Rotavirus vaccine, live (By mouth)

Brand Name(s)

Rotarix

There may be other brand names for this medicine.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Diarrhea, nausea, or vomiting.
• Fever, rash, red eyes, red mouth, swollen glands, and swollen hands and feet.
• Red or black stools, or changes in your child's bowel movements.
• Severe stomach pain.

If you notice these less serious side effects, talk with your doctor:

• Cough or runny nose.
• Crying, fussiness, or irritability.
• Loss of appetite.

Introduction

Rotavirus Vaccine, Live (ROE-ta-vye-rus VAX-een, lyve)

Prevents infants and children from getting a rotavirus stomach infection.

How to Use This Medicine

Liquid

• A nurse or other trained health professional will give your child this vaccine. It is given by mouth.
• Your child should receive 2 doses of this medicine. The first dose should be given at around 6 weeks of age. The second dose should be given at least 4 weeks after the first dose. Both doses should be given to your child before 6 months of age.
• This medicine comes with a patient information leaflet. Read the information carefully. Ask your doctor if you have any questions.

If a dose is missed:

• This medicine needs to be given on a fixed schedule. If your child missed the scheduled dose, call your child's doctor for another appointment.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your child's doctor knows if your child is receiving a treatment that may weaken the immune system, such as steroid medicine, radiation treatment, or medicine to treat cancer.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

When This Medicine Should Not Be Used

Your child should not receive this medicine if he or she has had an allergic reaction to live rotavirus vaccine, or has an inherited disease called severe combined immunodeficiency disease (SCID). If your child has a history of intussusception (a serious bowel problem) or was born with serious digestive problems that may cause intussusception, including a blocked bowel, he or she should not receive this medicine.

Warnings While Using This Medicine

• Make sure your child's doctor knows if your child has diarrhea, vomiting, a weak immune system because of a disease (such as HIV or AIDS), or any type of cancer.
• Tell your child's doctor if your child spends time with a person who has immune system problems or is getting cancer treatment.
• Call your child's doctor right away if your child has diarrhea, blood in their stool, high fever, severe stomach pain, or vomiting. These could be symptoms of a serious bowel problem called intussusception.
• The oral applicator of this vaccine contains dry natural latex rubber. Make sure your child's doctor knows if your child has had an allergic reaction to latex rubber.