What is the most important information I should know about rabeprazole sodium delayed-release capsules?
Your child should take rabeprazole sodium delayed-release capsules exactly as prescribed, at the lowest dose possible and for the shortest time needed.
Rabeprazole sodium delayed-release capsules may help your child's acid-related symptoms, but your child could still have serious stomach problems. Talk with your child's doctor.
Rabeprazole sodium delayed-release capsules can cause serious side effects, including:

• A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including rabeprazole sodium delayed-release capsules, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with rabeprazole sodium delayed-release capsules. Call your child’s doctor right away if your child has a decrease in the amount that they urinate or if they have blood in their urine.
• Diarrhea caused by an infection (Clostridium difficile) in your child’s intestines. Call your child’s doctor right away if your child has watery stools or stomach pain that does not go away. Your child may or may not have a fever.
• Bone fractures (hip, wrist or spine). Bone fractures in the hip, wrist or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your child’s doctor if your child has a bone fracture, especially in the hip, wrist or spine.
• Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take PPI medicines, including rabeprazole sodium delayed-release capsules, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your child’s doctor right away if they have new or worsening joint pain or a rash on their cheeks or arms that gets worse in the sun.

Talk to your child’s doctor about your child’s risk of serious side effects.
Rabeprazole sodium delayed-release capsules can have other serious side effects. See "What are the possible side effects of rabeprazole sodium delayed-release capsules?"

What are rabeprazole sodium delayed-release capsules?
Rabeprazole sodium delayed-release capsules are a prescription medicine called a proton pump inhibitor (PPI). Rabeprazole sodium delayed-release capsules reduce the amount of acid in the stomach.
Rabeprazole sodium delayed-release capsules are used in children 1 year to 11 years of age to treat Gastroesophageal Reflux Disease (GERD) for up to 12 weeks.
Rabeprazole sodium delayed-release capsules are not effective in treating GERD in children under 1 year of age.
Rabeprazole sodium delayed-release capsules should not be used to treat GERD in babies younger than 1 month of age.

Your child should not take rabeprazole sodium delayed-release capsules if they are:

• allergic to rabeprazole, any other PPI medicine, or any of the ingredients in rabeprazole sodium delayed-release capsules. See the end of this Medication Guide for a complete list of ingredients.
• taking a medicine that contains rilpivirine (EDURANT, COMPLERA, ODEFSEY) used to treat HIV-1 (Human Immunodeficiency Virus).

Before your child takes rabeprazole sodium delayed-release capsules, tell your child’s doctor about all of your child’s medical conditions, including if they:

• have low magnesium levels in their blood.
• have liver problems.
• are pregnant or plan to become pregnant. It is not known if rabeprazole sodium delayed-release capsules can harm an unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if rabeprazole sodium delayed-release capsules passes into breast milk. Talk to your child’s doctor about the best way to feed her baby if she takes rabeprazole sodium delayed-release capsules.

Tell your child’s doctor about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your child’s doctor if your child takes warfarin (COUMADIN, JANTOVEN) or methotrexate (Otrexup, Rasuvo,Trexall, Xatmep).

How should my child take rabeprazole sodium delayed-release capsules?

• Your child should take rabeprazole sodium delayed-release capsules exactly as prescribed. Your child’s doctor will prescribe the dose that is right for your child.
• Your child should take rabeprazole sodium delayed-release capsules 1 time each day.
• Your child should take rabeprazole sodium delayed-release capsules 30 minutes before a meal.
• Your child should not swallow the rabeprazole sodium delayed-release capsule whole.
• Prepare and give a dose of rabeprazole sodium delayed-release capsules to your child as follows:
  • Open the rabeprazole sodium delayed-release capsule in the direction that the arrow (↑) on the capsule is pointing. Sprinkle all of the capsule contents onto a small amount of soft food such as applesauce, fruit or vegetable based baby food, or yogurt. You may also empty all of the capsule contents into a small amount of infant formula, apple juice, or a pediatric electrolyte solution. The food or liquid that you use should be at or below room temperature.
  • Your child should swallow the entire mixture. They should not chew or crush the granules.
  • Your child should take the entire dose within 15 minutes of preparing it. Do not save it for use later.
• If your child misses a dose of rabeprazole sodium delayed-release capsules, they should take it as soon as possible. If it is almost time for their next dose, they should not take the missed dose. Your child should take their next dose at their regular time. They should not take 2 doses at the same time.
• If your child takes too much rabeprazole sodium delayed-release capsules, call your child’s doctor or your poison control center at 1-800-222-1222 right away, or go to the nearest emergency room.

• Low vitamin B-12 levels in the body can happen in people who have taken rabeprazole sodium delayed-release capsules for a long time (more than 3 years). Tell your child’s doctor if your child has symptoms of low vitamin B-12 levels, including shortness of breath, lightheadedness, irregular heartbeat, muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness in the arms and legs.
• Low magnesium levels in the body can happen in people who have taken rabeprazole sodium delayed-release capsules for at least 3 months. Tell your child’s doctor if your child has symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice.
• Stomach growths (fundic gland polyps). People who take PPI medicines for a long time have an increased risk of developing a certain type of stomach growths called fundic gland polyps, especially after taking PPI medicines for more than 1 year.

The most common side effects of rabeprazole sodium delayed-release capsules include: vomiting, stomach-area (abdomen) pain, diarrhea, headache, and nausea.
These are not all of the possible side effects of rabeprazole sodium delayed-release capsules. Call your child’s doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store rabeprazole sodium delayed-release capsules?
Store rabeprazole sodium delayed-release capsules in a dry place at room temperature between 68°F to 77°F (20°C to 25°C).
Keep rabeprazole sodium delayed-release capsules and all medicines out of the reach of children.

General Information about the safe and effective use of rabeprazole sodium delayed-release capsules.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use rabeprazole sodium delayed-release capsules for a condition for which it was not prescribed. Do not give rabeprazole sodium delayed-release capsules to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your child's doctor or pharmacist for information about rabeprazole sodium delayed-release capsules that is written for health professionals.

What are the ingredients in rabeprazole sodium delayed-release capsules?
Active ingredient: rabeprazole sodium
Inactive ingredients: colloidal silicon dioxide, diacetylated monoglycerides, ethylcellulose, hydroxypropyl cellulose, hypromellose phthalate, magnesium oxide, magnesium stearate, mannitol, talc, titanium dioxide, carrageenan, potassium chloride, FD&C Yellow, No. 6 (in the 10 mg capsule), and gray printing ink.

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