Fluarix

Package Leaflet: Information for the User

Fluarix, Suspension for Injection in a Pre-filled Syringe

This is a trivalent influenza vaccine (split virion, inactivated).
The content of this package leaflet has been prepared in the assumption that it will be read by the person receiving the vaccine. However, since this vaccine may be administered to adults and children, it is possible that the content of the package leaflet will be reviewed by a parent or guardian of the child.

Read the package leaflet carefully before using the vaccine, as it contains important information for the patient.

• Keep this package 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 for a specific person. Do not pass it on to others.
• If the patient experiences any side effects, including any not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Fluarix and what is it used for
• 2. Important information before using Fluarix
• 3. How to use Fluarix
• 4. Possible side effects
• 5. How to store Fluarix
• 6. Contents of the pack and other information

1. What is Fluarix and what is it used for

Fluarix is a vaccine intended for use in adults and children from 6 months of age to prevent influenza.
Influenza is a disease of the upper respiratory tract and lungs caused by the influenza virus. The most common symptoms of influenza are high temperature, sore throat, cough, general aches and pains, headache, weakness, and fatigue. Post-influenza complications can occur, especially in very young, older, and immunocompromised individuals.

How does Fluarix work?

• Fluarix contains killed viruses that cannot cause influenza.
• Fluarix stimulates the immune system of the vaccinated person to produce antibodies against the specific viruses the vaccine is designed to protect against, which helps prevent the disease.
• The vaccine has been developed against influenza viruses based on official recommendations.
• Like all vaccines, Fluarix may not fully protect all vaccinated individuals.

2. Important information before using Fluarix

When not to use Fluarix:

• If the patient is allergic to the active substances or any of the other ingredients of this vaccine (listed in section 6) or to any ingredient that may be present in very small amounts, such as egg albumen (ovalbumin), hydrocortisone, gentamicin sulfate, formaldehyde, and sodium deoxycholate.

Warnings and precautions:

Before administering Fluarix, discuss with your doctor, pharmacist, or nurse:

• if the patient has an acute infection with high fever. Vaccination should be postponed until the patient feels better. Mild infection, such as a cold, is not a contraindication to vaccination, but discuss with your doctor, pharmacist, or nurse beforehand.
• if the patient has bleeding problems or a tendency to bruise.

After or even before administration of each injection, fainting (especially in adolescents) may occur. Inform your doctor, pharmacist, or nurse if the patient has fainted during injection in the past.
If the patient has weakened immune systems, e.g., due to HIV infection or immunosuppressive therapy, Fluarix may not be fully effective.
Tell your doctor, pharmacist, or nurse if any of the above applies to the person to be vaccinated or if the patient is unsure.

Fluarix and other medicines

Tell your doctor, pharmacist, or nurse about all medicines being taken now or recently, and any medicines planned to be taken.
Inform about any recently administered vaccines.
If Fluarix is administered at the same time as other vaccines, each vaccine should be administered at a different injection site.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before using this vaccine.

Driving and using machines

Some of the effects mentioned below in section 4 "Possible side effects" (e.g., fatigue or dizziness) may temporarily affect the ability to drive or operate machinery.
Do not drive or operate machinery if the patient does not feel well.

Fluarix contains sodium

This vaccine contains less than 1 mmol of sodium (23 mg) per dose, which is considered "sodium-free".

Fluarix contains potassium

This vaccine contains potassium, less than 1 mmol (39 mg) per dose, which is considered "potassium-free".

Fluarix contains polysorbate 80

This vaccine contains no more than 0.415 mg of polysorbate 80 per dose. Polysorbates may cause allergic reactions. Consult a doctor if the patient is allergic to this substance.

3. How to use Fluarix

Fluarix is administered as a single intramuscular injection of 0.5 ml.

Use in children

Children under 9 years of age who have not been previously vaccinated against influenza should receive a second dose at least 1 month after the first dose. Ensure the child receives all doses of the vaccine to achieve better protection against influenza.
For further questions on the use of this vaccine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.
For further information on possible side effects of Fluarix, consult a doctor, pharmacist, or nurse.

Side effects reported during general use of Fluarix include:

Severe side effects

Tell your doctor immediately if the patient experiences any of the following severe side effects; urgent medical attention may be needed.
Rare:may occur in up to 1 in 1,000 doses of the vaccine

• Severe allergic reactions (anaphylaxis). Can be recognized by:
• itching rash on hands and feet
• swelling of the eyes and face
• difficulty breathing or swallowing
• sudden drop in blood pressure and loss of consciousness. These reactions usually occur within 15 minutes of vaccination. However, if any of these symptoms occur, seek medical attention immediately.

Other side effects

Tell your doctor, pharmacist, or nurse if the patient experiences any of the following side effects.
Rare:may occur in up to 1 in 1,000 doses of the vaccine

• Nerve inflammation (neuritis), brain and spinal cord inflammation (encephalomyelitis), transient nerve inflammation causing pain, weakness, and paralysis known as Guillain-Barré syndrome
• Skin reactions that can spread across the body, including itching (pruritus, urticaria) and skin redness (erythema), rash
• Temporary swelling of lymph nodes in the neck, under the arms, or in the groin (transient lymphadenopathy)
• Flu-like symptoms, general feeling unwell. Tell your doctor, pharmacist, or nurse if the patient experiences any of these side effects.

Side effects observed in clinical trials with Fluarix include:

Side effects that occurred in children from 6 months to less than 6 years of age

Very common:may occur in more than 1 in 10 doses of the vaccine

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

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

• Nausea
• Vomiting
• Diarrhea
• Abdominal pain
• Fever

Side effects that occurred in children from 6 to less than 18 years of age

Very common:may occur in more than 1 in 10 doses of the vaccine

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

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

• Nausea
• Vomiting
• Diarrhea
• Abdominal pain
• Joint pain
• Chills
• Fever

Side effects that occurred in adults 18 years of age and older

Very common:may occur in more than 1 in 10 doses of the vaccine

• Pain at the injection site
• Fatigue
• Headache
• Muscle pain

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

• Redness, swelling, or hard lump at the injection site
• Chills
• Sweating
• Joint pain
• Nausea
• Vomiting
• Diarrhea
• Abdominal pain

Rare:may occur in up to 1 in 100 doses of the vaccine

• Fever
• Dizziness

Reporting side effects

If side effects occur, including any not listed in the package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Fluarix

• Store in a place out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of that month.
• The "Lot" abbreviation means the batch number of the product.
• Store in a refrigerator (2°C - 8°C).
• Do not freeze.
• Store in the original package to protect from light.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Fluarix contains

The active substance is split, inactivated influenza virus from the following strains*:

A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238)

15 micrograms of HA**

A/Croatia/10136RV/2023 (H3N2)-like strain (A/Croatia/10136RV/2023, X-425A)

15 micrograms of HA**

B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26)

15 micrograms of HA**
in a 0.5 ml dose
* grown in fertilized eggs from healthy flocks
** hemagglutinin
This vaccine is in line with the recommendations of the World Health Organization (WHO) (for the Northern Hemisphere) and the European Union for the 2025/2026 season.
Other ingredients of the vaccine are: sodium chloride, disodium phosphate dodecahydrate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride hexahydrate, α-tocopherol hydrogen succinate, polysorbate 80, octoxynol 10, and water for injections.

What Fluarix looks like and contents of the pack

• Fluarix is a suspension for injection in a pre-filled syringe.
• Fluarix is a colorless to slightly opalescent liquid.
• Fluarix is available in packs of 1 and 10 pre-filled syringes, with or without needles.
• Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder: Manufacturer:

GlaxoSmithKline Biologicals S.A.
GlaxoSmithKline Biologicals
Rue de l’Institut 89
SmithKline Beecham Pharma GmbH&Co. KG
1330 Rixensart
Zirkusstrasse 40
Belgium
01069 Dresden
Germany

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

Date of last revision of the package leaflet: July 2025

Other sources of information

Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
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Information intended for healthcare professionals only:
Before administration, inspect the vaccine for any visible signs of damage or physical changes.
Shake before use to obtain a colorless to slightly opalescent liquid. If any changes are observed, do not administer the vaccine.
Administer the entire contents of the pre-filled syringe.
Instructions for the pre-filled syringe

Hold the pre-filled syringe by the body, not by the plunger.
Luer Lock adapter
Twist the needle hub of the pre-filled syringe in a counter-clockwise direction to remove it.
Plunger
Body
Needle hub

Attach the needle to the pre-filled syringe by twisting the needle hub onto the Luer Lock adapter (LLA) in a clockwise direction until it clicks into place.
Do not pull the plunger out of the body of the pre-filled syringe. If this happens, do not administer the vaccine.
Needle hub
Disposal
Any unused product or waste material should be disposed of in accordance with local requirements.