HAVRIX 1440 ADULT, PRE-FILLED SYRINGE SUSPENSION FOR INJECTION

Introduction

Package Leaflet: Information for the User

Havrix 1440 Adult, injectable suspension in pre-filled syringe

Vaccine against hepatitis A (inactivated, adsorbed)

Read all of this leaflet carefully before you or your child starts receiving this vaccine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.

• This vaccine has been prescribed for you or your child, do not pass it on to others.
• If you or your child experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

This leaflet has been written assuming that the person receiving the vaccine is reading it, although it can be administered to adolescents from 16 years of age, so you may need to read it for your child.

Contents of the pack

1. What Havrix 1440 Adult is and what it is used for
2. What you need to know before you start receiving Havrix 1440 Adult
3. How Havrix 1440 Adult is administered
4. Possible side effects
5. Storage of Havrix 1440 Adult

1. Contents of the pack and further information

1. What Havrix 1440 Adult is and what it is used for

What Havrix 1440 Adult is used for

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

What hepatitis A is

• 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 can include: fever, general malaise, loss of appetite, diarrhea, nausea, abdominal discomfort, dark-colored urine, and jaundice (yellowing of the eyes and skin). Most people recover completely, although sometimes the disease can be severe and require hospitalization, and in rare cases, it can cause acute liver failure.

How Havrix 1440 Adult works

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, it is possible that Havrix 1440 Adult may not completely protect all vaccinated individuals.

2. What you need to know before you start receiving Havrix 1440 Adult

Havrix 1440 Adult must not be administered if:

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

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

Havrix 1440 Adult must not be administered if any of the above applies to you. If you are not sure, 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 a 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.

Fainting can 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 and Havrix 1440 Adult

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might 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 and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before receiving Havrix 1440 Adult.

Driving and using machines

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

Havrix 1440 Adult contains phenylalanine, polysorbate 20, sodium, and potassium

This vaccine contains 0.166 mg of phenylalanine per dose.

Phenylalanine may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

This vaccine contains 0.050 mg of polysorbate 20 per dose. Polysorbates can cause allergic reactions. Inform your doctor if you have any known allergy.

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

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

3. How Havrix 1440 Adult is administered

How the vaccine is administered

• Your doctor or nurse will administer Havrix 1440 Adult by injection into a muscle, usually in the upper arm.
• Havrix 1440 Adult can be injected under the skin if you have thrombocytopenia or severe bleeding 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 to be administered 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 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. 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 miss a dose of Havrix 1440 Adult

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

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.

Serious side effects

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

• allergic reactions: the signs can include local or generalized 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 can occur before you leave the doctor's office.

Tell your doctor immediately if you notice any of the serious side effects listed above.

Side effects that occurred during clinical trials with Havrix 1440 Adult were 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 with up to 1 in 10 doses of the vaccine):

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

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

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

Rare(these may occur with up to 1 in 1,000 doses of vaccine):

• decreased or lost skin sensitivity to pain or touch
• muscle spasms
• itching
• chills

Side effects that occurred after marketing of Havrix 1440 Adult were the following:

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Havrix 1440

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

Do not use this vaccine after the expiry date stated on the packaging. The expiry date is the last day of the month stated.

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 via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Havrix 1440 Adult

The active substance is hepatitis A virus (inactivated) adsorbed onto aluminum hydroxide. Each 1 ml dose of the vaccine contains 1440 ELISA units of hepatitis A virus.

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

Appearance of the product and pack contents

Injectable suspension.

Havrix 1440 Adult is a turbid liquid injectable.

Havrix 1440 Adult is available in a pre-filled syringe with or without needles; pack sizes of 1, 5, 10, and 25.

Not all pack 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)

Spain

Tel.: +34 900 202 700

[email protected]

Manufacturer:

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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:03/2025

Other sources of information

Detailed information on this medicine is available 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:

Havrix 1440 Adult is a turbid liquid suspension. During storage, the contents may present a fine white deposit and a clear, colorless supernatant.

Before administration, the vaccine should be inspected visually for 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 slightly opaque white suspension. Discard the vaccine if the contents appear otherwise.

Instructions for the pre-filled syringe

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.