Dexlansoprazole Oral capsule, biphasic release

What is this medicine?

DEXLANSOPRAZOLE (dex lan SOE pra zole) prevents the production of acid in the stomach. It is used to treat gastroesophageal reflux disease (GERD) and inflammation of the esophagus.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• liver disease

• low levels of magnesium in the blood

• an unusual or allergic reaction to dexlansoprazole, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Swallow the capsules whole with a drink of water. Follow the directions on the prescription label. Do not crush or chew. Take your medicine at regular intervals. Do not take more often than directed.

If you have difficulty swallowing the capsules, you may open the capsule and sprinkle the contents on a tablespoon of applesauce. Do not crush the contents of the capsule into the food. Swallow the dose immediately after preparing it. Do not chew. Follow with a drink of water.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• nelfinavir

• rilpivirine

• St. John's Wort

This medicine may also interact with the following medications:

• certain antiviral medicines for HIV or AIDS like atazanavir, saquinavir, ritonavir

• certain medicines for fungal infections like ketoconazole, itraconazole, voriconazole

• dasatinib

• digoxin

• erlotinib

• iron salts

• methotrexate

• mycophenolate mofetil

• nilotinib

• tacrolimus

• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

It can take several days before your stomach pain gets better. Check with your doctor or health care professional if your condition does not start to get better, or if it gets worse.

You may need blood work done while you are taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• bone, muscle or joint pain

• breathing problems

• chest pain or chest tightness

• dark yellow or brown urine

• dizziness

• fast, irregular heartbeat

• feeling faint or lightheaded

• fever or sore throat

• muscle spasm

• palpitations

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• seizures

• tremors

• unusual bleeding or bruising

• unusually weak or tired

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• constipation

• diarrhea

• dry mouth

• headache

• nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture. Throw away any unused medicine after the expiration date.