DEXILANT- dexlansoprazole capsule, delayed release
Takeda Pharmaceuticals America, Inc.
Read this Medication Guide before you start taking DEXILANT 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 DEXILANT?
DEXILANT may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.
DEXILANT can cause serious side effects, including:
DEXILANT can have other serious side effects. See “What are the possible side effects of DEXILANT?”
What is DEXILANT?
DEXILANT is a prescription medicine called a proton pump inhibitor (PPI). DEXILANT reduces the amount of acid in your stomach.
DEXILANT is used in adults:
GERD happens when acid from your stomach enters 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.
It is not known if DEXILANT is safe and effective in children under 18 years of age.
Who should not take DEXILANT?
Do not take DEXILANT if you are allergic to dexlansoprazole or any of the other ingredients in DEXILANT. See the end of this Medication Guide for a complete list of ingredients in DEXILANT.
What should I tell my doctor before taking DEXILANT?
Before you take DEXILANT, tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. DEXILANT may affect how other medicines work, and other medicines may affect how DEXILANT 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 DEXILANT?
What are the possible side effects of DEXILANT?
DEXILANT may 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 DEXILANT, or during treatment, if you will be taking DEXILANT for a long period of time.
The most common side effects of DEXILANT include:
Other side effects:
Your doctor may stop DEXILANT 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 DEXILANT. 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 DEXILANT?
Keep DEXILANT and all medicines out of the reach of children.
General information about DEXILANT
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DEXILANT for a condition for which it was not prescribed. Do not give DEXILANT 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 DEXILANT. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about DEXILANT that is written for healthcare professionals.
For more information, go to www.DEXILANT.com or call 1-877-825-3327.
What are the ingredients in DEXILANT?
Active ingredient: dexlansoprazole.
Inactive ingredients: sugar spheres, magnesium carbonate, sucrose, low-substituted hydroxypropyl cellulose, titanium dioxide, hydroxypropyl cellulose, hypromellose 2910, talc, methacrylic acid copolymers, polyethylene glycol 8000, triethyl citrate, polysorbate 80, and colloidal silicon dioxide. The capsule shell is made of hypromellose, carrageenan and potassium chloride. Based on the capsule shell color, blue contains FD&C Blue No. 2 aluminum lake; gray contains black ferric oxide; and both contain titanium dioxide.
Instructions for Use
If you have trouble swallowing DEXILANT capsules whole, you may take or give them as follows:
Taking DEXILANT with applesauce:
Giving DEXILANT with water using an oral syringe:
Giving DEXILANT with water through a nasogastric tube (NG tube):
For people who have a nasogastric (NG) tube that is size 16 French or larger, DEXILANT may be given as follows:
This Medication Guide and Instructions for Use have been approved by the U.S. Food and Drug Administration.
Takeda Pharmaceuticals America, Inc.
Deerfield, IL 60015
Revised: August 2013
DEXILANT is a trademark of Takeda Pharmaceuticals U.S.A., Inc. registered with the U. S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.
All other trademark names are the property of their respective owners.
©2009-2013 Takeda Pharmaceuticals America, Inc.