ADACEL® (Tdap) is a vaccine. Vaccines are used to protect against infectious diseases. They work by causing the body to produce its own protection against the bacteria that cause the targeted diseases.

This vaccine is used to boost protection against diphtheria, tetanus and pertussis (whooping cough) in children from the age of four years, adolescents and adults, following a complete primary course of vaccination.

Use of ADACEL® during pregnancy allows protection to be passed on to the child in the womb to protect her/him from whooping cough during the first few months of life.

Limitations in the protection provided

ADACEL® will only prevent these diseases if they are caused by the bacteria targeted by the vaccine. You or your child could still get similar diseases if they are caused by other bacteria or viruses.

ADACEL® does not contain any live bacteria or viruses and it cannot cause any of the infectious diseases against which it protects.

Remember that no vaccine can provide complete, life long protection in all people who are vaccinated.

To make sure that ADACEL® is suitable for you or your child, it is important to tell your doctor or nurse if any of the points below apply to you or your child. If there is anything you do not understand, ask your doctor or nurse to explain.

Do not use ADACEL® if you or your child

·       has had an allergic reaction:

-      to diphtheria, tetanus or pertussis vaccines

-      to any of the other ingredients (listed in section 6)

-      to any residual component carried over from manufacture (formaldehyde, glutaraldehyde) which may be present in trace amounts.

·       has ever had a severe reaction affecting the brain within one week after a previous dose of a whooping cough vaccine

·       has an acute severe febrile illness. The vaccination should be delayed until you or your child has recovered. A minor illness without fever is not usually a reason to defer vaccination. Your doctor will determine if you or your child should receive ADACEL®.

Warnings and precautions

Tell your doctor or nurse before vaccination if you or your child has

·       received a booster dose of a vaccine for diphtheria and tetanus within the last 4 weeks. In this case you or your child should not receive ADACEL® and your doctor will decide on the basis of official recommendations when you or your child can receive a further injection.

·       had a Guillain-Barré syndrome (temporary loss of movement and feeling in all or part of the body) within 6 weeks of a previous dose of a tetanus containing vaccine. Your doctor will decide if you or your child should receive ADACEL®.

·       a progressive illness affecting the brain/nerves or uncontrolled fits. Your doctor will first start treatment and vaccinate when the condition has stabilized.

·       a poor or reduced immune system, due to

-        medication (e.g., steroids, chemotherapy or radiotherapy)

-        HIV infection or AIDS

-        any other illness.

The vaccine may not protect as well as it protects people whose immune system is healthy. If possible, vaccination should be postponed until the end of such disease or treatment.

·       any problems with the blood that causes easy bruising, or bleeding for a long time after minor cuts (for instance due to a blood disorder such as haemophilia or thrombocytopenia or treatment with blood thinning medicines).

Fainting can occur following, or even before, any needle injection. Therefore tell the doctor or nurse if you or your child fainted in connection with a previous injection.

Other medicines or vaccines and ADACEL®

 Tell your doctor, pharmacist or nurse if you or your child is taking, has recently taken or might take any other medicines.

As ADACEL® does not contain any live bacteria, it can generally be given at the same time as other vaccines or immunoglobulins, but at a different injection site. Studies have demonstrated that ADACEL® can be used at the same time as any of the following vaccines: a hepatitis B vaccine, a poliovirus vaccine (injected or oral), an inactivated flu vaccine and a recombinant Human Papillomavirus vaccine respectively. Injections of more than one vaccine at the same time will be given in different limbs.

If you or your child is receiving medical treatment affecting you or your child's blood or immune system (such as blood thinning medicines, steroids or chemotherapy), please refer to the section "Warnings and precautions" above.

Pregnancy, breast-feeding and fertility

 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® during pregnancy. 

Driving and using machines

It has not been studied if the vaccine affects the ability to drive or use machines. The vaccine has no or negligible influence on the ability to drive and use machines.

When you or your child will be given the vaccine

Your doctor will determine if ADACEL® is suitable for you or your child, depending on:

·   what vaccines have been given to you or your child in the past

·   how many doses of similar vaccines have been given to you or your child in the past

·   when the last dose of a similar vaccine was given to you or your child.

You or your child must have had the complete primary courses of diphtheria and tetanus vaccines before having ADACEL®.

It is safe to have ADACEL® if you or your child has not had the complete primary course of whooping cough vaccines but protection may not be as good as in people who have already had the whooping cough vaccine.

Your doctor will decide how long you have to wait between vaccinations.

If you are pregnant, the doctor will help you decide if you should receive ADACEL® during pregnancy.

Dosage and method of administration

 Who will give you ADACEL®?

 ADACEL® should be given by healthcare professionals who have been trained in the use of vaccines and at a clinic or surgery that is equipped to deal with any rare severe allergic reaction to the vaccine.

Dosage 

All age groups for whom ADACEL^® is indicated will receive one injection (half a millilitre).

In case you or your child experience an injury which requires preventive action for tetanus disease, your doctor may decide to give ADACEL® with or without tetanus immunoglobulin.

ADACEL^® can be used for repeat vaccination. Your doctor will give you advice on repeat vaccination.

Method of administration

 Your doctor or nurse will give you the vaccine into a muscle in the upper outer part of the arm (deltoid muscle).

Your doctor or nurse will not give you the vaccine into a blood vessel, into the buttocks or under the skin. In case of blood clotting disorders they may decide to inject under the skin, although this might result in more local side effects, including a small lump under the skin.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, ADACEL® can cause side effects, although not everybody gets them.

Serious allergic reactions

 If any of these symptoms occur after leaving the place where you or your child received the injection, you must consult a doctor IMMEDIATELY.

·      difficulty in breathing

·      blueness of the tongue or lips

·      a rash

·      swelling of the face or throat

·      low blood pressure causing dizziness or collapse.

When these signs or symptoms occur they usually develop very quickly after the injection is given and while you or your child is still in the clinic or doctor’s surgery. Serious allergic reactions are a very rare possibility (may affect up to 1 in 10,000 people) after receiving any vaccine.

Other side effects

 The following side effects were observed during clinical studies carried out in specific age groups.

In children aged 4 to 6 years

Very common (may affect more than 1 in 10 people) :

• decreased appetite,
• headache
• diarrhoea
• tiredness
• pain
• redness and swelling in the area where the vaccine was injected.  

Common (may affect up to 1 in 10 people) :

• nausea,
• vomiting,
• rash,
• aching (all over the body) or muscular weakness,
• aching or swollen joints,
• fever,
• chills,
• underarm lymph node disorder.

In adolescents aged 11 to 17 years

Very common (may affect more than 1 in 10 people) :

• headache
• diarrhoea
• nausea
• aching (all over the body) or muscular weakness
• aching or swollen joints
• tiredness/weakness
• feeling unwell
• chills
• pain
• redness and swelling in the area where the vaccine was injected.

Common (may affect up to 1 in 10 people) :

• vomiting,
• rash
• fever
• underarm lymph node disorder.

In adults aged 18 to 64 years

Very common (may affect more than 1 in 10 people) :

• headache
• diarrhoea
• aching (all over the body) or muscular weakness
• tiredness/weakness
• feeling unwell
• pain redness and swelling in the area where the vaccine was injected.

Common (may affect up to 1 in 10 people) :

• nausea,
• vomiting
• rash
• aching or swollen joints
• fever
• chills
• underarm lymph node disorder.

The following additional adverse events have been reported in the various recommended age groups during the commercial use of ADACEL®. The frequency of these adverse events cannot be precisely calculated, as it would be based on voluntary reporting in relation to the estimated number of vaccinated persons.

·       Allergic / serious allergic reactions (how you can recognize such a reaction, you can find in the beginning of section 4), ‘pins and needles’ or numbness, paralysis of part or all the body (Guillain-Barré syndrome), inflammation of the nerves in the arm (brachial neuritis), loss of function in the nerve that supplies the facial muscles (facial palsy), fits (convulsions), fainting, inflammation of the spinal cord (myelitis), inflammation of the muscular part of the heart (myocarditis), itching, hives, inflammation of a muscle (myositis), extensive limb swelling associated with redness, warmth, tenderness or pain in the area where the vaccine was injected, bruising, abscess, or a small lump in the area where the vaccine was injected.

Reporting of side effects

If you or your child get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the end of this leaflet.. By reporting side effects, you can help provide more information on the safety of this medicine.

If any side effects get serious or if you notice any side effects not listed in the leaflet, please tell your doctor, pharmacist or healthcare provider.

Keep this medicine out of reach and sight of children.

Store in a refrigerator (2° to 8°C). Do not freeze. Discard the vaccine if exposed to freezing. Do not use after the expiry date which is stated on the label after “EXP”. The expiry date refers to last day of month.

Keep the container in the outer carton in order to protect from light.