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The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

Adacel Polio contains the active ingredients diphtheria toxoid, tetanus toxoid, pertussis toxoid, pertussis filamentous haemagglutinin, pertussis fimbriae 2+3, pertactin and poliovirus types 1,2 and 3 (Vero). Adacel Polio is used to help to protect you or your child against whooping cough (pertussis), tetanus, diphtheria and polio. For more information, see Section 1. Why am I using Adacel Polio? in the full CMI.

Do not use if you or your child has ever had an allergic reaction to Adacel Polio or any of the ingredients listed at the end of the CMI, or if you or your child ever had a disease of brain without an apparent cause within 7 days of a previous pertussis, tetanus or diphtheria vaccination. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Adacel Polio? in the full CMI.

Some medicines may interfere with Adacel Polio and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

Adacel Polio is given by your doctor, nurse or pharmacist. More instructions can be found in Section 4. How do I use Adacel Polio? in the full CMI.

For more information, see Section 5. What should I know while using [insert medicine]? in the full CMI.

Common side effects include a local reaction around the injection site such as bruising, redness, itchiness, tenderness, pain or discomfort, warmth, burning or stinging, swelling or the formation of hard lumps or scars, rash, headaches, tiredness, weakness or fatigue, fever, rigors, soreness, aching muscles, muscle tenderness or weakness (not caused by exercise), joint pain or swelling, irritability, nausea and vomiting, diarrhoea.
Serious side effects can include red, itchy rash or hives, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing, a temporary inflammation of the nerves, causing pain, weakness, and paralysis in the extremities and often progressing to the chest and face, severe pain and decreased mobility of arm and shoulder, fits or convulsion, fainting, tingling or numbness of the hands or decreased feeling or sensitivity of the vaccinated arm, a paralysed nerve in the face, dizziness, generally feeling unwell, pale skin, stomach pain . See your doctor immediately if you notice this.For more information, including what to do if you or your child have any side effects, see Section 6. Are there any side effects? in the full CMI.

Active ingredient(s): Pertussis Vaccine - Acellular and Diphtheria and Tetanus Toxoids (Adsorbed) Combined with Inactivated Poliovirus Type 1, 2 and 3 (Vero cell)

This leaflet provides important information about using Adacel Polio. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Adacel Polio.

Where to find information in this leaflet:

Adacel Polio contains the active ingredients diphtheria toxoid, tetanus toxoid, pertussis toxoid, pertussis filamentous haemagglutinin, pertussis fimbriae 2+3, pertactin and poliovirus types 1,2 and 3 (Vero).

Adacel Polio is a vaccine used to help to protect you or your child against whooping cough (pertussis), tetanus, diphtheria and polio.

Adacel Polio works by causing the body to produce its own protection against whooping cough, tetanus, diphtheria, and polio. It does this by making substances called antibodies in the blood, which fight the bacteria and toxins that cause these diseases. If a vaccinated person comes into contact with these bacteria and toxins, the body is usually ready to destroy them.

It usually takes several weeks after vaccination to develop protection against these diseases.

Use of Adacel Polio during pregnancy allows antibodies to be passed to the baby in the womb from the pregnant woman to protect the baby from whooping cough during the first few months of life.

Most people will produce enough antibodies against these diseases. However, as with all vaccines, 100% protection cannot be guaranteed.

The vaccine will not give you or your child any of these diseases.

The chance of a severe reaction from Adacel Polio is very small, but the risks from not being vaccinated against these diseases may be very serious. Polio, whooping cough, tetanus and diphtheria cause significant sickness and sometimes death in unvaccinated infants, children, and adults.

This vaccine is for use as a booster in adults, adolescents and children aged four years and older who have previously received childhood immunisation. Children from four to six years of age should have already received four doses of whooping cough, tetanus, diphtheria and polio vaccine. Adacel Polio is not intended for primary immunisation.

Adacel Polio is not recommended for use in children under 4 years.

After vaccination, you or your child may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Tell your doctor or nurse if you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby. Your doctor will help you decide if you should receive Adacel Polio during pregnancy.

Adacel Polio may be administered during pregnancy for prevention of pertussis in young infants.

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Tell your doctor if you or your child has had any vaccines in the last 4 weeks.

Your doctor will advise you if Adacel Polio is to be given with another vaccine.

Your doctor and pharmacist may have more information on medicines and vaccines to be careful with or avoid during vaccination with Adacel Polio.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Adacel Polio.

Adacel Polio is given as an injection, usually into your

upper arm muscle by a doctor or nurse.

Keep an updated record of your vaccinations.

Adacel Polio should not normally interfere with your ability to drive or operate machinery. However, it may cause light-headedness, tiredness, drowsiness in some people.

Adacel Polio is usually stored in the doctor's surgery or clinic, or at the pharmacy. However, if you need to store Adacel Polio:

Do not use Adacel Polio after the expiry date which is stated on the carton after EXP.

Do not use Adacel Polio if the packaging is torn or shows signs of tampering.

Keep it where young children cannot reach it.

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of this medicine.

This medicine is only available with a doctor's prescription.

Do not take this medicine if you are allergic to any of these ingredients.

Adacel Polio is a sterile, uniform cloudy, white suspension for injection.

Aust R 106576 - Syringe

Australia:

sanofi-aventis australia pty ltd

12 - 24 Talavera Road

Macquarie Park

NSW 2113, Australia

Tel: 1800 816 806

New Zealand:

sanofi-aventis new zealand limited

Level 8,

56 Cawley St

Ellerslie

Auckland

New Zealand

Tel: 0800 727 838

This leaflet was prepared in June 2021.

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