Leaflet: information for the user

Engerix-B Junior 10 micrograms/0.5 ml pre-filled syringe suspension

Hepatitis B vaccine (ADNr, adsorbed) (VHB)

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This vaccine has been prescribed for you/your child only, and must not be given to anyone else.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Throughout this leaflet, any reference to “you” also means “your child”.

1.What Engerix-B Junior is and what it is used for

2.What you need to know before you receive Engerix-B Junior

3.How Engerix-B Junior is administered

4.Possible side effects

1. Storage of Engerix-B Junior

1. Contents of the pack and additional information

Engerix‑B Junior is a vaccine used to protect against infection by hepatitis B. It may also help protect against infection by hepatitis D.

This vaccine can be administered to newborns, children, and adolescents up to 15 years of age inclusive.

Hepatitis B is an infectious liver disease caused by a virus. Some people have the hepatitis B virus in their body, but they cannot eliminate it. These people can continue to infect others and are known as carriers. The spread of the disease occurs when the virus enters the body through contact with bodily fluids, usually blood, from an infected person.

If a mother is a carrier of the virus, she can transmit the virus to her child during birth. It is also possible to contract the virus from a carrier through, for example, unprotected sex, sharing injectable needles, or receiving medical treatment with equipment that has not been properly sterilized.

The main symptoms of the disease include: headache, fever, discomfort (nausea) and jaundice (the skin and eyes turn yellow), although in approximately three out of every 10 patients there are no symptoms of the disease. Of those infected with hepatitis B, one in 10 adults and up to nine in 10 children will become carriers of the virus and are likely to develop severe liver damage and in some cases, liver cancer.

How Engerix-B Junior works

Engerix-B Junior contains a small amount of the outer covering of the hepatitis B virus. This outer covering is not infectious and cannot cause the disease.

• When you receive the vaccine, it will activate your body's immune system to prepare it to protect against these viruses in the future.
• Engerix-B Junior will not protect you if you have already contracted the hepatitis B virus.
• Engerix-B Junior can only help you protect against infection by the hepatitis B virus.

You should not receive Engerix-B Junior:

• If you are allergic (hypersensitive) to Engerix-B Junior or to any of the other components of this vaccine (listed in section 6).
• If you have a fever (high body temperature).

Engerix-B Junior should not be administered if any of the above circumstances affect you. If you are unsure, speak with your doctor or pharmacist before receiving Engerix-B Junior. Inform your doctor or pharmacist if you have any allergies or if you have ever had any health problems after receiving a vaccine.

Warnings and precautions

Consult your doctor or pharmacist before receiving Engerix-B Junior if you:

• Are on dialysis due to a kidney problem or if you have a condition that may affect your immune system.

People who require dialysis, have chronic liver problems, are hepatitis C carriers, or are HIV positive may also receive Engerix-B Junior. This is because hepatitis B infections can be severe in these patients. You will find more information about kidney problems and dialysis in section 3.

If you are unsure whether any of the above situations affect you, consult your doctor before receiving Engerix-B Junior.

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

Like other vaccines, Engerix-B Junior may not fully protect you against hepatitis B. A combination of factors such as advanced age, sex, being overweight, being a smoker, and some chronic conditions can reduce the immune response to the vaccine. If any of this affects you, your doctor may decide to perform a blood test or administer additional doses of Engerix-B Junior to ensure you are protected.

Use of Engerix-B Junior with other medicines

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

Engerix-B Junior can be administered at the same time as most routine vaccines. Your doctor will ensure that the vaccines are injected separately and in different parts of the body.

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

It is unlikely that Engerix-B Junior will affect your ability to drive or operate machinery. However, do not drive or operate machinery if you feel unwell.

Engerix-B Junior contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per dose, making it essentially "sodium-free".

How your vaccine is administered

Your doctor will administer the recommended dose of Engerix-B Junior.

Engerix-B Junior will be administered:

• as an injection into the muscle of the upper arm in children and adolescents
• as an injection into the thigh in newborns and young children
• as an injection under the skin if you easily bruise or have coagulation problems.

How much is administered

You will receive a series of injections of Engerix-B Junior. Once you have completed the injection schedule, you can expect long-term protection against hepatitis B.

• Newborns, children, and adolescents up to 15 years of age will normally receive the vaccine in a dose of 10 micrograms/0.5 ml.

There are several administration options for Engerix-B Junior. Your doctor will choose the most suitable schedule for you.

Schedule 1 – for newborns, children, and adolescents up to 15 years of age

First injection– now

Second injection– 1 month after the first injection

Third injection– 6 months after the first injection

Schedule 2 – for newborns, children, and adolescents up to 15 years of age

First injection– now

Second injection– 1 month after the first injection

Third injection– 2 months after the first injection

Fourth injection– 12 months after the first injection

• Schedule 2 in newborns will allow Engerix-B Junior to be administered at the same time as other routine childhood vaccines.
• This schedule can also be used in the case of recent exposure to hepatitis B, as it will provide faster protection.

It is very important that you attend your injections at the recommended frequency. If you have any questions about the amount of vaccine you will receive, consult your doctor.

Vaccination and childbirth

If you have hepatitis B and have just given birth, either schedule 1 or 2 can be used to vaccinate your child.

• Your doctor will also decide whether to administer hepatitis B immunoglobulins (human antibodies) to your child at the time of the first injection. This will help protect your child from hepatitis B. They will be administered in another injection site.

Renal problems and dialysis

If your child has a renal problem or is on dialysis, your doctor may decide to perform a blood test or administer extra doses of the vaccine to ensure your child is protected.

Like all vaccines, this vaccine may cause side effects, although not everyone will experience them. The following side effects may occur with this vaccine:

Allergic reactions

If you have an allergic reaction, seek medical attention immediately. Symptoms may include:

• Swelling of the face
• Low blood pressure
• Difficulty breathing
• The skin turns blue
• Loss of consciousness.

These symptoms usually start very shortly after the injection is administered. Seek medical attention immediately if they occur after leaving the consultation.

Other side effects include:

Very common(these may occur with more than 1 in 10 doses of the vaccine): headache, pain and redness at the injection site, feeling tired, irritability.

Common(these may occur up to 1 in 10 doses of the vaccine): numbness, nausea or vomiting, diarrhea or abdominal pain, loss of appetite, fever (high body temperature), general feeling of discomfort, swelling at the injection site, reactions at the injection site, such as hardening.

Uncommon(these may occur up to 1 in 100 doses of the vaccine): dizziness, muscle pain, symptoms similar to the flu.

Rare(these may occur up to 1 in 1,000 doses of the vaccine): swollen lymph nodes, hives, skin rash and itching, joint pain, tingling.

Adverse reactions reported during the marketing of Engerix-B Junior are: easy bruising and inability to stop bleeding if a cut is made, low blood pressure, inflammation of blood vessels, sudden swelling of the face around the mouth and throat area (angioneuritic edema), inability to move muscles (paralysis), inflammation of nerves (neuritis) that may cause numbness or tingling, including temporary inflammation of nerves, causing pain, weakness, and paralysis in the limbs and often progressing to the chest and face (Guillain-Barré syndrome), eye nerve disease (optic neuritis) and multiple sclerosis, difficulty moving arms or legs (neuropathy), brain inflammation (encephalitis), degenerative brain disease (encephalopathy), infection around the brain (meningitis), seizures (convulsions), numbness of the skin to pain or touch (hypoesthesia), purple or purple-red patches on the skin (lichen planus), red or purple spots on the skin, pain and stiffness in the joints (arthritis), muscle weakness.

In very premature newborns (at 28 weeks of gestation or earlier) the periods between breathing may be longer than normal during the 2-3 days following vaccination.

Reporting of adverse reactions

Ifyouexperience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use, https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

• Keep this vaccine out of sight and reach of children.
• Do not use this vaccine after the expiration date that appears on the label and packaging, after CAD. The expiration date is the last day of the month indicated.
• Store in a refrigerator (between 2 °C and 8 °C).
• Do not freeze.
• Store in the original packaging to protect it from light.
• Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Engerix-B Junior

• The active ingredient is the outer coat of the hepatitis B virus. Each dose contains 10 micrograms/0.5 ml of protein composed of this outer coat adsorbed on hydrated aluminium hydroxide.
• The other components are sodium chloride, sodium phosphate dihydrate, sodium phosphate dibasic and water for injection preparations.

Appearance of the product and contents of the package

Engerix-B Junior is a white turbid injectable liquid.

Engerix-B Junior (10 micrograms/0.5 ml) is available in pre-filled syringe with or without separate needles; package sizes of 1 and 10.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel.: +34 900 202 700

[email protected]

Manufacturer

GlaxoSmithKline Biologicals s.a., Rue de l’Institut 89, B-1330 Rixensart, Belgium

or

SmithKline Beecham, S.A., Carretera de Ajalvir. Km. 2.5.- 28806 Alcalá de Henares. Madrid

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Austria, Denmark, Finland, Iceland, Norway, Sweden: Engerix-B

Belgium, Luxembourg: Engerix B Junior

France, Ireland, Italy: Engerix B-10

Germany: Engerix-B Children

Greece: Engerix

Spain, Netherlands: Engerix-B Junior

Portugal: Engerix B

Last review date of this leaflet:02/2024

Other sources of information

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

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This information is intended solely for healthcare professionals:

Once stored, the contents may appear as a fine white deposit with a clear colourless supernatant. After agitation, the vaccine is slightly opaque.

Before using the vaccine, visually inspect for foreign particles and/or abnormal physical appearance. Do not administer the vaccine if you observe either.

The entire contents of the single-dose container must be withdrawn and used immediately after extraction.

Instructions for the pre-filled syringe

Disposal of waste

The disposal of unused medicinal product and any waste materials derived from the use of this product should be in accordance with local requirements.