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ACIPHEX SPRINKLE- rabeprazole sodium capsule, delayed release


  1. Patient Information
  2. Aciphex Sprinkle Can Cause Serious Side Effects, Including:
  3. Your Child Should Not Take Aciphex Sprinkle If They Are:
  4. Prepare And Give A Dose Of Aciphex Sprinkle To Your Child As Follows:
  5. Active Ingredient:

Patient Information 

Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide).

Acute Interstitial Nephritis

Advise the patient or caregiver to call the patient s healthcare provider immediately if they experience signs and/or symptoms associated with acute interstitial nephritis[
Your child should take ACIPHEX Sprinkle exactly as prescribed, at the lowest dose possible and for the shortest time needed.
ACIPHEX Sprinkle may help your child's acid-related symptoms, but your child could still have serious stomach problems.Talk with your child's doctor.

Aciphex Sprinkle Can Cause Serious Side Effects, Including: 

  • A type of kidney problem (acute interstitial nephritis).Some people who take proton pump inhibitor (PPI) medicines, including ACIPHEX Sprinkle, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with ACIPHEX Sprinkle. 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 ACIPHEX Sprinkle, 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.
ACIPHEX Sprinkle can have other serious side effects.
ACIPHEX Sprinkle is a prescription medicine called a proton pump inhibitor (PPI). ACIPHEX Sprinkle reduces the amount of acid in the stomach.
ACIPHEX Sprinkle is used in children 1 year to 11 years of age to treat Gastroesophageal Reflux Disease (GERD) for up to 12 weeks.
ACIPHEX Sprinkle is not effective in treating GERD in children under 1 year of age.
ACIPHEX Sprinkle should not be used to treat GERD in babies younger than 1 month of age.

Your Child Should Not Take Aciphex Sprinkle If They Are: 

  • allergic to rabeprazole, any other PPI medicine, or any of the ingredients in ACIPHEX Sprinkle.

    • Your child should take ACIPHEX Sprinkle exactly as prescribed. Your child s doctor will prescribe the dose that is right for your child.
    • Your child should take ACIPHEX Sprinkle 1 time each day.
    • Your child should take ACIPHEX Sprinkle 30 minutes before a meal.
    • Your childshould notswallow the ACIPHEX Sprinkle capsule whole.

Prepare And Give A Dose Of Aciphex Sprinkle To Your Child As Follows: 

  • Open the ACIPHEX Sprinkle 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 dosewithin 15 minutesof preparing it. Do not save it for use later.
  • If your child misses a dose of ACIPHEX Sprinkle, 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 ACIPHEX Sprinkle, call your child s doctor or your poison control center at 1-800-222-1222 right away, or go to the nearest emergency room.
  • 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 Blue No.2 Aluminum Lake (in the 5 mg capsule), FD&C Yellow, No. 6 (in the 10 mg capsule), and gray printing ink.

    Distributed and Marketed by Cerecor, Inc. Rockville, MD 20850
    ACIPHEX is a registered trademark of Eisai R&D Management Co., Ltd;
    ACIPHEX Sprinkle is a trademark of Eisai R&D Management Co., Ltd, each of which is licensed to Cerecor, Inc.
    For more information, go to www.aciphexsprinkle.com.

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    Revised: April 2019




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