Prospecto:information for the user

Vaxigrip Tetra, pre-filled syringe suspension

Tetravalent influenza vaccine (inactivated virus fractions)

Read this prospectus carefully before you or your child are vaccinated because it contains important information for you or your child.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This vaccine has been prescribed only for you or your child and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you or your child experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1.What Vaxigrip Tetra is and how it is used

2.What you need to knowbeforeyou or your child start using Vaxigrip Tetra

3.How to use Vaxigrip Tetra

4.Possible adverse effects

5Storage of Vaxigrip Tetra

6. Contents of the package and additional information

Vaxigrip Tetra is a vaccine.

This vaccine is administered to you or your child from 6 months of age, and it is indicated to protect you or your child from the flu.

When Vaxigrip Tetra is injected into a person, the immune system (the body's natural defense system) will produce protection (antibodies) against infection.

When the vaccine is administered during pregnancy, in addition to protecting the pregnant woman, it also protects the baby from birth to 6 months of age through the transmission of the mother's protection to the baby during pregnancy (see also sections 2 and 3).

None of the components of the vaccine can cause the flu.

The use of Vaxigrip Tetra should be based on official recommendations.

The flu is an illness that can spread quickly and is caused by different types of strains that can change each year. Due to this potential change in circulating strains each year, as well as the duration of the protection expected from the vaccine, vaccination is recommended every year. There is a higher risk of contracting the flu during the cold months between October and March. If you or your child did not get vaccinated in the fall, it is possible to get vaccinated in the spring since you or your child are at risk of getting infected with the flu during that period. Your doctor will be able to recommend the best date for vaccination.

The goal of Vaxigrip Tetra is to protect you or your child against the four virus strains contained in the vaccine after about 2 to 3 weeks of the injection.The incubation period of the flu is a few days, so if you or your child are exposed to the flu immediately before or after vaccination, you or your child may develop the illness.

The vaccine will not protect you or your child against the common cold, even if some of the symptoms are similar to the flu.

To ensure that Vaxigrip Tetra is suitable for you or your child, it is essential that you consult your doctor or pharmacist if any of the points described below affect you or your child. If you do not understand something, consult your doctor or pharmacist to clarify it.

Do not use Vaxigrip Tetra

• If you or your child are allergic to:

• The active ingredients or
• Any of the other components of this vaccine (listed in section 6), or
• Any of the components that may be present in minimal amounts, such as eggs (ovalbumin or chicken proteins), neomycin, formaldehyde, or octoxinol-9.

• If you or your child have a disease accompanied by high or moderate fever or an acute disease, in this case, vaccination will be delayed until you have recovered.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Vaxigrip Tetra.

Consult your doctor before vaccinating if you or your child have:

- A weakened immune response (immunodeficiency or treatment with medications that affect the immune system),

- Bleeding problems or easily form bruises.

Your doctor will decide if you or your child should receive the vaccine. Before or after any injection, dizziness may occur (especially in adolescents), so inform your doctor or nurse if you or your child have fainted on previous occasions after receiving an injection.

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

Not all babies under 6 months of age born to pregnant women who were vaccinated during pregnancy will be protected.

If, for any reason, you or your child undergo blood tests a few days after vaccination against the flu, please inform your doctor. This is because false positive results have been observed in some patients recently vaccinated.

Children

It is not recommended to use Vaxigrip Tetra in children under 6 months of age.

Use of Vaxigrip Tetrawithother medications

Inform your doctor or pharmacist if you or your child are using, have used recently, or may need to use any other medication or vaccine.

• Vaxigrip Tetra can be administered at the same time as other vaccines, in different limbs.
• The immune response may decrease in the case of immunosuppressive treatments, such as corticosteroids, cytotoxic medications, or radiation therapy.

Pregnancy andlactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this vaccine.

Vaxigrip Tetra can be used in all stages of pregnancy.

Vaxigrip Tetra can be used during breastfeeding.

Your doctor/pharmacist will be able to decide if you should be vaccinated with Vaxigrip Tetra.

Driving and operating machinery

Vaxigrip Tetrahas a negligible or insignificantinfluenceon the ability to drive and operate machinery.

Vaxigrip Tetra contains potassium and sodium

This medicine contains less than 1 mmol of potassium (39 mg) and less than 1 mmol of sodium (23 mg) per dose; it is essentially "potassium-free" and "sodium-free".

Dosage

Adults: 1 dose of 0.5 ml.

Use in children

Children from 6 months to 17 years of age receive a dose of 0.5 ml.

If your child is under 9 years of age and has not been previously vaccinated against influenza, a second dose of 0.5 ml should be administered after an interval of at least 4 weeks.

If you are pregnant, a dose of 0.5 ml administered during pregnancy may protect your baby from birth to 6 months of age. For further information, ask your doctor or pharmacist.

How Vaxigrip Tetra is administered

Your doctor or nurse will administer the recommended dose of the vaccine with an injection into a muscle or under the skin.

If you or your child receive more Vaxigrip Tetra than they should

In some cases, an unintended higher dose was administered.

In these cases, when adverse events were reported, they were in line with those described after administration of the recommended dose (see Section 4).

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

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

Allergic reactions

Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency department if you or your child experience allergic reactions (notified as rare: may affect up to 1 in 1,000 people) that can be life-threatening. Symptoms may include skin rash, itching, hives, redness, difficulty breathing, shortness of breath, facial swelling, lip, throat, or tongue swelling, cold and sticky skin, palpitations, dizziness, weakness, or fainting.

Other reported side effects in adults and older people

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

• Headache, muscle pain (myalgia),general feeling of being unwell (dyspnea)(1), pain at the injection site.

(1)Common in older people

Common (may affect up to 1 in 10 people)

• Fever(2), chills, reactions at the injection site: redness (erythema), swelling, hardness (induration).

(2)Rare in older people

Rare (may affect up to 1 in 100 people)

• Dizziness(3), diarrhea, feeling of illness (nausea)(4), fatigue, reactions at the injection site: bruises (ecchymosis), itching (pruritus), and heat.

(3)Rare in adults(4)Rare in older people

• Hot flashes: only observed in older people.
• Swelling of the lymph nodes in the neck, armpit, or groin (lymphadenopathy): only observed in adults.

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

• Abnormal sensations of touch, pain, heat, and cold (paresthesia), drowsiness, excessive sweating (hyperhidrosis), unusual fatigue and weakness (asthenia), flu-like illness.
• Joint pain (arthralgia), discomfort at the injection site: only observed in adults.

Other reported side effects in children aged 3 to 17 years

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

• Headache, muscle pain (myalgia), general feeling of being unwell (dyspnea), chills(5), reactions at the injection site: pain, swelling, redness (erythema)(5), hardness (induration)(5).

(5)Common in children aged 9 to 17 years

Common (may affect up to 1 in 10 people)

• Fever, hematoma at the injection site (ecchymosis).

Poorly common (may affect up to 1 in 100 people) inchildren aged 3 to 8 years:

• Temporary decrease in the number of certain blood cells called platelets; when the number is low it may lead to excessive bleeding in the skin or bleeding (transient thrombocytopenia): only observedin a 3-year-old child
• Crying, restlessness
• Dizziness, diarrhea, vomiting, upper abdominal pain, joint pain (arthralgia), fatigue, heat at the injection site.

Poorly common (may affect 1 in 100 people) inchildren aged 9 to 17 years:

• Diarrhea, itching at the injection site (pruritus).

Other reported side effects in children aged 6 to 35 months

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

• Vomiting(1), muscle pain (myalgia)(2), irritability(3), loss of appetite(3), general feeling of being unwell (dyspnea)(2), fever.

(1)Poorly common in children aged 24 to 35 months(2)Rare in children under 24 months of age

(3)Rare in children aged 24 to 35 months.

-Reactions at the injection site: pain/pain on palpation, redness (erythema).

-Headache: only observed in children aged 24 months and older.

-Drowsiness, abnormal crying: only observed in children under 24 months of age.

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

• Chills: only observed in children aged 24 months and older.
• Reactions at the injection site: hardness (induration), swelling, hematoma (ecchymosis)

Poorly common (may affect up to 1 in 100 people):

• Diarrhea, hypersensitivity.

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

• Flu-like illness, reactions at the injection site: rash, pruritus (itching).

In children aged 6 months to 8 years who receive 2 doses, the side effects are similar both after the first dose and after the second dose. Some side effects may occur after the administration of the second dose in children aged 6 months to 35 months.

These side effects, when observed, normally occurred within the first 3 days following vaccination and disappeared, on their own, between 1 and 3 days after onset. Most of these side effects were of mild intensity.

In general, side effects were less frequent in older people than in adults and children.

The following side effects have been observed after administering Vaxigrip. These side effects may also occur with Vaxigrip Tetra:

• Pain located in the nerve route (neuralgia), seizures (convulsions), neurological disorders that may result in neck stiffness, confusion, numbness, pain, and weakness of the limbs, loss of balance, loss of reflexes, paralysis of a part or the entire body (encephalomyelitis, neuritis, Guillain-Barré syndrome).
• Inflammation of blood vessels (vasculitis) that may lead to skin rashes and, in very rare cases, to temporary kidney problems.
• Transient thrombocytopenia, lymphadenopathy, paresthesia in other age groups other than those described above for these side effects.

Reporting of side effects

If you or your child experience any type of side effect, consult your doctor, pharmacist, even if it is possible side effects that do not appear in this prospectus. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of sight and reach of children.

Do not usethis vaccine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacisthow to dispose ofthe packaging and unusedmedicines. By doing so, you will help protect the environment.

Composition of Vaxigrip Tetra

• The active principles are: Inactivated, split influenza virus of the following strains*:

• Strain similar to A/Victoria/4897/2022 (H1N1)pdm09: (IVR-238)....... 15 micrograms HA**
• Strain similar to A/Thailand/8/2022 (H3N2): A/California/122/2022 (SAN-022)... 15 micrograms HA**
• Strain similar to B/Austria/1359417/2021: B/Michigan/01/2021 ..…...…………... 15 micrograms HA**
• B/Phuket/3073/2013............................................................................ 15 micrograms HA**

Per dose of 0.5 ml

* Cultivated in embryonated chicken eggs from healthy chickens

** Hemagglutinin

This vaccine meets the recommendations of the World Health Organization (Northern Hemisphere) and the European Union's decision for the 2024-2025 campaign.

• The other components are a buffer solution containing sodium chloride, dihydrate sodium phosphate, dihydrogen potassium phosphate, potassium chloride, and water for injection preparations.

Some components such as eggs (ovoalbumin, chicken proteins), neomycin, formaldehyde, or octoxinol-9 may be present in very small quantities (see section 2).

Appearance of the product and contents of the packaging

After shaking it carefully, the vaccine is a slightly whitish and opalescent liquid.

Vaxigrip Tetra is presented in a pre-filled syringe containing 0.5 ml of injectable suspension, with a fixed needle or without a needle (packs of 1, 10, or 20) or with a safety needle (in packs of 1 or 10).

Only some sizes of packaging may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Manufacturer responsible:

The batch release manufacturer is:

Sanofi Winthrop Industrie

1541 avenue Marcel Mérieux

69280 Marcy l'Etoile

France

or

Sanofi Winthrop Industrie

Voie de l'Institut – Parc Industriel d'Incarville

B.P 101

27100 Val de Reuil

France

or

SANOFI-AVENTIS ZRT

Campona U.1 (Harbor Park )

Budapest 1225

Hungary

Tel: +34 93 485 94 00

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

Last revision date of thisleaflet: 06/2024

Othersources of information

You can access detailed and updated information about this medicinal product by scanning the QR code included in the packaging with your smartphone. You can also access this information on the following internet address: https://vaxigriptetra-nh.info.sanofi.----------------------------------------------------------------------------------------------------------------------------------

This information is intended solely for medical professionals or healthcare professionals:

As with all injectable vaccines, medical treatment and appropriate supervision should be available in the event 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 presents foreign particles in the suspension.

Do not mix 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 Vaxigrip Tetra.

Preparation for administration

Instructions for use of the safety needle with the pre-filled syringe Luer Lock:

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