LANSOPRAZOLE- lansoprazole capsule, delayed release 
Dr.Reddy's Laboratories Ltd.

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MEDICATION GUIDE

Lansoprazole Delayed-Release Capsules, USP

(lan soe' pra zole)  

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:

Children:

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 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:

Lansoprazole delayed-release capsules 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 capsules if you are: 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, REDITREX, XATMEP).  

How should I take lansoprazole delayed-release capsules?

• Take lansoprazole delayed-release capsules exactly as prescribed by your doctor.

• Do not change your dose or stop taking lansoprazole delayed-release capsules without talking to your doctor.

• Take lansoprazole delayed-release capsules before meals.  

Lansoprazole Delayed-Release Capsules:

o Swallow 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 or 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(NG tube).

• If you miss a dose of lansoprazole delayed-release capsules, 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 capsules, 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 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 ?”

Low vitamin B12 levels in the body can happen in people who have taken lansoprazole delayed-release capsules 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.

Low magnesium levels in the body can happen in people who have taken lansoprazole delayed-release capsules for at least 3 months. Tell your doctor 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.  

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.

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 20° to 25° C (68° to 77° F)

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 purposes 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.  

You can ask your doctor or pharmacist for information about lansoprazole delayed-release capsules that is written for healthcare professionals.  

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.  

All other trademark names are the property of their respective owners. 

For more information, call 1-888-375-3784.  

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

INSTRUCTIONS FOR USE  

Lansoprazole Delayed-Release Capsules, USP(lan soe' pra zole)  

Important: ·

Lansoprazole delayed-release capsules  

Taking lansoprazole delayed-release capsules with certain food:

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?

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

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.  

All other trademark names are the property of their respective owners.  

Rx only

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally – 500 090 INDIA

Revised: 1220

Dispense with Medication Guide available at:

www.drreddys.com/medguide/lansoprazoledrcaps.pdf

Revised: 12/2020
Dr.Reddy's Laboratories Ltd.