LANSOPRAZOLE- lansoprazole capsule, delayed release pellets 
Zydus Pharmaceuticals (USA) Inc.

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MEDICATION GUIDE

Lansoprazole

(lan-SO-pruh-zole)

Delayed-release Capsules, USP

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

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

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:

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

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?

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

In adults, lansoprazole delayed-release capsules are used for:

Pediatrics:

Give lansoprazole delayed-release capsules exactly as prescribed by your child's doctor. Do not increase the dose of lansoprazole delayed-release capsules or give your child P lansoprazole delayed-release capsules longer than the amount of time your doctor tells you to.

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

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

Do not take Lansoprazole Delayed-release Capsules if you are:

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

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).

How should I take Lansoprazole Delayed-release Capsules?

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:

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

These are not all the possible side effects of lansoprazole delayed-release capsules. 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?

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

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

General information about the safe and effective use of lansoprazole.

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 that you have. It may harm them. You can ask your doctor or pharmacist for information about lansoprazole delayed-release capsules that is written for health professionals.

What are the ingredients in Lansoprazole Delayed-release Capsules?

Active ingredient: lansoprazole, USP

Inactive ingredients:

Corn starch, D&C red # 28, FD&C blue # 1, FD&C red # 40, gelatin, hydroxypropyl cellulose, hypromellose, low substituted hydroxypropyl cellulose, magnesium carbonate heavy powder, methacrylic acid copolymer dispersion, polyethylene glycol, polysorbate 80, sucrose, sugar spheres, talc and titanium dioxide. The capsule shell is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.

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

Manufactured by:

Cadila Healthcare Ltd.

Ahmedabad, India

Distributed by:

Zydus Pharmaceuticals (USA) Inc.

Pennington, NJ 08534

Rev.: 06/18

INSTRUCTIONS FOR USE

Lansoprazole (lan-SO-pruh-zole) Delayed-release Capsules, USP

Important:

Lansoprazole delayed-release capsules

Taking lansoprazole delayed-release capsules with certain foods:

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 applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
  3. Swallow right away.

Taking lansoprazole delayed-release capsules with certain juices:

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 apple juice, orange juice or tomato juice.
  3. Stir.
  4. Swallow right away.
  5. To make sure that the entire dose is taken, add 1/2 cup or more of juice to the glass, stir and swallow right away.

Giving lansoprazole delayed-release capsules through a nasogastric tube (NG tube) size 16 French or larger:

You can only use apple juice.

  1. Place 40 mL of apple juice into a clean container.
  2. Open the capsule and empty the granules into the container of apple juice.
  3. Use a catheter-tip syringe to draw up the apple juice and granule mixture.
  4. Gently mix the catheter-tip syringe to keep the granules from settling.
  5. Attach the catheter-tip syringe to the NG tube.
  6. Give the mixture right away through the NG tube that goes into the stomach. Do not save the apple juice and granule mixture for later use.
  7. Refill the catheter-tip syringe with 40 mL of apple juice and mix gently. Flush the NG tube with apple juice.

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.

Revised: 12/2019
Zydus Pharmaceuticals (USA) Inc.