Prospect: information for the user

Fluarix Tetra injectable suspension in pre-filled syringe

Influenza vaccine (fractionated and inactivated virus)

This prospectus has been written assuming that the person receiving the vaccine will read it. However, the vaccine may be administered to adolescents and children, so you may be reading it for your child.

Read this prospectus carefully before you or your child receives this vaccine,because it contains important information for you.

• 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 other people.
• If you or your child experience adverse effects,consult your doctor, eveniftheydo not appear in this prospectus. See section 4.

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

2.What you need to know before receiving Fluarix Tetra

3.How Fluarix Tetra is administered

4.Possible adverse effects

5Storage of Fluarix Tetra

6.Contents of the package and additional information

Fluarix Tetra is a vaccine that helps protect you from the flu, especially in people with a high risk of complications associated with the disease. The use of Fluarix Tetra should be based on official recommendations.

When Fluarix Tetra is administered to a person, their immune system (the body's natural defense system) will produce its own protection (antibodies) against the disease. None of the components of the vaccine can cause the flu.

The flu is a rapidly spreading disease caused by different types of strains that can change each year. This is why you may need to be vaccinated annually. The period with the highest risk of contracting the flu is during the cold months, between October and March. If you did not get vaccinated in the fall, it is recommended that you do so before spring, as you will be at risk of getting infected until then. Your doctor will recommend the best time for you to get vaccinated.

Fluarix Tetra will protect you against four strains of the virus from approximately 2 or 3 weeks after the injection.

The incubation period of the flu is a few days, so if you are exposed to the flu immediately before or after getting vaccinated, you can still develop the disease.

The vaccine will not protect you against the common cold, although some of the symptoms may be similar to those of the flu.

To ensure that Fluarix Tetra is suitable for you, it is essential to inform your doctor or pharmacist if any of the following points affect you. If you do not understand something, ask your doctor or pharmacist to explain it to you.

Do not use Fluarix Tetra

• If you are allergic to the active ingredients or any of the other components of this medication (listed in section 6) or to any component that may be present in very small quantities such as eggs (ovalbumin or chicken proteins), formaldehyde, gentamicin sulfate, or sodium desoxycholate.
• If you have any illness accompanied by high fever or an acute infection, the vaccination should be postponed until you have recovered.

Warnings and precautions

Consult your doctor or pharmacist before receiving Fluarix Tetra:

• If you have a weakened immune response (due to immunodeficiency or medications affecting the immune system)
• If, for any reason, you are to undergo blood tests a few days after the flu vaccination. This is because false-positive results have been observed in blood tests of some patients who had recently been vaccinated
• If you have a coagulation problem or easily develop bruises.

Your doctor will decide if you should receive the vaccine.

Before or after any injection, dizziness may occur (especially in adolescents), so inform your doctor or nurse if you have fainted on previous occasions after receiving an injection.

Like all vaccines, Fluarix Tetra may not protect all vaccinated individuals completely.

Use of Fluarix Tetra with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Fluarix Tetra can be administered at the same time as other vaccines if they are injected in different limbs.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Your doctor or pharmacist will decide if you should receive Fluarix Tetra. Ask your doctor or pharmacist for advice before taking any medication.

Driving and operating machinery

The influence of Fluarix Tetra on the ability to drive and operate machinery is negligible or insignificant.

Fluarix Tetra contains sodium

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

Fluarix Tetra contains potassium

This medication contains less than 39 mg (l mmol) of potassium per dose, making it essentially "potassium-free".

Dose

Adults will receive a dose of 0.5 ml.

Use in children:

Children 6 months of age and older will receive a dose of 0.5 ml.

If your child is under 9 years of age and has not been previously vaccinated against influenza, they should receive a second dose at least 4 weeks after the first dose.

Form and/or route of administration

Your doctor will administer the recommended dose of the vaccine via an injection into the muscle.

If you have any other questions about the use of thismedication,ask your doctororpharmacist.

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

The following side effects were observed during clinical trials:

Side effects that occurred in children between 6 and 36 months of age

Very common(may occur with more than 1 in 10 doses of the vaccine):loss of appetite, irritability,sleepiness, pain and/orrednessat the injection site.

Common(may occur up to 1 in 10 doses of the vaccine):fever, swellingat the injection site.

Side effects that occurred in children between 3 and 6 years of age

Very common(may occur with more than 1 in 10 doses of the vaccine):pain and/orredness and/or swellingat the injection site, irritability.

Common(may occur up to 1 in 10 doses of the vaccine):loss of appetite, sleepiness, fever.

Uncommon(may occur up to 1 in 100 doses of the vaccine):skin rash, itchingat the injection site.

Side effects that occurred in children between 6 and 18 years of age

Very common(may occur with more than 1 in 10 doses of the vaccine):muscle pain, pain and/orredness and/or swellingat the injection site, fatigue.

Common(may occur up to 1 in 10 doses of the vaccine):nausea, diarrhea, vomiting, stomach pain,headache, joint pain, chills, fever.

Uncommon(may occur up to 1 in 100 doses of the vaccine):skin rash,itchingat the injection site.

Side effects that occurred in adults ≥18 years of age

Very common(may occur with more than 1 in 10 doses of the vaccine):painat the injection site, fatigue, muscle pain (myalgia).

Common(may occur up to 1 in 10 doses of the vaccine):headache, nausea, diarrhea, vomiting, stomach pain, joint pain(arthralgia),fever, chills,redness and/or swelling at the injection site.

Uncommon(may occur up to 1 in 100 doses of the vaccine):bruising (hematoma), itching (pruritus) around the area where the vaccine is injected,dizziness.

In addition, the side effects that occurred during studiesin subjects from 3 years of agewith Fluarix (trivalent influenza vaccine) were:

Common(may occur up to 1 in 10 doses of the vaccine):hardening (induration) around the area where the vaccine is injected,sweating.

These reactions usually disappear within 1-2 days without treatment.

In addition to the side effects mentioned earlier, the following side effects occurred during the routine use of Fluarix and/or Fluarix Tetra:

Rare(may occur up to 1 in 1000doses of the vaccine):

• Allergic reactions:
• • leading to a medical emergency due to a failure of the circulatory system to provide adequate blood flow to the different organs of the body (shock),
  • swelling, more evident in the head and neck, including the face, lips, tongue, throat, or any other part of the body (angioedema).

• skin reactions that can spread throughout the body, including itching of the skin (pruritus, urticaria) and redness (erythema) of the skin.
• neurological disorders that can cause stiffness in the neck, confusion, numbness, pain, and weakness in the limbs, loss of balance, loss of reflexes, partial or total paralysis of the body (encephalomyelitis, neuritis, Guillain-Barré syndrome).
• temporary swelling of the lymph nodes in the neck, armpits, or groin (transient lymphadenopathy).
• symptoms similar to those of the flu, general malaise.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for the 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.

Keepthis vaccineout of sight and reach of children.

Do not usethis vaccineafter the expiration date that appears on thecontainerafter CAD. The expiration date is the last day of the month indicated.

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

Do not freeze.

Store in the outer packaging to protect it from light.

Drugs should not be disposed of through drains or in the trash. Dispose of the containers and unused medications at the SIGREpoint at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medications. By doing so, you will help protect the environment.

Composition of Fluarix Tetra

The active ingredients are:: inactivated, split influenza virus of the following strains*:

Strain similar toA/Victoria/4897/2022(H1N1)pdm09:

(IVR-238) derived fromA/Victoria/4897/202215 micrograms of HA**

Strain similar to A/Thailand/8/2022 (H3N2):

(IVR-237) derived fromA/Thailand/8/202215 micrograms of HA**

Strain similar toB/Austria/1359417/2021:

(BVR-26) derived from B/Austria/1359417/202115 micrograms of HA**

Strain similar toB/Phuket/3073/2013:

(wild) derived fromB/Phuket/3073/201315 micrograms of HA**

per dose of 0.5 ml

* propagated in embryonated chicken eggs from healthy chicken groups

**hemagglutinin

This vaccine meets the World Health Organization (WHO) recommendation for the Northern Hemisphere and the European Union recommendation for the 2024/2025 campaign.

The other components are:: sodium chloride, sodium phosphate dodecahydrate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride hexahydrate, hydrogen succinate of α-tocopherol, polysorbate 80, octoxinol 10 and water for injection.

Appearance of the product and contents of the package

Fluarix Tetra is a pre-filled syringe suspension.

Fluarix Tetra is available in pre-filled syringe of 1 dose with or without separate needles; package sizes of 1 and 10.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

GlaxoSmithKline Biologicals s.a.

Rue de l’Institut 89

B-1330 Rixensart

Belgium

Manufacturer responsible

GlaxoSmithKline Biologicals NL der SmithKline Beecham Pharma GmbH & Co. KG

Zirkusstrasse 40

D-01069 Dresden

Germany

Local representative

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel.: +34 900 202 700

[email protected]

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

Date of the last review of this leaflet:07/2024

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

--------------------------------------------------------------------------------------------------------------------This information is intended solely for healthcare professionals:

As with all injectable vaccines, adequate medical treatment and supervision should always be available in case of anaphylactic reactions following administration of the vaccine.

The immunization should be carried out by intramuscular injection.

Fluarix Tetra should not be administered by intravascular route.

Fluarix Tetra can be administered at the same time as other vaccines. The immunization should be carried out in different limbs.

Allow the vaccine to reach room temperature before use.

Shake before use. Visually inspect before administration.

Instructions for the pre-filled syringe

Waste disposal

The disposal of unused medicinal product and all materials that have been in contact with it, should be in accordance with local regulations.