Prospect: information for the user

Rotarix oral suspension in dosing tube

live rotavirus vaccine

Read this prospect carefully before your child receives this vaccine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This vaccine has been prescribed only for your child, and should not be given to others.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect.See section 4.

Rotarix is a live attenuated virus vaccine, containing human rotavirus, which helps protect your child from the age of 6 weeks against gastroenteritis (diarrhea and vomiting) caused by a rotavirus infection.

How Rotarix works

Rotavirus infection is the most common cause of severe diarrhea in infants and young children. Rotavirus is easily transmitted through hand-to-mouth contact with the feces of an infected person. Most children with rotavirus diarrhea recover on their own. However, some children become severely ill with a severe case of vomiting, diarrhea, and fluid loss that puts their life at risk and requires hospitalization.

When the vaccine is administered to a person, the immune system (the body's natural defense) will produce antibodies against the most frequently occurring types of rotavirus. These antibodies protect against the disease caused by these types of rotavirus.

Like all vaccines, Rotarixmay not prevent all vaccinated individuals from contracting infections by rotavirus that it aims to protect against.

Rotarix should not be administered

• if your child has had a previous allergic reaction torotavirus vaccinesor to any of the other components of this vaccine (listed in section 6). Signs of an allergic reaction may include skin rash with itching, difficulty breathing, and swelling of the face or tongue.
• if your child has had a previousintestinal intussusception (a bowel obstruction in which a segment of the intestine has slipped into another segment).
• if your child was born with agastrointestinal malformation that could cause intestinal intussusception.
• if your child has a rare genetic disorder that affects their immune system called severe combined immunodeficiency (SCID).
• if your childhas a severe infection with high fever. It may be necessary to postpone vaccination until they have recovered. A minor infection, such as a cold, should not be a problem for vaccination, but please inform your doctor first.
• if your child hasdiarrhea or vomiting. It may be necessary to postpone vaccination until they have recovered.

Warnings and precautions

Consult your doctor/healthcare professional before your child receives Rotarix if:

• they are in close contact with a family member who has a weakened immune system, for example, someone with cancer or taking medications that can weaken their immune system.
• they have any gastrointestinal problems.
• they have not gained weight or grown as expected.
• they have any disease or are taking any medication that reduces their resistance to infectionor if their mother took during pregnancy any medication that may weaken the immune system.

If after receiving Rotarix your child experiences severe stomach pain, persistent vomiting, bloody stools, swollen abdomen, and/or high fever, contact a doctor/healthcare professional immediately (see also section 4 “Possible side effects”).

Please take the precaution of washing your hands thoroughly after changing used diapers.

Use of Rotarix with other medications

Inform your doctor if your child is using or has used recently or may have to use any other medicationor has recently received any other vaccine.

Rotarix can be administered at the same time as your child receives other recommended vaccines, such as the diphtheria, tetanus, pertussis (whooping cough) vaccine, the Haemophilus influenzae type b vaccine, the oral or inactivated poliovirus vaccine, the hepatitis B vaccine, as well as the conjugated pneumococcal and meningococcal group C vaccines.

Use ofRotarixwith food and drinks

There are no restrictions on your child's food or liquid intake, including breastfeeding, both before and after vaccination.

Breastfeeding

Based on evidence generated in clinical trials, breastfeeding does not reduce protection against rotavirus gastroenteritis conferred by Rotarix. Therefore, breastfeeding can continue during the vaccination period.

Rotarix contains saccharose, glucose, phenylalanine, and sodium

If your doctor has mentioned that your child has an intolerance to some sugars, please speak with your doctor before your child receives this vaccine.

This vaccine contains 0.15 micrograms of phenylalanine per dose. Phenylalanine can be harmful if your child has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This vaccine contains 34 mg of sodium (main component of table salt/for cooking) per dose.

The doctor or nurse will administer the recommended dose of Rotarix to your child. The vaccine (1.5 ml of liquid) will be administeredorally. Under no circumstances should thisvaccine be administered byinjection.

Your child will receive two doses of the vaccine. Each dose will be administered separately with an interval of at least 4 weeks between the two doses. The first dose will be administered from 6 weeks of age. The two doses of the vaccine must have been administered by 24 weeks of age, althoughpreferably they should be administered before 16 weeks of age.

Rotarix can be administered to premature newborns following the same vaccination schedule as the rest of newborns, as long as the gestation has lasted at least 27 weeks.

If your child spits out or regurgitates most of the vaccine dose, a single replacement dose can be administered in the same visit.

When administering the first dose with Rotarix to your child, it is recommended that your child also receive Rotarix as the second dose (and not another rotavirus vaccine).

It is essential that you follow the instructions indicated by your doctor or nurse regarding subsequent visits. If you forgot to return to your doctor on the scheduled appointment,talk to your doctor.

Like all medications,this vaccinemay produce adverse effects, although not all people will experience them.

The following adverse effects may occur with this vaccine:

• Frequent (may occur in up to 1 in 10 vaccine doses):

• diarrhea
• irritability

• Less frequent (may occur in up to 1 in 100 vaccine doses):

• abdominal pain(see also in the next paragraph the signs of the rare adverse effect intestinal invagination)
• flatulence
• skin inflammation

Adverse effects reported during the marketing of Rotarix include:

• Very rare: hives (urticaria)
• Very rare: intestinal invagination (part of the intestine becomes blocked or twisted). The signs may include severe stomach pain, persistent vomiting, blood in the stool, abdominal swelling, and/or high fever.Contact a doctor/healthcare professional immediately if your child experiences any of these symptoms
• blood in stool
• in premature children (born at 28 weeks of gestation or earlier), the periods between breathing may be longer than normal during the 2-3 days following vaccination
• children with a rare genetic disorder called severe combined immunodeficiency (SCID) may experience stomach or intestinal inflammation (gastroenteritis) and may eliminate the vaccine virus in their stool. The signs of gastroenteritis may include nausea, vomiting, stomach cramps (colics or retching) or diarrhea

Reporting Adverse Effects

If your child experiences any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus.The adverse effects can also be reported directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use,www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this vaccine out of sight and reach of children.

Do not use this vaccine afterthe expiration date that appears on thecontainer.The expiration date is the last day of the month indicated.

Store in a refrigerator (between2°Cand8°C).

Do not freeze.

Store in the original packaging to protect it from light.

Once opened, the vaccine must be used immediately.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of containers and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Rotarix

• The active principle is:

Human rotavirus strainRIX4414 (live, attenuated)*not less than 106,0CCID50

* Produced in Vero cells

• The other components ofRotarixare: sucrose, disodium adipate, Modified Eagle's Medium by Dulbecco (MEDM) (containing phenylalanine, sodium, glucose, and other substances), sterile water (see also section 2, “Rotarix contains sucrose, glucose, phenylalanine, and sodium”).

Appearance of the productand size of the container

Suspensionoral

Rotarix is supplied asa clear, colorless liquid in a single-dose dosing tube (1.5 ml).

Rotarix is available in containers of 1, 10, or 50.

Only some container sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

GlaxoSmithKline Biologicals SA

Rue de l’Institut 89

B-1330 Rixensart

Belgium

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet: 01/2022

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu

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This information is intended for healthcare professionals only:

The vaccine is presented as a clear, colorless liquid, free of visible particles, fororaladministration.

The vaccine is ready to use (no reconstitution or dilution is required).

The vaccine is administeredorallywithout being mixed with other vaccines or solutions.

The vaccine should be visually inspected to observe any foreign particles and/or physical appearance variation. In case of any of these circumstances, discard the vaccine.

The disposal of unused vaccines and all materials that have been in contact with them will be carried out in accordance with local regulations.

Instructions for vaccine administration:

Read the instructions for use completely before starting to administer the vaccine

Discard the empty tube and cap in approved biological waste containers in accordance with local regulations.