Cervarix vaccine suspension for injection 0.5ml pre-filled syringes

Cervarix is a vaccine which is used to give women immunity to human papillomavirus. Infection with human papillomavirus may lead to cervical lesions or cervical cancer. This medicine may prevent some of these conditions by giving immunity to human papillomavirus infection.

Cervarix is usually given to you by a healthcare professional. It should be used in accordance with official guidelines and is given as a course of three injections. The person responsible for giving you your vaccine will make sure that you get the right dose.

If you feel that the vaccine is making you unwell talk to someone involved in your medical care.

The person with responsibility for giving you your vaccine will make sure that you have your vaccine at the correct time.

This vaccine will be given to you as an injection. If you have any concerns about this vaccine or how this will be given to you, talk to someone who is involved in your medical care.

In the case of Cervarix, the person who is responsible for giving you your vaccine will make sure that you are given the correct dose.

As Cervarix is a vaccine which is usually given as a fixed course, considerations to stopping this vaccine are only relevant if you have a problem after the first or second dose of the vaccine.

As Cervarix will be given to you as an injection, it will usually be stored by the medical team.

In the case of Cervarix:

Cervarix is not suitable for everyone and some people should not use it. Other people should only use it with special care. Before you have the vaccine it is important that the person giving you this vaccine knows if you have any medical history.

Your prescriber may not prescribe it at all if you:

Your prescriber may take extra care when prescribing this medicine for you if you:

Furthermore the prescriber may only prescribe this medicine with special care or may not prescribe it at all for a girl under the age of 9 years.

A vaccine is only made available to the public if the clinical trials have shown that the benefits of having the vaccine outweigh the risks.

Once a vaccine has been licensed, information on the vaccine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a vaccine is different. It is difficult to predict which side-effects you will have from having a particular vaccine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your vaccine.

Very common: More than 1 in 10 people who have Cervarix:

• headaches
• injection site problems such as redness, swelling, paraesthesiae, pain or hardening of the skin
• muscle pain or tenderness
• tiredness

Common: More than 1 in 100 people who have Cervarix:

• diarrhoea
• fever
• gastrointestinal problems
• itching
• joint pain
• nausea
• skin rash or rashes
• stomach pain
• urticaria
• vomiting

Uncommon: More than 1 in 1000 people who have Cervarix:

• feeling dizzy
• respiratory tract infection

The frequency of these side-effects is unknown:

• allergic reactions including anaphylactic reactions
• angioedema
• lymphadenopathy

If you feel unwell or if you have concerns about a side-effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call NHS Direct on 0845 46 47.

If you are taking any medicines that have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist, or you have bought medicines over the counter without prescriptions you should tell the person the names of these medicines before having the vaccine.

If Cervarix is given at the same time as another vaccine, the vaccines should be given at different injection sites.

The following medicines may interact with Cervarix:

The following types of medicine may interact with Cervarix:

If you are taking Cervarix and one of the above medicines or types of medicines, make sure your prescriber knows about it.

Medicines can interact with complementary preparations and vitamins. In general, there is not much information available about interactions between medicines and complementary preparations or vitamins.

If you are planning to take or are already taking any complementary preparations and vitamins you should ask your prescriber whether there are any known interactions with Cervarix.

Your prescriber can advise whether it is appropriate for you to take combinations that are known to interact.

If you experience any unusual effects while having this vaccine in combination with complementary preparations and vitamins, you should tell your prescriber.

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

Like all medicines Cervarix can cause side effects. You should see how this medicine affects you and then judge if you are safe to drive or operate machinery. If you are in any doubt, talk to your prescriber.

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Cervarix:

Alcohol can interact with certain medicines.

In the case of Cervarix:

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Cervarix:

You should discuss your personal circumstances with your doctor if you are pregnant or want to become pregnant.

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Cervarix:

Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this vaccine.

Vaccines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the vaccine. Some may be used to prolong the life of the vaccine.

Cervarix contains:

If you are not able to have any of the ingredients in your vaccine or if you have reacted badly to Cervarix before, do not have Cervarix. Talk to someone involved in your medical care as soon as possible.