Twinrix Paediatric, suspension for injectionHepatitis A(inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)

Twinrix Paediatric is a vaccine used in infants, children and adolescents from 1 year up to and including 15 years to prevent two diseases: hepatitis A and hepatitis B. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.

• Hepatitis A: Hepatitis A is an infectious disease, which can affect the liver. This disease is caused by the hepatitis A virus. The hepatitis A virus can be passed from person to person in food and drink, or by swimming in water contaminated by sewage. Symptoms of hepatitis A begin 3 to 6 weeks after coming into contact with the virus. These consist of nausea (feeling sick), fever and aches and pains. After a few days the whites of eyes and skin may become yellowish (jaundice). The severity and type of symptoms can vary. Young children may not develop jaundice. Most people recover completely but the illness is usually severe enough to keep people off work for about a month.
• Hepatitis B: Hepatitis B is caused by the hepatitis B virus. It causes the liver to become swollen (inflamed). The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people.

Vaccination is the best way to protect against these diseases. None of the components in the vaccine are infectious.

Twinrix Paediatric should not be given:

• if you have/ your child has previously had any allergic reaction to Twinrix Paediatric, or any ingredient contained in this vaccine. The active substances and other ingredients in Twinrix Paediatric are listed at the end of the leaflet. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
• if you have/ your child has previously had an allergic reaction to any vaccine against hepatitis A and hepatitis B diseases.
• if you have/ 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.

Take special care with Twinrix Paediatric:

• if you have/ your child has experienced any health problems after previous administration of a vaccine.
• if you have/ your child has a bleeding problem or bruise/ bruises easily.

Using other medicines or vaccines

Twinrix Paediatric can be given with a Human Papillomavirus (HPV) vaccine at a separate injection site (another part of your body, e.g. the other arm) during the same visit.

Please tell your doctor if you are/ your child is taking or have/ has recently taken any other medicines, including medicines obtained without a prescription or have/ has recently received any other vaccine.

Pregnancy and breast-feeding

Take special care with Twinrix Paediatric if you are or think you may be pregnant or if you intend to become pregnant. Your doctor will discuss with you the possible risks and benefits of having Twinrix Paediatric during pregnancy.
It is not known if Twinrix Paediatric passes into breast milk, however the vaccine is not expected to cause problems in breast-fed babies.

Important information about some of the ingredients of Twinrix Paediatric

Please tell your doctor if you have/ your child has had an allergic reaction to neomycin (antibiotic).

You/ your child will receive a total of three injections over 6 months. Each injection is given on a separate visit. The first dose will be given on an elected date. The remaining two doses will be given one month, and six months after the first dose.

• First dose: at an elected date
• Second dose: 1 month later
• Third dose: 6 months after the first dose

Your doctor will advise on the possible need for extra doses, and future booster dosing.

If you miss/ your child misses a scheduled injection, talk to your doctor and arrange another visit.

Make sure you finish/ your child finishes the complete vaccination course of three injections. If not, you/ your child may not be fully protected against the diseases.

The doctor will give Twinrix Paediatric as an injection into your upper arm muscle or into the thigh muscle of your child.

The vaccine should never be given into a vein.

Like all medicines, Twinrix Paediatric can cause side effects, although not everybody gets them.

The frequency of possible side effects listed below is defined using the following convention:

Very common (these may occur with more than 1 in 10 doses of the vaccine)
Common (these may occur with up to 1 in 10 doses of the vaccine)
Uncommon (these may occur with up to 1 in 100 doses of the vaccine)
Rare (these may occur with up to 1 in 1,000 doses of the vaccine)
Very rare (these may occur with up to 1 in 10,000 doses of the vaccine)

Side effects occured during clinical studies or routine use of the vaccine or with individual hepatitis A and hepatitis B vaccines or with the adult formulation of Twinrix include:

Very common:

• Pain and redness at the injection site Common:
• Drowsiness, headache
• Nausea
• Loss of appetite
• Swelling or bruising at the injection site
• Generally feeling unwell, tiredness
• Fever equal to or greater than 37.5°C
• Irritability Uncommon:
• Diarrhoea, vomiting, stomach pain
• Rash
• Aching muscles
• Upper respiratory tract infection Rare:
• Swollen glands in the neck armpit or groin (lymphadenopathy)
• Dizziness
• Loss of skin sensitivity to pain or touch (hypoaesthesia)
• Feeling of pins and needles (paraesthesia)
• Hives, itching
• Joint pain
• Low blood pressure
• Flu-like symptoms such as high temperature, sore throat, runny nose, cough and chills Very rare:
• Reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)
• Purple or red brown spots visible through the skin (thrombocytopenic purpura)
• Swelling or infection of the brain (encephalitis)
• Degenerative disease of the brain (encephalopathy)
• Inflammation of nerves (neuritis)
• Numbness or weakness of the arms and legs (neuropathy), paralysis
• Fits or seizures
• Swelling of the face, mouth or throat (angioneurotic oedema)
• Purple or reddish-purple bumps on the skin (lichen planus), serious skin rashes (erythema multiforme)
• Joint swelling, muscular weakness
• Infection around the brain which may give severe headache with stiff neck and sensitivity to light (meningitis)
• Inflammation of some blood vessels (vasculitis)
• Serious allergic reactions (anaphylaxis, anaphylactoid reactions and mimicking serum sickness). Signs of serious allergic reactions may be rashes that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness. Such reactions may occur before leaving the doctor?s surgery. However, if you get any of these symptoms you should contact a doctor urgently.
• Abnormal laboratory liver test results
• Multiple sclerosis, swelling of the spinal cord (myelitis)
• Drooping eyelid and sagging muscles on one side of the face (facial palsy)
• A temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities and often progressing to the chest and face (Guillain-Barré syndrome)
• A disease of the nerves of the eye (optic neuritis)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Twinrix Paediatric 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Twinrix Paediatric contains

• The active substances are: Hepatitis A virus (inactivated) 1,2360 ELISA Units Hepatitis B surface antigen 3,410 micrograms

1234Produced on human diploid MRC-5 cells Adsorbed on aluminium hydroxide, hydrated 0.025 milligrams Al3Produced in yeast cells Saccharomyces cerevisiae by recombinant DNA technology Adsorbed on aluminium phosphate 0.2 milligrams Al3

• The other ingredients in Twinrix Paediatric are: sodium chloride, water for injections.

What Twinrix Paediatric looks like and contents of the pack

Suspension for injection.

Twinrix Paediatric is a white, slightly milky liquid presented in a glass vial (0.5 ml).

Twinrix Paediatric is available in packs of 1, 3 and 10.

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:

BelgiëBelgiqueBelgien GlaxoSmithKline s.a.n.v. TélTel 32 2 656 21 11 LuxembourgLuxemburg GlaxoSmithKline s.a.n.v. TélTel 32 2 656 21 11

Magyarország GlaxoSmithKline Kft. Tel. 36-1-2255300 . .10 1408 . 359 2 953 10 34

Malta GlaxoSmithKline Malta Tel 356 21 238131 eská republika GlaxoSmithKline s.r.o. Tel 420 2 22 00 11 11 gsk.czmailgsk.com

Danmark GlaxoSmithKline Pharma AS Tlf 45 36 35 91 00 dk-infogsk.com Nederland GlaxoSmithKline BV Tel 31 030 69 38 100 nlinfogsk.com

Deutschland GlaxoSmithKline GmbH Co. KG Tel 49 089 360448701 produkt.infogsk.com Norge GlaxoSmithKline AS Tlf 47 22 70 20 00 firmapostgsk.no

Eesti GlaxoSmithKline Eesti OÜ Tel 372 667 6900 estoniagsk.com Österreich GlaxoSmithKline Pharma GmbH. Tel 43 1 970 75-0 at.infogsk.com

GlaxoSmithKline A.E.B.E. T 30 210 68 82 100 Polska GSK Commercial Sp. z o.o. Tel. 48 22 576 9000

España GlaxoSmithKline, S.A. Tel 34 902 202 700 es-cigsk.com Portugal Smith Kline French Portuguesa, Produtos Farmacêuticos, Lda. Tel 351 21 412 95 00 FI.PTgsk.com

România GlaxoSmithKline GSK SRL Tel 40 021 3028 208 France Laboratoire GlaxoSmithKline Tél 33 0 1 39 17 84 44 diamgsk.com

Ireland GlaxoSmithKline Ireland Ltd Tel 353 01 4955000 Slovenija GlaxoSmithKline d.o.o. Tel 386 0 1 280 25 00 medical.x.sigsk.com

Ísland GlaxoSmithKline ehf. Sími 354-530 3700 Slovenská republika GlaxoSmithKline Slovakia s.r.o. Tel 421 02 48 26 11 11 recepcia.skgsk.com

Italia GlaxoSmithKline S.p.A. Tel 39 04 59 21 81 11 SuomiFinland GlaxoSmithKline Oy PuhTel 358 10 30 30 30 Finland.tuoteinfogsk.com

GlaxoSmithKline Cyprus Ltd 357 22 39 70 00 Sverige GlaxoSmithKline AB Tel 46 08 638 93 00 info.produktgsk.com

Latvija GlaxoSmithKline Latvia SIA Tel 371 67312687 lv-epastsgsk.com United Kingdom GlaxoSmithKline UK Tel 44 0808 100 9997 customercontactukgsk.com

Lietuva

GlaxoSmithKline Lietuva UAB
Tel. +370 5 264 90 00
info.lt@gsk.com

This leaflet was last approved in

---------------------------------------------------------------------------------------------------------------------

The following information is intended for medical or healthcare professionals only:

Upon storage, a fine white deposit with a clear colourless supernatant can be observed.

The vaccine should be well shaken to obtain a slightly opaque, white suspension and visually inspected for any foreign particulate matter and/or variation of physical aspect prior to administration. In the event of either being observed, discard the vaccine.