Boostrix Suspension

BOOSTRIX is a vaccine used to protect you or your child against three diseases:

• Diphtheria: a serious bacterial infection that mainly affects the airways and sometimes the skin. The airways become swollen causing serious breathing problems and sometimes suffocation. The bacteria also release a poison. This can cause nerve damage, heart problems, and even death.
• Tetanus (Lockjaw): tetanus bacteria enter the body through cuts, scratches or wounds in the skin. Wounds that are more likely to get tetanus infection are burns, fractures, deep wounds or wounds that have soil, dust, horse manure or wood splinters in them. The bacteria release a poison. This can cause muscle stiffness, painful muscle spasms, fits and even death. The muscle spasms can be strong enough to cause bone fractures of the spine.
• Pertussis (Whooping cough): a highly infectious illness that affects the airways. It causes severe coughing that may lead to problems with breathing. The coughing often has a “whooping” sound. The cough may last for one to two months or longer. Whooping cough can also cause ear infections, chest infections (bronchitis) which may last a long time, lung infections (pneumonia), fits, brain damage and even death.

BOOSTRIX helps you or your child’s body make its own protection (antibodies). This will protect you and your child against the diseases mentioned above.

BOOSTRIX should not be administered to you:

• if you or your child are allergic (hypersensitive) to BOOSTRIX or any other ingredients contained in BOOSTRIX. The active substances and other ingredients in BOOSTRIX are listed above in section 6. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
• if you or your child have previously had an allergic reaction to any vaccine against diphtheria, tetanus or pertussis (whooping cough) diseases.
• if you or your child experienced problems of the nervous system (encephalopathy) within 7 days after previous vaccination with a vaccine against pertussis (whooping cough) disease.
• if you or your child experienced a temporary reduction in blood platelets (which increases risk of bleeding or bruising) or problems with the brain or nerves after previous vaccination with a vaccine against diphtheria and/or tetanus.

Check with your doctor if you think any of these apply to you or your child.

Warnings and precautions:

Take special care with BOOSTRIX: Tell your doctor or healthcare professional before being given the injection if:

• if you or your child have a severe infection with a high temperature. In these cases, the vaccination will be postponed until recovery. A minor infection such as a cold should not be a problem, but talk to your doctor first.
• if after previously having BOOSTRIX or another vaccine against pertussis (whooping cough) disease, you or your child had any problems, especially:
• a high temperature (over 40 °C) within 48 hours of vaccination
• a collapse or shock-like state within 48 hours of vaccination
• persistent crying lasting 3 hours or more within 48 hours of vaccination
• seizures/fits with or without a high temperature within 3 days of vaccination
• if you or your child are suffering from neurological disorders, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy (a disease of the brain).
• if you or your child have a bleeding problem or bruise(s) easily.
• if you or your child have a tendency to seizures/fits due to a fever, or if there is a family history of this.

Children or persons with a weakened immune system, for example due to HIV infection or due to medicines that suppress the immune system, may not get the full benefit from BOOSTRIX. Collapse or periods of unconsciousness or lack of awareness, seizures or fits have occurred in children given other vaccines containing one or more of the active constituents of BOOSTRIX. They usually occur within two to three days after vaccination.

You will not be expected to give yourself BOOSTRIX. It will always be given to you by a person who is qualified to do so. You or your child will receive a single injection at an agreed date. BOOSTRIX will be given as an injection into the muscle and should not be given into a vein. BOOSTRIX may be used if you or your child are at risk of getting tetanus because of an injury.

Your doctor will verify if you or your child have previously received vaccines against diphtheria, tetanus and/or pertussis. Repeat vaccination for diphtheria, tetanus and pertussis may be performed according to official recommendations. Your doctor will advise you.

BOOSTRIX can have side effects. Not all side effects reported for BOOSTRIX are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using BOOSTRIX, please consult your doctor, pharmacist or other healthcare professional for advice.

Allergic reactions: If any of the following happens, tell your doctor immediately or go to the casualty department at your nearest hospital:

• itchy rash of the hands and feet
• swelling of the eyes and face
• difficulty in breathing or swallowing
• sudden drop in blood pressure and loss of consciousness.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to BOOSTRIX. You may need urgent medical attention or hospitalisation. These reactions will usually occur before leaving the doctor’s surgery. However, if you or your child gets any of these symptoms you should contact a doctor urgently.

Side effects that occurred in children from 4 to 9 years of age: Frequent side effects include:

• irritability
• sleepiness
• swelling, pain, redness where the injection was given, tiredness, fever (more than 37,5 °C)
• loss of appetite
• headache
• vomiting and diarrhoea.

Less frequent side effects include:

• upper respiratory tract infection
• disturbances in attention
• discharge with itching of the eyes and crusty eyelids (conjunctivitis)
• skin rash
• pain, hard lump where the injection was given.

Side effects that occurred in adults, teenagers and children from the age of 10 years onwards: Frequent side effects include:

• headache, dizziness
• swelling, pain, redness where the injection was given, tiredness, generally feeling unwell, fever (more than 37,5 °C), hard lump and abscess at the injection site
• nausea.

Less frequent side effects include:

• upper respiratory tract infection, sore throat and discomfort when swallowing (pharyngitis)
• swollen glands in the neck, armpit or groin (lymphadenopathy)
• fainting (syncope)
• cough
• diarrhoea, vomiting
• excessive sweating (hyperhidrosis), itching, skin rash
• joint stiffness, joint pain (arthralgia), muscle ache (myalgia)
• fever (more than 39 °C), flu-like symptoms, such as fever, sore throat, runny nose, cough and chills, pain.

Other side effects that can occur in age group:

• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)
• seizures (with or without fever)
• hives (urticaria)
• large swelling of the injected limb, unusual weakness (asthenia).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of BOOSTRIX.

BOOSTRIX should be stored at +2 °C to +8 °C. During transport, recommended conditions of storage must be respected. Do not freeze. Discard if the vaccine has been frozen. Store all medicines out of reach of children. Do not use BOOSTRIX after the expiry date which is stated on the carton or on the label. The expiry date refers to the last day of that month. Store in the original package in order to protect from light. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.