Prospect: information for the user

Boostrix Polio, Pre-filled syringe suspension

Diphtheria, tetanus, pertussis (acellular component) and inactivated poliomyelitis (adsorbed, reduced antigen content) vaccine

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

• Keep this prospect, as you may need to read 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 other people.
• If you or your child experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Boostrix Polio is a vaccine indicated for booster vaccination in children from 3 years old, adolescents, and adults to prevent four diseases: diphtheria, tetanus (lockjaw), pertussis (whooping cough), and poliomyelitis (polio). The vaccine helps the body to 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 asphyxia. 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, horse manure, or wood 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:Pertussis is a highly contagious illness. The disease affects the respiratory tract causing severe coughing attacks that can interfere with normal breathing. The cough is often accompanied by a "whooping" sound, hence the common name of 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.

• Poliomyelitis (polio):Poliomyelitis, sometimes simply called "polio," is a viral infection that can have different effects. It often causes a mild disease but in some people causes permanent damage or even death. In its most severe form, the infection causes paralysis of the muscles (the muscles cannot move), including those necessary for breathing and walking. The affected limbs can become deformed painfully.

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

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

Do not administer Boostrix Polio:

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

Warnings and precautions

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

• if you or your child experienced any problems after a previous administration of Boostrix Polio or another pertussis vaccine, especially:
• • Fever (above 40°C) within 48 hours after vaccination
  • Collapse or a state similar to “shock” within 48 hours after vaccination
  • Prolonged, inconsolable 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 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 Polio, 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 Polio may not provide complete protection in all vaccinated patients.

Use of Boostrix Polio 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 recently any other vaccine.

Boostrix Polio can be administered at the same time as some vaccines. Use a different injection site for each type of vaccine, as the injection site will be different.

Boostrix Polio 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 intend to become pregnant, consult your doctor or pharmacist before receiving this vaccine.

The passage of Boostrix Polio into breast milk is unknown. Your doctor will inform you of the possible risks and benefits of administering Boostrix Polio during breastfeeding.

Driving and operating machinery

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

Boostrix Polio contains neomycin and polymyxin

This vaccine contains neomycin and polymyxin (antibiotics). Please inform your doctor if you or your child has had an allergic reaction to these components.

Boostrix Polio contains para-aminobenzoic acid, phenylalanine, sodium, and potassium

Boostrix Polio contains para-aminobenzoic acid. It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm.

This vaccine contains 0.0298 micrograms of phenylalanine in each dose. Phenylalanine may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This vaccine contains less than 1 mmol of sodium (23 mg) per dose; it is essentially “sodium-free”.

This vaccine contains potassium, less than 1 mmol (39 mg) per dose; it is essentially “potassium-free”.

• Boostrix Polio will be administered as an injection into a muscle.

• The vaccine must never be administered intravenously.

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

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

• Boostrix Polio may 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, Boostrix Polio can cause side effects, although not everyone will experience them.

As with all injectable vaccines, it may cause severe allergic reactions (anaphylactic and anaphylactoid reactions) in very rare occasions (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,
• rapid decrease 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 your 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, feeling sleepy.

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

Uncommon(may occur up to 1 in 100 doses of the vaccine): diarrhea, nausea, vomiting, stomach pain, inflammation of the lymph nodes in the neck, armpits or groin (lymphadenopathy), difficulty sleeping, apathy, dry throat, fatigue.

Coadministration with measles, mumps and rubella (MMR) vaccine or measles, mumps, rubella and varicella (MMRV) vaccine in children aged 3-6 years

In studies where Boostrix Polio was administered at the same time as the MMR or MMRV vaccines, skin eruptions and upper respiratory tract infections (including nasal discharge and sore throat) were frequently reported. Fever, irritability, fatigue, loss of appetite and gastrointestinal disturbances (including diarrhea and vomiting) were reported more frequently (very common) than in studies where Boostrix Polio was administered alone.

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, fatigue, headache.

Common(may occur up to 1 in 10 doses of the vaccine): fever equal to or greater than 37.5°C, bruising, itching, hardening, warmth at the injection site, stomach pain, nausea, vomiting.

Uncommon(may occur up to 1 in 100 doses of the vaccine): fever greater than 39°C, extensive swelling of the limb where the vaccine was applied, chills, pain, dizziness, joint pain, muscle pain, itching, oral herpes, lymphadenopathy, loss of appetite, tingling or numbness in the hands or feet (paresthesia), drowsiness, asthma.

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

Additionally, the following side effects were reported during clinical trials with Boostrix (GlaxoSmithKline booster vaccine against diphtheria, tetanus and pertussis):

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

Uncommon(may occur up to 1 in 100 doses of the vaccine):attention disorders, discharge with itching of the eyes and eyelids with crust (conjunctivitis), dolor.

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

Very common(may occur with more than 1 in 10 doses of the vaccine):general malaise.

Common(may occur up to 1 in 10 doses of the vaccine):indurationor abscess at the injection site.

Uncommon(may occur up to 1 in 100 doses of the vaccine):upper respiratory tract infection, sore throat and difficulty swallowing (pharyngitis), fainting (syncope), cough, diarrhea, excessive sweating (hyperhidrosis), skin eruption, joint stiffness, muscle stiffness and joint stiffness, symptomssimilar to the flu, such as fever, sore throat, runny nose, cough and chills.

After administration of tetanus vaccines, in very rare occasions (up to a maximum of 1 in 10,000 doses of the 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 leaflet. 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.

Drugs should not be disposed of through drains or in the trash. Dispose of the containers and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medications. By doing so, you will help protect the environment.

Composition of Boostrix Polio

• The active principles 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

Inactivated poliovirus

Type 1 (Mahoney strain)240 antigen units D

Type 2 (MEF-1 strain)28 antigen units D

Type 3 (Saukett strain)232 antigen units D

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

and aluminum phosphate (AlPO4)0.2 milligrams Al3+

2propagated in Vero cells

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.

• The other components are: Medium 199 (containing amino acids (including phenylalanine), mineral salts (including sodium and potassium), vitamins (including para-aminobenzoic acid) and other substances), sodium chloride, and water for injection.

Appearance of the product and contents of the package

Injectable suspension in a pre-filled syringe.

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

Boostrix Polio 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 marketed.

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

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Boostrix Polio:Belgium, Bulgaria, Czech Republic, Denmark, Germany, Greece, Spain, Iceland, Latvia, Lithuania, Luxembourg, Hungary, Netherlands, Norway, Austria, Poland, Portugal, Slovenia, Finland, Sweden

Boostrix Polio Lag:Slovak Republic

Boostrix Tetra:France

IPV-Boostrix:Ireland, Malta

Polio Boostrix:Italy

Boostrix-IPV:Romania

Last review date of this leaflet: April 2023

Other sources of information

Detailed information on this medicinal product 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 use, the vaccine should be left at room temperature and shaken well to obtain a white, turbid, and homogeneous suspension. Before administration, the vaccine should be visually examined to observe any foreign particles and/or variation in physical appearance. 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 medicinal product and all materials that have been in contact with it, will be carried out in accordance with local regulations.