Rotarix: detailed information

Package leaflet: Information for the user

Rotarix oral suspension in pre-filled oral applicator

live rotavirus vaccine
Please read this leaflet carefully before the child is vaccinated because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This vaccine has been prescribed for this child only. Never give it to anyone else.
If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Rotarix is and what it is used for
What you need to know before your child receives Rotarix
How Rotarix is given
Possible side effects
How to store Rotarix
Contents of the pack and other information

1. What Rotarix is and what it is used for

Rotarix is a viral vaccine containing live attenuated human rotavirus, which helps protect
the child, starting from the age of 6 weeks, against gastroenteritis (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.
The rotavirus spreads easily through hand-to-mouth contact after contact with the faeces of an infected person. Most children with rotavirus diarrhoea recover spontaneously. However, some children become seriously ill with frequent vomiting, diarrhoea, and dangerous fluid loss, which requires hospitalisation.
When a child is vaccinated, the immune system (the body's natural defences) will develop
antibodies against the most common types of rotavirus. These antibodies protect against disease caused by
these types of rotavirus.
As with all vaccines, Rotarix may not fully protect all children who have been vaccinated against rotavirus infections.

2. What you should know before your child receives Rotarix

Rotarix must not be given

If your child has previously had an allergic reaction to rotavirus vaccines or to any of the other ingredients of this vaccine (listed in section 6). Signs of an allergic reaction may include itchy skin rash, difficulty breathing, or swelling of the face or tongue;
If your child has previously had intussusception (a bowel obstruction in which one segment of the intestine slides into another);
If your child was born with a bowel malformation that could lead to intussusception;
If your child has a rare inherited disease affecting the immune system called severe combined immunodeficiency (SCID);
If your child has a severe infection with high fever, vaccination may need to be postponed until recovery. A mild infection such as a cold should not be a problem, but you should still discuss it with the doctor first;
If your child has diarrhoea or vomiting, vaccination may need to be postponed until recovery.

Warnings and precautions
Talk to your doctor or healthcare professional before your child receives Rotarix if your child:

Is in close contact with a family member who has a weakened immune system, i.e. someone with cancer or who is taking medicines that may weaken the immune system;
Has any gastrointestinal disorder;
Has not gained weight or has not grown as expected;
Has any illness or is taking any medicine that may reduce resistance to infections, or if the mother received during pregnancy any medicine that may weaken the immune system.

After your child has received Rotarix, contact a doctor/healthcare professional immediately if your child develops stomach pain, persistent vomiting, blood in the stool, abdominal swelling and/or high fever (see also section 4 “Possible side effects”).
As always, please take care to wash hands thoroughly after changing soiled diapers.

Other medicines and Rotarix
Tell the doctor if your child is taking, has recently taken, or might take any other medicines, or if your child has recently received other vaccinations.
Rotarix may be given to your child at the same time as other vaccines usually recommended, such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, oral or inactivated polio, hepatitis B, as well as pneumococcal and meningococcal serogroup C conjugate vaccines.

Rotarix with food and drink
There are no restrictions on food or drink intake for your child, either before or after vaccination.

Breast-feeding
Based on evidence from clinical studies, breast-feeding does not reduce the protection provided by Rotarix against rotavirus gastroenteritis. Therefore, breast-feeding can be continued during the vaccination course.

Rotarix contains sucrose, glucose, phenylalanine and sodium
If your doctor has diagnosed your child with an intolerance to certain sugars, contact the doctor before the vaccine is administered.
This vaccine contains 0.15 micrograms of phenylalanine per dose. Phenylalanine may be harmful if your child has phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.
This vaccine contains 32 mg of sodium (the main component of table salt) per dose.

3. How Rotarix is administered

The doctor or nurse will administer the recommended dose of Rotarix to the child. The vaccine (1.5 mL
of liquid) will be given orally. Under no circumstances should this vaccine be administered by
injection.
The child will receive two doses of this vaccine. Each dose will be given separately, with a minimum
interval of 4 weeks between doses. The first dose may be administered from 6 weeks of age. Both doses
of the vaccine should be administered by 24 weeks of age, although it is preferable to administer them
before 16 weeks of age.
Rotarix may be administered to infants who were born prematurely, following the same vaccination
schedule, provided that the pregnancy lasted at least 27 weeks.
If the child refuses the vaccine or regurgitates most of the dose, an additional dose may be administered
during the same vaccination session.
When Rotarix is administered as the first dose, it is recommended that Rotarix (and not another rotavirus
vaccine) also be used for the second dose.
It is important to follow the doctor’s or nurse’s instructions regarding follow-up visits. If you forget to
return to the doctor as scheduled, please consult the doctor for advice.

4. Possible side effects

Like all medicines, this vaccine may cause side effects, although not every child will experience them.
The following side effects may occur with this vaccine:

Common (may occur in up to 1 in 10 doses of vaccine):
- diarrhoea
- irritability
Uncommon (may occur in up to 1 in 100 doses of vaccine):
- abdominal pain (see also below for signs of the very rare side effect of intestinal intussusception)
- flatulence
- skin inflammation

Side effects reported during the marketing of Rotarix include:

Very rare: urticaria
Very rare: intestinal intussusception (when one part of the intestine folds into another). Signs may include severe stomach pain, persistent vomiting, blood in the stool, bloated abdomen and/or high fever. Contact a doctor/healthcare professional immediately if the child shows any of these symptoms.
blood in the stool.
in infants born very prematurely (at 28 weeks of gestation or earlier), breathing pauses (apnoea) longer than normal may occur for 2-3 days after vaccination.
children with a rare inherited disease called severe combined immunodeficiency (SCID) may develop inflammation of the stomach or intestines (gastroenteritis) and may shed the vaccine virus in their stools. Signs of gastroenteritis may include nausea, vomiting, stomach cramps or diarrhoea.

Reporting of side effects
If the child experiences any side effects, including those not listed in this leaflet, consult a doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rotarix

Keep this vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Keep in the original packaging to protect from light.
The vaccine should be used immediately after opening.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rotarix contains

The active substances are:

Human rotavirus strain RIX4414 (live, attenuated)* not less than 10 CCID
*Produced on Vero cell lines

The other excipients in Rotarix are: sucrose, disodium adipate, modified Dulbecco’s medium (DMEM) (containing phenylalanine, sodium, glucose and other substances), sterile water (see also section 2, “Rotarix contains sucrose, glucose, phenylalanine and sodium”)

Description of the appearance of Rotarix and contents of the pack
Oral suspension in a pre-filled oral applicator.
Rotarix is supplied as a clear, colourless liquid in a single-dose pre-filled oral applicator (1.5 mL).
Rotarix is available in packs of 1, 5, 10 or 25 doses.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
GlaxoSmithKline Biologicals SA
Rue de l’Institut 89
B-1330 Rixensart
Belgium

For further information about Rotarix, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
GlaxoSmithKline Pharmaceuticals SA/NV
Tél/Tel: +32 10 85 52 00

България
GlaxoSmithKline Biologicals SA
Тел.: +359 80018205

Česká republika
GlaxoSmithKline s.r.o.
Tel: +420 2 22 00 11 11
[email protected]

Danmark
GlaxoSmithKline Pharma A/S
Tlf: +45 36 35 91 00
[email protected]

Deutschland
GlaxoSmithKline GmbH & Co. KG
Tel: +49 (0)89 360448701
[email protected]

Eesti
GlaxoSmithKline Biologicals SA
Tel: +372 8002640

Ελλάδα
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Tηλ: +30 210 68 82 100

España
GlaxoSmithKline, S.A.
Tel: +34 900 202 700
[email protected]

France
Laboratoire GlaxoSmithKline
Tél: +33 (0)1 39 17 84 44
[email protected]

Hrvatska
GlaxoSmithKline Biologicals SA
Tel.: +385 800787089

Ireland
GlaxoSmithKline (Ireland) Ltd
Tel: +353 (0)1 495 5000

Ísland
Vistor hf.
Sími: +354 535 7000

Italia
GlaxoSmithKline S.p.A.
Tel: +39 (0)45 7741 111

Κύπρος
GlaxoSmithKline Biologicals SA
Τηλ: +357 80070017

Latvija
GlaxoSmithKline Biologicals SA
Tel: +371 80205045

Lietuva
GlaxoSmithKline Biologicals SA
Tel: +370 80000334

Luxembourg/Luxemburg
GlaxoSmithKline Pharmaceuticals SA/NV
Tél/Tel: +32 10 85 52 00

Magyarország
GlaxoSmithKline Biologicals SA
Tel.: +36 80088309

Malta
GlaxoSmithKline Biologicals SA
Tel: +356 80065004

Nederland
GlaxoSmithKline BV
Tel: +31 (0)33 2081100

Norge
GlaxoSmithKline AS
Tlf: +47 22 70 20 00

Österreich
GlaxoSmithKline Pharma GmbH
Tel: +43 (0)1 97075 0
[email protected]

Polska
GSK Services Sp. z o.o.
Tel.: +48 (22) 576 9000

Portugal
Smith Kline & French Portuguesa - Produtos Farmacêuticos, Lda.
Tel: +351 21 412 95 00
[email protected]

România
GlaxoSmithKline Biologicals SA
Tel: +40 800672524

Slovenija
GlaxoSmithKline Biologicals SA
Tel: +386 80688869

Slovenská republika
GlaxoSmithKline Biologicals SA
Tel: +421 800500589

Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: +358 10 30 30 30

Sverige
GlaxoSmithKline AB
Tel: +46 (0)8 638 93 00
[email protected]

United Kingdom (Northern Ireland)
GlaxoSmithKline Biologicals SA
Tel: +44 (0)800 221 441
[email protected]

This leaflet was last updated on

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu

The following information is intended exclusively for healthcare professionals:

For oral administration, the vaccine is a clear, colourless liquid, free from
visible particles.
The vaccine is ready to use (reconstitution or dilution is not required).
The vaccine must be administered orally without mixing it with any other vaccine or solution.
The vaccine should be inspected visually for any foreign particles and/or changes
in physical appearance. If any such phenomena are observed, discard the vaccine.
Any unused vaccine and waste materials derived from this vaccine must be disposed of in
accordance with local regulations.
Instructions for vaccine administration:

Schematic drawing with a syringe crossed out by a black X over a syringe being applied near a person's face

Two hands holding a syringe to remove the cap with a movement indicated by a curved black arrow

Dispose of the empty oral applicator and its cap in approved biological waste containers in accordance with local regulations.

Package Leaflet: Information for the user

Rotarix oral suspension in squeezable tubes

live vaccine against rotavirus
Please read this leaflet carefully before the child is vaccinated as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This vaccine has been prescribed for the child only. Never give it to others.
If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Rotarix is and what it is used for
What you should know before your child receives Rotarix
How Rotarix is administered
Possible side effects
How to store Rotarix
Contents of the pack and other information

1. What Rotarix is and what it is used for

Rotarix is a viral vaccine containing live attenuated human rotavirus, which helps protect the
child, starting from the age of 6 weeks, against gastroenteritis (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 spreads easily through hand-to-mouth contact after contact with the faeces of an infected person.
Most children with rotavirus diarrhoea recover spontaneously. However, some children become seriously ill with frequent vomiting, diarrhoea and life-threatening fluid loss, requiring hospitalisation.
When a child is vaccinated, the immune system (the body's natural defences) produces antibodies against the most common types of rotavirus. These antibodies protect against disease caused by these rotavirus types.
As with all vaccines, Rotarix may not fully protect all vaccinated children against rotavirus infections.

2. What you need to know before your child receives Rotarix

Rotarix must not be given

If your child has previously had an allergic reaction to rotavirus vaccines or to any of the other ingredients of this vaccine (listed in section 6). Signs of an allergic reaction may include itchy skin rash, difficulty breathing, or swelling of the face or tongue;
If your child has previously had intussusception (a bowel obstruction in which one segment of the intestine slides into another);
If your child was born with an intestinal malformation that could lead to intussusception;
If your child has a rare inherited disease affecting the immune system called severe combined immunodeficiency (SCID);
If your child has a severe infection with high fever, vaccination may need to be postponed until recovery. A mild infection such as a cold should not be a problem, but you should still discuss it with the doctor first;
If your child has diarrhoea or vomiting, vaccination may need to be postponed until recovery.

Warnings and precautions
Talk to your doctor or healthcare professional before your child receives Rotarix if your child:

Is in close contact with a family member who has a weakened immune system, i.e. someone with cancer or taking medicines that may weaken the immune system;
Has any gastrointestinal disorder;
Has not gained weight or grown as expected;
Has any illness or is taking any medicine that reduces resistance to infections, or if the mother received any medicine during pregnancy that may weaken the immune system.

After your child has received Rotarix, contact a doctor or healthcare professional immediately if your child develops stomach pain, persistent vomiting, blood in the stool, abdominal swelling and/or high fever (see also section 4 “Possible side effects”).
As always, be sure to wash your hands thoroughly after changing soiled diapers.

Other medicines and Rotarix
Tell the doctor if your child is taking, has recently taken, or might take any other medicines, or if your child has recently received any other vaccinations.
Rotarix may be given to your child at the same time as other vaccines usually recommended, such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, oral or inactivated polio, hepatitis B, as well as pneumococcal conjugate and meningococcal serogroup C conjugate vaccines.

Rotarix with food and drink
There are no restrictions on your child eating or drinking before or after vaccination.

Breastfeeding
Based on evidence from clinical studies, breastfeeding does not reduce the protection provided by Rotarix against rotavirus gastroenteritis. Therefore, breastfeeding can be continued during the vaccination course.

3. How Rotarix is administered

The child will receive two doses of this vaccine. Each dose will be given separately, with a minimum interval of 4 weeks between doses. The first dose may be administered from the age of 6 weeks. Both doses of the vaccine should be administered by 24 weeks of age; however, it would be preferable for them to be given before 16 weeks of age.

Rotarix can be administered to infants who were born preterm according to the same vaccination schedule, provided that the pregnancy lasted at least 27 weeks.

If the child refuses or regurgitates most of the vaccine dose, an additional dose may be administered during the same vaccination session.

When Rotarix is given as the first dose, it is recommended that Rotarix (and not another rotavirus vaccine) also be used for the second dose.

It is important that you follow the doctor’s or nurse’s instructions regarding follow-up visits. If you forget to return to the doctor as scheduled, please consult your doctor for advice.

4. Possible side effects

Like all medicines, this vaccine may cause side effects, although these do not occur in all children.
The following side effects may occur with this vaccine:

Common (may occur in up to 1 in 10 doses of vaccine):
- diarrhoea
- irritability
Uncommon (may occur in up to 1 in 100 doses of vaccine):
- abdominal pain (see also below for signs of very rare side effects of intestinal intussusception)
- flatulence
- skin inflammation

Side effects reported during the post-marketing use of Rotarix include:

Very rare: urticaria
Very rare: intestinal intussusception (when one part of the intestine folds into another). Signs may include severe stomach pain, persistent vomiting, blood in the stool, swollen abdomen and/or high fever. Contact a doctor/healthcare professional immediately if the child shows any of these symptoms.
blood in the stool
in infants born very prematurely (at 28 weeks of gestation or earlier), longer than normal pauses between breaths may occur for 2-3 days after vaccination
in children with a rare inherited disease called severe combined immunodeficiency (SCID), inflammation of the stomach or intestine (gastroenteritis) may occur, and the child may shed the vaccine virus in the stool. Signs of gastroenteritis may include nausea, vomiting, stomach cramps or diarrhoea.

Reporting of side effects
If the child experiences any side effect, including those not listed in this leaflet, consult a doctor or pharmacist. You may also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rotarix

Keep this vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Keep in the original packaging to protect from light.
The vaccine should be used immediately after opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rotarix contains

The active substances are:

Human rotavirus strain RIX4414 (live, attenuated)* not less than 10 CCID
*Produced on Vero cell lines

The other excipients in Rotarix are: sucrose, disodium adipate, modified Dulbecco’s medium (DMEM) (containing phenylalanine, sodium, glucose and other substances), sterile water (see also section 2, “Rotarix contains sucrose, glucose, phenylalanine and sodium”)

Description of the appearance of Rotarix and contents of the pack
Oral suspension.
Rotarix is supplied as a clear, colourless liquid in a single-dose squeezable tube (1.5 mL).
Rotarix is available in packs of 1, 10 or 50 doses.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

GlaxoSmithKline Biologicals SA
Rue de l’Institut 89
B-1330 Rixensart
Belgium

For further information on Rotarix, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals SA/NV GlaxoSmithKline Biologicals SA
Tél/Tel: + 32 10 85 52 00 Tel: +370 80000334

България Luxembourg/Luxemburg
GlaxoSmithKline Biologicals SA GlaxoSmithKline Pharmaceuticals SA/NV
Тел. +359 80018205 Tél/Tel: + 32 10 85 52 00

Česká republika Magyarország
GlaxoSmithKline s.r.o. GlaxoSmithKline Biologicals SA
Tel: + 420 2 22 00 11 11 Tel.: +36 80088309
[email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S GlaxoSmithKline Biologicals SA
Tlf: + 45 36 35 91 00 Tel: +356 80065004
[email protected]

Deutschland Nederland
GlaxoSmithKline GmbH & Co. KG GlaxoSmithKline BV
Tel: + 49 (0)89 360448701 Tel: + 31 (0)33 2081100
[email protected]

Eesti Norge
GlaxoSmithKline Biologicals SA GlaxoSmithKline AS
Tel: +372 8002640 Tlf: + 47 22 70 20 00

Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. GlaxoSmithKline Pharma GmbH.
Tηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]

España Polska
GlaxoSmithKline, S.A. GSK Services Sp. z o.o.
Tel: + 34 900 202 700 Tel.: + 48 (22) 576 9000
[email protected]

France Portugal
Laboratoire GlaxoSmithKline Smith Kline & French Portuguesa - Produtos
Tél: + 33 (0) 1 39 17 84 44 Farmacêuticos, Lda.
[email protected] Tel: + 351 21 412 95 00
[email protected]

Hrvatska România
GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA
Tel.: +385 800787089 Tel: +40 800672524

Ireland Slovenija
GlaxoSmithKline (Ireland) Ltd GlaxoSmithKline Biologicals SA
Tel: + 353 (0)1 495 5000 Tel: +386 80688869

Ísland Slovenská republika
Vistor hf. GlaxoSmithKline Biologicals SA
Sími: +354 535 7000 Tel: +421 800500589

Italia Suomi/Finland
GlaxoSmithKline S.p.A. GlaxoSmithKline Oy
Tel:+ 39 (0)45 7741 111 Puh/Tel: + 358 10 30 30 30

Κύπρος Sverige
GlaxoSmithKline Biologicals SA GlaxoSmithKline AB
Τηλ: +357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]

Latvija United Kingdom (Northern Ireland)
GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA
Tel: +371 80205045 Tel: + 44 (0)800 221 441
[email protected]

This leaflet was last updated on

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu

The following information is intended exclusively for healthcare professionals:

For oral administration, the vaccine is presented as a clear, colourless liquid, free from
visible particles.
The vaccine is ready to use (reconstitution or dilution is not required).
The vaccine must be administered orally without mixing it with any other vaccine or solution.
The vaccine must be inspected visually for the presence of foreign particles and/or any changes
in physical appearance. If any such phenomena are observed, discard the vaccine.
Any unused vaccine and waste materials derived from this vaccine must be disposed of in
accordance with local regulations.
Instructions for vaccine administration:
Read the instructions for use carefully in their entirety before beginning vaccine administration.

Technical diagram of a medical device with reference lines indicating different parts and an enlargement of the upper tip

Technical drawing showing a hand removing the protective cap from a medical device via a movement towards the

Two hands holding a medical device to attach a cylindrical cap onto the top of a pen-shaped container

Technical drawing showing a hand inserting a vial into a device and an enlarged view of the tip with a cross-shaped hole

Black and white drawing of a hand holding an applicator to administer medication on a newborn's cheek

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

Package Leaflet: Information for the User

Rotarix oral suspension in a multiple presentation of single-dose squeeze tubes (5 single doses) connected by a bar
live vaccine against rotavirus
Please read this leaflet carefully before the child is vaccinated because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This vaccine has been prescribed for this child only. Never give it to anyone else.
If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Rotarix is and what it is used for
What you need to know before your child receives Rotarix
How Rotarix is administered
Possible side effects
How to store Rotarix
Contents of the pack and other information

1. What Rotarix is and what it is used for

Rotarix is a viral vaccine containing live attenuated human rotavirus, which helps protect the
child, from the age of 6 weeks, against gastroenteritis (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 spreads easily through hand-to-mouth contact after contact with the faeces of an infected person.
Most children with rotavirus diarrhoea recover spontaneously. However, some children become seriously ill with frequent vomiting, diarrhoea and life-threatening fluid loss, requiring hospitalisation.
When a child is vaccinated, the immune system (the body's natural defences) produces antibodies against the most common types of rotavirus. These antibodies protect against disease caused by these types of rotavirus.
As with all vaccines, Rotarix may not fully protect all vaccinated children against rotavirus infections.

2. What you should know before your child receives Rotarix

Rotarix must not be given

If the child has previously had an allergic reaction to rotavirus vaccines or to any of the other components of this vaccine (listed in section 6). Signs of an allergic reaction may include itchy skin rash, difficulty breathing, or swelling of the face or tongue;
If the child has previously had intussusception (a bowel obstruction in which one part of the intestine slides into another);
If the child was born with an intestinal malformation that could lead to intussusception;
If the child has a rare inherited disease affecting the immune system called severe combined immunodeficiency (SCID);
If the child has a serious infection with high fever, vaccination may need to be postponed until recovery. A mild infection such as a cold should not be a problem, but you should still consult your doctor first;
If the child has diarrhoea or vomiting, vaccination may need to be postponed until recovery.

Warnings and precautions
Talk to your doctor or healthcare professional before your child receives Rotarix if the child to be vaccinated:

Is in close contact with a family member who has a weakened immune system, i.e. someone with cancer or who is taking medicines that may weaken the immune system;
Has any gastrointestinal disorder;
Has not gained weight or grown as expected;
Has any illness or is taking any medicine that reduces resistance to infections, or if the mother received during pregnancy any medicine that may weaken the immune system.

After the child has received Rotarix, contact a doctor/healthcare professional immediately if the child develops stomach pain, persistent vomiting, blood in the stool, abdominal swelling and/or high fever (see also section 4 “Possible side effects”).
As always, please take care to wash your hands thoroughly after changing soiled diapers.

Other medicines and Rotarix
Tell the doctor if the child is taking, has recently taken, or might take any other medicines, or if the child has recently received any other vaccinations.
Rotarix can be given to the child at the same time as other vaccines usually recommended, such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, oral or inactivated polio, hepatitis B, as well as pneumococcal conjugate and meningococcal serogroup C conjugate vaccines.

Rotarix with food and drink
There are no restrictions on the child's intake of food or drink, either before or after vaccination.

Rotarix contains sucrose, glucose, phenylalanine and sodium
If the doctor has diagnosed the child to be vaccinated with an intolerance to certain sugars, contact the doctor before the vaccine is administered.
This vaccine contains 0.15 micrograms of phenylalanine per dose. Phenylalanine may be harmful if the child has phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot eliminate it properly.
This vaccine contains 32 mg of sodium (the main component of table salt) per dose.

3. How Rotarix is administered

The doctor or nurse will administer the recommended dose of Rotarix to the child. The vaccine (1.5 mL of liquid) will be given orally. Under no circumstances should this vaccine be administered by injection.
The child will receive two doses of this vaccine. Each dose will be given separately, with a minimum interval of 4 weeks between doses. The first dose may be administered from 6 weeks of age. Both doses of the vaccine should be administered by 24 weeks of age, although it would be preferable to administer them before 16 weeks of age.
Rotarix can be administered to infants who were born preterm according to the same vaccination schedule, provided that the gestation period was at least 27 weeks.
If the child refuses or regurgitates most of the vaccine dose, an additional dose may be administered during the same vaccination session.
When Rotarix is administered as the first dose, it is recommended that Rotarix (and not another rotavirus vaccine) also be used for the second dose.
It is important to follow your doctor’s or nurse’s instructions regarding follow-up visits. If you forget to return to the doctor as scheduled, please consult your doctor for advice.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although these do not occur in all children.
The following side effects may occur with this vaccine:

Common (may occur up to 1 in 10 doses of vaccine):
- diarrhoea
- irritability
Uncommon (may occur up to 1 in 100 doses of vaccine):
- abdominal pain (see also below for signs of very rare side effects of intestinal intussusception)
- flatulence
- skin inflammation

Side effects reported during post-marketing use of Rotarix include:

Very rare: urticaria
Very rare: intestinal intussusception (when one part of the intestine folds into itself or becomes twisted). Signs may include severe stomach pain, persistent vomiting, blood in the stool, bloated abdomen and/or high fever. Contact a doctor/healthcare professional immediately if the child shows any of these symptoms.
blood in the stool
in infants born very prematurely (at 28 weeks of gestation or earlier), longer than normal pauses between breaths may occur for 2-3 days after vaccination
in children with a rare inherited disease called severe combined immunodeficiency (SCID), inflammation of the stomach or intestine (gastroenteritis) may occur and the child may shed the vaccine virus in the stool. Signs of gastroenteritis may include nausea, vomiting, stomach cramps or diarrhoea.

Reporting of side effects
If the child experiences any side effect, including those not listed in this leaflet, consult a doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rotarix

Keep this vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Store in the original packaging to protect from light.
The vaccine should be used immediately after opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rotarix contains

The active substances are:

Human rotavirus strain RIX4414 (live, attenuated)* not less than 10 CCID
*Produced on Vero cell lines

The other excipients in Rotarix are: sucrose, disodium adipate, modified Dulbecco's medium (DMEM) (containing phenylalanine, sodium, glucose and other substances), sterile water (see also section 2, “Rotarix contains sucrose, glucose, phenylalanine and sodium”)

Description of the appearance of Rotarix and contents of the pack
Oral suspension.
Rotarix is supplied as a clear, colourless liquid in 5 single-dose squeeze tubes (5 x 1.5 mL) connected by a bar.
Rotarix is available in packs of 50 tubes.
Not all pack sizes may be marketed.