InfoCons Consumer Protection informs you – Infanrix hexa – 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.

What is i n this leafl et 1. What Infanrix hexa is and what it is used for 2. What you need to know b efore your child receives Infanrix hexa 3. How Infanrix hexa is given 4. Possible side effects 5. How to store Infanrix hexa 6. Contents of the pack and other information

ℹ️ 1. What Infanrix hexa is and what it is used for

Infanrix hexa is a vaccine used to protect your child against six diseases:

• Diphtheria: a serious bacterial infection that mainly affects the airways and sometimes the skin , causing serious breathing problems , sometimes suffocation. The bacteria also release a poison . This can cause nerve damage, heart problems, and even death.
• Tetanus : tetanus bacteria commonly found in soi l, dust, horse manure and wood splinters enter the body through cuts, scratches or wounds in the skin, and release a poison . This can cause muscle stiffness, painful muscle spasms, fits and even death.
• Whooping cough (Pertussis ): a highly contagious bact erial infection that affects the airways , causing a long- lasting cough, which often has a “whooping” sound. It can also cause ear infections, chest infections ( bronchitis ), lung infections ( pneumonia ), fits, brain damage and even death.
• Hepatitis B: is caused by the hepatitis B virus, which attacks the liver. The virus can cause lifelong infection and may lead to cirrhosis and liver cancer .
• Polio : a viral infection , sometimes causing nerve injury an d permanent damage, which can make the muscles unable to move (paralysis) , including the muscles needed for breathing and walking . It can cause permanent damage or even death.
• Haemophilus influenzae type b (Hib) : a bacterial infection. It can cause meningitis (brain inflammation), which can lead to mental slowness ( retardation ), cerebral palsy, deafness, epilepsy or partial blindness. It can also cause swelling of the throat causing death by suffocation. It can also infect the blood, heart, lungs, bones, j oints and tissues of the eyes and mouth.

How Infanrix hexa works

38 • Infanrix hexa helps your child’s body make its own protection (antibodies). This will protect your child against these diseases.

• As with all vaccines, Infanrix hexa may not fully protect all children who are vaccinated.
• The vaccine cannot cause the diseases that it protects your child from.

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

Infanrix hexa should not be given

• if your child is allergic to:
• Infanrix hexa or any of the ingredient s of this vaccine (listed in section 6) .
• formaldehyde.
• neomycin or poly myxin (antibiotics).

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

• if your child has had an allergic reaction to any vaccine against diphtheria, tetanus, whooping cough, hepatitis B, polio or Haemophilus influenzae type b.
• if your child has had problems of the nervous system within 7 days after previous vaccination with a vaccine against whooping cough
• if your child has a severe infection with a high temperature (over 38°C ).

A minor infection such as a cold should not be a problem, but talk to your doctor first.

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

Warnings and precautions

Talk to your doctor or pharmacist before your child is given Infanrix hexa :

• if after previously having Infanrix hexa or another vaccine against whooping cough, your child had any problems, especially:
• a high temperature (over 40°C) within 48 hours of vaccination
• a collapse or “shock -like” state within 48 hours of vaccination
• persistent crying lasting 3 hours or more within 48 hours of vaccination
• fits with or without a high temperature within 3 days of vaccination
• if your child has an undiagnosed or progressive disease of the brain or epilepsy which is not controlled. After control of the disease the vaccine can be given .
• if your child has a bleeding problem or bruises easily
• if your child tends to have fits when they have a fever, or if there is a history of this in the family .
• if your child should become unresponsive or experience seizures (fits) afte r the vaccination, please contact your doctor immediately. See also section 4 Possible side effects.
• if your baby was born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2 -3 days after vaccinati on. These babies may require respiratory monitoring for 48 -72 h following the administration of the first two or three doses of Infanrix hexa.

If any of the above apply to your child (or you are not sure), talk to your doctor or pharmacist before your chi ld is given Infanrix hexa.

Other medicines and Infanrix hexa

Your doctor may ask you to give your child a medicine that lowers fever (such as paracetamol) before or immediately after Infanrix hexa is given. This can help to lower some of the side effects (febrile reactions) of Infanrix hexa.

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

Infanrix hexa contains neomycin , polymyxin , para -aminobenzoic acid , phenylalanine , sodium and potassium This vaccine contains neomycin and polymyxin (antibiotics). T ell your doctor if your child has had an allergic reaction to these ingredients.

Infanrix hexa contains para -aminobenzoic acid . It may cause allergic reactions (possibly delayed), and exceptionally, bronchospasm .

The vaccine contains 0.0298 microgram phenylalanine in each dose. Phenylalanine may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly .

The vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium -free’.

The vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium -free’.

💊 3. How Infanrix hexa is given

How much is given

• Your child will have a total of two or three injections with respectively at least 2 or 1 month (s) between each injection .
• You will be told by the doctor or nurse when you r child should come back for their next injections.
• If additional injections (booster s) are necessary, the doctor will tell you.

How the vaccine is given

• Infanrix hexa will be given as an injection into a muscle.
• The vaccine should never be given into a blood vessel or into the skin .

If your child misses a dose

• If your child misses an injection which is due, it is important that you make another appointment.
• Make sure y our child finishes the complete vaccination course. If not, your child may not be fully protected against the diseases.

❗ 4. Possible side effects

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

Allergic reactions If your child has an allergic reaction, see your doctor straight away. The s igns may include :

• rashes that may be itchy or blistering
• swelling of the eyes and face
• difficulty in breathing or swallowing
• a sudden drop in blood pres sure and loss of consciousness.

These signs usually start very soon after the injection has been given. Talk to a doctor straight away if they happen after leaving the doctor’s surgery.

See your doctor straight away if your child has any of the following serious side effects:

• collapse
• times when they lose consciousness or have a lack of awareness
• fits – with or without fever These side effects have happened very rarely with Infanrix hexa as with other vaccines against whooping cough. They usually happen within 2 to 3 days after vaccination.

Other side effects include

40 Very common (these may occur with more than 1 in 10 doses of the vaccine ): sleepiness, loss of appetite , high temperature of 38°C or higher , swelling, pain, redness where the injection was given , unusual crying, feeling irritab le or restless.

Common (these may occur with up to 1 in 10 doses of the vaccine ): diarrhoea , being sick ( vomiting ), high temperature of more than 39.5°C , swelling larger than 5 cm or hard lump where the injection was given, feeling nervous .

Uncommon (these may occur with up to 1 in 100 doses of the vaccine) : upper respiratory tract infection, tiredness , cough, large swelling at the injected limb .

Rare ( these may occur with up to 1 in 1,000 doses of the vaccine) : bronchitis , rash, swollen glands in the neck, armpit or gro in (lymphadenopathy) , bleeding or bruising more easily than normal (thrombocytopenia) , 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, temporarily stopping breathing (apnoea) , swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowi ng or breathing (angioedema) , swelling of the whole injected limb , blisters .

Very rare (these may happen with up to 1 in 10,000 doses of the vaccine) : itching ( dermatitis ).

Experience with hepatitis B vaccine In extremely rare cases the following side effects have been reported with hepatitis B vaccine : paralysis , numbness or weakness of the arms and legs (neur opathy) , inflammation of some nerves, possibly with pins and needles or loss of feeling or normal movement (Guillain- Barré syndrome) , swelling or infection of the brain (encephalopathy, encephalitis) , infection around the brain (meningitis) .

The causal re lationship to the vaccine has not been established.

Bleeding or bruising more easily than normal (thrombocytopenia) has been reported with hepatitis B vaccines.

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 Infanrix hexa

• 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).
• Store in the original package in order to protect from light.
• Do not freeze. Freezing destroys the vaccine.
• 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 protect the environment.

📦 6. Contents of the pack and other information

What Infanrix hexa contains

The active substances are:

41 Diphtheria toxoid1 not less than 30 International Units ( IU) Tetanus toxoid1 not less than 40 International Units ( IU) Bordetella pertussis antigens Pertussis toxoid1 25 micrograms Filamentous Haemagglutinin1 25 micrograms Pertactin1 8 micrograms Hepatitis B surface antigen2,3 10 micrograms Poliovirus (inactivated) type 1 (Mahoney strain)4 40 D -antigen unit type 2 (MEF -1 strain)4 8 D-antigen unit type 3 (Saukett strain)4 32 D -antigen unit Haemophilus influenzae type b polysaccharide 10 micrograms (polyribosylribitol phosphate)3 conjugated to tetanus toxoid as carrier protein approximately 25 micrograms 1adsorbed on aluminium hydroxide, hydrated (Al(OH) 3) 0.5 milligrams Al3+ 2produced in yeast cells ( Saccharomyces cerevis iae) by recombinant DNA technology 3adsorbed on aluminium phosphate (AlPO 4) 0.32 milligrams Al3+ 4propagated in VERO cells The other ingredients are:

Hib powder: lactose anhydrous DTPa -HBV- IPV suspension: sodium chloride (NaCl), medium 199 (containing amino acids (including phenylalanine) , mineral salts (including sodium and potassium) , vitamins (including para -aminobenzoic acid) and other substances ) and water for injections

What Infanrix hexa looks like and contents of the pack

• The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis (DTPa- HBV- IPV) component is a white, slightl y milky liquid presented in a pre -filled syringe (0.5 ml).
• The Hib component is a white powder presented in a glass vial.
• Both components are mixed together just before your child receives the injection . The mixed appearance is a white, slightly milky liquid.
• Infanrix hexa is available in 1- dose vial + pre -filled syringe , pack sizes of 1 and 10 with or without separate needles , and a multipack of 5 packs, each containing 10 vials (1-dose) and 10 pre -filled syringes (1-dose) , without separate needles.
• Not al l 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 H older :

België/ Belgi que/Belgien GlaxoSmithKline Pharmaceuticals SA /NV Tél/Tel: + 32 10 85 52 00 България GlaxoSmithKline Biologicals SA Тел.: +359 80018205 Lietuva GlaxoSmithKline Biologicals SA Tel: +370 80000334 Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals SA /NV Tél/Tel: + 32 10 85 52 00 Česká republika Magyarország 42 GlaxoSmithKline s.r.o.

Tel: + 420 2 22 00 11 11 [email protected] 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 Ελλάδα GlaxoSmithKline Μονοπρόσωπη A.E.B.E.

Tηλ: + 30 210 68 82 100 Norge GlaxoSmithKline AS Tlf: + 47 22 70 20 00 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 Smith Kline & French Portuguesa – 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 (0) 10 30 30 30 Κύπρος GlaxoSmithKline Biologicals SA Τηλ: +357 80070017 Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 [email protected] Latvija United Kingdom (Northern Ireland) 43 GlaxoSmithKline Biologicals SA Tel: +371 80205045 GlaxoSmithKline Biologicals SA Tel: +44(0)800 221441 [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: https://www.ema.europa.eu .

This leaflet is available in all EU/EEA languages on the E uropean Medicines Agency website. —————————————————————————————————————————–

🩺 Information intended for healthcare professionals only

Upon storage, a clear liquid and white deposit may be observed in the pre -filled syringe containing the DTPa -HBV- IPV suspension. This is a normal observation.

The pre -filled syringe should be well shaken in order to obtain a homogeneous turbid white suspension.

The vaccine is reconstituted by adding the entire contents of the pre -filled syringe to the vial containing the powder. The mixture should then be well shaken until the powder is completely dissolved prior to administration.

The reconstituted vaccine appears as a sli ghtly more cloudy suspension than the liquid component alone. This is a normal observation.

The vaccine suspension should be inspected visually before and after reconstitution for any foreign particul ate matter and/or abnormal physical appearance. If eit her is observed, do not administer the vaccine.

44 Instructions for the pre -filled syringe Hold the syringe by the barrel, not by the plunger.

Unscrew the syringe cap by twisting it anticlockwise.

To attach the needle, connect the hub to the Luer Lock Adaptor and rotate a quarter turn clockwise until you feel it lock.

Reconstitute the vaccine as described above.

Do not pull the syringe plunger out of the barrel. If it happens, do not administer the vaccine.

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

Needle hub Plunger Luer Lock Adaptor Barrel Cap

📄 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 Infanrix hexa (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/00/152).

⚠️ 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.