Xolair 150mg powder and solvent for solution for injection vials

Xolair helps to control severe allergic asthma. It reduces the way in which the body responds to the allergens which cause severe allergic asthma.

It is only used for those patients who, despite using inhaled steroids in combination with inhaled long-acting beta agonists, are still having severe asthma attacks.

Xolair will not give you immediate relief of your symptoms once an asthma attack has started. If you have an asthma attack you must still use your fast-acting inhaled bronchodilator. If you are unsure on what to do when you have an asthma attack, ask your prescriber or asthma nurse.

Other information about Xolair:

Xolair is usually 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 that the medicine is making you unwell or you do not think it is working, 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 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.

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

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

The person in charge of your care will make the decision about when you should stop this medicine. If you experience any problems while having this medicine, talk to someone who is involved in your medical care.

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

Xolair 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 six years of age.

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

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

• headaches
• injection site problems such as pain, redness of the skin, itching and swelling

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

• a drop in blood pressure on standing or sitting up
• bronchospasm
• cancer
• cough
• diarrhoea
• fainting or brief loss of consciousness
• feeling dizzy
• flu or flu-like symptoms
• flushing
• indigestion
• nausea
• paraesthesiae
• pharyngitis
• photosensitivity skin reaction
• skin rash or rashes - seek immediate medical advice if you develop a rash
• sleepiness
• swelling of the arms
• tiredness
• urticaria - seek immediate medical advice if you develop urticaria
• weight gain

Rare: More than 1 in 10,000 people who have Xolair:

• allergic or anaphylactic reactions - seek immediate medical advice if you develop symptoms such as fever, joint pain or swelling or lymphadenopathy
• angioedema
• infections
• laryngeal oedema
• production of antibodies to Xolair

Very common: More than 1 in 10 children who have Xolair :

• fever
• headaches

Common: More than 1 in 100 children who have Xolair :

• stomach pain

The frequency of these side-effects is unknown:

• eosinophilia and vasculitis - this may lead to heart problems, neuropathy or worsening of breathing problems. Seek immediate medical advice if your breathing worsens while being treated with Xolair
• hair loss
• muscle pain or tenderness
• thrombocytopenia
• thromboembolic problems including stroke or heart attack some of these problems may be fatal

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 Xolair:

If you are taking Xolair 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 Xolair.

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 Xolair:

You should see how this medicine affects you before you judge whether you are safe to drive or operate machinery. If you are in any doubt about whether you should drive or operate machinery, 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 Xolair:

Alcohol can interact with certain medicines.

In the case of Xolair:

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 Xolair:

You need to discuss your specific circumstances with your doctor to weigh up the overall risks and benefits of taking this medicine. You and your doctor can make a decision about whether you are going to take this medicine during pregnancy.

If the decision is that you should not have Xolair, then you should discuss whether there is an alternative medicine that you could take during pregnancy.

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

In the case of Xolair:

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 medicine. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast-feed. You should not stop this medicine without taking advice from your doctor.

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.

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