DEXILANT- dexlansoprazole capsule, delayed release
DEXILANT SOLUTAB- dexlansoprazole tablet, orally disintegrating, delayed release
Takeda Pharmaceuticals America, Inc.
DEXILANT SoluTab (decks-i-launt sol-u-tab)
delayed-release orally disintegrating tablets
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 delayed-release capsules (DEXILANT capsules) are used in people 12 years of age and older:
DEXILANT SoluTab delayed-release orally disintegrating tablets (DEXILANT SoluTab) is used in people 12 years of age and older:
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 12 years of age.
DEXILANT is not effective for symptoms of GERD in children under 1 year of age.
Who should not take DEXILANT?
Do not take DEXILANT if you:
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 over-the-counter 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 methotrexate (Otrexup, Rasuvo, Trexall).
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 should I avoid while taking DEXILANT SoluTab?
Avoid taking DEXILANT SoluTab with alcohol.
Taking DEXILANT SoluTab with alcohol may affect how DEXILANT SoluTab works.
What are the possible side effects of DEXILANT?
DEXILANT may cause serious side effects, including:
The most common side effects of DEXILANT in adults include:
The most common side effects in children 12 to 17 years of age 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 the safe and effective use of 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 health professionals.
For more information, go to www.DEXILANT.com or call 1-877-825-3327.
What are the ingredients in DEXILANT capsules and DEXILANT SoluTab?
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.
Inactive ingredients: lactose monohydrate-microcrystalline cellulose spheres, magnesium carbonate, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, hypromellose, talc, titanium dioxide, mannitol, methacrylic acid copolymer, ethyl acrylate methyl methacrylate copolymer, polysorbate 80, glyceryl monostearate, triethyl citrate, anhydrous citric acid, ferric oxide, red; ferric oxide, yellow; polyethylene glycol 8000, methylacrylate methylmethacrylate methacrylic acid copolymer, microcrystalline cellulose, crospovidone, sucralose, strawberry durarome, and magnesium stearate.