FLUARIX TETRA

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I receiving FLUARIX TETRA?

FLUARIX TETRA contains inactivated influenza virus as the active ingredient. FLUARIX TETRA is used to vaccinate against some
strains of the influenza virus.
For more information, see Section 1. Why am I receiving FLUARIX TETRA? in the full CMI.

2. What should I know before I receive FLUARIX TETRA?

Do not use if you have ever had an allergic reaction to FLUARIX TETRA, any other influenza vaccine or any of the ingredients listed
at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become
pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I receive FLUARIX TETRA? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with FLUARIX TETRA and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How is FLUARIX TETRA given?

• Your doctor, nurse or pharmacist will give you FLUARIX TETRA as an injection into your upper arm or upper thigh muscle.
• For adults and older children: FLUARIX TETRA is generally given as a single injection.
• For children aged between 6 months and 9 years of age who have not received an influenza vaccine before: a second dose is
given 4 weeks after the first dose.
More instructions can be found in Section 4. How is FLUARIX TETRA given? in the full CMI.

5. What should I know after receiving FLUARIX TETRA?

Driving or using • Be careful before you drive or use any machines or tools until you know how FLUARIX TETRA affects
machines you.
• FLUARIX TETRA may cause dizziness or light-headedness in some people.
Looking after • FLUARIX TETRA will normally be stored at the doctor’s surgery or in the pharmacy.
your medicine • If you need to store FLUARIX TETRA, keep it in the refrigerator between 2oC and 8oC. Do not freeze.
For more information, see Section 5. What should I know after receiving FLUARIX TETRA? in the full CMI.

6. Are there any side effects?

Side effects which have been reported following administration of FLUARIX TETRA include redness, swelling, a hard lump,
soreness, bruising or itching around the injection site, pain at the injection site, fever, chills, shivering, sweating, dizziness,
headache, a general feeling of being unwell, muscle aches and pain, joint pain, a loss of appetite, feeling sick, vomiting, diarrhoea,
stomach pain, irritability, drowsiness, fatigue and rash.
Allergic reactions have also occurred following administration of FLUARIX TETRA. Allergy is rare and severe reactions will usually
occur within the first few hours of vaccination. If this occurs go to the Emergency Department of the nearest hospital
immediately.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FLUARIX TETRA 1
FLUARIX TETRA
Active ingredient(s): inactivated split influenza vaccine

Consumer Medicine Information (CMI) 2. What should I know before I receive

This leaflet provides important information about using FLUARIX TETRA?
FLUARIX TETRA. You should also speak to your doctor or
Warnings
pharmacist if you would like further information or if you
have any concerns or questions about using FLUARIX Do not receive FLUARIX TETRA if:
TETRA.
• you are allergic to FLUARIX TETRA, any other influenza
Where to find information in this leaflet:
vaccine, or any of the ingredients listed at the end of
this leaflet.
1. Why am I receiving FLUARIX TETRA?
2. What should I know before I receive FLUARIX TETRA? Always check the ingredients to make sure you can
3. What if I am taking other medicines? use this medicine.
4. How is FLUARIX TETRA given? • you or your child have a severe infection with a high
5. What should I know after receiving FLUARIX TETRA? temperature. Your doctor may decide to delay
6. Are there any side effects? vaccination with FLUARIX TETRA until the illness has
7. Product details passed. A minor infection such as a cold is not usually
a reason to delay vaccination but talk to your doctor,
1. Why am I receiving FLUARIX TETRA? nurse or pharmacist about this before being
FLUARIX TETRA contains inactivated split influenza virus vaccinated.
as the active ingredient. If you are unwell and cannot receive FLUARIX TETRA, talk
FLUARIX TETRA is used to help prevent certain types of to your doctor, nurse or pharmacist about when you can
influenza. receive it.
The vaccine works by causing the body to produce its own Check with your doctor if you/your child:
protection (antibodies) against four different types of
influenza virus. • have any other medical conditions
• have an immune deficiency condition
The types of influenza antigen contained in FLUARIX TETRA
• have a bleeding disorder
may change from one year to another. Each year the
• take any medicines for any other condition
Australian Influenza Vaccine Committee (AIVC)
• have had or have Guillain-Barre Syndrome, an
recommends which strains to include in the vaccine. This
inflammatory illness affecting the nerves and resulting
decision is based on the types of influenza virus thought
in muscle weakness
most likely to occur during the next flu season.
• have received another vaccine
Therefore, it is recommended to receive an influenza • are allergic to latex
vaccination every year.
You may be at risk of developing certain side effects. It is
FLUARIX TETRA will only protect you against the four
important you understand these risks and how to monitor
types of influenza virus used to make the vaccine. It will
for them. See additional information under Section 6. Are
not protect you from influenza caused by other types of
there any side effects?
influenza virus or from infections with other agents that
cause flu-like symptoms (such as the common cold). Pregnancy and breastfeeding
FLUARIX TETRA cannot give you influenza when you Check with your doctor, nurse or pharmacist if you are
receive it as the virus in the vaccine has been killed. pregnant or intend to become pregnant. They will discuss
Influenza is an infectious illness and is spread by small with you the risks and benefits involved in receiving
droplets from the nose, throat or mouth of an infected FLUARIX TETRA.
person. The most common symptoms of influenza include Talk to your doctor, nurse or pharmacist if you are
fever, sore throat, runny nose, coughing, general aches breastfeeding or intend to breastfeed.
and pains, headache, weakness and tiredness. Most
people recover completely within one week. It is not expected that FLUARIX TETRA will cause problems
for breastfed babies.
The risk of serious complications (e.g. pneumonia and
death) is greater in very young, very old and chronically ill Fainting
people.
Fainting can occur following, or even before, any needle
FLUARIX TETRA can be used in adults and children older injection. Tell the person giving you your injection if you or
than 6 months of age. your child have ever fainted with a previous injection.

FLUARIX TETRA 2
3. What if I am taking other medicines? You should do this even if there are no signs of
discomfort or poisoning.
Tell your doctor, nurse or pharmacist if you are taking any
other medicines, including any medicines, vitamins or
5. What should I know after receiving
supplements that you buy without a prescription from
your pharmacy, supermarket or health food shop. FLUARIX TETRA?
Some medicines may interfere with FLUARIX TETRA and Driving or using machines
affect how it works.
Be careful before you drive or use any machines or tools
• theophylline – a medicine used in chronic obstructive until you know how FLUARIX TETRA affects you.
pulmonary disease and asthma
FLUARIX TETRA may cause dizziness or light-headedness in
• phenytoin, phenobarbitone, carbamazepine –
some people.
medicines used in the treatment of seizures, fits and
epilepsy Looking after your medicine
• warfarin – a medicine used to thin your blood to
prevent blood clots • FLUARIX TETRA will usually be stored at the doctor’s
• steroids, ciclosporin – medicines used to suppress the clinic or at the pharmacy.
immune system • If you need to store FLUARIX TETRA it is important to
keep it in the refrigerator between 2oC and 8oC.
Check with your doctor or pharmacist if you are not sure • DO NOT FREEZE FLUARIX TETRA. FREEZING THIS
about what medicines, vitamins or supplements you are MEDICINE WILL DESTROY THE VACCINE.
taking and if these affect FLUARIX TETRA.
Follow the instructions on the carton on how to take care
of your medicine properly.
4. How is FLUARIX TETRA given?
Keep it where young children cannot reach it.
How much is given
Getting rid of any unwanted medicine
• Your doctor, nurse or pharmacist will give you
FLUARIX TETRA as an injection Do not use this medicine after the expiry date.
• For adults and children over the age of 6 months, 0.5
mL is given 6. Are there any side effects?
How it is given All medicines can have side effects. If you do experience
any side effects, most of them are minor and temporary.
• FLUARIX TETRA is generally injected into the upper However, some side effects may need medical attention.
arm or upper thigh muscle
See the information below and, if you need to, ask your
When is it given doctor or pharmacist if you have any further questions
about side effects.
• For adults and older children: FLUARIX TETRA is
generally given as a single dose each year before the Most side effects with FLUARIX TETRA are mild and usually
start of the influenza season which usually occurs clear up within a few days. These effects, as with other
during winter vaccines, usually occur around the injection site.
• For children aged between 6 months and 9 years of Less serious side effects
age who have not received an influenza vaccine
before: a second dose is given 4 weeks after the first Less serious side effects What to do
dose • redness, swelling, a hard lump, Speak to your
If a scheduled dose is missed, talk to your doctor or nurse soreness, bruising or itching doctor if you
and arrange another visit as soon as possible. around the injection site have any of
Vaccination against influenza should be repeated every • pain at the injection site these less
year as different types of influenza virus strains can occur • fever, chills, shivering, sweating, serious side
in different years. dizziness, headache, malaise effects and
(generally feeling unwell) they worry you.
If you are given too much FLUARIX TETRA
• muscle aches and pain
If you think that you have been given too much FLUARIX • joint pain
TETRA, you may need urgent medical attention. • loss of appetite, feeling sick,
You should immediately: vomiting, diarrhoea, stomach
pain
• phone the Poisons Information Centre • irritability
(by calling 13 11 26), or • drowsiness
• contact your doctor, or • fatigue
• go to the Emergency Department at your nearest • rash
hospital.

FLUARIX TETRA 3
Serious side effects Always make sure you speak to your doctor or
pharmacist before you decide to stop taking any of your
Serious side effects What to do medicines.
• transient swollen glands in the Call your doctor
neck, armpit or groin straight away, 7. Product details
• painful swelling in the arms or or go straight
legs to the What FLUARIX TETRA contains
• vomiting Emergency Active ingredient A/ Victoria/4897/2022
• flu-like symptoms such as a high Department at (H1N1)pdm09-like strain
your nearest (main ingredient)
temperature, sore throat, runny
hospital if you A/ Thailand/8/2022 (H3N2)-like
nose, cough and chills
strain
• weakness of muscles notice any of
these serious B/Austria/1359417/2021-like
side effects. strain
In very young children, high fevers B/Phuket/3073/2013-like strain
may result in convulsions (fits). It is
advisable to monitor young children Other ingredients dibasic sodium phosphate
for high fevers post influenza (inactive ingredients) dodecahydrate
vaccination. dl-alpha-tocopheryl acid
succinate
There have been rare reports of formaldehyde (≤ 5 micrograms)
Guillain-Barre Syndrome (an gentamicin sulphate (trace
inflammatory illness affecting nerves amount)
and resulting in muscle weakness).
hydrocortisone (trace amount)
However these events have not been
definitively linked to the use of magnesium chloride
influenza vaccines. hexahydrate
• allergic reaction monobasic potassium
phosphate
Signs of an allergic reaction include:
octoxinol 10
swelling of the limbs, face, eyes,
ovalbumin (≤ 0.05 micrograms)
inside of the nose, mouth or throat
polysorbate 80
shortness of breath, breathing or
swallowing difficulties potassium chloride
hives, itching (especially of the hands sodium chloride
or feet), reddening of the skin sodium deoxycholate (trace
(especially around the ears) or amount)
severe skin reactions
water for injections
unusual tiredness or weakness that is
sudden and severe
Allergy to FLUARIX TETRA is rare. The manufacture of this product includes exposure to
Severe reactions will usually occur bovine derived materials. No evidence exists that any case
within the first few hours of of vCJD (considered to be the human form of bovine
vaccination. If this occurs go to the spongiform encephalopathy) has resulted from the
Emergency Department of the administration of any vaccine product.
nearest hospital immediately. FLUARIX TETRA is not made with any human blood, blood
products or substances made of human origin.
Tell your doctor or pharmacist if you notice anything else
that may be making you feel unwell. Do not take this medicine if you are allergic to any of
these ingredients.
Other side effects not listed here may occur in some
people. What FLUARIX TETRA looks like
Reporting side effects FLUARIX TETRA is a colourless to slightly opalescent
suspension.
After you have received medical advice for any side effects
you experience, you can report side effects to the AUST R 200674 – pre-filled syringes available in packs of
Therapeutic Goods Administration online at either 1 or 10 syringes without needles.
www.tga.gov.au/reporting-problems. By reporting side AUST R 242512 – pre-filled syringes available in packs of
effects, you can help provide more information on the either 1 or 10 syringes without needles.
safety of this medicine.
Not all presentations and pack sizes may be distributed.

FLUARIX TETRA 4
Who distributes FLUARIX TETRA
GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street
Abbotsford, VIC 3067

Trade marks are owned by or licensed to the GSK group of

companies.
© 2023 GSK group of companies or its licensor.

This leaflet was prepared on 22 November 2023.

Version 12.0

FLUARIX TETRA 5