Supemtek Tetra

Package leaflet: Information for the user

Supemtek Tetra

injectable solution in a pre-filled syringe
Quadrivalent influenza vaccine (recombinant, cell culture-derived)
Read this leaflet carefully before receiving this medicine 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, nurse, or pharmacist.
• This vaccine has been prescribed for you only. Do not give it to others.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Supemtek Tetra is and what it is used for

Supemtek Tetra is a vaccine for adults and children aged 9 years and older. This vaccine
helps protect you against influenza. Supemtek Tetra does not contain eggs, due to the technology
used in its production.
When a person is given Supemtek Tetra, the body's natural defence system (the immune system)
develops protection against the influenza virus.
None of the vaccine ingredients can cause influenza.
As with all vaccines, Supemtek Tetra may not fully protect all vaccinated individuals.
When to get vaccinated against influenza
Influenza is a disease that can spread very quickly.

• It is caused by different strains that can change each year. This is why you should be vaccinated every year.
• The highest risk of catching influenza is during the colder months, from October to March.
• If you were not vaccinated in autumn, it is still reasonable to be vaccinated up to spring, as there remains a risk of catching influenza until that time. Your doctor will be able to recommend the best time for you to be vaccinated.

2. What you need to know before receiving Supemtek Tetra

Do not use Supemtek Tetra if you are allergic to:

• the active substances or to any of the other ingredients of this medicine (listed in section 6);
• ethoxylated castor oil (ottilfenolo etossilato), a residue from the manufacturing process.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving Supemtek Tetra.
As with all vaccines, Supemtek Tetra may not fully protect all vaccinated individuals.
Before receiving the vaccine, inform your doctor, nurse, or pharmacist if:

• you have an acute illness accompanied by fever. Vaccination may be postponed until the fever has resolved.
• you have a weakened immune response (immunodeficiency or use of medicines that affect the immune system such as anticancer drugs, i.e. chemotherapy, or corticosteroids).
• you have a bleeding disorder or a tendency to bruise easily.
• you have previously fainted after an injection. Fainting can occur after or even before an injection.
  If any of the above conditions apply to you (or if you are unsure), consult your doctor, pharmacist, or nurse before receiving Supemtek Tetra.

Other medicines and Supemtek Tetra
Inform your doctor or nurse if you are currently using, have recently used, or might use any other medicines, including those obtained without a prescription, or if you have recently received any other vaccine.
Supemtek Tetra may be administered simultaneously with other vaccines, using different limbs.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before receiving this vaccine. Your doctor/pharmacist will help you decide whether or not to receive Supemtek Tetra.

Driving and using machines
Supemtek Tetra does not affect, or affects only negligibly, the ability to drive or operate machinery.
However, exercise caution when driving or operating machinery if your reaction ability is reduced due to any of the side effects listed in section 4 (Possible side effects).

Supemtek Tetra contains sodium and polysorbate 20
This vaccine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.
This medicine contains 0.0275 mg of polysorbate 20 (E432) per 0.5 mL dose. Polysorbates may cause allergic reactions.

3. How Supemtek Tetra is administered

Supemtek Tetra is administered by your doctor, nurse, or pharmacist as an intramuscular injection in the upper arm (deltoid muscle).
Adults and children aged 9 years and older:
One dose of 0.5 mL.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following adverse reactions have been reported with Supemtek Tetra:

Very serious side effects
Contact your doctor or healthcare provider immediately, or go immediately to the nearest emergency room if you experience severe allergic reactions (anaphylactic reaction). These can potentially be life-threatening.
Symptoms may include:

• difficulty breathing, shortness of breath
• swelling of the face, lips, throat or tongue
• cold, clammy skin
• palpitations
• dizziness, weakness, fainting
• skin rash or itching

Contact your doctor or healthcare provider immediately, or go immediately to the nearest emergency room if you experience any of the following side effects:

• stiff neck, confusion, numbness, pain and weakness in limbs, loss of balance, loss of reflexes, paralysis of part or all of the body (Guillain-Barré syndrome).

Other side effects

Very common (may affect more than 1 in 10 people)

• headache
• feeling of tiredness (fatigue)
• muscle pain
• joint pain
• tenderness at injection site
• pain at injection site
  Muscle pain and joint pain are common in adults aged 50 years and older.

Common (may affect up to 1 in 10 people)

• feeling unwell (nausea)
• redness, swelling, hardening and bruising around the area where the vaccine is injected
• fever, shaking/chills
  Fever is rare in adults aged 50 years and older. Bruising has been reported in children/adolescents aged between 9 and 17 years.

Uncommon (may affect up to 1 in 100 people)

• asthma
• cough
• mouth and throat pain
• diarrhoea, vomiting, abdominal discomfort and reduced appetite
• itching sensation
• skin irritation
• skin rash
• flu-like symptoms
• itching at injection site
  Itching sensation is rare in adults aged 50 years and older. Skin irritation and skin rash have not been reported in adults aged 50 years and older. Flu-like symptoms have not been reported in adults aged 18 to 49 years. Vomiting, reduced appetite, abdominal discomfort and asthma have not been reported in adults aged 18 years and older.

Rare (may affect up to 1 in 1,000 people)

• dizziness
• hives (urticaria)
  Dizziness and hives have not been reported in adults aged 18 to 49 years. Dizziness is uncommon in children/adolescents aged between 9 and 17 years.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Supemtek Tetra

Keep this vaccine out of the sight and reach of children.
Store in the refrigerator (2 °C – 8 °C). Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
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 that month.
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 Supemtek Tetra contains
One dose (0.5 mL) contains:
The active substances are haemagglutinin (HA) proteins from the following influenza virus strains*:
Virus type A/xxxxxx (H1N1) ......................................... 45 micrograms HA
Virus type A/xxxxxx (H3N2) ......................................... 45 micrograms HA
Virus type B/xxxxxx ....................................................... 45 micrograms HA
Virus type B/xxxxxx ....................................................... 45 micrograms HA
* produced using recombinant DNA technology, employing a baculovirus expression system in a continuous insect cell line derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda.
This vaccine complies with the World Health Organization (WHO) recommendations (northern hemisphere) and with the European Union (EU) recommendations for the {year/year} season.
The other ingredients are: polysorbate 20 (E432), sodium chloride, monobasic sodium phosphate, dibasic sodium phosphate, water for injections (see section 2).

Description of the appearance of Supemtek Tetra and package contents
Supemtek Tetra is an injectable solution in a pre-filled syringe (injection) (ready-to-use syringe).
Supemtek Tetra is a clear, colourless solution.
Each pre-filled syringe contains a single dose (0.5 mL) of injectable solution.
Supemtek Tetra is available in pack sizes containing 1, 5 or 10 pre-filled syringes without needle or with separate needle.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly
France

Manufacturer
Sanofi Winthrop Industrie
Voie de l’Institut - Parc Industriel d'Incarville
B P 101
27100 Val de Reuil
France

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .

The following information is intended exclusively for healthcare professionals:

Appropriate medical treatment and supervision must always be readily available in the
event of a rare anaphylactic reaction following vaccination.
Perform a visual inspection of the vaccine for the presence of particulate matter and discoloration prior
to administration. Do not administer the vaccine if particulate matter and/or any change in physical
appearance is observed.