Prospecto:information for the user

Twinrix Pediatric, Pre-filled Syringe Suspension

Vaccine (HAB) (adsorbed) anti-hepatitis A (inactivated) and anti-hepatitis B (ADNr)

Read this prospect carefully before your child starts receiving this vaccine,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

• This vaccine has been prescribedonlyto you/your child, and must not be given to other people.
• If your child experiences adverse effects, consult yourdoctor or pharmacist,even if they do not appear in this prospect. See section 4.

This prospect has been written assuming that the person receiving the vaccine is the one reading it. However, the vaccine may be administered to children and adolescents, so you may be reading it for your child.

Twinrix Pediatric is a vaccine used in children and adolescents from 1 year of age up to 15 years inclusive to prevent two diseases: hepatitis A and hepatitis B. The vaccine works by making the body produce its own protection (antibodies) against these diseases.

• Hepatitis A: Hepatitis A is an infectious disease that can affect the liver. This disease is caused by the hepatitis A virus. Hepatitis A can be transmitted from person to person through food and drinks, or by swimming in waters contaminated with sewage. The symptoms of hepatitis A begin3 to6 weeks after coming into contact with the virus. These include nausea (discomfort), fever, and pain. After several days the whites of the eyes and the skin may turn yellowish (jaundice). The severity and type of symptoms can vary. Young children may not develop jaundice. Most people recover completely but the disease is usually severe enough to prevent patients from working for approximately a month.

• Hepatitis B: Hepatitis B is caused by the hepatitis B virus. It causes inflammation of the liver. The virus is found in bodily fluids such as blood, semen, vaginal secretions, or saliva (sputum) of infected individuals.

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

Twinrix Pediatric should not be administered if:

• you are allergic to:

• the active ingredientsor to any of the other components of this vaccine(listed in section 6)
• neomycin.

The signs of an allergic reaction may include skin rash with itching, difficulty breathing, and facial or tongue swelling

• you have had a previous allergic reaction to any vaccine against hepatitis A and hepatitis B

• you have a severe infection with fever (over38°C). A minor infection, such as a cold, should not be a problem for vaccination, but inform your doctor first.

Warnings and precautions

Consult your doctor or pharmacist beforereceiving Twinrix Pediatric if:

• you have experienced any health problems after previous administration of a vaccine
• you have a weakened immune system due to a disease or pharmacological treatment

• you have any bleeding problems or bruise easily.

Before or after any injection, you may experience dizziness (especially in adolescents), so inform your doctor or nurse if you have fainted on previous occasions after receiving an injection.

Other medicines and Twinrix Pediatric

Twinrix Pediatric can be administered with a human papillomavirus (HPV) vaccine at a different injection site (e.g., the other arm) on the same medical visit.

Inform your doctoror pharmacistif you are using, have used recentlyor may need to use any other medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before receiving this vaccine.

The passage of Twinrix Pediatric to breast milk is unknown, however, it is not expected to cause problems for infants.

Twinrix Pediatric contains neomycin and sodium

Inform your doctor if you have had an allergic reaction to neomycin (antibiotic).

This vaccine contains less than 1mmolof sodium (23mg) per dose; this is essentially “sodium-free”.

You will receive a total of three injections over a period of 6 months. Each injection will be administered in a separate visit. The first dose will be administered on the chosen date. The other two doses will be administered one month and six months after the first dose.

• First dose: on the chosen date
• Second dose: 1 month after
• Third dose: 6 months after the first dose

Your doctor will inform you if additional doses and future booster doses are necessary.

If you miss one of the scheduled injections, speak with your doctor to schedule another visit.

Make sure to complete the entire three-injection vaccination cycle. Otherwise, you may not be fully protected against diseases.

Your doctor will administer the Twinrix Pediatric injection in the upper muscle of your child's arm or in the muscle of their thigh.

The vaccine must never be injected into a vein.

If you have any other questions about the use of this vaccine, ask your doctor or pharmacist.

Like all medicines,this vaccinemay cause side effects, although not everyone will experience them.

The side effects that may occur are as follows:

Side effects that occurred during clinical trials or during routine use of the vaccine or with individual hepatitis A and hepatitis B vaccines or with the adult formulation of Twinrix.

Very common(may occur in more than 1 in 10 vaccine doses): pain and redness at the injection site.

Common(may occur up to 1 in 10 vaccine doses): drowsiness, headache, nausea, loss of appetite, inflammation or rashes at the injection site, general discomfort, fatigue, fever equal to or greater than37.5°C, irritability.

Uncommon(may occur up to 1 in 100 vaccine doses): diarrhea, vomiting, stomach pain, skin rash, muscle pain, upper respiratory tract infection.

Rare(may occur up to 1 in 1,000 vaccine doses): inflammation of the neck, armpit, or groin glands (lymphadenopathy), dizziness, loss of skin sensitivity to pain or touch (hypoesthesia), tingling sensation (paresthesia), urticarial rash, itching, joint pain, low blood pressure, flu-like symptoms such as fever, sore throat, runny nose, cough, and chills.

Very rare(may occur up to 1 in 10,000 vaccine doses): reduction of platelets, which increases the risk of bleeding or appearance of rashes (thrombocytopenia), purple or brownish-red patches visible through the skin (purpura thrombocytopenic), inflammation or infection of the brain (encephalitis), degenerative brain disease (encephalopathy), inflammation of the nerves (neuritis), numbness or weakness of the arms and legs (neuropathy), paralysis, seizures, inflammation of the face, mouth, or throat (angioneuritic edema), purple or purplish-red skin swelling (lichen planus), severe skin eruptions (erythema multiforme), joint inflammation, muscle weakness, infection around the brain that can cause severe headache with neck stiffness and sensitivity to light (meningitis), inflammation of some blood vessels (vasculitis), abnormal liver function test results, multiple sclerosis, spinal cord inflammation (myelitis), drooping eyelids and facial muscle sagging on one side of the face (facial paralysis), temporary nerve inflammation, which causes pain, weakness, and paralysis of the limbs and often progresses to the chest and face (Guillain-Barré syndrome), eye nerve disease (optic neuritis), immediate pain at the injection site, itching, and burning sensation.

Severe allergic reactions (anaphylaxis, anaphylactoid reactions, and serum sickness-like reactions) may also occur very rarely (up to 1 in 10,000 vaccine doses). Some signs of severe allergic reactions may include skin rashes with itching or blisters, eye and face inflammation, difficulty breathing or swallowing, sudden drop in blood pressure, and loss of consciousness. These reactions may occur before leaving the doctor's office. In any case, if any of these symptoms appear, seek medical attention immediately.

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it ispossibleside effects that do not appear in this prospectus.You can also report them directly through thenational notification system included in Appendix V. By reporting side effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do notuse this medicationafterthe expiration date that appears on thecontainer.The expiration date is the last day of the month indicated.

Store in the refrigerator (between2°Cand8°C).

Store in the original packaging to protect it from light.

Do not freeze. Freezing destroys the vaccine.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of containers and medications that are no longer needed. This will help protect the environment.

Composition ofTwinrix Pediatric

• The active principles are:

Human diploid cell vaccine (MRC-5) 1360 ELISA units

Aluminum hydroxide adsorbed 20.025 mg Al 3+

Recombinant DNA vaccine produced in yeast (Saccharomyces cerevisiae) 3

Aluminum phosphate adsorbed 40.2 mg Al 3+

• The other components of Twinrix Pediatric are: sodium chloride, water for injection.

Appearance ofTwinrix Pediatricand contents of the container

Ready-to-use injectable suspension in pre-filled syringe.

Twinrix Pediatric is a white, slightly milky liquid.

Twinrix Pediatric is available in pre-filled syringe of 1 dose with or without separate needles, container sizes of 1, 10 and 50.

Only some container sizes may be marketed.

Marketing authorization holder and manufacturer

GlaxoSmithKline Biologicals s.a.

Rue de l’Institut 89

B-1330 Rixensart

Belgium

For further information about this medicinal product, please consult the representative of the marketing authorization holder in your country.:

Last update of the summary of product characteristics:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu,and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

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This information is intended for healthcare professionals only:

During storage, a fine white deposit with a clear and colourless layer on top may be observed.

The vaccine must be resuspended before use. Once resuspended, the vaccine will have a white, turbid and uniform appearance.

Resuspension of the vaccine to obtain a white, turbid and uniform suspension

The vaccine must be resuspended by following the steps below.

1. Hold the syringe upright with a closed hand.
2. Agitate the syringe by turning it upside down and then back upright.
3. Repeat this action vigorously for at least 15 seconds.
4. Inspect the vaccine again:
   1. If the vaccineappears as a white, turbid and uniform suspension, it is ready to use (it should not have a translucent appearance).
   2. If the vaccine still does not appear as a white, turbid and uniform suspension, turn it upside down and then back upright for at least another 15 seconds and then inspect again.

Before administration, the vaccine must be visually inspected to observe any foreign particles and/or abnormal physical appearance. If any of these circumstances are observed, do not administer the vaccine.

Instructions for the pre-filled syringe after resuspension

Disposal of residues

The disposal of unused medicinal product and all materials that have been in contact with it must be in accordance with local requirements.