Fostair 200/6 micrograms per actuation pressurised inhalation solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk with your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Fostair is and what it is used for
2. What you need to know before you use Fostair
3. How to use Fostair
4. Possible side effects
5. How to store Fostair
6. Contents of the pack and other information

• if you are allergic to beclometasone dipropionate or formoterol fumarate dihydrate or any of the other ingredients of this medicine (listed in section 6).

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 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.

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.

Fostair should not be used in children and adolescent less than 18 years old.

• 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.

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.

Fostair is unlikely to affect your ability to drive and use machines.

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.

Adults and the elderly:

The recommended dose is two actuations twice daily.

The maximum daily dose is 4 actuations.

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.

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.

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 inhaler containing beclometasone dipropionate previously, your doctor will advise you on the exact dose of Fostair you should take for your asthma.

If you feel that the medicine is not very effective, always talk to your doctor before increasing the dose.

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.

Fostair is for inhalation use

This medicine is contained in a pressurised canister in a plastic casing with a mouthpiece. There is a counter on the back of the inhaler, which tells you how many doses are left. Each time you press the canister, a puff of medicine is released and the counter will count down by one. Take care not to drop the inhaler as this may cause the counter to count down.

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
• Check the dose counter. If you are testing your inhaler for the first time, the counter should read 120.

Whenever possible, stand or sit in an upright position when inhaling.

Before you start inhaling, check the dose counter: any number between “1” and “120” shows that there are doses left. If the dose counter shows “0” there are no doses left – dispose of your inhaler and get a new one.

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.

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 and check the dose counter.

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.

You should get a replacement when the counter shows the number 20. Stop using the inhaler when the counter shows 0 as any actuations left in the device may not be enough to give you a full dose.

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.

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

• 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.

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.

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 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.

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.

The other ingredients are: norflurane (HFA 134-a), ethanol anhydrous, hydrochloric acid.

Fostair is a pressurised inhalation solution contained in an aluminium coated canister with a metering valve, fitted in a plastic actuator which incorporates a dose counter (120 actuations pack) or a dose indicator (180 actuations pack), 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.