Uses of Rotavirus Oral Vaccine:

• It is used to prevent very bad stomach problems caused by rotavirus infection.

What do I need to tell my doctor BEFORE I take Rotavirus Oral Vaccine?

• If your child is allergic to rotavirus oral vaccine; any part of rotavirus oral vaccine; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.
• If your child has any of these health problems: Birth defect of the stomach or bowel (like Meckel diverticulum) that has not been fixed by surgery, diarrhea or is throwing up, or severe combined immunodeficiency disease (SCID).
• If your child has ever had a very bad type of bowel blockage or twisting (intussusception).
• If your child has an infection or an illness with a fever.

This is not a list of all drugs or health problems that interact with rotavirus oral vaccine.

Tell the doctor and pharmacist about all of your child's drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take rotavirus oral vaccine with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while I take Rotavirus Oral Vaccine?

• Tell all of your child's health care providers that your child is taking rotavirus oral vaccine. This includes your child's doctors, nurses, pharmacists, and dentists.
• If your child has a latex allergy, talk with the doctor. Some products have latex.
• This medicine may not protect all people who use it. Talk with the doctor.
• Tell the doctor if your child will be in close contact with people who have a weak immune system. This includes people with cancer, immune system problems, or who take drugs that weaken the immune system. There is a chance of spreading the vaccine virus to these people.

How is this medicine (Rotavirus Oral Vaccine) best taken?

Give rotavirus oral vaccine as ordered by your child's doctor. Read all information given to you. Follow all instructions closely.

• It is given by mouth only.

What do I do if I miss a dose?

• Call your child's doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child's doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Wheezing or coughing.
• Ear pain.
• The chance of a severe type of bowel blockage or twisting may be raised in infants and children after taking rotavirus oral vaccine. Most of the time, this has happened within 7 days after the first dose. Sometimes, this can happen up to many weeks after the last dose. Call the doctor right away if your child has blood in the stools; high fever; or severe diarrhea, throwing up, or stomach pain.
• Rarely, a very bad health problem called Kawasaki disease has happened with rotavirus oral vaccine. This health problem can affect the heart and can be deadly if left untreated. Call the doctor right away if your child has high fever, rash, red eyes or mouth, swollen glands, or swelling in the arms or legs.

What are some other side effects of Rotavirus Oral Vaccine?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child's doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:

• Feeling fussy.
• Runny nose.
• Fever.
• Not hungry.
• Throwing up.
• Crying that is not normal.
• Diarrhea.
• Sore throat.

These are not all of the side effects that may occur. If you have questions about side effects, call your child's doctor. Call your child's doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Rotavirus Oral Vaccine?

• If you need to store rotavirus oral vaccine at home, talk with your child's doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

• If your child's symptoms or health problems do not get better or if they become worse, call your child's doctor.
• Do not share your child's drug with others and do not give anyone else's drug to your child.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about rotavirus oral vaccine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.