Fluarix

ANNEX II
LABELLING AND PACKAGE LEAFLET

Package leaflet: Information for the user

Fluarix injectable suspension in pre-filled syringe

Trivalent inactivated influenza vaccine (split virion)
This leaflet has been written assuming that the person reading it is the one receiving the vaccine, but
it may be read by someone on behalf of another person.
Please read this entire leaflet carefully before starting to receive this vaccine, 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, pharmacist, or nurse.
• This vaccine has been prescribed for you only. Do not give it to other people.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Fluarix is and what it is used for

Fluarix is a vaccine used to prevent influenza in adults and children aged 6 months and older.
Influenza is a disease of the upper respiratory tract and lungs caused by infection with an influenza virus. The most common symptoms of influenza are high fever, sore throat, cough, general discomfort and body aches, headache, weakness, and fatigue. Complications may occur especially in the very young, the elderly, and individuals with weakened immunity to infections.
How Fluarix works

• Fluarix contains inactivated viruses that cannot cause influenza.
• Fluarix stimulates the body's immune system to produce antibodies against the specific viruses for which the vaccine has been designed. This will help prevent the disease.
• The vaccine targets influenza viruses in accordance with official recommendations.
• As with all vaccines, Fluarix may not fully protect all vaccinated individuals.

2. What you need to know before receiving Fluarix

Do not receive Fluarix if:

• you are 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 very small amounts such as ovalbumin (a protein from egg), hydrocortisone, gentamicin sulfate, formaldehyde, and sodium deoxycholate.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving Fluarix if:

• you have a severe infection with high fever. If this is the case, vaccination may need to be postponed until you feel better. A minor infection such as a cold should not be a problem, but discuss it with your doctor, pharmacist, or nurse first.
• you have a bleeding disorder or bruise easily.

Fainting may occur (particularly in adolescents) before or after any injection with a needle. Therefore, inform your doctor, pharmacist, or nurse if you have ever fainted after a previous injection.
People with a weakened immune system, for example due to HIV infection or due to medicines that suppress the immune system, may not get the full benefit from Fluarix.
If any of the conditions listed above apply to you (or if you are unsure), talk to your doctor, pharmacist, or nurse before receiving Fluarix.

Other medicines/vaccines and Fluarix
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, or if you have recently received any other vaccines.
If Fluarix is to be given at the same time as other vaccines, a different injection site must be used for each type of vaccine.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before receiving this vaccine.

Driving and using machines
Some of the side effects mentioned in section 4 "Possible side effects" (e.g. feeling tired or dizzy) may temporarily affect your ability to drive or use machinery. Do not drive or operate machinery or tools if you do not feel well.

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

Fluarix contains potassium
This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially "potassium-free".

Fluarix contains polysorbate 80
This medicine contains no more than 0.415 mg of polysorbate 80 per dose. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies to this substance.

3. How to administer Fluarix

Fluarix is administered as a single 0.5 ml injection into a muscle.
Use in children
Children under 9 years of age who have not been previously vaccinated against influenza will receive a second injection at least one month after the first injection. Ensure that your child completes the full vaccination course. This will maximize the protection provided by Fluarix.
If you have any doubts regarding the use of this vaccine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Ask your doctor, pharmacist, or nurse if you would like more information about the possible side effects of Fluarix.

Side effects that have been reported during general use of Fluarix include:
Serious side effects
Tell your doctor immediately if you notice any of the following serious side effects; urgent medical treatment may be required.
Rare: may occur in up to 1 in 1,000 doses of vaccine

• Severe allergic reactions (anaphylactic reactions). These may be recognized by:
• itchy rash of the 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 after vaccination. However, if any of these signs occur, urgent medical attention is required.

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

• Inflammation of the nerves (neuritis), inflammation of the brain and spinal cord (encephalomyelitis), temporary inflammation of the nerves causing pain, weakness, and paralysis, known as Guillain-Barré syndrome
• Skin reactions that may spread throughout the body, including itching (pruritus, urticaria) and redness of the skin (erythema), rash
• Temporary swelling of the glands in the neck, armpit, or groin (transient lymphadenopathy)
• Flu-like symptoms, general feeling of being unwell. Inform your doctor, pharmacist, or nurse if you notice any of the above-listed side effects.

Side effects observed during clinical studies with Fluarix were:
Side effects observed in children aged 6 months to less than 6 years
Very common: may occur in more 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 in up to 1 in 10 doses of vaccine

• Malaise
• Vomiting
• Diarrhea
• Stomach ache
• Fever

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

• Malaise
• Vomiting
• Diarrhea
• Stomach ache
• Joint pain
• Chills
• Fever

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

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

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

• Redness, swelling, or hard nodule at injection site
• Chills
• Sweating
• Joint pain
• Malaise
• Vomiting
• Diarrhea
• Stomach ache

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

• Fever
• Dizziness

Reporting of side effects
If you experience any side effects, 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

• Keep this vaccine out of the sight and reach of children.
• Do not use this vaccine after the expiry date which is stated on the label and on the carton after 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 the medicine 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 contains
The active substance is: Influenza viruses (split, inactivated) from the following strains*:
A/Victoria/4897/2022 (H1N1)pdm09 – equivalent strain (A/Victoria/4897/2022, IVR-238)
HA**15 micrograms
A/Thailand/8/2022 (H3N2) – equivalent strain (A/Thailand/8/2022, IVR-237)
HA**15 micrograms
B/Austria/1359417/2021 – equivalent strain (B/Austria/1359417/2021, BVR-26)
HA**15 micrograms
per 0.5 ml dose
* propagated in embryonated hens' eggs from flocks of healthy chickens
** haemagglutinin
This vaccine complies with the World Health Organization (WHO) recommendations (Northern Hemisphere) and with the EU recommendations for the 2024/2025 season.
The other components are: sodium chloride, dibasic sodium phosphate dodecahydrate, monobasic potassium phosphate, potassium chloride, magnesium chloride hexahydrate, -tocopherol succinic acid, polysorbate 80, octoxynol 10 and water for injections.

Description of the appearance of Fluarix and contents of the pack

• Fluarix is an injectable suspension in a pre-filled syringe.
• Fluarix is a colourless, slightly opalescent liquid.
• Fluarix is available in pre-filled syringes of 1 dose with or without separate needles, in pack sizes of 1 and 10.
• Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
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 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 Italian Medicines Agency

The following information is intended exclusively for healthcare professionals:

Before administration, vaccines must be visually inspected for the presence of foreign particles and/or physical changes.
Before use, the vaccine should be shaken well to obtain a colourless, slightly opalescent liquid. Discard if the contents appear different.
The entire contents of the syringe must be injected.
Instructions for the pre-filled syringe

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

Needle hub
To attach the needle to the syringe, connect the needle hub to the Luer Lock adapter and rotate one-quarter turn clockwise until a click is felt, indicating secure attachment.
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.