Havrix 1440 Adulto, injectable suspension in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Havrix 1440 Adult, injectable suspension in pre-filled syringe

Hepatitis A vaccine (inactivated, adsorbed)

Read this entire leaflet carefully before you or your child starts receiving this vaccine, because 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, pharmacist, or nurse.

• This vaccine has been prescribed only for you or your child and should not be given to other people.

• If you or your child experience any adverse reactions, consult 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 the one reading it, although it may be administered to adolescents aged 16 years and older; therefore, you may need to read it on behalf of your child.

Contents of the leaflet

1. What Havrix 1440 Adult is and what it is used for
2. What you need to know before receiving Havrix 1440 Adult
3. How Havrix 1440 Adult is administered
4. Possible adverse effects
5. How to store Havrix 1440 Adult
6. Contents of the pack and other 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 the age of 16 years and adults against 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 spread from person to person or through contact with contaminated water, food, and drinks.
• Symptoms of hepatitis A range from mild to severe and may include: fever, general malaise, loss of appetite, diarrhoea, nausea, abdominal discomfort, dark-coloured 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 may lead to 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, Havrix 1440 Adult may not fully protect all vaccinated individuals.

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

Do not administer Havrix 1440 Adult if:

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

Signs of an allergic reaction may include: itchy rash, difficulty breathing, and swelling of the face or tongue.

Do 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 serious infection with high fever. The vaccine may be given 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 illness and/or treatments. Your doctor will determine whether additional doses are needed,
• you have bleeding problems or bruise easily.

Fainting may occur before or after any injection with a needle. Therefore, inform the doctor, pharmacist, or nurse if you have previously fainted after an injection.

Other medicines and Havrix 1440 Adult

Inform your doctor, pharmacist, or nurse if you are using, have recently used, or might need to use any other vaccines or medicines.

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 are planning 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 none or 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 if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

This vaccine contains 0.050 mg of polysorbate 20 per 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; i.e., essentially "sodium-free".

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

3. How Havrix 1440 Adult is administered

How the vaccine is administered

• Your doctor or nurse will administer Havrix 1440 Adult as an injection into a muscle, usually in the upper arm.
• Havrix 1440 Adult may exceptionally be injected under the skin if you have thrombocytopenia or if you have severe bleeding disorders.

How much is administered

• You will receive 1 dose of Havrix 1440 Adult (1 ml suspension) on the date scheduled by your doctor or nurse.
• A second dose (booster) is recommended between 6 and 12 months after the first dose, although it may be given 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 whether a dose is needed and when it should be administered.

4. Possible adverse effects

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

Serious adverse effects

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

• allergic reactions: signs may include localised or widespread skin rash, which may cause itching or blistering, 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 you leave the doctor's office.

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

Adverse effects observed during clinical trials with Havrix 1440 Adult were the following:

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

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

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

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

Uncommon (may occur in up to 1 in 100 doses of the 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 chills

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

• decreased or loss of skin sensitivity to pain or touch
• muscle soreness
• itching
• chills

Adverse effects reported after marketing of Havrix 1440 Adult were the following:

• seizures or convulsions
• inflammation of blood vessels causing narrowing or blockage (vasculitis)
• severe allergic reaction causing swelling of the face, tongue or throat, which may lead to difficulty swallowing or breathing
• hives, red spots that often itch and which usually start on the limbs and sometimes on the face and rest of the body
• joint pain

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 container. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2 °C and 8 °C).

Do not freeze.

Keep in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at the pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Havrix 1440 Adult

The active substance is hepatitis A virus (inactivated), adsorbed onto aluminium hydroxide. Each 1 ml dose of 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 contents of the pack

Injectable suspension.

Havrix 1440 Adult is a cloudy injectable liquid.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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:

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 European Economic Area member states under the following names:

Date of the most recent review of this leaflet: 03/2025

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.

This information is intended for healthcare professionals only:

Havrix 1440 Adult is a cloudy liquid suspension. During storage, it may present a fine white deposit and a colourless, clear supernatant.

Before administration, the vaccine should be inspected visually for any foreign particles and/or changes in physical appearance. Prior to use, the pre-filled syringe must be shaken well to obtain a slightly opaque white suspension. Discard the vaccine if the contents appear different.

Instructions for the pre-filled syringe

Waste disposal

Disposal of unused medication and all materials that have come into contact with it must be carried out in accordance with local regulations.