InfoCons Consumer Protection informs you – Synflorix – 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 your child gets 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 Synflorix is and what it is used for

Synflorix is a pneumococcal conjugate vaccine. Your doctor or nurse will inject your child with this vaccine.

It is used to help protect your child from 6 weeks up to 5 years of age against: a bacteria called ‘ Streptococcus pneumoniae ’. This bacteria can cause serious illnesses including meningitis, sepsis and bacteraemia (bacteria in blood stream) as well as ear infection or pneumonia.

How Synflorix works

Synflorix helps your body to make its own antibodies. The antibodies form a part of the immune system that will protect your child against these diseases.

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

Synflorix should not be given if:

• your child is allergic to the active substance, or any of the other ingredients of this vaccine (listed in s ection 6).

Signs of an allergic reaction may include itchy skin rash, being short of breath and swelling of the face or tongue.

• your child has a severe infection with a high temperature (over 38 °C). If this applies to your child then the vaccination will be postponed until your child is feeling better. A minor infection such as a cold should not be a problem. However, talk to your doctor first.

Synflorix should not be given if any of the above applies to your child. If you are not sure, talk to your doctor or pharmacist before your child is given Synflorix.

Warnings and precautions

Check with your doctor or pharmacist before this vaccine is given if:

• your child has a bleeding problem or bruises easily.

In children as of 2 years of age, fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if your child fainted with a previous injection.

As with all vaccines, Synflorix may not fully protect all children who are vaccinated.

Synflorix will only protect against infections caused by the bacteria for which the vaccine has been developed.

Children with a weakened immune system (such as due to human immunodeficiency virus ( HIV) infection or immunosuppressive therapy) may not get the full benefit from Synflorix.

If you are not sure, talk to your doctor or pharmacist before having Synflorix.

Children above 5 years old For children above 5 years old safety and efficacy of the vaccine have not been established, therefore vaccinatio n of these children is not recommended.

Other medicines and Synflorix

Tell your doctor or pharmacist if your child is taking , has recently taken or might take any other medicines , or if they have recently received any other vaccine. Synflorix may not work as well if your child is taking medicines that affect the immune system to fight infection.

Synflorix can be given at the same time as other childhood vaccines such as diphtheria , tetanus, pertussis (whooping cough), Haemophilus influenzae type b, oral or inactivated polio, hepatitis B, measles -mumps -rubella, varicella, oral rotavirus vaccines as well as meningococcal serogroup C and serogroups A, C, W -135, Y conjugate vaccines. A different place for the injection will be used for each vaccine.

Your doctor may ask you to give your child a medicine that lowers fever (such as paracetamol) before or immediately after Synflorix is given , especially in children being vaccinated with Synflorix and vaccines containing whole cell pertussis at the same time. It is also recommended to administer a medicine that lowers fever in children with convulsion disorders or with prior history of febrile convulsions.

However if your child has received paracetamol before or immediately after Synflorix is given, the obtained levels of antibodies may be slightly reduced. It is not known whether the reduction in antibody levels has an impact on the protection against pneumococcal disease.

Synflorix contain s sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.

💊 3. How Synflorix is given

How the vaccine is given Synflorix is always injected into a muscle. This is usually in the thigh or upper arm.

How much is given Usually, your child (from 6 weeks to 6 mont hs of age) will receive a course of 4 injections according to official recommendations or an alternative schedule may be used by the health care professional. It is important to follow the instructions from the doctor or nurse to complete the courses of in jections.

• Each injection will be given at least one month apart except for the last injection (booster), which will be given at least 6 months after the third injection.
• The first injection may be given from the age of 6 weeks onwards. The last injection (booster) may be given from the age of 9 months onwards.
• You will be told when your child should come back for the next injections.

Preterm infants (born after 27 weeks and less than 37 week s of pregnancy):

Your child (from 2 months to 6 months of age) wi ll receive 3 injections with an interval of at least one month between each dose. At least six months after the last injection, your child will receive an additional injection (booster).

Infants aged 7 to 11 months will receive 2 injections. Each injection will be given at least one month apart. A third injection (booster) will be given in the second year of life with at least two months apart.

Children aged 12 months to 5 years will receive 2 injections. Each injection will be given at least two months a part.

Special populations:

Children from 6 weeks up to 5 years of age considered to be at a higher risk of pneumococcal infection (such as those with HIV infection , sickle cell disease or impaired or abnormal functioning of the spleen ) may receive Synflor ix. Please speak to your doctor for information on the number and timing of injections for your child.

If your child misses an injection If your child misses an injection, it is important that you make another appointment. This is so that you and your doctor can talk about what steps need to be taken to protect your child.

If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.

❗ 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Severe allergic reactions may very rarely occur (with up to 1 in 10,000 doses of the vaccine). These can be recognised by:

• raised and itchy rash (hives)
• swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
• collapse These reactions will usually occur before leaving the doctor’s surgery. However, if your child gets any of these symptoms you should contact a doctor urgently.

Very common (these may occur with more than 1 in 10 doses of the vaccine)

• pain, redness and swelling where the injection is given
• high temperature of 38° C or higher (fever)
• feeling sleepy
• feeling irritable
• loss of appetite

Common (these may occur with up to 1 in 10 doses of the vaccine)

• hardness where the injection is given

Uncommon (these may occur with up to 1 in 100 doses of the vaccine)

• itching, blood clot, bleeding or a small lump where the injection is given 65 • nausea, diarrhoea or feeling sick (vomiting)
• unusual crying
• temporarily stopping breathing (apnoea) if your child is born prematurely (before or at 28 weeks of pregnancy)
• headache
• skin rash
• diffuse s welling of the injected limb, sometimes involving the adjacent joint
• hives

Rare (these may occur with up to 1 in 1,000 doses of the vaccine)

• fits without temperature or due to high temperature (fever)
• allergic reactions such as skin allergies
• collapse (sudden onset of muscle floppiness), periods of unconsciousness or lack of awareness, and paleness or bluish skin discoloration

Very rare ( these may occur with up to 1 in 10,000 doses of the vaccine)

• Kawasaki disease (major signs of the illness are for instance: fever, skin rash, swollen lymph glands, inflammation and rash of the mucous membranes of the mouth and throat) Booster doses of Synflorix may increase the risk of side effects.

For children > 12 months of age, the risk of pain at the inj ection site may increase with increasing age.

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.

Reporting of side effects

If your child gets any 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 Synflorix

Keep this medicine out of the sight and reach of children.

• Do not use this medicine 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).
• Store in the original package in order to protect from light.
• Do not freeze.

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

📦 6. Contents of the pack and other information

What Synflorix contains

• The active substances are:

One 0.5 ml dose contains:

Pneumococcal polysaccharide serotype 1 1,2 1 microgram Pneumococcal polysaccharide serotype 41,2 3 micrograms 66 Pneumococcal polysaccharide serotype 51,2 1 microgram Pneumococcal polysaccharide serotype 6B1,2 1 microgram Pneumococcal polysaccharide serotype 7F1,2 1 microgram Pneumococcal polysaccharide serotype 9V1,2 1 microgram Pneumococcal polysaccharide serotype 141,2 1 microgram Pneumococcal polysaccharide serotype 18C 1,3 3 micrograms Pneumococcal polysaccharide serotype 19F 1,4 3 micrograms Pneumococcal polysaccharide serotype 23F1,2 1 microgram 1 adsorbed on aluminium phosphate 0.5 milligram Al3+ in total 2 conjugated to protein D (derived from non- typeable Haemophilus influenzae ) carrier protein 9-16 micrograms 3 conjugated to tetanus toxoid carrier protein 5-10 micrograms 4 conjugated to diphtheria toxoid carrier protein 3-6 micrograms

• The other ingredients are: sodium chloride (see section 2 for further information) , 2-phenoxyethanol and water for injections

What Synflorix looks like and contents of the pack

• Suspension for injection in multidose container (4 doses)
• Synflorix is a turbid white suspension.
• Synflorix is available in vials for 4 doses in packs of 10 or 100.
• Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

GlaxoSmithKline Biologicals s.a.

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:

Belgique /Belgi ë/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v.

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 s.a./n.v.

Tél/Tel: + 32 10 85 52 00 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] Portugal GlaxoSmithKline – Produtos Farmacêuticos, Lda.

Tel: + 351 21 412 95 00 [email protected] Hrvatska GlaxoSmithKline Biologicals SA Tel.: +385 800787089 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 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

68 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

A fine white deposit with a clear colourless supernatant may be observed upon storage of the vial. This does not constitute a sign of deterioration.

The content of the vial should be inspected vi sually both before and after shaking for any foreign particulate matter and/or abnormal physical appearance prior to administration. In the event of either being observed, discard the vaccine.

The vaccine should be allowed to reach room temperature before use.

The vaccine should be well shaken before use.

After first opening of the 4- dose vial, the vaccine may be stored for a maximum of 28 days in a refrigerator (2 °C – 8° C). If not used within 28 days it should be discarded.

When using a multidose vial , each 0.5 ml dose should be withdrawn using a sterile needle and syringe; precautions should be taken to avoid contamination of the contents.

The vaccine is for intramuscular use only. Do not administer intravascularly.

If Synflorix is co- administered w ith other vaccines, different injection sites should be used.

Synflorix should not be mixed with other vaccines. If a vaccine dose is withdrawn into a syringe for injection, the needle used for withdrawal must be replaced by a needle suitable for intramuscular injection.

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

📄 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 Synflorix (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/09/508).

⚠️ 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.