LANSOPRAZOLE  - lansoprazole capsule, delayed release 
Actavis Inc

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MEDICATION GUIDE

Lansoprazole delayed-release capsules


 (lan-soe'-pra-zole)
 
Read this Medication Guide before you start taking lansoprazole delayed-release capsules 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 delayed-release capsules?

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

Lansoprazole delayed-release capsules can cause serious side effects, including:

· Diarrhea. Lansoprazole delayed-release capsules 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 delayed-release capsules 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 delayed-release capsules.

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

What are lansoprazole delayed-release capsules?

Lansoprazole delayed-release capsule is a prescription medicine called a proton pump inhibitor (PPI). Lansoprazole delayed-release capsules reduce the amount of acid in your stomach.

Lansoprazole delayed-release capsules are used in adults:

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.

Lansoprazole delayed-release capsules are used in children and adolescents (ages 1 to 17):

Lansoprazole delayed-release capsules are not effective for symptoms of GERD in children under the age of 1 year.

Who should not take lansoprazole delayed-release capsules?

What should I tell my doctor before taking lansoprazole delayed-release capsules?

Before you take lansoprazole delayed-release capsules, tell your doctor if you:

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Lansoprazole delayed-release capsules may affect how other medicines work, and other medicines may affect how lansoprazole delayed-release capsules works.

Especially tell your doctor if you take:

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 delayed-release capsules?

o   You shouldswallow lansoprazole delayed-release capsules whole.

o   Do not crush or chew lansoprazole delayed-release capsules.

o   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.

o   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.

What are the possible side effects of lansoprazole delayed-release capsules?

Lansoprazole delayed-release capsules can cause serious side effects, including:

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

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

The most common side effects of lansoprazole delayed-release capsules in adults and children include:

Other side effects:

Your doctor may stop lansoprazole delayed-release capsules 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 delayed-release capsules. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store lansoprazole delayed-release capsule?

Keep lansoprazole delayed-release capsules and all medicines out of the reach of children.

General information about lansoprazole delayed-release capsules

Medicines are sometimes prescribed for conditions other than those listed in a Medication Guide. Do not use lansoprazole delayed-release capsules for conditions for which it was not prescribed. Do not give lansoprazole delayed-release capsules 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 delayed-release capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about lansoprazole delayed-release capsules that is written for healthcare professionals.

For more information, call Actavis Inc. at 1-800-432-8534.

What are ingredients in lansoprazole delayed-release capsules?

Active ingredient: lansoprazole.

Inactive ingredients in lansoprazole delayed-release capsules:

Acetone, hypromellose, isopropyl alcohol, light magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, sugar spheres, talc and titanium dioxide.

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

Manufactured by:

NATCO PHARMA LIMITED,

Kothur- 509228,

AP, India.

Distributed by:

Actavis Inc.
60 Columbia Road, Bldg. B
Morristown, NJ 07960 USA 

Revised: 01/2013
 
Actavis Inc