Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Fostair is a pressurised inhalation solution containing two active substances which are inhaled through your mouth and delivered directly into your lungs.
The two active substances are: Beclometasone dipropionate, which belongs to a group of medicines called corticosteroids that have an anti-inflammatory action reducing the swelling and irritation in your lungs.
Formoterol fumarate dihydrate, which belongs to a group of medicines called long-acting bronchodilators that relax the muscles in your airways and helps you to breathe more easily.
These two active substances make breathing easier. They also help to prevent asthma symptoms such as shortness of breath, wheezing and coughing.
Fostair is used to treat asthma in adults.
If you are prescribed Fostair it is likely that either: • your asthma is not adequately controlled by using inhaled corticosteroids and "as needed" shortacting bronchodilators or • your asthma responds well to both corticosteroids and long-acting bronchodilators
Do not use Fostair: • if you are allergic to beclometasone dipropionate or formoterol fumarate dihydrate or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Fostair if you have any of the following: • heart problems, such as angina (heart pain, pain in the chest), heart failure, narrowing of the arteries, valvular heart disease or any other known abnormalities of your heart • high blood pressure or if you know that you have an aneurysm (an abnormal bulging of the blood vessel wall) • disorders of your heart rhythm such as increased or irregular heart rate, a fast pulse rate or palpitations, or if you have been told that your heart trace is abnormal • an overactive thyroid gland • low blood levels of potassium • any disease of your liver or kidneys • diabetes (if you inhale high doses of formoterol your blood glucose may increase. When you start using this medicine and from time to time during treatment you may need to have some additional blood tests to check your blood sugar) • tumour of the adrenal gland (known as a phaeochromocytoma) • are due to have an anaesthetic. Depending on the type of anaesthetic, it may be necessary to stop taking Fostair for at least 12 hours before the anaesthesia • if you are being, or have ever been, treated for tuberculosis (TB) or if you have a known viral or fungal infection of your chest • if you must avoid alcohol for any reason
If any of the above applies to you, always inform your doctor before you use Fostair. If you have or had any medical problems or allergies or if you are not sure whether you can use Fostair talk to your doctor, asthma nurse or pharmacist before using this medicine. Your doctor may wish to measure the potassium levels in your blood from time to time especially if your asthma is severe. Like many bronchodilators Fostair can cause a sharp fall in your serum
PACKAGE LEAFLET: INFORMATION FOR THE USER
200/6 micrograms per actuation pressurised inhalation solution beclometasone dipropionate/ formoterol fumarate dihydrate
For use in adults
Please read the back of this leaflet
Should you need to go to the hospital, remember to take all of your medicines and inhalers with you, including Fostair and any medicines or tablets bought without a prescription, in their original packaging, if possible.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents Fostair should not be used in children and adolescent less than 18 years old.
Other medicines and Fostair: • Tell your doctor, pharmacist or nurse if you are taking, have recently taken any other medicines, including medicines obtained without a prescription. This is because Fostair may affect the way some other medicines work. Also, some medicines may affect the way Fostair works.
In particular, tell your doctor, pharmacist or nurse if you are using any of the following medicines: • Some medicines may increase the effects of Fostair and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat). • Beta-blocker medicines. Beta blockers are medicines used to treat many conditions including heart problems, high blood pressure and glaucoma (increased pressure in the eyes). If you need to use beta blockers including eye drops, the effect of formoterol may be reduced or formoterol may not work at all. • Beta adrenergic drugs (drugs which work in the same way as formoterol) may increase the effects of formoterol. • Medicines for treating abnormal heart rhythms (quinidine, disopyramide, procainamide). • Medicines used to treat allergic reactions (antihistamines). • Medicines to treat symptoms of depression or mental disorders such as monoaminoxidase inhibitors (for example phenelzine and isocarboxazid), tricyclic antidepressants (for example amitryptiline and imipramine), phenothiazines. • Medicines to treat Parkinson's Disease (L-dopa). • Medicines to treat an underactive thyroid gland (L-thyroxine). • Medicines containing oxytocin (which causes uterine contraction). • Medicines to treat mental disorders such as monoaminoxidase inhibitors (MAOIs), including drugs with similar properties like furazolidone and procarbazine. • Medicines to treat heart disease (digoxin). • Other medicines used to treat asthma (theophylline, aminophylline or steroids). • Diuretics (water tablets). Also tell your doctor if you are going to have a general anaesthetic for an operation or for dental work.
Pregnancy, breast- feeding and fertility There are no clinical data on the use of Fostair during pregnancy. Fostair should not be used if you are pregnant, think that you might be pregnant or are planning to become pregnant, or if you are breast-feeding, unless you are advised to do so by your doctor.
Driving and using machines Fostair is unlikely to affect your ability to drive and use machines.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will give you a regular check-up to make sure you are taking the optimal dose of Fostair. Your doctor will adjust your treatment to the lowest dose that best controls your symptoms.
Dosage: Adults and the elderly: The recommended dose is two actuations twice daily. The maximum daily dose is 4 actuations.
At-risk patients: There is no need for dose adjustment if you are older. No information is available regarding the use of Fostair in people with liver or kidney problems.
Use in children and adolescents less than 18 years of age: Children and adolescents aged less than 18 years must NOT take this medicine.
potassium level (hypokalaemia). This is because a lack of oxygen in the blood combined with some other treatments you may be taking together with Fostair can make the fall in potassium level worse.
If you take higher doses of inhaled corticosteroids over long periods, you may have more of a need for corticosteroids in situations of stress. Stressful situations might include being taken to hospital after an accident, having a serious injury or before an operation. In this case, the doctor treating you will decide whether you may need to increase your dose of corticosteroids and may prescribe some steroid tablets or a steroid injection.
Fostair contains alcohol Fostair contains 9 mg of alcohol (ethanol) in each actuation which is equivalent to 0.25 mg/kg per dose of two actuations. The amount in two actuations of this medicine is equivalent to less than 1 ml of wine or beer. The small amount of alcohol in this medicine will not have any noticeable effects.
Remember: You should always have your quick-acting "reliever" inhaler with you at all times to treat worsening symptoms of asthma or a sudden asthma attack.
Fostair is effective for the treatment of asthma in a dose of beclometasone dipropionate which may be lower than that of some other inhalers containing this substance. If you have been using a different
Please read the back of this leaflet
PAG. 2/6 0108016999/01
inhaler containing beclometasone dipropionate previously, your doctor will advise you on the exact dose of Fostair you should take for your asthma.
Do not increase the dose If you feel that the medicine is not very effective, always talk to your doctor before increasing the dose.
If your asthma gets worse: If your symptoms get worse or are difficult to control (e.g. if you are using a separate "reliever" inhaler more frequently) or if your "reliever" inhaler does not improve your symptoms, see your doctor immediately. Your asthma may be getting worse and your doctor may need to change your dose of Fostair or prescribe alternative treatment.
Method of administration: Fostair is for inhalation use This medicine is contained in a pressurised canister in a plastic casing with a mouthpiece.
How to use your inhaler Whenever possible, stand or sit in an upright position when inhaling.
If you need to take another actuation, keep the inhaler in the vertical position for about half a minute, then repeat steps 2 to 5.
Important: Do not perform steps 2 to 5 too quickly.
After use, close with the protective cap. To lower the risk of a fungal infection in the mouth and throat, rinse your mouth, gargle with water or brush your teeth each time you use your inhaler.
If you see 'mist' coming from the top of the inhaler or the sides of your mouth, this means that Fostair will not be getting into your lungs as it should. Take another puff, following the instruction starting again from step 2.
If you think the effect of Fostair is too much or not enough, tell your doctor or pharmacist.
If you find it difficult to operate the inhaler while starting to breathe in you may use the AeroChamber Plus spacer device. Ask your doctor, pharmacist or a nurse about this device. It is important that you read the package leaflet which is supplied with your AeroChamber Plus spacer device and that you follow the instructions on how to use and how to clean it, carefully.
Cleaning You should clean your inhaler once a week. When cleaning, do not remove the canister from the actuator and do not use water or other liquids to clean your inhaler.
To clean your inhaler: 1. Remove the protective cap from the mouthpiece by pulling it away from your inhaler. 2. Wipe inside and outside of the mouthpiece and the actuator with a clean, dry cloth or tissue. 3. Replace the mouthpiece cover
If you use more Fostair than you should: • taking more formoterol than you should can have the following effects: feeling sick, being sick, heart racing, palpitations, disturbances of heart rhythm, certain changes in the electrocardiogram (heart trace), headache, trembling, feeling sleepy, too much acid in the blood, low blood potassium levels, high levels of glucose in the blood. Your doctor may wish to carry out some blood tests to check your blood potassium and blood glucose levels • taking too much beclometasone dipropionate can lead to short-term problems with your adrenal glands. This will get better within a few days however your doctor may need to check your serum cortisol levels Tell your doctor if you have any of these symptoms.
If you forget to use Fostair: Take it as soon as you remember. If it is almost time for your next dose, do not take the dose you have missed, just take the next dose at the correct time. Do not take a double dose to make up for a forgotten dose.
Testing your inhaler Before using the inhaler for the first time or if you have not used the inhaler for 14 days or more, you should test your inhaler to make sure that it is working properly. • Remove the protective cap from the mouthpiece • Hold your inhaler upright with the mouthpiece at the bottom • Direct the mouthpiece away from yourself and firmly depress the canister to release one puff
1 2 3 4 5 1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust and dirt or any other foreign objects. 2. Breathe out as slowly and deeply as possible. 3. Hold the canister vertically with its body upwards and put your lips around the mouthpiece. Do not bite the mouthpiece. 4. Breathe in slowly and deeply through your mouth and, just after starting to breathe in press down firmly on the top of the inhaler to release one actuation. If you have weak hands, it may be easier to hold the inhaler with both hands: hold the upper part of the inhaler with both index fingers and its lower part with both thumbs. 5. Hold your breath for as long as possible and, finally, remove the inhaler from your mouth and breathe out slowly. Do not breathe into the inhaler.
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0108016999/01 PAG. 3/6
If you stop using Fostair: Even if you are feeling better, do not stop taking Fostair or lower the dose. If you want to do this, talk to your doctor. It is very important for you to use Fostair regularly even though you may have no symptoms.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
As with other inhaler treatments there is a risk of worsening shortness of breath and wheezing immediately after using Fostair and this is known as paradoxical bronchospasm. If this occurs, you should STOP using Fostair immediately and use your quick-acting "reliever" inhaler straightaway to treat the symptoms of shortness of breath and wheezing. You should contact your doctor immediately.
Other possible side effects are listed below according to their frequency.
Common (may affect up to 1 in 10 people): • fungal infections (of the mouth and throat) • headache • hoarseness • sore throat
Uncommon (may affect up to 1 in 100 people): • palpitations, unusually fast heart beat and heart rhythm disorders • some changes in the electrocardiogram (ECG) • increase in blood pressure • flu like symptoms • sinus inflammation • rhinitis • inflammation of the ear • throat irritation • cough and productive cough • asthma attack • fungal infections of the vagina • nausea • abnormal or impaired sense of taste • burning of the lips • dry mouth • swallowing difficulties • indigestion • upset stomach • diarrhoea • pain in muscle and muscle cramps • reddening of the face and throat • increased blood flow to some tissues in the body • excessive sweating • trembling • restlessness • dizziness • nettle rash or hives • alterations of some constituents of the blood: 0 fall in the number of white blood cells 0 increase in the number of blood platelets 0 fall in the level of potassium in the blood 0 increase in blood sugar level 0 increase in the blood level of insulin, free fatty acid and ketones
Rare (may affect up to 1 in 1,000 people): • chest tightness • missed heartbeat (caused by premature contraction of the heart's ventricles) • decrease in blood pressure • kidney inflammation • swelling of skin and mucous membrane persisting for several days
Very rare (may affect up to 1 in 10,000 people): • shortness of breath • worsening of asthma • a fall in the number of blood platelets • swelling of the hands and feet
Tell your doctor immediately if you experience any hypersensitivity reactions like skin allergies, skin itching, skin rash, reddening of the skin, swelling of the skin or mucous membranes especially of the eyes, face, lips and throat.
The following side effects have also been reported as "uncommon" in patients with chronic obstructive pulmonary disease: • pneumonia; tell your doctor if you notice any of the following symptoms: increase in sputum production, change in sputum colour, fever, increasing cough, increased breathing problems • reduction of the amount of cortisol in the blood; this is caused by the effect of corticosteroids on your adrenal gland • irregular heart beat
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PAG. 4/6 0108016999/01
Using high-dose inhaled corticosteroids over a long time can cause in very rare cases systemic effects. These include: • problems with how your adrenal glands work (adreno-suppression) • decrease in bone mineral density (thinning of the bones) • growth retardation in children and adolescents • increased pressure in your eyes (glaucoma) • cataracts
Not known (frequency cannot be estimated from the available data): • sleeping problems • depression or anxiety • nervousness • feeling over-excited or irritable. These events are more likely to occur in children but the frequency is not known. • Blurred vision
Reporting of side effects If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme: Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
For the pharmacist: Store in a refrigerator (2-8°C) for a maximum of 18 months.
Do not store the inhaler above 25 °C.
If the inhaler has been exposed to severe cold, warm it with your hands for a few minutes before using. Never warm it by artificial means.
Warning: The canister contains a pressurised liquid. Do not expose the canister to temperatures higher than 50 °C. Do not pierce the canister.
Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
What Fostair contains: The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate. Each metered dose from the inhaler contains 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a delivered dose from the mouthpiece of 177.7 micrograms of beclometasone dipropionate and 5.1 micrograms of formoterol fumarate dihydrate.
What Fostair looks like and contents of the pack: Fostair is a pressurised inhalation solution contained in an aluminium coated canister with a metering valve, fitted in a plastic actuator with a plastic protective cap. Each pack contains: 1 pressurised container (which provides 120 actuations) 2 pressurised containers (which provide 120 actuations each) 1 pressurised container (which provides 180 actuations)
Not all pack sizes may be marketed.
Marketing authorisation holder: Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, UK.
Manufacturer responsible for batch release: Chiesi Farmaceutici S.p.A., Via San Leonardo 96, 43122 Parma - Italy
Chiei S.A.S., 2 rue des Docteurs Alberto et Paolo Chiesi 41260 La Chaussée Saint-Victor - France
This leaflet was last revised in February 2026.
For the patients: Do not use this medicine beyond 3 months from the date you get the inhaler from your pharmacist and never use after the expiry date which is stated on the carton and label after Exp. The expiry date refers to the last day of that month.
The other ingredients are: norflurane (HFC-134a), ethanol anhydrous, hydrochloric acid. This medicine contains fluorinated greenhouse gases. Each inhaler contains 10.356 g of norflurane (HFC-134a) corresponding to 0.015 tonne CO2 equivalent (global warming potential GWP = 1430).
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0108016999/01 PAG. 5/6
CP0040-12-SA PAG. 6/6 0108016999/01
Fostair 200/6 micrograms per actuation pressurised inhalation solution (WITHOUT dose counter) comes as solution containing 6 microgram. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Fostair 200/6 micrograms per actuation pressurised inhalation solution (WITHOUT dose counter) is formoterol fumarate dihydrate.
Medicines with the same active substance include: Atimos Modulite 12 micrograms/actuation pressurised inhalation solution, Formoterol Easyhaler 12 micrograms per dose inhalation powder, Oxis Turbohaler 12, inhalation powder, Oxis Turbohaler 6, inhalation powder. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Fostair 200/6 micrograms per actuation pressurised inhalation solution (WITHOUT dose counter), as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Fostair is indicated in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate:
- patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled rapid-acting beta2-agonist or
- patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists.
Fostair is indicated in adults.
Posology
Fostair is not intended for the initial management of asthma. The dosage of the components of Fostair is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated but also when the dose is adjusted. If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of beta2-agonists and/or corticosteroids by individual inhalers should be prescribed.
Beclometasone dipropionate in Fostair is characterised by an extrafine particle size distribution which results in a more potent effect than formulations of beclometasone dipropionate with a non-extra fine particle size distribution (100 micrograms of beclometasone dipropionate extrafine in Fostair are equivalent to 250 micrograms of beclometasone dipropionate in a non-extrafine formulation). Therefore the total daily dose of beclometasone dipropionate administered in Fostair should be lower than the total daily dose of beclometasone dipropionate administered in a non-extrafine beclometasone dipropionate formulation.
This should be taken into consideration when a patient is transferred from a beclometasone dipropionate non-extrafine formulation to Fostair; the dose of beclometasone dipropionate should be lower and will need to be adjusted to the individual needs of the patients.
Dose recommendations for adults 18 years and above:
Two inhalations twice daily.
The maximum daily dose is 4 inhalations.
Fostair 200/6 should be used as maintenance therapy only. A lower strength (Fostair 100/6) is available for maintenance and reliever therapy.
Patients should be advised to have their separate short-acting bronchodilator available for rescue use at all times.
Patients should be regularly reassessed by a doctor, so that the dosage of Fostair remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. When long term control of symptoms is maintained with the lowest recommended dosage, then the next step could include a test of inhaled corticosteroid alone.
Fostair 200/6 should not be used for step-down treatment but a lower strength of the beclometasone dipropionate component in the same inhaler is available for step-down treatment (Fostair 100/6 micrograms).
Patients should be advised to take Fostair every day even when asymptomatic.
Special patient groups:
There is no need to adjust the dose in elderly patients. There are no data available for use of Fostair in patients with hepatic or renal impairment (see section 5.2).
Dose recommendations for children and adolescents under 18 years:
Fostair 200/6 should not be used in children and adolescents less than 18 years.
Method of administration
Fostair is for inhalation use.
To ensure proper administration of the drug, the patient should be shown how to use the inhaler correctly by a physician or other health professional. Correct use of the pressurised metered dose inhaler is essential in order that treatment is successful. The patient should be advised to read the Patient Information Leaflet carefully and follow the instructions for use as given in the Leaflet.
Fostair inhaler is provided with a counter on the back of the actuator, which shows how many doses are left. For the 120 doses presentation each time the patient presses the canister, a puff of medicine is released and the counter counts down by one. For the 180 presentation, each time the patient presses the canister the counter rotates by a small amount and the number of puffs remaining is displayed in intervals of 20. Patients should be advised not to drop the inhaler as this may cause the counter to count down.
Testing the inhaler
Before using the inhaler for the first time or if the inhaler has not been used for 14 days or more, the patient should release one actuation into the air in order to ensure that the inhaler is working properly (priming). Before priming the 120 or 180 actuation pressurised containers, the counter/indicator should read 121 or 180, respectively. After testing the inhaler for the first time, the counter should read 120 or 180.
Use of the inhaler:
If the inhaler has been exposed to severe cold, patients should warm it with their hands for a few minutes before using it. They should never warm it by artificial means.
Whenever possible patients should stand or sit in an upright position when inhaling from their inhaler.
1. Patients should remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust and dirt or any other foreign objects.
2. Patients should breathe out as slowly and deeply as possible.
3. Patients should hold the canister vertically with its body upwards and put the lips around the mouthpiece without biting the mouthpiece.
4. At the same time, patients should breathe in slowly and deeply through the mouth. After starting to breathe in, they should press down on the top of the inhaler to release one puff.
5. Patients should hold the breath for as long as possible and, finally, they should remove the inhaler from the mouth and breathe out slowly. Patients should not breathe out into the inhaler.
To inhale a further puff, patients should keep the inhaler in a vertical position for about half a minute and repeat steps 2 to 5.
IMPORTANT: patients should not perform steps 2 to 5 too quickly.
After use, patients should close the inhaler with protective cap and check the dose counter.
Patients should be advised to get a new inhaler when the dose counter or indicator shows the number 20. They should stop using the inhaler when the counter shows 0 as any puffs left in the device may not be enough to release a full dose
If mist appears following inhalation, either from the inhaler or from the sides of the mouth, the procedure should be repeated from step 2.
For patients with weak hands it may be easier to hold the inhaler with both hands. Therefore the index fingers should be placed on the top of the inhaler canister and both thumbs on the base of the inhaler.
Patients should rinse their mouth or gargle with water or brush the teeth after inhaling (see section 4.4).
The canister contains a pressurised liquid. Patients should be advised not to expose to temperatures higher than 50°C and not to pierce the canister.
Cleaning
Patients should be advised to read the Patient Information Leaflet carefully for cleaning instructions. For the regular cleaning of the inhaler, patients should remove the cap from the mouthpiece and wipe the outside and inside of the mouthpiece with a dry cloth. They should not remove the canister from the actuator and should not use water or other liquids to clean the mouthpiece.
Patients who find it difficult to synchronise aerosol actuation with inspiration of breath, may use the AeroChamber Plus spacer device. They should be advised by their doctor, pharmacist or a nurse in the proper use and care of their inhaler and spacer and their technique checked to ensure optimum delivery of the inhaled drug to the lungs. This may be obtained by the patients using the AeroChamber Plus by one continuous slow and deep breath through the spacer, without any delay between actuation and inhalation.
Hypersensitivity to active substances or to any of the excipients listed in section 6.1.
Pharmacokinetic interactions
Beclometasone dipropionate undergoes a very rapid metabolism via esterase enzymes.
Beclometasone is less dependent on CYP3A metabolism than some other corticosteroids, and in general interactions are unlikely; however, the possibility of systemic effects with concomitant use of strong CYP3A inhibitors (e.g. ritonavir, cobicistat) cannot be excluded, and therefore caution and appropriate monitoring is advised with the use of such agents.
Pharmacodynamic interactions
Beta-adrenergic blockers can weaken or inhibit the effect of formoterol. Fostair should therefore not be given together with beta-adrenergic blockers (including eye drops) unless there are compelling reasons.
On the other hand, concomitant use of other beta-adrenergic drugs can have potentially additive effects, therefore caution is required when theophylline or other beta-adrenerigic drugs are prescribed concomitantly with formoterol.
Concomitant treatment with quinidine, disopyramide, procainamide, phenothiazines, antihistamines, monoamine oxidase inhibitors and tricyclic antidepressants can prolong the QTc-interval and increase the risk of ventricular arrhythmias.
In addition L-dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2-sympathomimetics.
Concomitant treatment with monoamine oxidase inhibitors including agents with similar properties such as furazolidone and procarbazine may precipitate hypertensive reactions.
There is an elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons.
Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate a possible hypokalaemic effect of beta2-agonists (see section 4.4.). Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides.
Fostair contains a small amount of ethanol. There is a theoretical potential for interaction in particularly sensitive patients taking disulfiram or metronidazole.
Fertility
There are no data in humans. In animal studies in rats, the presence of beclometasone dipropionate at high doses in the combination was associated with reduced female fertility and embryotoxicity (see section 5.3).
Pregnancy
There is no experience with or evidence of safety of propellant HFA-134a in human pregnancy or lactation. However studies of the effect of HFA-134a on reproductive function and embryofetal development in animals have revealed no clinically relevant adverse effects.
There are no relevant clinical data on the use of Fostair in pregnant women. Animal studies using beclometasone dipropionate and formoterol combination showed evidence of toxicity to reproduction after high systemic exposure (see 5.3 Preclinical safety data). Because of the tocolytic actions of beta2-sympathomimetic agents particular care should be exercised in the run up to delivery. Formoterol should not be recommended for use during pregnancy and particularly at the end of pregnancy or during labour unless there is no other (safer) established alternative.
Fostair should only be used during pregnancy if the expected benefits outweigh the potential risks.
Breast feeding
There are no relevant clinical data on the use of Fostair in lactation in humans.
Although no data from animal experiments are available, it is reasonable to assume that beclometasone dipropionate is secreted in milk, like other corticosteroids.
While it is not known whether formoterol passes into human breast milk, it has been detected in the milk of lactating animals.
Administration of Fostair to women who are breast-feeding should only be considered if the expected benefits outweigh the potential risks.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Fostair therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fostair is unlikely to have any effect on the ability to drive and operate machinery.
Inhaled doses of Fostair 100/6 up to twelve cumulative actuations (total beclometasone dipropionate 1200 micrograms, formoterol 72 micrograms) have been studied in asthmatic patients. The cumulative treatments did not cause abnormal effect on vital signs and neither serious nor severe adverse events were observed.
Excessive doses of formoterol may lead to effects that are typical of beta2-adrenergic agonists: nausea, vomiting, headache, tremor, somnolence, palpitations, tachycardia, ventricular arrhythmias, prolongation of QTc interval, metabolic acidosis, hypokalaemia, hyperglycaemia.
In case of overdose of formoterol, supportive and symptomatic treatment is indicated. Serious cases should be hospitalised. Use of cardioselective beta-adrenergic blockers may be considered, but only subject to extreme caution since the use of beta-adrenergic blocker medication may provoke bronchospasm. Serum potassium should be monitored.
Acute inhalation of beclometasone dipropionate doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not need emergency action as adrenal function recovers in a few days, as verified by plasma cortisol measurements. In these patients treatment should be continued at a dose sufficient to control asthma.
Chronic overdose of inhaled beclometasone dipropionate: risk of adrenal suppression (see section 4.4.). Monitoring of adrenal reserve may be necessary. Treatment should be continued at a dose sufficient to control asthma.
Ask anything about Fostair 200/6 micrograms per actuation pressurised inhalation solution (WITHOUT dose counter). The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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