Leaflet: information for the user

Engerix-B 20 micrograms/1 ml pre-filled injectable suspension

Hepatitis B vaccine (ADNr, adsorbed) (VHB)

Read this leaflet carefully before starting to receive 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 alone, and you must not give it 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.

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

2.What you need to know before receiving Engerix-B

3.How to administer Engerix-B

4.Possible side effects

1. Storage of Engerix-B
2. Contents of the pack and additional information

Engerix‑B 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 both adults and adolescents aged 16 years or older. In exceptional circumstances, it can also be administered to children and adolescents between 11 and 15 years of age (see section 3).

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 it 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 works

Engerix-B 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 itself against these viruses in the future.
• Engerix-B will not protect you if you have already contracted the hepatitis B virus.
• Engerix-B can only help protect you against infection by the hepatitis B virus.

Do not administer Engerix-B:

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

Engerix-B should not be administered if any of the above circumstances apply to you. If you are unsure, speak with your doctor or pharmacist before receiving Engerix-B. 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 if:

• You are undergoing 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 disease, are hepatitis C carriers, or are HIV positive may also receive Engerix-B. 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 apply to you, consult your doctor before receiving Engerix-B.

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

Like other vaccines, Engerix-B may not provide complete protection 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 this applies to you, your doctor may decide to perform a blood test or administer additional doses of Engerix-B to ensure you are protected.

Other medicines and Engerix-B

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

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

Pregnancy and breastfeeding

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

Driving and operating machinery

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

Engerix-B contains sodium

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

How your vaccine is administered

Your doctor will administer the recommended dose of Engerix-B

Engerix-B will be administered:

• as an injection into the muscle of the upper arm
• 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. Once you have completed the injection schedule, you can expect long-term protection against hepatitis B.

Adults and adolescents 16 years of age and older will receive the vaccine in a dose of 20 micrograms/1 ml.

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

Schedule 1 – for adults or adolescents 16 years of age and older

First injection– now

Second injection– 1 month after the first injection

Third injection– 6 months after the first injection

Schedule 2 – for adults or adolescents 16 years of age and older

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

• This schedule can also be used in the case of recent exposure to hepatitis B, as it will provide faster protection.

Schedule 3 – only for adults (18 years of age and older)

This schedule will only be administered in exceptional circumstances, for example if you need to travel to a high-risk area within a month of being vaccinated.

First injection– now

Second injection– 1 week after the first injection

Third injection– 3 weeks after the first injection

Fourth injection– 12 months after the first injection

Schedule 4 – only for children and adolescents between 11 and 15 years of age

This schedule is only used if there is doubt that the child will receive the third injection. For this schedule, Engerix-B (20 micrograms/1 ml) will be used. This will provide a higher level of protection than two doses of Engerix-B Junior (10 micrograms/0.5 ml).

First injection– now

Second injection– 6 months after the first injection

• This two-dose schedule does not always provide protection until after the second dose. This schedule is only used when there is a relatively low risk of hepatitis B infection during the vaccination schedule and when it can be ensured that this schedule will be completed.

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

Renal problems and dialysis

• Individuals 16 years of age and older

If you have renal problems or are on dialysis, your doctor may decide to vaccinate you with four double doses (2 x 20 micrograms/1 ml) of vaccine at 0, 1, 2, and 6 months. Your doctor may also decide to perform a blood test to ensure you are protected against hepatitis B.

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(these may occur in up to 1 in 10,000 doses of the vaccine)

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 begin 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 in more than 1 in 10 doses of the vaccine): pain and redness at the injection site, feeling tired, irritability.

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

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

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

Very rare(these may occur in up to 1 in 10,000 doses of the vaccine): 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 loss of sensation or numbness, 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), multiple sclerosis, difficulty moving arms or legs (neuropathy), brain inflammation (encephalitis), degenerative brain disease (encephalopathy), meningitis around the brain, seizures (convulsions), loss of skin sensitivity to pain or touch (hypoesthesia), purple or purple-red patches on the skin (lichen planus), red or purple spots on the skin, joint pain and stiffness (arthritis), muscle weakness.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use,www.notificaRAM.es.By reporting side effects, 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 at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Engerix-B

• The active ingredient is the outer envelope of the hepatitis B virus. Each dose contains 20 micrograms/1 ml of protein composed of this outer envelope adsorbed on hydrated aluminum 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 is a white turbid injectable liquid.

Engerix-B (20 micrograms/ml) is available inpre-filled syringe of 1 dose with or without separate needles; package sizes of 1 and 10.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

GlaxoSmithKline, S.A.

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

28760 Tres Cantos (Madrid)

Tel.: +34 900 202 700

[email protected]

Responsible for manufacturing

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 medicine is authorized in the member states of the European Economic Areawith the following names:

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

Belgium, Luxembourg, Portugal: Engerix B

France, Ireland, Italy: Engerix B-20

Germany: Engerix-B Adult

Greece: Engerix

Last review date of this leaflet:02/2024

Other sources of information

The detailed information on this medicine 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 colorless 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 vial must be withdrawn and used immediately after extraction.

Instructions for the pre-filled syringe

Disposal of waste

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