you get any of the following symptoms with lansoprazole.
• rash
• face swelling
• throat tightness
• difficulty breathing

Your doctor may stop lansoprazole if these symptoms happen.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of lansoprazole. For more information, ask your doctor or pharmacist.

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 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

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

General information about lansoprazole

Medicines are sometimes prescribed for conditions 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 you have. It may harm them.

This Medication Guide summarizes the most important information about lansoprazole. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about lansoprazole that is written for healthcare professionals.

For more information, call Mylan Pharmaceuticals Inc. at 1-877-4-INFO-RX (1-877-446-3679).

What are the ingredients in lansoprazole?

Active ingredient: lansoprazole.

Inactive ingredients in lansoprazole delayed-release capsules: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, sucrose, sugar spheres, talc and titanium dioxide. In addition, the 15 mg gelatin capsule contains FD&C Green No. 3 and FD&C Red No. 40; the 30 mg gelatin capsule contains FD&C Blue No. 1 and FD&C Red No 3; for both strengths the gelatin capsules contain gelatin and titanium dioxide.

The printing ink contains black iron oxide, propylene glycol, shellac and potassium hydroxide.

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