EFLUELDA TETRA Injectable Suspension in Pre-filled Syringe

Introduction

Package Leaflet: Information for the User

Efluelda Tetra, injectable suspension in a pre-filled syringe

Tetra-valent influenza vaccine (inactivated, fragmented virus), 60 micrograms HA/strain

This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may experience. The last section of section 4 will provide information on how to report side effects.

Read all of this leaflet carefully before you are vaccinated 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 to you, do not pass it on to others, even if their symptoms are the same as yours, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What Efluelda Tetra is and what it is used for
2. What you need to know before you use Efluelda Tetra
3. How to use Efluelda Tetra
4. Possible side effects
5. Storage of Efluelda Tetra
6. Contents of the pack and further information

1. What Efluelda Tetra is and what it is used for

Efluelda Tetra is a vaccine. This vaccine helps protect people aged 60 and over against influenza virus. The use of Efluelda Tetra should be based on official recommendations on influenza vaccination.

When you receive Efluelda Tetra, your immune system (the body's natural defense system) will produce its own protection (antibodies) against the disease. None of the vaccine components can cause influenza.

Influenza is a contagious respiratory disease caused by the influenza virus, which can result in mild to severe illness, and serious complications such as pneumonia, which can lead to hospitalization or even death. Influenza is a disease that can spread rapidly and is caused by different strains that can change every year. Due to this potential change in circulating strains annually, as well as the duration of protection provided by the vaccine, annual vaccination is recommended. The highest risk of contracting influenza is during the cold months between October and March. If you were not vaccinated in the fall, it is still advisable to get vaccinated until spring, as you are at risk of contracting influenza until then. Your doctor will be able to recommend the best date for vaccination.

Efluelda Tetra is designed to protect you against the four strains of the virus contained in the vaccine, approximately 2 to 3 weeks after injection. Additionally, if you are exposed to influenza immediately before or after vaccination, you may still develop the disease, since the incubation period of influenza is a few days.

The vaccine will not protect you against the common cold, even if some of the symptoms are similar to those of influenza.

2. What you need to know before you start using Efluelda Tetra

To ensure that Efluelda Tetra is suitable for you, it is important that you inform your doctor or pharmacist if any of the following points apply to you. If there is anything you do not understand, ask your doctor or pharmacist to explain it to you.

Do not use Efluelda Tetra:

• if you are allergic to:

• the active substances, or
• to any of the other components of this vaccine (listed in section 6), or
• to any of the components that may be present in minimal amounts, such as eggs (ovoalbumin, chicken proteins) and formaldehyde.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Efluelda Tetra.

Talk to your doctor before getting vaccinated if you:

• have a weakened immune system (immunodeficiency or are taking medications that affect the immune system),
• have bleeding problems or bruise easily,
• have experienced Guillain-Barré Syndrome (GBS) (severe muscle weakness) after receiving an influenza vaccine,
• have a high or moderate fever or an acute illness, vaccination should be postponed until you have recovered.

Your doctor will decide if you should receive the vaccine.

Fainting can occur after, or even before, any injection with a needle. Therefore, inform your doctor or nurse if you have fainted with a previous injection.

Like all vaccines, Efluelda Tetra may not fully protect all people who are vaccinated.

If you have a blood test a few days after influenza vaccination, please inform your doctor. This is because false-positive results have been observed in serological tests in some recently vaccinated patients.

Children

This vaccine must not be used in children, it is only for adults aged 60 and over.

Other medicines and Efluelda Tetra

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines or vaccines.

• If Efluelda Tetra is to be administered at the same time as other vaccines, the vaccines should always be administered in different limbs.
• Note that adverse reactions can be intensified by any co-administration.
• The immune response may be reduced in the case of immunosuppressive treatments, such as corticosteroids, cytotoxic medications, or radiation therapy.

Pregnancy and breastfeeding

Efluelda Tetra is only indicated for use in adults aged 60 and over.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this vaccine. Your doctor/pharmacist will help you decide if you should receive Efluelda Tetra.

Driving and using machines

Efluelda Tetra has a negligible influence on the ability to drive and use machines. However, if you feel unwell or dizzy, it is not recommended to drive.

Efluelda Tetra contains sodium

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

3. How to use Efluelda Tetra

Adults aged 60 and over receive a dose of 0.7 ml.

How Efluelda Tetra is administered

Your doctor, pharmacist, or nurse will administer the recommended dose of the vaccine as an injection into the muscle or under the skin.

If you have any doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Allergic reactions

See a doctor IMMEDIATELYif you experience:

• Severe allergic reactions:

• which can lead to a medical emergency with low blood pressure, shortness of breath, wheezing, or difficulty breathing, rapid heartbeat, and weak pulse, cold, clammy skin (cold sweat), dizziness, which can lead to collapse (anaphylaxis [including angioedema, e.g., swelling more apparent on the face, lips, tongue, throat, or any other part of the body, and which can cause difficulty swallowing or breathing]).

See a doctor if you experience:

• Allergic reactions such as skin reactions that can spread throughout the body, including itching, hives, rash.

These side effects are rare (may affect up to 1 in 1,000 people).

Other reported adverse effects

The following adverse effects were reported in adults aged 60 and over.

Very common (may affect more than 1 in 10 people):

• Injection site reactions: pain, redness (erythema)
• General feeling of being unwell (malaise), headache, muscle pain (myalgia)

Common (may affect up to 1 in 10 people):

• Injection site reactions: swelling, bruising, hardness (induration)
• Fever, chills (shivering)

Uncommon (may affect up to 1 in 100 people):

• Injection site reactions: itching
• Fatigue, lethargy, feeling sick (nausea), vomiting, diarrhea
• Cough, muscle weakness, indigestion (dyspepsia), throat inflammation (oropharyngeal pain)

Rare (may affect up to 1 in 1,000 people):

• Abnormal lack of energy (asthenia), flushing, joint pain (arthralgia), dizziness, night sweats, rash, numbness or tingling (paresthesia), nasal inflammation (rhinorrhea), vertigo, excessive blood in the white of the eye (ocular hyperemia)
• Pain in the limbs

Frequency not known: the frequency cannot be estimated from the available data:

• Decrease in the number of certain types of particles in the blood called platelets; a low number of these can result in excessive bruising or bleeding (thrombocytopenia)
• Swelling of the glands in the neck, armpit, or groin (lymphadenopathy)
• Neurological disorders that can result in stiffness of the neck, confusion, numbness, pain, and weakness of the limbs, loss of balance, loss of reflexes, paralysis of part or all of the body (encephalomyelitis and transverse myelitis, brachial neuritis, Guillain-Barré Syndrome), facial paralysis (Bell's palsy), vision disorders due to optic nerve dysfunction (optic neuritis/neuropathy), seizures (including febrile seizures), fainting (syncope) shortly after vaccination
• Inflammation of blood vessels (vasculitis) that can cause skin rashes and, in very rare cases, temporary kidney problems, dilation of blood vessels (vasodilation)
• Chest pain
• Wheezing, feeling of pressure in the throat, difficulty breathing (dyspnea).

Most side effects usually occurred within 3 days after vaccination and resolved within 3 days. The intensity of these side effects was mild to moderate.

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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of Efluelda Tetra

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

Do not use this vaccine after the expiry date which is stated on the label and on the carton after EXP. The expiry date is the last day of the month shown.

Store in a refrigerator (between 2 °C and 8 °C). Do not freeze. Keep the syringe in the outer packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Efluelda Tetra Composition

The active principles are: Influenza virus (inactivated, split) of the following strains *:

• Strain similar to A/Victoria/4897/2022 (H1N1)pdm09: (IVR-238).…. 60 micrograms HA**

• Strain similar to A/Croatia/10136RV/2023 (H3N2): (X-425A)…...…60 micrograms HA **

• Strain similar to B/Austria/1359417/2021: B/Michigan/01/2021 .……60 micrograms HA**

• B/Phuket/3073/2013………………………….……………………...60 micrograms HA**

Per 0.7 ml dose

• grown in embryonated chicken eggs

** hemagglutinin

This vaccine complies with the recommendations of the WHO (World Health Organization) (Northern Hemisphere) and the EU decision for the 2025/2026 campaign.

The other components are: a buffer solution containing sodium chloride, sodium phosphate monobasic, sodium phosphate dibasic, water for injectable preparations, and octoxinol-9.

Some components such as eggs (ovoalbumin, chicken proteins) or formaldehyde may be present in very small quantities (see Section 2).

Appearance ofEflueldaTetra andcontainer content

The vaccine, after careful shaking, is a colorless opalescent liquid.

Efluelda Tetra is an injectable suspension of 0.7 ml presented in a pre-filled syringe with or without a needle (in packs of 1, 5, or 10) or with a safety needle (in packs of 1 or 10).

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

The marketing authorization holder is:

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

The manufacturer is:

Sanofi Winthrop Industrie

Voie de l’Institut - Parc Industriel d’Incarville

B.P 101

27100 Val de Reuil

France

Local Representative

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Tel: +34 93 485 94 00

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

Date of the last revision of this prospectus:July 2025

Other sources of information

The latest approved information on this medicinal product is available by scanning the QR code included in the packaging or at the following internet address: https://eflueldatetra-nh.info.sanofi

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This information is intended solely for healthcare professionals:

As with all injectable vaccines, medical treatment and appropriate supervision should be available in case of an anaphylactic episode following administration of the vaccine.

The vaccine should reach room temperature before use.

Shake before use. The vaccine should not be used if it contains foreign particles in the suspension.

It should not be mixed with other medicinal products in the same syringe.

This vaccine should not be injected directly into any blood vessel.

See also Section 3. How to use Efluelda Tetra

?Preparation for administration

Instructions for using the safety needle with the Luer Lock syringe:

The disposal of unused vaccines and all materials that have come into contact with them will be carried out in accordance with local regulations.