Rotarix is a viral vaccine, containing live, attenuated human rotavirus, that helps to protect your child, from the age of 6 weeks, against gastro-enteritis (diarrhoea and vomiting) caused by rotavirus infection.

How Rotarix works

Rotavirus infection is the most common cause of severe diarrhoea in infants and young children. Rotavirus is easily spread from hand-to-mouth due to contact with stools from an infected person. Most children with rotavirus diarrhoea recover on their own. However, some children become very ill with severe vomiting, diarrhoea and life-threatening loss of fluids that requires hospitalisation.

When a person is given the vaccine, the immune system (the body’s natural defences) will make antibodies against the most commonly occurring types of rotavirus. These antibodies protect against disease caused by these types of rotavirus.

As with all vaccines, Rotarix may not completely protect all people who are vaccinated against the rotavirus infections it is intended to prevent.

Rotarix should not be given

·            if your child has previously had any allergic reaction to rotavirus vaccines or any of the other ingredients of this vaccine (listed in section 6). Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.

·            if your child has previously had intussusception (a bowel obstruction in which one segment of bowel becomes enfolded within another segment).

·            if your child was born with a malformation of the gut that could lead to intussusception.

·            if your child has a rare inherited illness which affects their immune system called Severe Combined Immunodeficiency (SCID).

·            if your child has a severe infection with a high temperature. It might be necessary to postpone the vaccination until recovery. A minor infection such as a cold should not be a problem, but talk to your doctor first.

·            if your child has diarrhoea or is vomiting. It might be necessary to postpone the vaccination until recovery.

Warnings and precautions

Talk to your doctor/health care professional before your child receives Rotarix if:

·            he/she has a close contact such as a household member who has a weakened immune system, e.g., a person with cancer or who is taking medicines that may weaken the immune system.

·            he/she has any disorder of the gastrointestinal system.

·            he/she has not been gaining weight and growing as expected.

·            he/she has any disease or is taking any medicine which reduces his/her resistance to infection or if his/her mother has taken during pregnancy any medicine that may weaken the immune system.

·            Taking Immunosuppressive therapies including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to vaccines.

After your child has received Rotarix, contact a doctor/health care professional right away if your child experiences severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high fever (see also section 4 “Possible side effects”).

As always, please take care to wash your hands thoroughly after changing soiled nappies.

Other medicines and Rotarix

Tell your doctor if your child is taking, has recently taken or might take any other medicines or has recently received any other vaccine.

Rotarix may be given at the same time your child receives other normally recommended vaccines, such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, oral or inactivated polio, hepatitis B vaccines as well as pneumococcal and meningococcal serogroup C conjugate vaccines.

Rotarix with food and drink

There are no restrictions on your child’s consumption of food or liquids, either before or after vaccination.

Breast-feeding

Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against rotavirus gastro-enteritis afforded by Rotarix. Therefore, breast-feeding may be continued during the vaccination schedule.

Rotarix contains sucrose, glucose, phenylalanine and sodium

If you have been told by your doctor that the child being vaccinated has an intolerance to some sugars, contact your doctor before your child receives this vaccine.

This vaccine contains 0.15 microgram phenylalanine in each dose. Phenylalanine may be harmful if your child has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

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

The doctor or nurse will administer the recommended dose of Rotarix to your child. The vaccine (1.5 ml liquid) will be given orally. Under no circumstance should this vaccine be administered by injection.

Your child will receive two doses of the vaccine. Each dose will be given on a separate occasion with an interval of at least 4 weeks between the two doses. The first dose may be given from the age of 6 weeks. The two doses of the vaccine must have been given by the age of 24 weeks, although they should preferably have been given before 16 weeks of age.

Rotarix may be given according to the same vaccination course to infants who were born prematurely, provided that the pregnancy had lasted at least 27 weeks.

In case your child spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit.

When Rotarix is given to your child for the first dose, it is recommended that your child also receives Rotarix (and not another rotavirus vaccine) for the second dose.

It is important that you follow the instructions of your doctor or nurse regarding return visits. If you forget to go back to your doctor at the scheduled time, ask your doctor for advice.

Like all medicines, this vaccine can cause side effects, although not everybody gets them.

The following side effects may happen with this vaccine:

¨          Common (These may occur with up to 1 in 10 doses of the vaccine):

·     diarrhoea 

·     irritability

¨          Uncommon (These may occur with up to 1 in 100 doses of the vaccine):

·     abdominal pain (see also below for signs of very rare side effects of intussusception)

·     flatulence

·     inflammation of the skin

Side effects that have been reported during marketed use of Rotarix include:

·     Very rare: hives (urticaria)

·     Very rare: intussusception (part of the intestine gets blocked or twisted). The signs may include severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high fever. Contact a doctor/health care professional right away if your child experiences one of these symptoms.

·     blood in stools

·     in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.

·     children with a rare inherited illness called Severe Combined Immunodeficiency (SCID) may have an inflamed stomach or gut (gastroenteritis) and pass the vaccine virus in their stools. The signs of gastroenteritis may include feeling sick, being sick, stomach cramps or diarrhoea.

To report any side effect(s):

Kingdom of Saudi Arabia

-National Pharmacovigilance centre (NPC)

·     Fax: +966-11-205-7662

·     Reporting Hotline: 19999

·     E-mail: npc.drug@sfda.gov.sa

·     Website: https://ade.sfda.gov.sa

-GlaxoSmithKline - Head Office, Jeddah

·       Tel:  +966-12-6536666

·       Mobile: +966-56-904-9882

·       Email: saudi.safety@gsk.com 

·       Website: https://gskpro.com/en-sa/

·       P.O. Box 55850, Jeddah 21544, Saudi Arabia

·     Keep this vaccine out of the sight and reach of children.

·     Do not use this vaccine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

·     Store in a refrigerator (2°C – 8°C).

·     Do not freeze.

·     Store in the original package in order to protect from light.

·     The vaccine should be used immediately after opening.

·     Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines your child no longer uses. These measures will help to protect the environment.