Fluarix

Package leaflet: Information for the user

Fluarix, suspension for injection in pre-filled syringe
Trivalent influenza vaccine (split virion, inactivated)
The text of this leaflet has been prepared with the assumption that it will be read by the person receiving
the vaccine. However, since this vaccine may be administered to both adults and children, it is possible that
the content of the leaflet will be reviewed by a parent or guardian of a child.
Please read this leaflet carefully before using the vaccine, as it contains important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist or nurse.
• This vaccine has been prescribed for a specific individual. Do not pass it on to others.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet:

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

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

Fluarix is a vaccine intended for use in adults and children from 6 months of age onwards
for the prevention of influenza.
Influenza is a disease of the upper respiratory tract and lungs caused by infection with the influenza virus. The most common symptoms of influenza include high fever, sore throat, cough, general aches and discomfort, headache, weakness and fatigue. Influenza-related complications may occur especially in very young individuals, the elderly, and those with weakened immunity to infections.
How does Fluarix vaccine work?

• Fluarix vaccine contains inactivated viruses that cannot cause influenza.
• Fluarix vaccine stimulates the immune system of the vaccinated person to produce antibodies against specific viruses targeted by the vaccine. This will help prevent the disease.
• The vaccine has been developed against influenza viruses based on official recommendations.
• As with all vaccines, Fluarix may not fully protect all vaccinated individuals.

2. Important information before using Fluarix vaccine

When not to use Fluarix vaccine:

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

Warnings and precautions:
Before administering Fluarix vaccine, discuss the following with a doctor, pharmacist, or nurse:

• If the patient has an acute infection accompanied by high fever. Vaccination should be postponed until the patient feels better. A mild infection, such as a cold, is not a contraindication to vaccination, but it is advisable to consult a doctor, pharmacist, or nurse beforehand.
• If the patient has bleeding disorders or a tendency to bruise easily.

Fainting may occur after or even before receiving any injectable vaccine (particularly in adolescents). Therefore, inform the doctor, pharmacist, or nurse if the patient has ever fainted during or after an injection.
If the patient has a weakened immune system, for example due to HIV infection or taking medications that affect the immune system, the Fluarix vaccine may not be fully effective.
Inform the doctor, pharmacist, or nurse if any of the above statements apply to the person who is to receive the Fluarix vaccine, or if the patient is unsure whether any of the above apply.

Fluarix and other medicines
Tell the doctor, pharmacist, or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Inform them about any vaccines recently administered.
If Fluarix is administered simultaneously with other vaccines, each vaccine should be given at a different injection site.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before receiving this vaccine.

Driving and operating machinery
Some of the side effects listed 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 or tools if the patient does not feel well.

Fluarix contains sodium
This vaccine contains less than 1 mmol of sodium (23 mg) per dose, i.e., the medicine is considered "sodium-free".

Fluarix contains potassium
This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e., the medicine 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 the Fluarix vaccine

The Fluarix vaccine is administered as a single 0.5 ml intramuscular injection.
Use in children
Children under 9 years of age who have not previously been vaccinated against influenza should receive a second dose at least one month after the first dose. Make sure the child receives all doses of the vaccine, as this will help provide better protection against the disease.
If you have any further questions about the use of this vaccine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this vaccine can cause adverse reactions, although not everyone will experience them.
For additional information about possible adverse reactions of Fluarix vaccine,
please consult your doctor, pharmacist, or nurse.
Adverse reactions reported during general use of Fluarix vaccine include:
Serious adverse reactions
Inform your doctor immediately if you notice any of the following
serious adverse reactions; urgent medical attention may be required.
Rare: may occur no more frequently than 1 in 1,000 doses of vaccine

• Severe allergic reactions (anaphylactic reactions). These can be recognized by:
• itching rash on the palms and soles
• 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 after vaccination. However, if any of these symptoms occur, seek immediate medical attention.

Other adverse reactions
Inform your doctor, pharmacist, or nurse if you notice any of the
following adverse reactions.
Rare: may occur no more frequently than 1 in 1,000 doses of 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 may spread throughout 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)
• Influenza-like symptoms, general malaise. Inform your doctor, pharmacist, or nurse if you experience any of the above adverse reactions.

The following adverse reactions were observed in clinical trials with Fluarix vaccine:
Adverse reactions observed in children aged 6 months to less than 6 years
Very common: may occur more frequently than 1 in 10 doses of vaccine

• loss of appetite
• irritability
• drowsiness
• pain at injection site
• redness at injection site
• swelling at injection site

Common: may occur no more frequently than 1 in 10 doses of vaccine

• nausea
• vomiting
• diarrhoea
• abdominal pain
• fever

Adverse reactions observed in children aged 6 to less than 18 years
Very common: may occur more frequently than 1 in 10 doses of vaccine

• headache
• muscle pain
• fatigue
• pain at injection site
• redness at injection site
• swelling at injection site

Common: may occur no more frequently than 1 in 10 doses of vaccine

• nausea
• vomiting
• diarrhoea
• abdominal pain
• joint pain
• chills
• fever

Adverse reactions observed in adults aged 18 years and older
Very common: may occur more frequently than 1 in 10 doses of vaccine

• pain at injection site
• fatigue
• headache
• muscle aches

Common: may occur no more frequently than 1 in 10 doses of vaccine

• redness, swelling, or hard lump at injection site
• chills
• sweating
• joint pain
• nausea
• vomiting
• diarrhoea
• abdominal pain

Rare: may occur no more frequently than 1 in 100 doses of vaccine

• fever
• dizziness

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in
this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps gather more information on the safety of the medicine.
Adverse reactions can also be reported to the responsible entity.

5. How to store the Fluarix vaccine

• Keep the vaccine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label and the outer carton after: EXP. The expiry date refers to the last day of the specified month.
• The abbreviation "Lot" indicates the product batch number.
• Store in a refrigerator (2°C - 8°C).
• Do not freeze.
• Store in the original packaging 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 in use. 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 derived 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**
per 0.5 ml dose
* propagated in embryonated chicken eggs from healthy flocks
** hemagglutinin
This vaccine complies with the recommendations of the World Health Organization (WHO) (for the northern hemisphere) and the European Union for the 2025/2026 season.
Other components 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 colourless and slightly opalescent liquid.
• Fluarix is available as a single-dose pre-filled syringe, with needles supplied separately in the packaging or without needles, in pack sizes of 1 and 10.
• Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Manufacturer:
GlaxoSmithKline Biologicals S.A. GlaxoSmithKline Biologicals
Rue de l’Institut 89 Filia SmithKline Beecham Pharma GmbH&Co. KG
1330 Rixensart Zirkusstrasse 40
Belgium 01069 Dresden
Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Other sources of information
Detailed information about this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

Information intended exclusively for qualified medical personnel:

Before administering the vaccine, inspect it visually for the presence of foreign particles and/or physical changes.
Shake well before use to obtain a colourless, slightly opalescent liquid. If any changes are observed, the vaccine must not be administered.
The entire contents of the pre-filled syringe must be administered.
Instructions for the pre-filled syringe

Hold the pre-filled syringe by the
Luer Lock adapter body, not by the plunger.
Unscrew the syringe cap
Plunger by turning it counterclockwise.
Cap

Attach the needle to the
Needle cap pre-filled syringe by connecting
the needle cap to the Luer Lock adapter (Luer
Lock Adaptor, LLA) and rotating it a quarter
turn clockwise until a click is felt,
indicating that the needle is locked.
Do not pull the plunger out of the
syringe barrel. If this occurs,
do not administer the vaccine.
Disposal
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.