Boostrix

Package Leaflet: Information for the User

Boostrix, injectable suspension in pre-filled syringe

Diphtheria, tetanus and pertussis (acellular component) vaccine (adsorbed, reduced antigen content)
Please read all of this leaflet carefully before you or your child are vaccinated 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 or pharmacist.
• This vaccine has been prescribed for you or your child only. Never give it to others.
• If you or your child experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Boostrix is and what it is used for
2. What you need to know before you or your child receive Boostrix
3. How to use Boostrix
4. Possible side effects
5. How to store Boostrix
6. Contents of the pack and other information

1. What Boostrix is and what it is used for

Boostrix is a vaccine used as a booster dose in children from 4 years of age, adolescents and adults for the prevention of three diseases: diphtheria, tetanus and pertussis (whooping cough). The vaccine works by stimulating the body to produce protection (antibodies) against these diseases.

• Diphtheria: Diphtheria mainly affects the respiratory tract and sometimes the skin. The respiratory tract generally becomes inflamed (swollen), causing serious breathing problems and sometimes leading to suffocation. Diphtheria bacteria also release a toxin (poisonous substance) that can damage the nervous system, cause heart problems and even death.
• Tetanus: Tetanus bacteria enter the body through cuts, scratches or wounds to the skin. Wounds at highest risk of infection include burns, fractures, deep wounds or wounds contaminated with soil, dust, horse manure or wood splinters. The bacteria release a toxin (poisonous substance) that can cause muscle stiffness, painful muscle spasms, seizures and even death. Muscle spasms can be so severe as to cause fractures of the spinal bones.
• Pertussis (whooping cough): Pertussis is a highly contagious disease. It affects the respiratory tract, causing repeated severe coughing fits that can interfere with normal breathing. The cough is often followed by a convulsive inhalation, hence the common name "whooping cough". The cough may last for 1–2 months or longer. Pertussis can also lead to ear infections, long-lasting bronchitis, pneumonia, seizures, brain damage and even death.

None of the ingredients contained in the vaccine can cause diphtheria, tetanus or whooping cough.
The use of Boostrix during pregnancy will help protect your baby from pertussis during the first months of life, before the baby receives primary immunization.

2. What you should know before you or your child receive Boostrix

Boostrix must not be administered:

• if you or your child have previously had an allergic reaction to Boostrix or to any of the other ingredients contained in this vaccine (listed in section 6) or to formaldehyde. Signs of an allergic reaction may include itchy, red rash, shortness of breath, swelling of the face or tongue
• if you or your child have previously had an allergic reaction to any other vaccine against diphtheria, tetanus or pertussis (whooping cough)
• if you or your child have experienced neurological problems (encephalopathy) within 7 days after previous vaccination with a pertussis-containing vaccine (whooping cough)
• if you or your child have a severe infection with high fever (over 38°C). A mild infection is not a problem, but you should inform your doctor beforehand
• if you or your child have experienced temporary reduction in blood platelets (increasing the risk of bleeding or bruising) or problems affecting the brain or nerves after a previous vaccination with a diphtheria and/or tetanus vaccine.

Warnings and precautions
Talk to your doctor or pharmacist before you or your child receive Boostrix:

• if you or your child have experienced health problems after previous administration of Boostrix or other pertussis (whooping cough) vaccines, especially:
  • High fever (over 40°C) within 48 hours after vaccination;
  • Collapse or shock-like state within 48 hours after vaccination;
  • Persistent crying lasting 3 hours or more, occurring within 48 hours after vaccination;
  • Seizures/convulsions with or without high fever occurring within 3 days after vaccination
• if your child has progressive or undiagnosed brain disease or uncontrolled epilepsy. The vaccine should be administered only after the condition has been stabilized
• if you or your child have bleeding disorders or bruise easily
• if you or your child have a tendency to febrile seizures/convulsions or there is a family history of such events
• if you or your child have long-term immune system problems of any kind (including HIV infection). In such cases, you or your child may still receive Boostrix, but the protection against infections after vaccination may not be as effective as in children or adults with normal immune response to infections.

Fainting may occur (particularly in adolescents) during or even before any injection with a needle. Therefore, inform the doctor or nurse if you or your child have previously fainted after an injection.
Like all vaccines, Boostrix may not fully protect all individuals who are vaccinated.
Other medicines and Boostrix
Tell your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines, or if you have recently received other vaccinations.
Boostrix can be administered at the same time as certain other vaccines. A different injection site will be used for each type of vaccine.
Boostrix may be less effective if you or your child are taking medicines that reduce the ability of your immune system to fight infections.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before receiving this vaccine.
It is not known whether Boostrix passes into breast milk. Your doctor will inform you about the possible risks and benefits of receiving Boostrix while breastfeeding.
Driving and using machines
It is unlikely that Boostrix will affect the ability to drive or operate machinery.
Boostrix contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially "sodium-free".

3. How to use Boostrix

• Boostrix is administered as an intramuscular injection.
• The vaccine must never be given into blood vessels.
• You or your child will receive a single injection of Boostrix.
• The doctor will check whether you or your child have previously received vaccines against diphtheria, tetanus and/or pertussis.
• Boostrix may be administered in case of suspected tetanus infection, although additional measures will be required, such as appropriate wound management and/or administration of tetanus antitoxin, to reduce the risk of developing the disease.
• Your doctor will inform you about booster vaccinations.

4. Possible side effects

Like all medicines, this vaccine may cause side effects, although not everybody experiences them.
As with all injectable vaccines, severe allergic reactions (anaphylactic and anaphylactoid reactions) may occur very rarely (up to 1 case per 10,000 doses of vaccine). These may be recognized by:

• Skin rashes such as itching or blistering
• Swelling of the eyes and face
• Difficulty breathing or swallowing
• Sudden drop in blood pressure and loss of consciousness. These reactions may occur before leaving the doctor's office. However, if you or your child experience any of these symptoms, you must contact a doctor immediately.

Side effects observed during clinical studies in children aged 4 to 8 years
Very common (may occur in more than 1 in 10 doses of vaccine): pain, redness and swelling at the injection site, irritability, drowsiness, fatigue.
Common (may occur in up to 1 in 10 doses of vaccine): loss of appetite, headache, fever equal to or above 37.5°C (including fever above 39°C), extensive swelling of the limb where the vaccine was administered, vomiting and diarrhoea.
Uncommon (may occur in up to 1 in 100 doses of vaccine): upper respiratory tract infection, attention disorders, eye discharge with itching and crusting (conjunctivitis), skin erythema, hard swelling at the injection site, pain.

Side effects observed during clinical studies in adults, adolescents and children aged 10 years and older
Very common (may occur in more than 1 in 10 doses of vaccine): pain, redness and swelling at the injection site, headache, fatigue, general malaise.
Common (may occur in up to 1 in 10 doses of vaccine): fever equal to or above 37.5°C, dizziness, nausea, hard swelling and abscess at the injection site.
Uncommon (may occur in up to 1 in 100 doses of vaccine): fever above 39°C, pain, muscle stiffness and joint stiffness, vomiting, diarrhoea, joint rigidity, joint pain, muscle pain, itching, excessive sweating (hyperhidrosis), skin erythema, swollen glands in the neck, armpit or groin (lymphadenopathy), sore throat and pain during swallowing (pharyngitis), upper respiratory tract infection, cough, fainting (syncope), influenza-like symptoms such as fever, sore throat, runny nose, cough and chills.

The following side effects have been reported during routine use of Boostrix and are not specific to any age group:

• Swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing (angioedema)
• Collapse or periods of unconsciousness or lack of awareness
• Seizures (with or without fever)
• Hives (urticaria)
• Unusual weakness (asthenia)

Following administration of the tetanus vaccine, a temporary inflammation of the nerves causing pain, weakness and paralysis in the limbs, often spreading to the chest and face (Guillain-Barré syndrome), has been reported very rarely (up to 1 case per 10,000 doses of vaccine).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Boostrix

Keep this vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date stated on the packaging and on the label of the pre-filled syringe following the word EXP. The expiry date refers to the last day of the month.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze. Freezing will damage the vaccine.
Keep in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Boostrix contains

• The active substances are:
  Diphtheria toxoid not less than 2 International Units (IU) (2.5 Lf)
  Tetanus toxoid not less than 20 International Units (IU) (5 Lf)
• Bordetella pertussis* antigens:
  Pertussis toxoid 8 micrograms
  Filamentous haemagglutinin 8 micrograms
  Pertactin 2.5 micrograms
  adsorbed onto aluminium hydroxide hydrate (Al(OH)_) 0.3 milligrams Al and aluminium phosphate (AlPO_) 0.2 milligrams Al

Aluminium hydroxide and aluminium phosphate are included in this vaccine as adjuvants.
Adjuvants are substances included in some vaccines to speed up, enhance, and/or prolong the
protective effect of the vaccine.

• The other components are: sodium chloride and water for injections.

Description of the appearance of Boostrix and package contents
Injectable suspension in a pre-filled syringe.
Boostrix is a slightly opalescent white liquid contained in a pre-filled syringe (0.5 ml).
Boostrix is available in 1-dose pre-filled syringes, with or without separate needles, in pack sizes of 1 and 10.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
GlaxoSmithKline S.p.A. - Viale dell’Agricoltura 7 - 37135 Verona - Italy

Responsible producer for batch release
GlaxoSmithKline Biologicals s.a., rue de l’Institut 89 – 1330 Rixensart (Belgium)

Other sources of information
Detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco)

The following information is intended for healthcare professionals only:

Before use, the vaccine should be brought to room temperature and shaken well to obtain a homogeneous, white,
turbid suspension. Prior to administration, the vaccine should be inspected visually for the presence of
particulate matter and/or any change in physical appearance. If either of these is observed, do not administer the
vaccine.
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 attach the needle to the syringe, gently connect the needle hub to the Luer Lock adapter and rotate one-quarter turn clockwise until a secure click is felt.
Do not remove the syringe plunger from the barrel. If this occurs, do not administer the vaccine.
Disposal
Any unused medicinal product or waste material must be disposed of in accordance with local requirements.