Package Insert: Information for the User

Havrix 1440 Adult, Pre-filled Syringe Suspension

Hepatitis A Vaccine (Inactivated, Adsorbed)

Read this package insert carefully beforeyou or your child starts receiving this vaccine, because it contains important information for you.

• Keep this package insert, as you 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.
• If you or your child experiences 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 adolescents aged 16 years or older, so you may need to read it for your child.

6.Contents of the package and additional information

What it is used forHavrix1440 Adult

Havrix 1440 Adult is a vaccine used to protect adolescents aged 16 years and older and adults from infection caused by the hepatitis A virus.

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 beverages.
• Symptoms of hepatitis A can range 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 the disease can be severe and require hospitalization, and in rare cases, it can cause acute liver failure.

How Havrix 1440 Adult works1440 Adult

Havrix 1440 Adult helps your body produce its own protection (antibodies) against the virus. These antibodies help protect you against the disease.

As with all vaccines, Havrix 1440 Adult may not protect all vaccinated individuals completely.

You should not administerHavrix1440 Adultif:

• You are allergic to the active ingredient or to any of the other components ofthis 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.

You should not administer Havrix 1440 Adult if any of the above situations apply to you. If you are unsure, consult your doctor, pharmacist, or nurse before receiving Havrix 1440 Adult.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before receiving Havrix 1440 Adult if:

• You have a severe infection with high temperature (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 medicines andHavrix1440 Adult

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

Havrix 1440 Adult can be administered at the same time as other vaccines and immunoglobulins. A different injection site should be used for each injection.

Pregnancy andbreastfeeding

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 1440 Adult.

Driving and operating machines

The influence of Havrix 1440 Adult on the ability to drive and operate machines is negligible or insignificant.

Havrix1440 Adult containsphenylalanine, polysorbate 20, sodium, and potassium

This vaccine contains 0.166 mg of phenylalanine in each 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 0.050 mg of polysorbate 20 in each dose. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

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

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

How the Vaccine is Administered

• The doctor or nurse will administer Havrix 1440 Adult via an injection into a muscle, usually in the upper arm.
• Havrix 1440 Adult may be injected subcutaneously if you have thrombocytopenia or severe hemorrhagic disorders.

How Much is Administered

• You will receive 1 dose of Havrix 1440 Adult (1 ml suspension) on the date agreed with your doctor or nurse.
• A second dose (booster) is recommended 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 More Havrix 1440 Adult Than You Should

It is highly 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. A few cases of accidental administration have been reported, and the adverse effects reported were similar to those reported with normal administration of the vaccine (listed in section 4).

If You Forget to Receive Havrix 1440 Adult

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 can cause itching or blisters, swelling of the eyes and face, difficulty breathing or swallowing, a 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 1440 Adult were the followingHavrix 1440 Adultwere the following:

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

• headache
• pain and redness at the injection site
• fatigue

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

• loss of appetite
• nausea
• vomiting
• diarrhea
• general feeling of discomfort
• fever of 37.5°C or higher
• swelling or hardening at the injection site

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

• upper respiratory tract infection
• runny or blocked nose
• dizziness
• muscle pain, muscle stiffness not caused by exercise
• flu-like symptoms, such as high temperature, sore throat, nasal discharge, cough, and shivering

Rare(these may occurup to 1 in 1,000 doses of the vaccine):

• decreased or loss of skin sensitivity to pain or touch
• muscle cramps
• itching
• shivering

The side effects that occurred after the commercialization of Havrix 1440 Adult 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 vaccineafterthe 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. Deposit the containers and medicines you no longer need at the SIGRE point of 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 1440 Adult

The active ingredient isinactivated hepatitis A virus adsorbed on aluminium hydroxide. Each dose of 1 ml of the vaccine contains 1440 units ELISA of hepatitis A virus.

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

Appearance of the product and contents of the pack

Injectable suspension.

Havrix 1440 Adult is aclearinjectableliquid.

Havrix 1440 Adult 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

Tel.: +34 900 202 700

[email protected]

Manufacturer responsible:

SmithKline Beecham, S.A.

Carretera de Ajalvir, km.2,5

28806 Alcalá de Henares (Madrid)

Spain

or

GlaxoSmithKline Biologicals s.a.

Rue de l´Institut 89

B-1330 Rixensart

Belgium

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

Last update of this leaflet: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 1440 Adult is aclearinjectableliquid.

During storage,the contents may show a 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 1440 Adult, 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 residues

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