Package Leaflet Information for the user

Fostair® 100/6 micrograms per actuation pressurised inhalation solution

(beclometasone dipropionate/formoterol fumarate)

For use in adults.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or 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, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

Your medicine is available using the above name, but will be referred to as Fostair throughout this leaflet.

What is in this leaflet:

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.    Content of the pack and other information

1.    What Fostair is and what it is used for

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 and formoterol fumarate dihydrate. Beclometasone dipropionate belongs to a group of medicines called corticosteroids which have an anti-inflammatory action reducing the swelling and irritation in your lungs.

Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators which relax the muscles in your airways and helps you to breathe more easily.

Together these two active substances make breathing easier, by providing relief from symptoms such as shortness of breath, wheezing and cough in patients with asthma or COPD and also help to prevent the symptoms of asthma.

Asthma

Fostair is indicated in the regular treatment of asthma in adult patients in whom:

•    asthma is not adequately controlled by using inhaled corticosteroids and ‘as needed’ short-acting bronchodilators.

or

•    asthma is responding well to treatment with both corticosteroids and long-acting bronchodilators.

COPD

Fostair can also be used to treat the symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a long term disease of the airways in the lungs which is primarily caused by cigarette smoking.

2.    What you need to know before you use Fostair Do not use Fostair:

•    if you are allergic or think you are allergic to one or other of the active ingredients of Fostair or if you are allergic to other medicines or inhalers used to treat asthma or to any of the other ingredients of Fostair (listed in section 6: Content of the pack and other information), contact your doctor for advice.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before using Fostair:

•    if you have any heart problems, such as angina (heart pain, pain in the chest), a recent heart

attack (myocardial infarction), heart failure, narrowing of the arteries around your heart (coronary heart disease), valvular heart disease or any other known abnormalities of your heart or if you have a condition known as hypertrophic obstructive cardiomyopathy (also known as HOCM, a condition where the heart muscle is abnormal).

•    if you have a narrowing of the arteries (also known as arteriosclerosis), if you have high blood pressure or if you know that you have an aneurysm (an abnormal bulging of the blood vessel wall)

•. if you have 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.

•    if you have an overactive thyroid gland.

•    if you have low blood levels of potassium.

•    if you have any disease of your liver or kidneys.

•    if you have diabetes (if you inhale high doses of formoterol your blood glucose may increase and therefore you may need to have some additional blood tests to check your blood sugar when you start using this inhaler and from time to time during treatment).

•    if you have a tumour of the adrenal gland (known as phaeochromocytoma).

•    if you are due to have an anaesthetic. Depending on the type of anaesthetic, it may be necessary to stop taking Fostair 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 have had any medical problems or any allergies or if you are not sure as to whether you can use Fostair talk to your doctor, asthma nurse or pharmacist before using the inhaler.

Treatment with a beta-2-agonist like the formoterol contained in Fostair can cause a sharp fall in your serum potassium level (hypokalaemia).

If you have severe asthma, you must take special care. This is because a lack of oxygen in the blood and some other treatments you may be taking together with Fostair, such as medicines for treating heart disease or high blood pressure, known as diuretics or ‘water tablets’ or other medicines used to treat asthma can make the fall in potassium level worse. For this reason your doctor may wish to measure the potassium levels in your blood from time to time.

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 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 package, if possible.

Children and adolescents

Fostair should not be used in children and adolescents less then 18 years old, until further data become available.

Other medicines and Fostair:

Tell your doctor or pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

Do not use beta blockers with this medicine. Beta blockers such as atenolol, propranolol and sotalol are used to treat a number of conditions including high blood pressure and heart conditions such as abnormal heart rhythms and heart failure; timolol is used to treat glaucoma. If you need to use beta blockers, and including beta blockers in eye-drops, the effect of formoterol may be reduced or formoterol may not work at all. On the other hand, using other beta adrenergic drugs (drugs which work in the same way as formoterol) may increase the effects of formoterol.

Using Fostair together with:

•    medicines for treating abnormal heart rhythms (quinidine, disopyramide, procainamide), medicines used to treat allergic reactions (antihistamines), medicines for treating symptoms of depression or mental disorders such as monoamine oxidase inhibitors (for example phenelzine and isocarboxazid), tricyclic antidepressants (for example amitriptyline and imipramine), phenothiazines, can cause some changes in the electrocardiogram (ECG, heart trace). They may also increase the risk of disturbances of heart rhythm (ventricular arrhythmias).

•    medicines for treating Parkinson’s Disease (L-dopa), to treat an underactive thyroid gland (L-thyroxine), medicines containing oxytocin (which causes uterine contractions) and alcohol can lower your heart’s tolerance to beta-2-agonists, such as formoterol.

•    monoamine oxidase inhibitors (MAOIs), including drugs with similar properties like furazolidone and procarbazine, used to treat mental disorders, can cause a rise in blood pressure.

•    medicines for treating heart disease (digoxin) can cause a fall in your blood potassium level. This may increase the likelihood of abnormal heart rhythms.

•    other medicines used to treat asthma (theophylline, aminophylline or steroids) and diuretics (water tablets) may cause a fall in your potassium level.

•    some anaesthetics can increase the risk of abnormal heart rhythms.

Pregnancy, breast-feeding and fertility

There are no clinical data on the use of Fostair during pregnancy. Fostair must 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. However if you experience side effects such as dizziness and/or trembling, your ability to drive or operate machinery may be affected.

Fostair contains alcohol

Fostair contains a small amount of alcohol. Each actuation (puff) from your inhaler contains 7mg of ethanol.

3. How to use Fostair Fostair is for inhalation use.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The pharmacist’s label will tell you how many puffs to take and how often they must be taken.

Asthma

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.

Fostair can be prescribed by your doctor in two different ways:

a)    Use Fostair every day to treat your asthma together with a separate “reliever “ inhaler to treat sudden worsening of asthma symptoms, such as shortness of breath, wheezing and cough

b)    Use Fostair every day to treat your asthma and also use Fostair to treat sudden worsening of your asthma symptoms, such as shortness of breath, wheezing and cough

a)    Using Fostair together with a separate “reliever”:

Adults and the elderly:

The recommended dose of this medicine is one or two puffs twice daily. The maximum daily dose is 4 puffs.

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.

b)    Using Fostair as your only asthma inhaler:

Adults and the elderly:

The recommended dose is one puff in the morning and one puff in the evening.

You should also use Fostair as a “reliever” inhaler to treat sudden asthma symptoms.

If you get asthma symptoms, take one puff and wait a few minutes.

If you do not feel better, take another puff.

Do not take more than 6 Fostair “reliever” puffs per day.

The maximum daily dose using Fostair as your only asthma inhaler is 8 puffs.

If you feel you need more puffs each day to control your asthma symptoms, contact your doctor to seek their advice. They may need to change your treatment.

Use in children and adolescents less than 18 years of age:

Children and adolescents aged less than 18 years must NOT take this medicine.

Chronic obstructive pulmonary disease (COPD)

Adults and the elderly:

The recommended dose is two puffs in the morning and two puffs in the evening.

At-risk patients:

Older people do not need to have their dose adjusted. No information is available regarding the use of Fostair in people with liver or kidney problems.    Please read the back of this leaflet ^

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 beclometasone dipropionate. 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.

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 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 carry out some blood tests to check your serum cortisol levels.

Tell your doctor if you have any of the above 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 double the dose.

If you stop using Fostair:

Do not lower the dose or stop using your medication.

Even if you are feeling better, do not stop using 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 your breathing gets worse:

If you develop worsening shortness of breath or wheezing (breathing with an audible whistling sound), straight after inhaling your medicine, stop using your Fostair inhaler immediately and use your quick acting ‘reliever’ inhaler straightaway. You should contact your doctor straightaway. Your doctor will assess your symptoms and if necessary may start you on a different course of treatment. See also section 4. Possible side effects.

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 or Fostair as a reliever inhaler more frequently) or if your ‘reliever’ inhaler or Fostair does not improve your symptoms, see your doctor immediately. Your asthma may be getting worse and your doctor may need to increase your dose of Fostair or prescribe alternative treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Method of administration:

Before using the inhaler for the first time or if you have not used the inhaler for 14 days or more, release one puff into the air to make sure the inhaler is working properly. Whenever possible, stand or sit in an upright position when inhaling.

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 on

If you need to take another puff, 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.

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, carefully following the instructions from Step 2 onwards.

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.

To lower the risk of a fungal infection in the mouth and throat, rinse your mouth or gargle with water or brush your teeth each time you use the inhaler.

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.

Cleaning:

Remove the cap from the mouthpiece and regularly (once a week) wipe the outside and inside of the mouthpiece with a dry cloth. Do not use water or other liquids to clean the mouthpiece.

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 the AeroChamber Plus™ spacer device and how to clean it carefully.

4. Possible side effects

Like all medicines, Fostair 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 must 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 straightaway.

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.

Other possible side effects are listed below according to their frequency.

Common (affecting less than 1 in 10 people):

• Fungal infections (of the mouth and throat), headache, hoarseness, sore throat.

Rare (affecting less than 1 in

•    tightness in the chest

•    sensation of a missed heartbeat

•    increase or decrease in blood pressure

1,000 people):

• inflammation of the kidney

• swelling of the skin and mucous membrane persisting for several days

Very rare (affecting less than 1 in 10,000 people):

• worsening of asthma    • a fall in the number of blood platelets

• ^short^{ness of breath}    • swelling of the hands and feet

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 (adrenosuppression) increased pressure in your eyes (glaucoma)

cataracts growth retardation (slowing of growth in children and adolescents

decrease in bone mineral density (thinning of the bones)

Unkown:

• Sleeping problems, depression or feeling worried, restless, nervous, over-excited or irritable. These effects are more likely to occur in children.

the top of the inhaler to release one puff.

Uncommon (affecting less than 1 in 100 people):

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

atwww.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on

the safety of this medicine.

5. How to store Fostair

•    Keep this medicine out of the sight and reach of children.

•    Do not use Fostair beyond five 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.

•    Do not store the inhaler above 25°C.

•    If the inhaler has been exposed to severe cold, take the canister out of the mouthpiece and 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.

•    Medicines should not be disposed of via waste water or household waste. Return all used, partially used and unused inhalers to your pharmacist to be disposed of. These measures will help to protect the environment.

•    If your inhaler fails to work properly or shows any signs of deterioration, you should seek the advice of your pharmacist.

6. Content of the pack and other information What Fostair contains:

Each actuation/metered dose (ex-valve) contains beclometasone dipropionate 100 micrograms and formoterol fumarate dihydrate 6 micrograms. This is equivalent to a delivered dose (ex-actuator) containing beclometasone dipropionate 84.6 micrograms and formoterol fumarate dihydrate 5 micrograms.

The other ingredients are: ethanol anhydrous, hydrochloric acid and the CFC-free propellant -norflurane (HFA-134a). To help protect the environment, the inhaler contains the CFC-free propellant, HFA-134a, which replaces completely the chlorofluorocarbon (CFC) propellants present in some other inhalers and appears to have a less damaging effect on the ozone layer. Fostair does not contain CFCs.

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. After use, close with the protective cap.

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, increase 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.

What Fostair looks like and contents of the pack:

Fostair is a pressurised solution contained in an aluminium canister with a metering valve, fitted in a polypropylene pink plastic actuator with a dark pink plastic protective cap.

Each pack contains one canister which provides 120 actuations (puffs).

Procured from within the EU by the Product Licence Holder: Expono Ltd, Smethwick, Birmingham, B66 2JT, UK. Repackaged by: N.G. Ltd, Birmingham, B66 2JT, UK.

Manufactured by: Chiesi Farmaceutici S.p.A., Via Palermo 26/A, I-43122 Parma, Italy.

POM

PL 22961/0127 - Fostair 100/6 micrograms per actuation pressurised inhalation solution.

Revision Date: 12.01.2016

Ref: 847

Fostair® is a registered trademark of Chiesi Farmaceutici S.p.A. AeroChamber Plus™ is a Trademark of Trudell Medical International