LANSOPRAZOLE - lansoprazole capsule, delayed release 
Sun Pharma Global FZE

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MEDICATION GUIDE


Lansoprazole Delayed-Release Capsules USP


Read this Medication Guide before you start taking lansoprazole delayed-release capsulesand 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 capsulesmay help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.

Lansoprazole delayed-release capsulescan cause serious side effects, including:


Lansoprazole delayed-release capsulescan 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 medicines called a proton pump inhibitor (PPI). Lansoprazole delayed-release capsules reduce the amount of acid in your stomach.
 

Lansoprazole delayed-release capsulesare 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 areused 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?

Do not take lansoprazole delayed-release capsulesif 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 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 capsulesmay affect how other medicines work, and other medicines may affect how lansoprazole delayed-release capsuleswork.
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:


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 capsulesfor a long period of time.
The most common side effects of lansoprazole delayed-release capsulesin adults and children include:


Other side effects:


Your doctor may stop lansoprazole delayed-release capsulesif 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 capsulesand 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 capsulesfor conditions for which it was not prescribed. Do not give lansoprazole delayed-release capsulesto 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 1-800-818-4555.
What are the ingredients in lansoprazole delayed-release capsules?
Active ingredient: lansoprazole.
Inactive ingredients in lansoprazole delayed-release capsules:
Sugar spheres, magnesium carbonate, low-substituted hydroxypropyl cellulose, hypromellose, corn starch, sucrose, methacrylic acid copolymer dispersion, polyethylene glycol, talc, titanium dioxide, and polysorbate 80.
Components of the gelatin capsule include gelatin, sodium lauryl sulfate, purified water, FD&C Blue No. 1, D&C Red No. 28, FD&C Red No. 40, FD&C Green # 3 (15 mg), and titanium dioxide.
The imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water.
The imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, titanium dioxide, potassium hydroxide, and purified water.
This Medication Guide has been approved by the U.S. Food and Drug Administration.

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 pellets on 1 tablespoon of either applesauce, ENSURE* pudding, cottage cheese, yogurt or strained pears.
  3. Swallow right away.
  1. Open the capsule.
  2. Sprinkle the pellets 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 ½ cup or more of juice to get out any leftover pellets. Swallow the juice right away.

Lansoprazole delayed-release capsules through a nasogastric tube (NG tube) 16 French or larger, as prescribed by your doctor:
You can only use apple juice.

  1. Open the capsule and empty the pellets into a syringe.
  2. Do not break or crush the pellets.
  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 pellets, 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.

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

Revised: 09/2013
 
Sun Pharma Global FZE