InfoCons Consumer Protection informs you – Rotarix – Package Leaflet

Before anything else

Read all of this leaflet carefully before your child receives this vaccine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This vaccine has been prescribed for your child only. Do not pass it on to others.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Rotarix is and what it is used for

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. H owever, 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.

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

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 t ongue.
• 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.

51 • 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 .

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 32 mg sodium (main component of cooking/table salt) in each dose .

💊 3. How Rotarix is given

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 gi ven 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.

❗ 4. Possible side effects

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

Contact a doctor/health care professional right away if your child experiences one of the following symptoms:

• Allergic reactions (frequency cannot be estimated from the available data), which may be severe (anaphylaxis), and may include: shortness of breath or allergic swelling that may affect the face, lips, tongue or throat.
• Intussusception (part of the intestine gets blocked or twisted) (frequency very rare) . The signs may include severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high fever.

The following other 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 above 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)
• 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, stoma ch cramps or diarrhoea.

Reporting of side effects

If your child gets any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix 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 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.

📦 6. Contents of the pack and other information

What Rotarix contains

• The active substances are:

Human rotavirus RIX4414 strain (live, attenuated)* not less than 10 6.0 CCID 50 *Produced on Vero cells

• The other ingredients in Rotarix are: sucrose , Di -sodium Adipate, Dulbecco’s Modified Eagle Medium (DMEM) (containing phenylalanine, sodium, glucose and other substances ), sterile

water , (see also section 2 , “Rotarix contains sucrose, glucose, phenylalanine and sodium” )

What Rotarix looks like and contents of the pack

Oral suspension.

Rotarix is supplied as clear and colourless liquid in 5 single dose squeezable tubes (5 x 1.5 mL) connected by a bar .

Rotarix is available in a pack of 50 tubes.

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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/ Belgique/Belgien GlaxoSmithKline Pharmaceuticals SA /NV Tél/Tel: + 32 10 85 52 00 Lietuva GlaxoSmithKline Biologicals SA Tel. +370 80000334 България GlaxoSmithKline Biologicals SA Тел. +359 80018205 Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals SA /NV Tél/Tel: + 32 10 85 52 00 54 Česká republika GlaxoSmithKline s.r.o.

Tel: + 420 2 22 00 11 11 [email protected] Magyarország GlaxoSmithKline Biologicals SA Tel.: +36 80088309 Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 [email protected] Malta GlaxoSmithKline Biologicals SA Tel: +356 80065004 Deutschland GlaxoSmithKline GmbH & Co. KG Tel: + 49 (0)89 360448701 [email protected] Nederland GlaxoSmithKline BV Tel: + 31 (0)33 2081100 Eesti GlaxoSmithKline Biologicals SA Tel: +372 8002640 Norge GlaxoSmithKline AS Tlf: + 47 22 70 20 00 Ελλάδα GlaxoSmithKline Μονοπρόσωπη A.E.B.E.

Tηλ: + 30 210 68 82 100 Österreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 [email protected] España GlaxoSmithKline, S.A.

Tel: + 34 900 202 700 [email protected] Polska GSK Services Sp. z o.o.

Tel.: + 48 (22) 576 9000 France Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44 [email protected] Hrvatska GlaxoSmithKline Biologicals SA Tel.: +385 800787089 Portugal Smith Kline & French Portuguesa – Produtos Farmacêuticos, Lda.

Tel: + 351 21 412 95 00 [email protected] România GlaxoSmithKline Biologicals SA Tel: +40 800672524 Ireland GlaxoSmithKline (Ireland) Ltd Tel: + 353 (0)1 495 5000 Slovenija GlaxoSmithKline Biologicals SA Tel: +386 80688869 Ísland Vistor hf .

Sími: +354 535 7000 Slovenská republika GlaxoSmithKline Biologicals SA Tel.: +421 800500589 Italia GlaxoSmithKline S.p.A.

Tel: + 39 (0)45 7741 111 Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 10 30 30 30 55 Κύπρος GlaxoSmithKline Biologicals SA Τηλ: +357 80070017 Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 [email protected] Latvija GlaxoSmithKline Biologicals SA Tel: +371 80205045 United Kingdom (Northern Ireland) GlaxoSmithKline Biologicals SA Tel: +44 (0)800 221 441 [email protected] This leaflet was last revised in .

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. ————————————————————————————————————————-

🩺 Information intended for healthcare professionals only

The vaccine is presented as a clear, colourless liquid, free of visible particles, for oral administration.

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

The vaccine is to be administered orally without mixing with any other vaccines or solutions.

The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed, discard the vaccine.

Any unused vaccine or waste material should be disposed of in accordance with local requirements.

Instructions for administration of the vaccine :

Please read the instructions for use all the way through before starting to give the vaccine.

• This vaccine is given orally straight from an individual tube.
• One oral tube delivers one dose of vaccine.
• This vaccine is ready to use – do not mix it with anything else.

A. What you need to do before giving Rotarix 1. Check the expiry date on the connecting bar.

2. Check the liquid in the oral tubes is clear, colourless and free from any particles.

• Do not use any of the oral tubes on the connecting bar if you notice anything unusual.

3. Check that each individual oral tube is not damaged and is still sealed.

• Do not use the affected oral tube if you notice anything unusual.

B. Get the oral tube ready 1. To separate one oral tube from the others starting at one end: a) Hold the tab of one of the end oral tubes to Connecting bar Neck Body Tab Expiry date: MM-YYYY Monodose oral tube separate it from the others. b) With your other hand, hold the tab of the oral tube next to it. c) Pull the tab and tear it away from the oral tube next to it.

2. To open the separated oral tube: d) Keep the separated oral tube held upright. e) Hold the tab of the separated oral tube in one hand and the connecting bar in the other hand. Do not hold the body of the oral tube, you may squeeze out some of the vaccine. f) Twist the separated oral tube. g) Pull it from the connecting bar.

C. Give the vaccine orally immediately after opening 1. To position the child to receive the vaccine:

• Seat the child leaning slightly backwards.

2. To administer the vaccine orally:

• Squeeze the liquid gently into the side of the child’s mouth, towards the inside of their cheek .
• You may need to squeeze the oral tube a few times to get all of the vaccine out – it is okay if a drop stays in the oral tube.

D. Store remaining doses in the fridge immediately Unused oral tubes that are still attached to the connecting bar must be put back in the fridge immediately after an oral tube has been used. This is so that the unused oral tubes can be used for the next vaccination.

Discard the used oral tubes in approved biological waste containers according to local regulations.

Oral administration only Expiry date: MM-YYYY 2°C to 8°C Put back in fridge immediately Twist Pull Pull ANNEX I V SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION (S) 58 Scientific conclusions Taking into account the PRAC Assessment Report on the PSUR(s) for rotavirus vaccine monovalent (live, oral), the scientific conclusions of PRAC are as follows:

In view of available data on from the literature and spontaneous reports including in some cases a close temporal relationship and in view of a plausible mechanism of action, the PRAC considers a causal relationship between rotavirus vaccine monovalent (li ve, oral) and anaphylactic reaction is at least a reasonable possibility. The PRAC concluded that the product information of products containing rotavirus vaccine monovalent (live, oral) should be amended accordingly.

Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.

Grounds for the variation to the terms of the Marketing Authorisation (s) On the basis of the scientific conclusions for rotavirus vaccine monovalent (live, oral) the CHMP is of the opinion that the benefit- risk balance of the medicinal product(s) containing rotavirus vaccine monovalent (live, oral) is unchanged subject to the p roposed changes to the product information.

The CHMP recommends that the terms of the marketing authorisation(s) should be varied.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Rotarix (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/05/330).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.