Package Insert: Information for the User

AVAXIM, pre-filled syringe injection

Inactivated, adsorbed hepatitis A vaccine

Read this package insert carefully before you are vaccinated, as 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 for you alone and should not be given to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

6. Contents of the container and additional information

Avoxim is a vaccine. Vaccines are used to protect you from infectious diseases. This vaccine helps to protect against hepatitis A infection in people aged 16 years and above.

Hepatitis A is an infection caused by a virus that attacks the liver. It can be contracted from food or drinks that contain the virus. Symptoms include jaundice (yellow discoloration of the skin) and general discomfort.

When you receive an injection of Avaxim, your body's natural defenses will produce protection against hepatitis A infection.

No use Avaxim:

- If you are allergic:

• to the active ingredient or to any of the components of Avaxim (listed in section 6).
• to neomycin, an antibiotic used during vaccine production that may be present in the vaccine in small quantities.
• to Avaxim

If you are sick with a high fever. You shouldpostpone your vaccination until you recover.

Warnings and precautions

Consult your doctor or nurse before starting to use Avaxim if you have:

• Liver disease.
• A weakened immune system due to:

- corticosteroids, cytotoxic drugs, radiation therapy, or other treatments that may weaken the immune system. Your doctor or nurse may want to wait until your treatment is completed.

- HIV infection (human immunodeficiency virus) or any disease that weakens the immune system. It is recommended to administer the vaccine even if it does not protect you in the same way as people with an unweakened immune system.

• Hemophilia or other situations where bruises or bleeding may occur easily.

After any injection with a needle, or even before, dizziness may occur, mainly in adolescents. Therefore, inform your doctor or nurse if you or your child has experienced dizziness with any previous injection.

This vaccine will not protect you against other viruses that attack the liver (such as the hepatitis B virus, hepatitis C virus, or hepatitis E virus).

If you are already infected with the hepatitis A virus at the time of using the vaccine, the vaccination may not be effective.

The vaccine cannot cause the infection against which it protects.

As with any vaccine, not all people who receive Avaxim will be definitively protected against hepatitis A infection.

Use of other vaccines or medications and Avaxim

This vaccine can be administered at the same time as the following vaccines, but in different parts of the body (for example, in the other arm or leg) and not mixed in the same syringe:

• Polysaccharide vaccine against typhoid fever
• Vaccine against yellow fever
• Immunoglobulins (antibodies obtained from blood donors)

Avaxim may not work if administered at the same time as immunoglobulins. However, it is very likely that you will still be protected against hepatitis A infection.

Inform your doctor, nurse, or pharmacist if you are taking, or have recently taken, any other medication, even those purchased without a prescription.

Pregnancy and lactation

If you are pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor or nurse before using this vaccine. They will decide whether the vaccination should be postponed or not.

It is possible to use this vaccine during lactation.

Driving and operating machinery

It is unlikely that this vaccine will have any effect on your ability to drive or operate machinery.

However, no studies have been developed.

Avaxim contains ethanol, phenylalanine, potassium, and sodium.

Avaximcontains 2 mg of alcohol (ethanol) in each dose of 0.5 ml. The small amount of alcohol contained in this medication does not have notable effects.

Avaxim contains 10 micrograms of phenylalanine in each dose of 0.5 ml, which is equivalent to 0.17 micrograms/kg for a person weighing 60 kg. Phenylalanine can be harmful to people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

Avaxim contains less than 1 mmol of potassium (39 mg) and sodium (23 mg) per dose, so it is considered essentially "potassium-free" and "sodium-free".

The vaccine will be administered by a doctor or nurse who have been trained in the use of the vaccine and are experienced in treating severe allergic reactions that are uncommon after injection..

Dosage

Avaxim is administered by a 0.5 ml injection for individuals aged 16 years or older.

You will be protected against hepatitis A around 14 days after receiving the single dose of Avaxim. This protection will last for up to 36 months.

If you need longer-term protection against hepatitis A, you will need a second dose (booster) of inactivated hepatitis A vaccine.

The second dose is preferably administered between 6 to 12 months after the primary immunization but can also be administered up to 36 months after the same.

This booster dose will protect you against hepatitis A for at least 10 years.

Avaxim can be administered as a booster dose if you have received a first dose of a different hepatitis A vaccine (including vaccines that protect against hepatitis A and typhoid fever).

Administration method

The doctor or nurse must shake the syringe immediately before use and check that the liquid is milky and turbid, and that there are no foreign particles.

Avaxim must be injected into the muscle in the outer upper arm. If you have a bleeding disorder, the injection may be administered under the skin. The doctor or nurse must not inject the vaccine into the skin or into a blood vessel.

Avaxim will not be administered in the buttocks.

Like all medicines and vaccines, Avaxim may have side effects, although not everyone will experience them.Severe allergic reactions

Although rare, severe or even life-threatening allergic reactions (anaphylactic reactions, including shock) can occur.

If you experience an allergic reaction,contact your doctor or healthcare professional immediately or go to the nearest hospital emergency department.

Allergic reactions can occur immediately or several days after vaccination and symptoms may include:

• difficulty breathing, blue discoloration of the tongue or lips
• dizziness (low blood pressure) and possibly fainting
• rapid heart rate and weak pulse, cold skin
• swelling of the face and neck
• itching and skin rash

Other side effects

Very common adverse reactions(reported in more than 1 in 10 people):

• mild pain at the injection site
• general feeling of weakness (asthenia)

Common adverse reactions(reported in less than 1 in 10 people but more than 1 in 100 people)

• headache
• nausea and vomiting
• loss of appetite
• diarrhea and/or abdominal pain (abdominal pain)
• muscle and joint pain (myalgia, arthralgia)
• mild fever

Uncommon adverse reactions(reported in less than 1 in 100 people but more than 1 in 1,000 people)

• redness (erythema) at the injection site

Rare adverse reactions(reported in less than 1 in 1,000 people but more than 1 in 10,000 people)

• lumps at the injection site (nodule at the injection site)
• temporary and slight changes in liver function parameters in blood tests (increased transaminases)

Unknown (frequency cannot be estimated from available data):

• syncope as a response to the injection

• rashes that in some cases have caused lumps and itching (including urticaria)

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 leaflet. 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 use the vaccine after the expiration date that appears on the box and on the syringe label after CAD. The expiration date is the last day of the month indicated.

Do not use this vaccine if foreign particles appear in suspension.

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

Do not freeze. If frozen, the vaccine must be rejected.

Store in the original packaging to protect it from light.Medicines should not be thrown down the drains or in the trash. Dispose of containers and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

Composition of Avaxim

• The active principle is

• HBsAg (inactivated)1,2............160 EU

1produced in diploid human cells (MRC-5)

2adsorbed on aluminium hydroxide, hydrated (0.3 milligrams of Al3+)

• The other components are

• 2-phenoxylethanol
• anhydrous ethanol
• formaldehyde
• Hanks' 199 medium*

• water for injection
• polysorbate 80

• hydrochloric acid and sodium hydroxide for pH adjustment.

* - Hanks' 199 medium (without red phenol) is a complex mixture of amino acids (including phenylalanine), mineral salts, vitamins, and other components.

Appearance of the product and contents of the package

The inactivated anti-hepatitis A vaccine is a turbid white suspension.

The vaccine is presented as a suspension for injection in a pre-filled syringe (0.5 ml of inactivated hepatitis A virus) with or without a fixed needle (pack sizes 1, 5, 10 or 20) or with 1 or 2 separate needles (pack sizes 1 or 10).

All presentations are not commercially available.

Holder of the marketing authorization

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Responsible for manufacturing

The manufacturer responsible for the release of batches is:

Sanofi Winthrop Industrie - 1541 avenue Marcel Mérieux - 69280 Marcy l'Etoile - France

Sanofi Winthrop Industrie - Voie de l'Institut – Parc Industriel d'Incarville B.P 101 - 27100 Val de Reuil - France

Sanofi-Aventis Zrt. Bdg. DC5 - Campona Utca 1.Budapest XXII - 1225 Budapest – Hungary

Local representative

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Tel: +34 93 485 94 00

This medicine is authorized in the member states of the European Economic Area under the following names:

Avaxim - Austria, Belgium, Germany, Denmark, Greece, Spain, Finland, Ireland, Italy, Luxembourg, Netherlands, Portugal, Sweden, United Kingdom.

Date of the last review of this leaflet: September 2021

Other sources of information

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/