LANSOPRAZOLE - lansoprazole capsule, delayed release 
REMEDYREPACK INC.

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SPL MEDGUIDE

MEDICATION GUIDE

Lansoprazole Delayed-Release Capsules, USP 

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:

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

Lansoprazole delayed-release capsules are used in adults:

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?

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

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

See “What is the most important information that I should know about lansoprazole delayed-release capsules?”

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 FDA at 1-800-FDA-1088.  

How should I store lansoprazole delayed-release capsules?

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 1-888-375-3784.  

What are the ingredients in lansoprazole delayed-release capsules?

Active ingredient: lansoprazole.  

Inactive ingredients in lansoprazole delayed-release capsules:

Ammonium hydroxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, simethicone, starch, sucrose, sugar spheres, talc, and titanium dioxide. 

Components of the gelatin capsule include gelatin, iron oxide red, iron oxide yellow, FD&C Blue 2, sodium lauryl sulphate and titanium dioxide for 15 mg capsules and gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulphate and titanium dioxide for 30 mg capsules. 

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

Patient Instructions for Use

Lansoprazole Delayed-Release Capsules USP 

Lansoprazole Delayed-Release Capsules

You can only use applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.

1. Open the capsule.

2. Sprinkle the granules on 1 tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.

3. Swallow right away.

You can only use apple juice, orange juice or tomato juice.

1 Open the capsule.

2 Sprinkle the granules into 60 mL (about ¼ cup) of either apple juice, orange juice or tomato juice.

3 Stir.

4 Swallow right away.

5 To make sure that the entire dose is taken, rinse the glass with 1/2 cup or more of juice to get out any leftover granules. Swallow the juice right away.

You can only use apple juice.

1 Open the capsule and empty the granules into a syringe.

2 Do not break or crush the granules.

3 Mix with 40 mL of apple juice. Do not use other liquids.

4 Attach the syringe to the NG tube and give the medicine in the syringe through the NG tube into the stomach.

5 After giving the granules, flush the NG tube with more apple juice to clear the tube.

Lansoprazole delayed-release capsules should not be used in foods or liquids not listed above.

How should I store lansoprazole delayed-release capsules?

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

This instruction for Use has been approved by the U.S. Food and Drug Administration. 

To reorder additional Medication Guides, please contact Dr. Reddy's Customer Service at 1-866-733-3952. 

All trademark names are the property of their respective owners.

Rx Only

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally – 500 090 INDIA 

Revised: 1112

 

Revised: 03/2013
 
REMEDYREPACK INC.