Package Insert: Information for the User

Boostrix, Pre-filled Suspension for Injection

Diphtheria, Tetanus, and Pertussis Vaccine (acellular component) (adsorbed, reduced antigen content)

Read this package insert carefully before you or your child receives this vaccine, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This vaccine has been prescribed only for you or your child, and should not be given to anyone else.
• If you or your child experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Boostrix is a vaccine indicated for booster vaccination in children from 4 years old, adolescents, and adults to prevent three diseases: diphtheria, tetanus (lockjaw), and pertussis (whooping cough). The vaccine helps the body produce its own protection (antibodies) against these diseases.

• Diphtheria:Diphtheria mainly affects the respiratory tract and sometimes the skin. Generally, the respiratory tract becomes inflamed (swollen) causing severe respiratory difficulties and sometimes asphyxiation. The bacteria also release a toxin (poison), which can cause neurological damage, heart problems, and even death.

• Tetanus (lockjaw):The tetanus bacteria enters the body through cuts, scratches, or skin wounds. Especially vulnerable wounds are burns, fractures, deep wounds, or wounds contaminated with dirt, dust, horse manure, or wooden splinters. The bacteria release a toxin (poison) that can cause muscle stiffness, painful muscle spasms, convulsions, and even death. Muscle spasms can be so strong that they cause spinal fractures.

• Pertussis (whooping cough):Pertussis is a highly infectious condition. The disease affects the respiratory tract causing severe coughing attacks that can interfere with normal breathing. The cough is often accompanied by a "howling" sound, hence the common name whooping cough. The cough can last 1-2 months or longer. It can also cause ear infections, prolonged bronchitis, pneumonia, convulsions, brain damage, and even death.

None of the vaccine components can cause diphtheria, tetanus, or pertussis.

Using Boostrix during pregnancy will help protect your baby from pertussis in the first few months of life, before they receive their primary immunization.

Do not administer Boostrix:

• If you or your child has had any previous allergic reaction to Boostrix or to any of the other components of this vaccine (listed in section 6) or to formaldehyde. Signs of an allergic reaction may include skin rash with itching, difficulty breathing, and inflammation of the face or tongue.
• If you or your child has had any previous allergic reaction to any vaccine against diphtheria, tetanus, or pertussis.
• If you or your child has experienced problems in the nervous system (encephalopathy) within 7 days after a previous vaccination with a vaccine against pertussis.
• If you or your child has had a severe infection with a high temperature (above 38 °C). A minor infection does not pose a problem, but consult your doctor first.
• If you or your child has experienced a temporary reduction in platelets in the blood (which increases the risk of bleeding or bruising) or nervous system or brain problems after a previous vaccination with a vaccine against diphtheria and/or tetanus.

Warnings and precautions

Consult your doctor or pharmacist before you or your child receives Boostrix:

• If you or your child experienced any problem after a previous administration of Boostrix or another vaccine against pertussis, especially:
• • Fever (above 40 °C) within 48 hours after vaccination.
  • Collapse or a state similar to "shock" within 48 hours after vaccination.
  • Prolonged crying lasting more than 3 hours, produced within 48 hours after vaccination.
  • Convulsions, with or without fever, produced within 3 days after vaccination.

• If your child suffers from an undiagnosed or progressive brain disease or uncontrolled epilepsy. The vaccine should be administered once the disease is controlled.
• If you or your child has bleeding problems or easily develops bruises
• If you or your child has a tendency to convulsions/attacks due to fever or if there is a family history of this
• If you or your child has persistent immune system problems due to any cause (including HIV infection). You or your child may receive Boostrix, but the protection against infections after vaccination will not be as good as in patients with adequate immune responses to infections.

Before or after any injection, dizziness may occur (especially in adolescents), so inform your doctor or nurse if you or your child has fainted after previous injections.

As with all vaccines, Boostrix may not provide complete protection in all vaccinated patients.

Use of Boostrix with other medications

Inform your doctor or pharmacist if you or your child is using, has used recently, or may need to use any other medication or if you have received another vaccine recently.

Boostrix can be administered simultaneously with other vaccines. A different injection site should be used for each type of vaccine. Boostrix may not provide an adequate response if you or your child takes medications that reduce the effectiveness of your immune system against infections.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before receiving this vaccine.

No data are available on whether Boostrix passes into breast milk. Your doctor will inform you of the possible risks and benefits of administering Boostrix during breastfeeding.

Driving and operating machinery

It is unlikely that Boostrix will have any effect on your ability to drive vehicles and operate machinery.

Boostrix contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose; that is, it is essentially "sodium-free".

• Boostrix will be administered as an injection into the muscle.

• The vaccine must never be administered intravenously.

• You or your child will receive a single injection of Boostrix.

• Your doctor will check if you or your child has previously received diphtheria, tetanus, and/or pertussis vaccines.

• Boostrix can be used in case of suspected tetanus infection, although additional measures should also be taken to reduce the risk of disease manifestation, such as wound treatment and/or administration of tetanus antitoxin.

• Your doctor will recommend repeating the vaccination.

Like all medicines, this vaccine may cause side effects, although not everyone will experience them.

As with all injectable vaccines, severe allergic reactions (anaphylactic and anaphylactoid reactions) may occur in very rare instances (up to a maximum of 1 in 10,000 doses of the vaccine). These can be recognized by:

• Skin eruptions such as itching or blisters,
• Swelling of the eyes and face,
• Difficulty breathing or swallowing,
• Unexpected drop in blood pressure andloss of consciousness.

These reactions may occur before leaving the doctor's consultation. However,if you notice any of these symptoms in yourself or your child, you must contact a doctor immediately.

Side effects that have occurred during clinical trials in children aged 4 to 8 years

Very common(may occur with more than 1 in 10 doses of the vaccine): pain, redness, and inflammation at the injection site, irritability, feeling of sleepiness, fatigue.

Common(may occur up to 1 in 10 doses of the vaccine): loss of appetite, headache, fever equal to or greater than 37.5 °C (including fever greater than 39 °C), extensive swelling of the limb where the vaccine was applied, vomiting, and diarrhea.

Uncommon(may occur up to 1 in 100 doses of the vaccine):upper respiratory tract infection, attention disorders, eye and eyelid secretion with itching and crust (conjunctivitis), skin eruption, induration at the site where the injection was administered, pain.

Side effects that have occurred during clinical trials in adults, adolescents, and children aged 10 years and above

Very common(may occur with more than 1 in 10 doses of the vaccine): pain, redness, and inflammation at the injection site, headache, fatigue, general discomfort.

Common(may occur up to 1 in 10 doses of the vaccine): fever equal to or greater than 37.5 °C, dizziness, nausea, induration and abscess at the injection site.

Uncommon(may occur up to 1 in 100 doses of the vaccine): fever greater than 39 °C, pain, muscle and joint stiffness, vomiting, diarrhea, joint stiffness, joint pain, muscle pain, itching, excessive sweating (hyperhidrosis), skin eruption, inflammation of the lymph nodes in the neck, armpits, or groin (lymphadenopathy), throat pain, and swallowing difficulties (pharyngitis), upper respiratory tract infection, cough, fainting (syncope), symptomssimilar to those of the flu, such as fever, sore throat, runny nose, cough, and chills.

The following side effects occurred during the routine use of Boostrix and are not specific to any age group:swelling of the face, lips, mouth, tongue, or throat that may cause difficulty breathing or swallowing (angioedema), collapse or loss of consciousness, seizures or attacks (with or without fever), hives (urticaria), unusual weakness (asthenia).

After administration of tetanus vaccines, in very rare instances (up to a maximum of 1 in 10,000 doses of vaccine) cases of temporary inflammation of the nerves have been reported, which cause pain, weakness, and paralysis in the limbs and often reach the chest and face (Guillain-Barré syndrome).

Reporting of side effects

If you or your child experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use,www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this vaccine out of sight and reach of children.

Do not use this vaccine after the expiration date that appears on the packaging and on the pre-filled syringe label after CAD. The expiration date is the last day of the month indicated.

Store in a refrigerator (between 2 °C and 8 °C).

Do not freeze. Freezing destroys the vaccine.

Store in the original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Boostrix

-The active ingredients are:

Diphtheria toxoid1no less than 2 International Units (UI) (2.5 Lf)

Tetanus toxoid1no less than 20 International Units (UI) (5 Lf)

Antigens ofBordetella pertussis

Pertussis toxoid18 micrograms

Filamentous hemagglutinin18 micrograms

Pertactin12.5 micrograms

1adsorbed on hydrated aluminum hydroxide (Al(OH)3)0.3 milligrams Al3+

and aluminum phosphate (AlPO4)0.2milligrams Al3+

Aluminum hydroxide and aluminum phosphate are included in the vaccine as adjuvants.

Adjuvants are substances included in certain vaccines to accelerate, improve, and/or prolong the protective effect of the vaccine.

Appearance of the product and contents of the package

Injectable suspension in pre-filled syringe.

Boostrix is a white, slightly milky liquid presented in a pre-filled syringe (0.5 ml).

Boostrix is available in pre-filled syringe of 1 dose with or without separate needles; package sizes of 1 and 10.

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos

(Madrid)

Tel: 900 202 700

[email protected]

Manufacturer responsible

GlaxoSmithKline Biologicals S.A.

Rue de l' Institut 89; 1330 Rixensart

Belgium

Last review date of this leaflet: April 2023

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

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This information is intended solely for healthcare professionals:

Before administration, the vaccine must be at room temperature and shaken well to obtain a white, turbid, and homogeneous suspension and visually inspected to observe any foreign particles and/or physical appearance variation before administration. In case of observing any of these circumstances, do not administer the vaccine.

Instructions for the pre-filled syringe

Disposal of residues:

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.