Dexlansoprazole

WHY is this medicine prescribed?

Dexlansoprazole is used to treat the symptoms of gastroesophageal reflux disease (GERD; a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus [tube between the throat and stomach]) in adults and children 12 years of age and older. It is also used to treat esophagitis (swelling that may damage tissues of the esophagus) in adults and children 12 years of age and older. Dexlansoprazole is used for the maintenance treatment of esophagitis and healing in adults and children 12 years of age and older. Dexlansoprazole is in a class of medications called proton pump inhibitors. It works by decreasing the amount of acid made in the stomach.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Dexlansoprazole comes as a delayed-release (releases the medication in the intestine to allow some of the medication to be released about 1 hour after it is taken and some of the medication to be released 4 to 5 hours later) capsule to take by mouth. It is usually taken once a day. Dexlansoprazole may be taken with or without food. Take dexlansoprazole at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take dexlansoprazole exactly as directed. Do not take more or less of it or take it more often or for a longer period of time than prescribed by your doctor.

Swallow the delayed-release capsules whole; do not chew or crush them. If you have difficulty swallowing capsules, you may open the capsule, sprinkle the contents on 1 tablespoon of applesauce, and swallow immediately without chewing. You can also open a capsule and pour the contents into 20 milliliters of water; using an oral syringe, draw up the entire amount, shake the syringe gently, and squirt the contents into your mouth immediately. Then draw an additional 10 mL of water into the syringe, shake gently, and squirt that water into your mouth.

The capsule contents can be given through a feeding tube. If you have a feeding tube, ask your doctor how you should take the medication. Follow these directions carefully.

Continue to take dexlansoprazole even if you feel well. Do not stop taking dexlansoprazole without talking to your doctor. If your condition does not improve or gets worse, call your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking dexlansoprazole,

• tell your doctor and pharmacist if you are allergic to dexlansoprazole, any other medications or any of the ingredients in dexlansoprazole delayed-release capsules. Ask your pharmacist for a list of the ingredients.

• Some medications should not be taken with dexlansoprazole. Other medications may cause dosing changes or extra monitoring when taken with dexlansoprazole. Make sure you have discussed any medications you are currently taking or plan to take before starting dexlansoprazole with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking dexlansoprazole, please get the advice of your doctor or pharmacist.

• The following nonprescription or herbal products may interact with dexlansoprazole: iron supplements, St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking dexlansoprazole. Do not start any of these medications while taking dexlansoprazole without discussing with your healthcare provider.

• tell your doctor if you have or have ever had a low level of magnesium, calcium, potassium, or sodium in your blood; hypoparathyroidism (condition in which the body does not produce enough parathyroid hormone [PTH; a natural substance needed to control the amount of calcium in the blood]); low levels of vitamin B12 in your body; osteoporosis (a condition in which the bones become thin and weak and break easily); an autoimmune disease (condition in which the body attacks its own organs, causing swelling and loss of function) such as systemic lupus erythematosus; or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking dexlansoprazole, call your doctor.

• talk to your doctor about the risks and benefits of taking dexlansoprazole if you are 70 years of age or older. Do not take this medication for a longer period of time than recommended by your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Dexlansoprazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• gas
• nausea
• vomiting
• diarrhea
• in men, difficulty achieving or maintaining an erection

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately, or get emergency medical help:

• blistering, peeling, or bleeding skin; sores on the lips, nose, mouth, or genitals; swollen glands; shortness of breath; fever; or flu-like symptoms
• rash; hives; itching; swelling of the eyes, face, lips, mouth, throat, or tongue; difficulty breathing or swallowing; or hoarseness
• irregular, fast, or pounding heartbeat; muscle spasms; uncontrollable shaking of a part of the body; excessive tiredness; lightheadedness; dizziness; or seizures
• severe diarrhea with watery stools, stomach pain, or a fever that does not go away
• new or worsening joint pain; rash on cheeks or arms that is sensitive to sunlight
• increased or decreased urination, blood in urine, fatigue, nausea, loss of appetite, fever, rash, or joint pain

Dexlansoprazole may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

People who take proton pump inhibitors such as dexlansoprazole may be more likely to fracture their wrists, hips, or spine than people who do not take one of these medications. People who take proton pump inhibitors may also develop fundic gland polyps (a type of growth on the stomach lining). These risks are highest in people who take high doses of one of these medications or take them for one year or longer. Talk to your doctor about the risk of taking dexlansoprazole.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain laboratory tests before and during your treatment.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking dexlansoprazole.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.