Fluarix Tetra

Package leaflet: Information for the user

Fluarix Tetra, injectable suspension in a pre-filled syringe

Influenza vaccine (split virus, inactivated)
This leaflet has been written with the assumption that it will be read by the person receiving the vaccine.
However, since the vaccine may be administered to adolescents and children, you may read it on behalf of your child.
Please read this leaflet carefully before receiving this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This vaccine has been prescribed only for you or your child. Do not give it to other people.
• If you or your child experience any adverse reactions, including those not listed in this leaflet, please consult your doctor. See section 4.

Contents of this leaflet

1. What Fluarix Tetra is and what it is used for
2. What you need to know before receiving Fluarix Tetra
3. How to receive Fluarix Tetra
4. Possible side effects
5. How to store Fluarix Tetra
6. Contents of the pack and other information

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

Fluarix Tetra is a vaccine. This vaccine helps protect you against influenza, particularly in individuals who are at high risk of developing associated complications.
The use of Fluarix Tetra should be based on official recommendations.
When you are given the Fluarix Tetra vaccine, your immune system (your body's natural defence system) will produce its own protection (antibodies) against the disease.
None of the components contained in the vaccine can cause influenza.
Influenza is an illness that can spread rapidly and is caused by different types of strains that can change each year. Therefore, this is why you may need to be vaccinated every year. The risk of getting influenza is higher during the colder months between October and March. If you were not vaccinated in the autumn, you can still be vaccinated up to spring, as you remain at risk of catching influenza until then. Your doctor will be able to advise you on the best time to be vaccinated.
Fluarix Tetra will protect you against the four virus strains contained in the vaccine starting from about 2-3 weeks after injection.
The incubation period of influenza is a few days; therefore, if you are exposed to influenza immediately before or immediately after vaccination, you may still develop the illness.
The vaccine will not protect you against the common cold, even though some of the symptoms may be similar to those of influenza.

2. What you need to know before taking Fluarix Tetra
To make sure that Fluarix Tetra is suitable for you, it is important to tell your doctor or pharmacist if any of the following apply to you. If there is anything you do not understand, ask your doctor or pharmacist for clarification.

Do not take Fluarix Tetra

• if you are allergic to the active substances or to any of the other ingredients (listed in section 6) or to any component that may be present in small amounts such as eggs (ovalbumin or chicken proteins), formaldehyde, gentamicin sulfate, or sodium deoxycholate.
• if you have an illness with high fever or an acute infection, vaccination should be postponed until after recovery.

Warnings and precautions
Talk to your doctor or pharmacist before taking Fluarix Tetra:

• if you have a weak immune response (immunodeficiency or are taking medicines that affect the immune system)
• if, for any reason, you need to have blood tests within a few days after influenza vaccination. This is because false positive test results have been observed in some patients who were recently vaccinated
• if you have bleeding problems or bruise easily.

Your doctor will decide whether you should receive the vaccine.
Fainting (especially in adolescents) may occur following or even before any injection with a needle; therefore, inform your doctor or nurse if you have previously fainted during an injection.
Like all vaccines, Fluarix Tetra may not fully protect all individuals who are vaccinated.

Other medicines and Fluarix Tetra
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Fluarix Tetra may be administered simultaneously with other vaccines using separate limbs.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Your doctor or pharmacist will be able to decide whether you should receive Fluarix Tetra. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Fluarix Tetra has no influence or negligible influence on the ability to drive or use machinery.

Fluarix Tetra contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is practically “sodium-free”.

Fluarix Tetra contains potassium
This medicine contains less than 1 mmol (39 mg) of potassium per dose, i.e., it is practically “potassium-free”.

3. How to take Fluarix Tetra

Dosage
Adults receive a 0.5 ml dose.
Use in children:
Children from 6 months of age receive a 0.5 ml dose.
If your child is under 9 years of age and has never previously received an influenza vaccine, a second dose should be administered at least 4 weeks after the first.
Method and/or route of administration
The doctor will administer the recommended dose of the vaccine as an intramuscular injection. If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this vaccine may cause side effects, although not everybody gets them.
The following side effects were observed during clinical studies.

Side effects observed in children aged 6 to 36 months
Very common (may occur in more than 1 in 10 doses of vaccine):

• Loss of appetite
• Irritability
• Sleepiness
• Pain at the injection site
• Redness at the injection site

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

• Fever
• Swelling at the injection site

Side effects observed in children aged 3 to 6 years
Very common (may occur in more than 1 in 10 doses of vaccine):

• Pain at the injection site
• Redness at the injection site
• Swelling at the injection site
• Irritability

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

• Loss of appetite
• Sleepiness
• Fever

Uncommon (may occur in up to 1 in 100 doses of vaccine):

• Rash
• Itching at the injection site

Side effects observed in children aged 6 to 18 years
Very common (may occur in more than 1 in 10 doses of vaccine):

• Muscle pain
• Pain at the injection site
• Redness at the injection site
• Swelling at the injection site
• Fatigue

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

• General malaise, diarrhoea, vomiting, stomach pain
• Headache
• Joint pain
• Chills
• Fever

Uncommon (may occur in up to 1 in 100 doses of vaccine):

• Rash
• Itching at the injection site

Side effects observed in adults aged ≥18 years
Very common (may occur in more than 1 in 10 doses of vaccine):

• Local reaction: pain
• Fatigue
• Muscle pain (myalgia)

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

• Headache
• General malaise, diarrhoea, vomiting, stomach ache
• Joint pain (arthralgia)
• Fever, chills
• Local reactions: redness, swelling

Uncommon (may occur in up to 1 in 100 doses of vaccine):

• Bruising (haematoma), itching (pruritus) around the injection site
• Dizziness

The following side effects were also observed during clinical studies with Fluarix (trivalent influenza vaccine) in individuals aged 3 years and older:
Common (may occur in up to 1 in 10 doses of vaccine):

• Hardness (induration) around the injection site
• Sweating

These reactions usually disappear without treatment within 1–2 days.
In addition to the side effects listed above, the following side effects have been reported during the use of Fluarix and/or Fluarix Tetra:
Rare (may occur in up to 1 in 1,000 doses of vaccine):

• Allergic reactions:
  • Medical emergency due to failure of the circulatory system to maintain adequate blood flow to organs (shock);
  • Marked swelling of the head and neck, including face, lips, tongue, throat, or any other part of the body (angioedema)
• Skin reactions that may spread throughout the body, including itching (pruritus, urticaria) and redness (erythema) of the skin
• Neurological disorders which may cause stiff neck, confusion, numbness, pain and weakness in limbs, loss of balance, loss of reflexes, paralysis of part or all of the body (encephalomyelitis, neuritis, Guillain-Barré syndrome)
• Temporary swelling of glands in the neck, armpits or groin (transient lymphadenopathy)
• Influenza-like symptoms, feeling of general discomfort (malaise)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fluarix Tetra

Keep this vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date stated on the cardboard box after the word "Exp". The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C - 8 °C).
Do not freeze.
Keep in the original packaging to protect from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fluarix Tetra contains
The active substance is: Influenza viruses (fragmented, inactivated) from the following strains*:
A/Victoria/4897/2022 (H1N1)pdm09 – equivalent strain (A/Victoria/4897/2022, IVR-238)
HA**15 micrograms
A/Croatia/10136RV/2023 - (H3N2) – equivalent strain (A/Croatia/10136RV/2023, X-425A)
HA**15 micrograms
B/Austria/1359417/2021– equivalent strain (B/Austria/1359417/2021, BVR-26)
HA**15 micrograms
B/Phuket/3073/2013 – equivalent strain (B/Phuket/3073/2013, wild type)
HA**15 micrograms
per 0.5 ml dose
* propagated in fertilized hen's eggs from healthy flocks
** haemagglutinin
This vaccine complies with the recommendations of the World Health Organization (WHO)
(northern hemisphere) and with the recommendations of the European Union for the influenza season
2025/2026.
The other components are:
sodium chloride, disodium phosphate dodecahydrate, monopotassium phosphate, potassium chloride, magnesium chloride hexahydrate, -tocopheryl succinic acid, polysorbate 80, octoxinol 10 and water for injections.

Description of the appearance of Fluarix Tetra and package contents
Fluarix Tetra is an injectable suspension supplied in a pre-filled syringe.
Fluarix Tetra is available in pre-filled syringes containing 1 dose, with or without separate needles, in pack sizes of 1 and 10.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
GlaxoSmithKline Biologicals s.a. Rue de l’Institut, 89 B-1330 Rixensart – Belgium
Local representative: GlaxoSmithKline S.p.A. Viale dell’Agricoltura, 7 - 37135 Verona - Italy

Manufacturer:
GlaxoSmithKline Biologicals – Branch of SmithKline Beecham Pharma GmbH & Co. KG –
Zirkusstrasse 40 – D-01069 Dresden (Germany)

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

The following information is intended exclusively for physicians or healthcare professionals:
As with all injectable vaccines, appropriate medical supervision and treatment must always be immediately available in the event of an anaphylactic reaction following vaccine administration.
Immunization should be performed by intramuscular injection.
Fluarix Tetra must never be administered intravascularly under any circumstances.
Fluarix Tetra may be administered concurrently with other vaccines. Immunizations should be administered in separate limbs.
The vaccine should reach room temperature before use.
Shake well before use. Visually inspect prior to administration.
Instructions for the pre-filled syringe

Luer Lock adapter
Hold the syringe by the barrel, not by the plunger.
Unscrew the syringe cap by turning it
counterclockwise.
Plunger
Barrel
Cap

Needle hub
To attach the needle, connect the needle hub to the Luer Lock adapter and rotate one-quarter turn clockwise until a click is felt.
Do not remove the syringe plunger from the barrel. If this occurs, do not administer the vaccine.
Disposal
Any unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.