Fluarix suspension for injection in pre-filled syringe
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Fluarix suspension for injection in a pre-filled syringe
Trivalent influenza vaccine (split virion, inactivated)
This leaflet has been written assuming that the person receiving the vaccine is the one reading it. However, you may be reading it on behalf of someone else.
Read all of this leaflet carefully before you start receiving this vaccine because it contains important information for you.
- Keep this leaflet, as 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 pass it on to others.
- If you experience any adverse reactions, consult your doctor, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of this leaflet
- What Fluarix is and what it is used for
- What you need to know before receiving Fluarix
- How Fluarix is given
- Possible side effects
- How to store Fluarix
- 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 (flu) in adults and children from 6 months of age.
Influenza is a respiratory illness affecting the upper airways and lungs, caused by infection with an influenza virus. The most common symptoms of influenza are: high fever, sore throat, cough, general aches, headache, weakness, and fatigue. Complications may occur, particularly in very young individuals, the elderly, and those with weakened immunity to infections.
How Fluarix works
- Fluarix contains inactivated (killed) viruses that cannot cause influenza.
- Fluarix stimulates the body's immune system to produce antibodies against specific influenza viruses for which the vaccine was 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 components of this vaccine (listed in section 6) or to any component that may be present in very small amounts, such as ovalbumin (an egg protein), hydrocortisone, gentamicin sulfate, formaldehyde, and sodium deoxycholate.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving Fluarix if:
-
you have a serious infection with high fever. If this applies to you, vaccination may need to be postponed until you feel better. A minor infection, such as a cold, should not be a problem, but speak with your doctor, pharmacist, or nurse first.
-
you have a bleeding disorder or bruise easily.
Fainting (especially in adolescents) may occur before or after any injection; therefore, inform your doctor, pharmacist, or nurse if you have previously fainted after receiving an injection.
Individuals with a weakened immune system, for example due to HIV infection or medications that suppress the immune system, may not be fully protected by Fluarix.
If any of the above apply to you (or you are unsure), speak with 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 need to take any other medicines, or if you have recently received any other vaccines.
If Fluarix is to be administered at the same time as other vaccines, a different injection site should be used for each vaccine.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before receiving this vaccine.
Driving and use of machines
Some of the side effects listed below in section 4 “Possible side effects” (e.g., fatigue or dizziness) may temporarily affect your ability to drive or operate machinery. Do not drive or operate machinery or tools if you do not feel well.
Fluarix contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per dose and is therefore essentially "sodium-free".
Fluarix contains potassium
This medicine contains less than 39 mg (1 mmol) of potassium per dose and is therefore considered 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 any known allergy to this substance.
3. How Fluarix is given
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 previously been vaccinated against influenza will receive a second injection at least one month after the first dose. Make sure your child completes the vaccination course. This will maximize the protection provided by Fluarix.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this vaccine may cause adverse effects, although not everyone will experience them.
Consult your doctor, pharmacist, or nurse if you would like more information about the possible adverse effects of Fluarix.
Adverse effects reported during general use of Fluarix:
Serious adverse effects
Inform your doctor immediately if you notice any of the following serious adverse effects; you may require urgent medical treatment.
Rare: these may occur in up to 1 in every 1,000 doses of the vaccine
- Severe allergic reactions (anaphylactic reactions). These can be recognized by:
- itchy rash in 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 you experience any of these symptoms, contact a doctor urgently.
Other adverse effects
Inform your doctor, pharmacist, or nurse if you notice any of the following adverse effects.
Rare: these may occur in up to 1 in every 1,000 doses of the vaccine
- Inflammation of nerves (neuritis), inflammation of the brain and spinal cord (encephalomyelitis), temporary inflammation of 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, armpits, or groin (transient lymphadenopathy)
- Flu-like symptoms, general malaise.
Inform your doctor, pharmacist, or nurse if you notice any of the adverse effects listed above.
Adverse effects observed during clinical trials with Fluarix:
Adverse effects in children aged 6 months to less than 6 years
Very common: these may occur in more than 1 in every 10 doses of the vaccine
- Loss of appetite.
- Irritability.
- Drowsiness.
- Pain at the injection site.
- Redness at the injection site.
- Swelling at the injection site.
Common: these may occur in up to 1 in every 10 doses of the vaccine
- Nausea.
- Vomiting.
- Diarrhea.
- Stomach pain.
- Fever.
Adverse effects in children aged 6 years to less than 18 years
Very common: these may occur in more than 1 in every 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: these may occur in up to 1 in every 10 doses of the vaccine
- Nausea.
- Vomiting.
- Diarrhea.
- Stomach pain.
- Joint pain.
- Chills.
- Fever.
Adverse effects in adults aged 18 years and older
Very common: these may occur in more than 1 in every 10 doses of the vaccine
- Pain at the injection site.
- Fatigue.
- Headache.
- Muscle aches.
Common: these may occur in up to 1 in every 10 doses of the vaccine
- Redness, swelling, or a hard lump at the injection site.
- Chills.
- Sweating.
- Joint pain.
- Nausea.
- Vomiting.
- Diarrhea.
- Stomach pain.
Uncommon: these may occur in up to 1 in every 100 doses of the vaccine
- Fever.
- Dizziness.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Fluarix
- Keep this vaccine out of the sight and reach of children.
- Do not use this vaccine after the expiry date stated on the label and packaging, after EXP. The expiry date refers to the last day of the month indicated.
- Store in a refrigerator (between 2 °C and 8 °C).
- Do not freeze.
- Keep in the outer packaging to protect from light.
- Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.
6. Contents of the pack and other information
Composition of Fluarix
The active substance is inactivated, split influenza virus from the following strains*:
A/Victoria/4897/2022(H1N1)pdm09-like strain:
(IVR-238) derived from A/Victoria/4897/2022 – 15 micrograms of HA**
A/Croatia/10136RV/2023(H3N2)-like strain:
(X-425A) derived from A/Croatia/10136RV/2023 – 15 micrograms of HA**
B/Austria/1359417/2021-like strain:
(BVR-26) derived from B/Austria/1359417/2021 – 15 micrograms of HA**
per 0.5 ml dose
- propagated in embryonated hen's eggs obtained from healthy flocks
** haemagglutinin
This vaccine complies with the World Health Organization (WHO) recommendations for the Northern Hemisphere and with the European Union recommendations for the 2025/2026 season.
The other components are: sodium chloride, disodium hydrogen phosphate dodecahydrate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride hexahydrate, α-tocopherol hydrogen succinate, polysorbate 80, octoxynol 10, and water for injections.
Appearance of the product 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 a pre-filled syringe with 1 dose, with or without separate needles; pack sizes of 1 and 10.
- Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline, S.A.
P.T.M. C/ Severo Ochoa, 2
28760 Tres Cantos (Madrid)
Tel.: +34 900 202 700
Manufacturer
GlaxoSmithKline Biologicals
Branch of SmithKline Beecham Pharma GmbH & Co. KG
Zirkusstrasse 40
01069 Dresden
Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Member State | Name |
Austria | Fluarix Trivalent |
Belgium, Luxembourg | Alpharix |
Spain, Finland, France, Italy, Norway, Netherlands, Poland, Portugal, Sweden | Fluarix |
Germany, Greece | Influsplit |
Date of the most recent review of this leaflet: 07/2025
Other sources of information
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).
<----------------------------------------------------------------------------------------------------------------------------------?
This information is intended for healthcare professionals only:
Vaccines should be inspected visually for any foreign particles and/or alterations in physical appearance before administration.
Before use, the vaccine should be shaken well to obtain a colorless, slightly opalescent liquid. Discard if the contents appear otherwise. Inject the entire contents of the syringe.
Instructions for the pre-filled syringe
| Hold the syringe by the barrel, not by the plunger. Unscrew the syringe cap by turning it counterclockwise. |
| To insert the needle, connect the base to the luer-lock adapter and turn it a quarter turn clockwise until you feel it lock into place. Do not remove the syringe plunger from the barrel. If this happens, do not administer the vaccine. |
Waste disposal
The disposal of unused medication and all materials that have come into contact with it must be carried out in accordance with local regulations.