Package Insert: Information for the User

Havrix 720 Junior, Pre-filled Injectable Suspension

Hepatitis A Vaccine (Inactivated, Adsorbed)

Read this entire package insert carefully before you or your child starts receiving this vaccine, as it contains important information for you.

• Keep this package insert, asyou may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.

• This vaccine has been prescribed only for you or your child, and should not be given to others.
• Ifyou or your childexperience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

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

6.Contents of the package and additional information

What it is used forHavrix 720 Junior

Havrix 720 Junior is a vaccine used to protect children and adolescents from 1 year to 15 years of age inclusive from infection caused by the hepatitis A virus.

Havrix 720 Junior can also be administered to adolescents from 16 years to 18 years of age inclusive, if necessary.

What is hepatitis A

• Hepatitis A is a liver disease caused by the hepatitis A virus.
• The hepatitis A virus can be transmitted from person to person or through contact with contaminated water, food, and drinks.
• The symptoms of hepatitis A vary from mild to severe, and may include: fever, general malaise, loss of appetite, diarrhea, nausea, abdominal discomfort, dark urine, and jaundice (yellowing of the eyes and skin). Most people recover completely, although in some cases, the disease can be severe and require hospitalization, and in rare cases, it can cause acute liver failure.

How Havrix 720 Junior works

• Havrix 720 Junior helps your body produce its own protection (antibodies) against the virus.These antibodies help protect you against the disease.
• As with all vaccines, Havrix 720 Junior may not protect all vaccinated individuals completely.

Do not administerHavrix 720 Junior if:

• You are allergic to the active ingredient or to any of the other components of this vaccine (listed in section 6) or to neomycin or formaldehyde.
• You have had an allergic reaction to any hepatitis A vaccine.

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

Do not administer Havrix 720 Junior if any of the above situations apply to you. If you are unsure, consult your doctor, pharmacist, or nurse before receiving Havrix 720 Junior.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before receiving Havrix 720 Junior if:

• You have a severe infection with high fever. The vaccine can be administered once you have recovered. A minor infection, such as a cold, should not be a problem, but consult your doctor first,
• You have a weakened immune system due to diseases and/or treatments. Your doctor will determine if additional injections are needed,
• You have bleeding problems or bruise easily.

Loss of consciousness may occur before or after any injection with a needle. Therefore, inform your doctor, pharmacist, or nurse if you have fainted with a previous injection.

Other medications andHavrix 720 Junior

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

Havrix 720 Junior can be administered at the same time as other vaccines and immunoglobulins. Use a different injection site for each injection.

Pregnancy andlactation

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before receiving Havrix 720 Junior.

Driving and operating machinery

The influence of Havrix 720 Junior on the ability to drive and operate machinery is negligible or insignificant.

Havrix 720 Junior containsphenylalanine, polysorbate 20, sodium, and potassium

This vaccine contains 0.083 mg of phenylalanine per dose.

Phenylalanine may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This vaccine contains 0.025 mg of polysorbate 20 per dose. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

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

This medication contains potassium, less than 1 mmol (39 mg) per dose; this is essentially "potassium-free".

How to administer the vaccine

• The doctor or nurse will administer Havrix 720 Junior by injection into a muscle, usually in the upper arm in children and adolescents.
• In young children, the injection may be administered in the thigh muscle.
• Havrix 720 Junior may be injected subcutaneously in exceptional cases if you have thrombocytopenia or severe hemorrhagic disorders.

How much is administered

• You will receive 1 dose of Havrix 720 Junior (0.5 ml suspension) on the agreed date with your doctor or nurse.
• It is recommended to administer a second dose (booster) between 6 and 12 months after the first dose, although it can be administered up to five years after the first dose, to ensure long-term protection.

If you receive moreHavrix 720 Juniorthan you should

It is very unlikely that an overdose will occur because the vaccine is supplied in a single-dose vial or syringe and is administered by a doctor or nurse. Few cases of accidental administration have been reported, and the reported adverse effects were similar to those reported with normal administration of the vaccine (listed in section 4).

If you forgot to receiveHavrix 720 Junior

Contact your doctor, who will decide if a dose is required and when to administer it.

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

Severe side effects

Inform your doctor immediately if you notice any of the following severe side effects; you may need urgent medical treatment:

-allergic reactions: symptoms may include local or generalised rashes that may cause itching or blisters, swelling of the eyes and face, difficulty breathing or swallowing, sudden drop in blood pressure, and loss of consciousness.

These reactions may occur before leaving the doctor's consultation.

Inform your doctor immediately if you notice any of the severe side effects listed above.

The side effects that occurred during clinical trials with Havrix 720 Junior were the following:

Very common(these may occur with more than 1 in 10 doses of the vaccine):

• irritability
• pain and redness at the injection site

Common(these may occur up to 1 in 10 doses of the vaccine):

• loss of appetite
• headache
• drowsiness
• nausea
• general feeling of discomfort
• fever of 37.5°C or higher
• swelling at the injection site

Uncommon(these may occur up to 1 in 100 doses of vaccine):

• runny or blocked nose
• vomiting
• diarrhea
• skin rash
• hardening at the injection site

The side effects that occurred after the commercialization of Havrix 720 Junior were the following:

• seizures or convulsions
• inflammation of blood vessels that causes narrowing or obstruction (vasculitis)
• severe allergic reaction that causes swelling of the face, tongue, or throat, which may cause difficulty swallowing or breathing
• hives, red patches that often itch and start on the extremities and sometimes on the face and rest of the body.
• joint pain

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish 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 medicine.

Keep this vaccine out of sight and reach of children.

Do not usethis vaccineafter the expiration date that appears on thecontainer.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. Dispose of the containers and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need.This will help protect the environment..

Composition of Havrix 720 Junior

The active ingredient isinactivated hepatitis A virus adsorbed on aluminium hydroxide. Each dose of 0.5 ml of the vaccine contains 720 units ELISA of hepatitis A virus.

The other components areamino acids for injection (containing phenylalanine), disodium phosphate, monopotassium phosphate, polisorbate 20(E-432), potassium chloride, sodium chloride, injectable preparation water (see section 2).

Appearance of the product and contents of the pack

Injectable suspension.

Havrix 720 Junior is a turbid injectable liquid.

Havrix 720 Junior is available in pre-filled syringe with or without needles; pack sizes of 1, 5, 10 and 25.

Only some pack sizes may be marketed.

Marketing authorisation holder and manufacturer responsible

Marketing authorisation holder:

GlaxoSmithKline, S.A.

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

28760 Tres Cantos (Madrid)

Spain

Phone: +34 900 202 700

[email protected]

Manufacturer responsible:

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)

Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Last update of the summary of product characteristics:03/2025

Other sources of information

The detailed information on this medicinal product is available 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 solely for healthcare professionals:

Havrix 720 Junior is a turbid liquid suspension.During storage,the contents may presenta fine white deposit and a transparent and colourless supernatant.

Before administration, the vaccine should be visually inspected to detect any foreign particles and/or variation in physical appearance. Before using Havrix 720 Junior, the pre-filled syringe should be shaken well to obtain a white slightly opaque suspension. Discard the vaccine if the contents show a different appearance.

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.