Fostair (beclometasone, formoterol)
|Main use||Active ingredient||Manufacturer|
|Asthma||Beclometasone dipropionate, formoterol fumarate dihydrate||Chiesi|
How does it work?
Fostair inhaler contains two active ingredients, beclometasone dipropionate and formoterol fumarate (previously known as eformoterol fumarate in the UK).
Beclometasone is a type of medicine known as a corticosteroid. Corticosteroids are hormones that are produced naturally by the adrenal glands. They have many important functions, including control of inflammatory responses. Beclometasone is a synthetic corticosteroid and is used to decrease inflammation in the lungs. (NB. Corticosteroids are often simply called steroids, but it should be noted that they are very different from another group of steroids, called anabolic steroids, which have gained notoriety because of their abuse by some athletes and body builders.)
When beclometasone is inhaled into the lungs it is absorbed into the cells of the lungs and airways. Here it works by preventing the release of certain chemicals from the cells. These chemicals are important in the immune system and are normally involved in producing immune and allergic responses that result in inflammation. By decreasing the release of these chemicals in the lungs and airways, inflammation is reduced.
In asthma, and in chronic obstructive airways disease (COPD) such as chronic bronchitis, the airways tighten due to inflammation and can also be blocked by mucus. This makes it difficult for air to get into and out of the lungs. Beclometasone is used in these lung conditions to prevent the inflammation and excess mucus formation, and therefore help prevent asthma attacks, wheezing and shortness of breath.
Formoterol is a type of medicine called a long-acting beta 2 agonist or bronchodilator. It works by acting on receptors in the lungs called beta 2 receptors. When formoterol stimulates these receptors it causes the muscles in the airways to relax. This allows the airways to open.
In asthma and COPD there is narrowing of the airways. By relaxing and opening the airways, formoterol makes it easier to breathe. Formoterol starts to work in one to three minutes and its effects last for about 12 hours.
Inhaling the medicines allows them to act directly in the lungs where they are needed. It also reduces the potential for side effects in other parts of the body, as the amount absorbed into the blood through the lungs is lower than if it is taken by mouth.
Fostair inhaler must be used regularly to reduce the inflammation in the lungs. Symptoms usually start to get better between three to seven days after starting treatment. However, it is important to continue using this medicine regularly; even after your symptoms have improved, in order to prevent them coming back.
What is it used for?
Fostair inhaler is used to treat people whose asthma is not controlled with regular corticosteroids and as needed short-acting bronchodilators (relievers, eg salbutamol). As it is a single inhaler, it can also simplify treatment for people who are already using both a corticosteroid inhaler and a long-acting bronchodilator inhaler.
Fostair can be used in one of two ways in the treatment of asthma. It can be taken regularly to prevent asthma attacks (maintenance therapy), with a separate reliever inhaler (eg salbutamol) used to relieve asthma attacks. Alternatively, it can be used regularly to prevent asthma attacks AND used as a reliever when needed to relieve asthma attacks (maintenance and reliever therapy).
Fostair inhaler is used for people with severe COPD who have repeated attacks of breathlessness, despite regular use of long-acting bronchodilators such as formoterol or salmeterol.
How do I use it?
- Make sure you read the information leaflet provided with your inhaler, as this will give detailed instructions on how to use and look after your inhaler.
- Fostair is a metered dose inhaler from which the medicine is inhaled into the lungs. Follow this link for instructions on how to use a metered dose inhaler.
- If you find it difficult to use the inhaler because you have problems pressing down the canister at the same time as breathing in, the AeroChamber Plus spacer device can be used with this inhaler to make it easier. Ask your pharmacist for more information and advice.
- Inhaling corticosteroids can sometimes cause a fungal infection in the mouth called oral thrush. To minimise the risk of this, you should rinse your mouth with water after each time you use this inhaler. Consult your doctor if you develop white patches in your mouth or throat, as these are symptoms of thrush and it may need to be treated.
- Always follow the instructions given by your doctor regarding how many puffs of Fostair to take and how often to take them. If you are unsure about anything ask your doctor or pharmacist for advice.
- If you forget to take a dose at your usual time don’t worry, just take your next dose when it is due. Do not take a double dose to make up for a missed dose.
- You should not suddenly stop using this inhaler, even if you don't currently have any symptoms, unless your doctor tells you otherwise. This is because stopping treatment is likely to make your symptoms come back.
- If you have been prescribed Fostair inhaler as maintenance and reliever therapy for asthma, you should make sure you carry it with you at all times so you can use it to relieve an asthma attack if needed. If you have been prescribed a separate reliever inhaler you should make sure you carry that with you at all times to relieve shortness of breath if needed.
- If you need to use your reliever medicine (either your separate reliever inhaler, eg salbutamol, or your Fostair inhaler) more frequently, or if it becomes less effective at treating attacks, you should consult your doctor because this may indicate that you are having a flare-up of your asthma, or it is getting worse.
- Don't exceed the dose of this medicine that your doctor has recommended you use.
- Inhalers may cause an unexpected increase in wheezing and difficulty breathing (paradoxical bronchospasm) straight after using them. If this happens, don't use the inhaler again, use your reliever inhaler to open your airways and consult your doctor immediately.
- Inhaled corticosteroids have considerably fewer side effects than steroids taken by mouth. However, when taken for long periods of time at high doses, inhaled steroids do have the potential to cause side effects such as glaucoma, cataracts, thinning of the bones (osteoporosis), slowed growth in children and adolescents, changes in mood or behaviour, and to suppress the functioning of the adrenal glands (glands that produce natural steroid hormones). For this reason your doctor will prescribe the lowest effective dose to control your symptoms, and monitor for these side effects. Do not exceed the dose of this medicine that your doctor has prescribed for you.
- If you need to take high doses of Fostair inhaler for a long time, your body may become temporarily reliant on the medicine. This is because long-term use of corticosteroids can cause the adrenal glands to stop producing natural steroids. For this reason treatment must not be suddenly stopped. If your doctor wants you to stop treatment your dose should be tapered down gradually, to allow the adrenal glands to start producing adequate amounts of natural steroids again. People taking high doses of Fostair for a long time may also need to take extra steroid medicines during times of physical stress, for example illnesses, serious accidents or surgery. This is because your adrenal glands would normally produce more steroid hormones to cope with these situations, however, if the action of your adrenal glands is suppressed, this increase in hormones won't happen naturally. For more information talk to your doctor or pharmacist.
- People with severe asthma should have regular blood tests to monitor the amount of potassium in their blood. This is because low oxygen levels in the blood (hypoxia) and various asthma medicines, including this one, can potentially lower blood potassium levels.
Not to be used in
- People with known sensitivity or allergy to any ingredient.
- The safety and effectiveness of this medicine in children and adolescents under 18 years of age has not been fully established. It is not currently recommended for this age group.
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Use with caution in
- Heart disease caused by inadequate blood flow to the heart (ischaemic heart disease, eg angina).
- Heart disease characterised by thickening of the internal heart muscle and a blockage inside the heart (hypertrophic obstructive cardiomyopathy).
- People with an irregular heartbeat (arrhythmia), or an abnormal heart rhythm seen as a 'prolonged QT interval' on a heart monitoring trace or ECG.
- People taking other medicines that can cause a 'prolonged QT interval' (see end of factsheet for examples).
- People with a serious defect in the heart's electrical message pathways resulting in decreased function of the heart (3rd degree heart block).
- People with narrowing of the tract through which blood is pumped out of the heart (idiopathic subvalvular aortic stenosis).
- Heart failure.
- High blood pressure (hypertension).
- People with a weakening in the wall of an artery that causes it to bulge outwards (aneurysm).
- Overactive thyroid gland (thyrotoxicosis).
- Tumour of the adrenal gland (phaeochromocytoma).
- Diabetes. It is recommended that people with diabetes should monitor their blood sugar more carefully when starting treatment with this medicine, as formoterol may increase blood sugar levels. If your diabetes treatment becomes less effective, ie your blood sugar levels are harder to control, you should consult your doctor.
- Severe liver disease.
- People with untreated low levels of potassium in the blood (hypokalaemia).
- People with fungal or viral infections in the airways.
- People with tuberculosis affecting the lungs.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- The safety of this medicine for use during pregnancy has not been established by the manufacturer and they do not recommend it for use in pregnancy, unless there is no alternative that is established as safer. However, it is important that asthma is well controlled in pregnant women. Wherever possible, asthma medications should be taken by inhaler, as this minimises the amount of medicine that enters the bloodstream and crosses the placenta. It is important to get medical advice from your doctor on how to control your asthma during pregnancy, but in general, inhaled medicines can be taken as normal during pregnancy.
- In general, asthma inhalers can be used as normal during breastfeeding, because the amount of medicine that passes into the breast milk after using an inhaler is negligable and unlikely to harm the baby. However, it is not known to what extent the medicines in this inhaler pass into breast milk and you should seek medical advice from your doctor before breastfeeding while using this medicine.
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.
Common (affect between 1 in 10 and 1 in 100 people)
- Sore throat (pharyngitis).
- Thrush infection of the mouth or throat (this can usually be avoided by brushing your teeth or rinsing your mouth with water after each time you use the inhaler).
Uncommon (affect between 1 in 100 and 1 in 1000 people)
- Throat irritation.
- Inflammation of the lining of the nose (rhinitis) causing a blocked or runny nose.
- Inflammation of the sinuses (sinusitis).
- Shaking, usually of the hands (tremor).
- Awareness of your heartbeat (palpitations).
- Faster than normal heartbeat (tachycardia).
- Redness of face and neck (flushing).
- Dry mouth.
- Burning sensation on the lips.
- Feeling sick or indigestion.
- Change in taste.
- Rash or itching.
- Increased sweating.
- Muscle pain or spasms.
- Low blood potassium level (hypokalaemia).
- High blood glucose level (hyperglycaemia).
Rare (affect between 1 in 1000 and 1 in 10,000 people)
- Chest pain (angina).
- Changes in blood pressure.
- Unexpected narrowing of the airways (paradoxical bronchospasm - see warning section above).
- Swelling of the face, throat or tongue (angioedema).
Very rare (affect less than 1 in 10,000 people)
- Systemic effects (eg, Cushing's syndrome, adrenal suppression, slowed growth in children and adolescents, decreased bone mineral density, cataract and glaucoma) may occur after high doses for prolonged periods - see warning above.
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while using this one, to make sure that the combination is safe.
Beta-blockers such as atenolol, propranolol or timolol should not generally be taken with this medicine. This is because beta-blockers have an opposite action to formoterol and can cause the airways to narrow, which can result in breathing difficulties. This problem has sometimes been seen with eye drops containing beta-blockers, eg used for glaucoma.
Formoterol can potentially cause a serious decrease in the levels of potassium in the blood (hypokalaemia), which may result in adverse effects. This effect can be increased by the following medicines, which can also lower potassium in the blood:
- xanthine derivates, such as theophylline or aminophylline
- corticosteroids, such as beclometasone and prednisolone
- other beta 2 agonists, such as salbutamol
- diuretics, such as bendroflumethiazide and furosemide.
This is why people with severe asthma, who may be taking several of these medicines, should have their blood potassium levels monitored regularly.
People taking digoxin may have an increased risk of abnormal heart rhythms if they experience abnormally low blood potassium levels while taking this medicine.
There may be an increased risk of abnormal heart rhythms (prolonged QT interval on the heart monitoring trace or ECG) if this medicine is taken in combination with other medicines that can have this effect, such as the following:
- certain antihistamines (terfenadine, astemizole, mizolastine)
- certain medicines for abnormal heartbeats (antiarrhythmics, eg quinidine, disopyramide, procainamide, amiodarone, dronedarone)
- certain antidepressants, eg clomipramine, citalopram, escitalopram
- certain antipsychotics, eg thioridazine, chlorpromazine, sertindole, haloperidol, pimozide
- certain antimalarials, eg halofantrine, chloroquine, quinine, artemether
- macrolide antibiotics, eg clarithromycin, erythromycin
Fostair inhaler contains a small amount of ethanol (alcohol) and theoretically may not be suitable for people taking the medicines disulfiram or metronidazole. This is because the ethanol may cause unpleasant symptoms such as hot flushes, abdominal cramps, nausea, vomiting, headache and palpitations in some people taking these medicines.
Other medicines containing the same active ingredients
There are currently no other medicines available in the UK that contain both beclometasone and formoterol. Both these medicines are available as separate inhalers.