TWINRIX PEDIATRIC, PRE-FILLED SYRINGE SUSPENSION

Introduction

Prospect:information for the user

Twinrix Pediatric, Injectable Suspension in Pre-filled Syringe

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

Read the entire prospectus carefully before you/your child starts receiving this vaccine,as it contains important information for you.

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

• This vaccine has been prescribed to you/your child only, and you should not give it to others.
• If you/your child experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this prospectus. See section 4.

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

Contents of the prospectus

1. What is Twinrix Pediatric and what is it used for
2. What you need to know before receiving Twinrix Pediatric
3. How to administer Twinrix Pediatric
4. Possible side effects
5. Storage of Twinrix Pediatric
6. Package contents and additional information

1. What is Twinrix Pediatric and what is it used for

Twinrix Pediatric is a vaccine used in children and adolescents from 1 year of age 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 drink, or by swimming in waters contaminated with sewage. The symptoms of hepatitis A begin 3 to 6 weeks after contact with the virus. These consist of nausea (discomfort), fever, and pain. After several days, the whites of the eyes and skin may turn yellow (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 for patients to be unable to work for about a month.

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

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

2. What you need to know before receiving Twinrix Pediatric

Twinrix Pediatric should not be administered if:

• you are allergic to:

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

Signs of an allergic reaction may include skin rash with itching, difficulty breathing, and swelling of the face or tongue.

• you have previously had an allergic reaction to any hepatitis A and hepatitis B vaccine

• you have a severe infection with fever (over 38°C). A minor infection, such as a cold, should not be a problem for vaccination, but tell your doctor first.

Warnings and precautions

Consult your doctor or pharmacist before receiving Twinrix Pediatric if:

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

• you have any bleeding problems or bruise easily.

Fainting (especially in adolescents) may occur before or after any injection, so you should inform your doctor or nurse if you have fainted after receiving an injection in the past.

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) during the same medical visit.

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Pregnancy and breastfeeding

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

It is not known if Twinrix Pediatric passes into breast milk; however, it is not expected to cause problems for breastfed babies.

Twinrix Pediatric contains neomycin and sodium

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

This vaccine contains less than 1 mmol of sodium (23 mg) per dose; this is, essentially, "sodium-free".

3. How to administer Twinrix Pediatric

You will receive a total of three injections over a period of 6 months. Each injection will be administered during 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 later
• Third dose: 6 months after the first dose

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

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

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

The doctor will administer the Twinrix Pediatric injection into the upper muscle of your arm or into the thigh muscle of your child.

The vaccine should never be injected into a vein.

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

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everyone gets 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 doses of vaccine): pain and redness at the injection site.

Common(may occur in up to 1 in 10 doses of vaccine): somnolence, headache, nausea, loss of appetite, swelling or bruising at the injection site, general malaise, fatigue, fever equal to or greater than 37.5°C, irritability.

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

Rare(may occur in up to 1 in 1,000 doses of vaccine): inflammation of the neck, armpit, or groin glands (lymphadenopathy), dizziness, loss of skin sensation 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 in up to 1 in 10,000 doses of vaccine): reduction of platelets, which increases the risk of bleeding or bruising (thrombocytopenia), purple or brownish-red spots visible through the skin (thrombocytopenic purpura), brain inflammation or infection (encephalitis), degenerative brain disease (encephalopathy), nerve inflammation (neuritis), numbness or weakness of the arms and legs (neuropathy), paralysis, seizures, facial, mouth, or throat inflammation (angioneurotic edema), purple or brownish-red skin swelling (lichen planus), severe skin rashes (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 laboratory test results, multiple sclerosis, spinal cord inflammation (myelitis), drooping eyelids and 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 reaction) can also occur very rarely (in up to 1 in 10,000 doses of the vaccine). Some signs of severe allergic reactions may include skin rashes with itching or blisters, eye and face swelling, difficulty breathing or swallowing, sudden drop in blood pressure, and loss of consciousness. These reactions can occur before leaving the doctor's office. In any case, if you experience any of these symptoms, you should see a doctor immediately.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this prospectus. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Twinrix Pediatric

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

Do not use this medicine after the expiration date stated on the package. The expiration date is the last day of the month indicated.

Store in a refrigerator (between 2°C and 8°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 wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Twinrix Pediatric

• The active substances are:

Hepatitis A virus (inactivated) 1,2 360 ELISA Units

Hepatitis B surface antigen 3,4 10 micrograms

1 Produced in human diploid cells (MRC-5)

2 Adsorbed on hydrated aluminum hydroxide 0.025 milligrams Al3+

3 Produced by recombinant DNA technology in yeast cells (Saccharomyces cerevisiae)

4 Adsorbed on aluminum phosphate 0.2 milligrams Al3+

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

Appearance of Twinrix Pediatric and package contents

Injectable suspension in pre-filled syringe.

Twinrix Pediatric is a white, slightly milky liquid.

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

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

GlaxoSmithKline Biologicals s.a.

Rue de l’Institut 89

B-1330 Rixensart

Belgium

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of last revision of this prospectus:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu and on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

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This information is intended only for healthcare professionals:

During storage, a fine white deposit with a clear and colorless layer above may be observed.

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

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

The vaccine should be resuspended by following the steps indicated below.

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

Before administration, the vaccine should be visually inspected for 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 waste

Disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.