Pandemrix vaccine emulsion and suspension for emulsion for injection

Pandemrix is used to give people immunity to the virus that causes swine flu. It only offers protection against certain strains of the virus.

Pandemrix is given to you by a healthcare professional. The person responsible for giving you your medicine will make sure that you get the right dose.

If you feel unwell after having the medicine then talk to your prescriber or someone involved in your medical care.

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

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

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

As Pandemrix is a vaccination which is given as one or two doses, considerations to stopping this medicine are not relevant.

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

Pandemrix is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

Furthermore the prescriber may only prescribe this medicine with special care or may not prescribe it at all for a child under the age of six months.

As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:

Over time it is possible that Pandemrix can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Pandemrix has become unsuitable, it is important that the prescriber is contacted immediately.

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

Once a medicine has been licensed, information on the medicine'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 medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, 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 medicine.

Very common: More than 1 in 10 adults who have Pandemrix :

• headaches
• increased sweating
• injection site problems such as hardening and warmth of the skin, inflammation, swelling, pain, redness, bruising or itching
• joint pain
• muscle pain or tenderness
• shivering
• tiredness

Very common: More than 1 in 10 children between 10 years and 17 years of age who have Pandemrix :

• gastrointestinal problems
• headaches
• muscle pain or tenderness
• pain
• redness of the skin
• shivering
• swelling
• tiredness

Very common: More than 1 in 10 children between six years and nine years of age who have Pandemrix :

• gastrointestinal problems
• headaches
• joint pain
• muscle pain or tenderness
• pain
• redness of the skin
• shivering
• swelling
• tiredness

Very common: More than 1 in 10 children between three years and five years of age who have Pandemrix :

• feeling drowsy
• feeling irritable
• fever
• loss of appetite
• pain
• redness of the skin
• shivering
• sweating
• swelling

Very common: More than 1 in 10 children between 6 months and 35 months of age who have Pandemrix :

• feeling drowsy
• feeling irritable
• loss of appetite
• pain
• redness of the skin
• swelling

Common: More than 1 in 100 adults who have Pandemrix :

• fever
• gastrointestinal problems such as diarrhoea, vomiting, stomach pain or nausea

Common: More than 1 in 100 children between 10 years and 17 years of age who have Pandemrix :

• fever
• joint pain
• sweating

Common: More than 1 in 100 children between six years and nine years of age who have Pandemrix :

• fever
• sweating

Common: More than 1 in 100 children between three years and five years of age who have Pandemrix :

• diarrhoea

Common: More than 1 in 100 children between 6 months and 35 months of age who have Pandemrix :

• fever

Uncommon: More than 1 in 1000 adults who have Pandemrix :

• difficulty sleeping
• feeling dizzy
• flu or flu-like symptoms
• general feeling of being unwell
• itching
• lymphadenopathy
• paraesthesiae
• skin rash or rashes

Very rare: Fewer than 1 in 10,000 people under 20 years of age who have Pandemrix :

• cataplexy
• narcolepsy

The frequency of these side-effects is unknown:

• abnormal muscle movement
• allergic reactions
• anaphylactic reactions
• angioedema
• convulsions
• eye or eyesight problems
• fainting or brief loss of consciousness
• may affect the results for certain tests
• paraesthesiae
• skin hypersensitivity reactions
• sleepiness
• urticaria

The following side effects have been reported in people who have had medicines similar to Pandemrix. The frequency of these side-effects in people who have Pandemrix is not known:

• blood problems
• kidney problems
• neuralgia
• neurological problems such as encephalomyelitis, neuritis and Guillain Barr syndrome
• vasculitis

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 more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following types of medicine may interact with Pandemrix:

If you are taking Pandemrix and one of the above 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 Pandemrix.

Your prescriber can advise whether it is appropriate for you to take combinations that are known to interact. They can also discuss with you the possible effect that the complementary preparations and vitamins may have on your condition.

If you experience any unusual effects while taking this medicine 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 Pandemrix 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 Pandemrix:

Alcohol can interact with certain medicines.

In the case of Pandemrix:

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.

You need to discuss your specific circumstances with your doctor to weigh up the overall risks and benefits of having this medicine. You and your doctor can make a decision about whether you are going to have this medicine while you are pregnant.

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

In the case of Pandemrix:

Women who are planning to breast-feed while having Pandemrix must inform their doctor or midwife.

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

Pandemrix contains:

If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Pandemrix before, do not have Pandemrix. Talk to your prescriber, pharmacist or nurse as soon as possible.