Asmanex 200micrograms/dose Twisthaler

Asmanex belongs to a class of medicines called steroids. Steroids are used to help reduce inflammation. Asmanex works in the air passages of the lungs. It helps to reduce inflammation and keep the airways open. This makes it easier to breathe.

Asmanex helps to prevent attacks of breathlessness or asthma. It will not give you fast relief of your symptoms once an attack has started. You must use your fast-acting reliever inhaler (inhaled bronchodilator) to relieve an attack of breathlessness or asthma. Ask your prescriber or nurse for advice on what to do if you have an asthma attack or attack of breathlessness.

You must take Asmanex every day for it to work. Asmanex will only prevent attacks of breathlessness or asthma if it is taken regularly. You should continue to take Asmanex even if you feel that your condition is under control. It is a good idea to take it at the same time or times every day. You should make taking it at a regular time part of your daily routine.

Other information about Asmanex:

Do not share your medicine with other people. It may not be suitable for them and may harm them.

The pharmacy label on your medicine tells you how much medicine you should have. It also tells you how often you should have your medicine. This is the dose that you and your prescriber have agreed you should have. You should not change the dose of your medicine unless you are told to do so by your prescriber.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber.

Some medicines work best if they are taken at a specific time of day. Getting the most benefit from your medicine can also be affected by what you eat, when you eat and the times at which you take other medicines.

Specific information on when to have Asmanex can be found in the Patient Information Leaflet that comes with this medicine or on the medicine label. You can also ask your doctor or pharmacist for information about when to take your medicine.

In the case of Asmanex:

Some medicines have specific instructions about how to take them. This is because they work better when taken correctly. These instructions can include getting the right dose and special instructions for preparing the medicine. Make sure you follow any specific instructions given to you by your prescriber or that are in the Patient Information Leaflet that comes with this medicine.

In the case of Asmanex:

Taking extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems. If you take extra doses of your medicine, you must get medical advice immediately. You may need a test to assess the effect of taking extra doses. This is because the effects of taking too much medicine are very complex so it is very important that you seek medical advice.

Contact your prescriber, pharmacist, specialist clinic or NHS Direct on 0845 46 47 for advice.

Make sure you take all of your medicine containers with you if you are advised to go to hospital.

Suddenly stopping your medicine may cause your original condition to return. This is why you must speak to your prescriber if you are having any problems having your medicine.

If you are not having any problems taking this medicine then do not stop having it, even if you feel better, unless advised to do so by your prescriber.

If you are in any doubt, contact your prescriber, pharmacist, specialist clinic or NHS Direct on 0845 46 47.

The instructions on how you should keep your medicine are on the pharmacy label. You should keep your medicine in the original container. This will help to keep your medicine in the best condition and also allow you to check the instructions. Do not take the medicine if the packaging appears to have been tampered with or if the medicine shows any signs of damage. Make sure that the medicine is out of the sight and reach of children.

In the case of Asmanex:

You must not take 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.

Asmanex 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 someone who is under the age of 12 years.

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

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

• difficulty speaking
• headaches
• infections of the mouth - to help reduce the chances of mouth infections happening, rinse your mouth with water after using the inhaler
• pharyngitis

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

• dry mouth and throat
• indigestion
• palpitations
• weight gain

The frequency of these side-effects is unknown:

• adrenal problems when changing from an oral steroid to Asmanex - some adrenal problems may be fatal
• aggressive behaviour
• depression
• eye or eyesight problems
• feeling anxious
• hyperactivity
• hypersensitivity reactions including rashes, urticaria, itching, erythema or oedema of the face, eyes, lips or throat
• if Asmanex is used in large amounts or for a long period of time other side-effects may occur. These are related to the effect that steroids have on the whole body. These may include Cushing's syndrome or cushing-like symptoms, growth suppression in children and adolescents or lowering of bone mineral density
• increased pressure in the eye
• psychological or behavioural problems
• sleeping problems
• uncovering of allergic conditions when changing from an oral steroid to Asmanex
• withdrawal symptoms can occur when changing from an oral steroid to Asmanex. These include joint or muscle pain, depression, lack of interest, or lack of energy
• worsening of asthma including cough, breathing difficulties, wheezing and bronchospasm - if you develop an increase in wheezing immediately after using Asmanex you must treat this immediately with a fast-acting inhaled bronchodilator (reliever inhaler) to relieve your symptoms and then seek immediate medical advice

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 Asmanex:

The following types of medicine may interact with Asmanex:

If you are taking Asmanex 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 Asmanex.

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 Asmanex:

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 Asmanex:

Alcohol can interact with certain medicines.

In the case of Asmanex:

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 Asmanex:

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 Asmanex, 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 Asmanex:

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. You should only breast-feed your baby while taking this medicine on the advice of your 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. They are also added to improve the medicine's appearance and to make it easier to use. Some may be used to prolong the life of the medicine.

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