Rotarix vaccine live oral suspension 1.5ml pre-filled syringes

Rotarix is a vaccine which is used to give children immunity to rotavirus infection.

Rotarix 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 prescribed times.

This medicine will be given to you by a healthcare professional. 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.

Having extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems.

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

As Rotarix is a vaccination which is usually given as two fixed doses, considerations to stopping this medicine are not relevant.

The medical team will often be responsible for looking after this medicine. However, if you are responsible for looking after this medicine make sure that you store it properly and safely. Check the label and Patient Information leaflet for details or ask a member of your medical team.

In the case of Rotarix:

Do not use the medicine after the expiry date shown on the packaging. If you have any unused medicine, return it to your pharmacist who will dispose of it safely.

Rotarix 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 an infant who is over 24 weeks of age.

Over time it is possible that Rotarix can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Rotarix 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.

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

• diarrhoea
• feeling irritable

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

• dermatitis
• flatulence
• gastrointestinal problems - seek immediate medical advice if you have stomach pain, persistent vomiting, blood in the stools, feeling of fullness in the stomach or fever

The frequency of these side-effects is unknown:

• apnoea
• bowel problems
• gastroenteritis
• passing rotavirus to other people

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 medicines may interact with Rotarix:

If you are taking Rotarix and any of the above 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 Rotarix.

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.

In the case of Rotarix:

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 Rotarix:

Alcohol can interact with certain medicines.

In the case of Rotarix:

This medicine is not given to adults so it's effects in pregnancy are not relevant.

This medicine is not given to adults so it's effects on breast-feeding are not relevant.

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.

Rotarix 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 Rotarix before, do not have Rotarix. Talk to your prescriber, pharmacist or nurse as soon as possible.