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FOSTAIR NEXTHALER 100 MICROGRAMS/6 MICROGRAMS PER ACTUATION INHALATION POWDER

Active substance(s): BECLOMETASONE DIPROPIONATE / FORMOTEROL FUMARATE DIHYDRATE / BECLOMETASONE DIPROPIONATE / FORMOTEROL FUMARATE DIHYDRATE / BECLOMETASONE DIPROPIONATE / FORMOTEROL FUMARATE DIHYDRATE

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Package leaflet: Information for the patient
FOSTAIR® NEXTthaler ® 100 micrograms/ 6 micrograms per
actuation, inhalation powder.
(beclometasone dipropionate/ formoterol fumarate)
Your medicine is known as the above but will be referred to as Fostair NEXThaler
throughout the remainder of this leaflet.
For use in adults
Read all of this leaflet carefully before you start taking 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, nurse or pharmacist.
 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 to your doctor, nurse or pharmacist. This includes any
possible side effects not listed in this leaflet.
What is in this leaflet
1. What Fostair NEXThaler is and what it is used for
2. What you need to know before you use Fostair NEXThaler
3. How to use Fostair NEXThaler
4. Possible side effects
5. How to store Fostair NEXThaler
6. Contents of the pack and other information
1. WHAT FOSTAIR NEXThaler IS AND WHAT IT IS USED FOR
Fostair NEXThaler is a powder that is inhaled through your mouth and delivered deeply into
your lungs. It contains two active ingredients: beclometasone dipropionate anhydrous and
formoterol fumarate dihydrate.
 Beclometasone dipropionate anhydrous belongs to a group of medicines commonly
referred to as steroids (technically corticosteroids). Steroids both treat and prevent
symptoms of asthma. They reduce the inflammation, swelling and irritation in the small air
passages of the lungs.
 Formoterol fumarate dihydrate belongs to a group of medicines called long-acting
bronchodilators. These relax the muscles in your airways, widening the airways so that it is
easier for you to breathe air in and out of your lungs.
These two active substances make breathing easier by providing relief from symptoms such as
shortness of breath, wheezing and coughing in patients with asthma or COPD and also help to
prevent asthma symptoms.
Asthma:
Fostair NEXThaler is used to treat asthma in adults.
If you are prescribed Fostair NEXThaler it is likely that either:
 Your asthma is not adequately controlled by using inhaled corticosteroids and “as needed”
short-acting bronchodilators
or
 Your asthma is responding well to both corticosteroids and long-acting bronchodilators.
COPD:
Fostair NEXThaler 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.

If any of the above applies to you, always inform your doctor before you use Fostair
NEXThaler.
If you are not sure whether you can use Fostair NEXThaler talk to your doctor, asthma
nurse or pharmacist before using the inhaler.
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 NEXThaler 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 NEXThaler can make the fall in potassium
level worse.
If you are using an inhaler to take high doses of corticosteroids over a long period of
time, 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 NEXThaler and any medicines or tablets bought without a
prescription, in their original package, if possible.
Children and adolescents
Do not give this medicine to children and adolescents aged less than 18 years.
Other medicines and Fostair NEXThaler
Before starting treatment, please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including any other inhalers and including medicines
obtained without a prescription. This is because Fostair NEXThaler may affect the way some
other medicines work. Also, some medicines can affect the way Fostair NEXThaler works.
Do not use beta blockers with this medicine. Beta blockers are medicines used to treat
many conditions including heart problems, high blood pressure or 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.
Using Fostair NEXThaler when you are taking the following medicines:


other drugs which work in the same way
as formoterol (i.e. beta adrenergic drugs,
commonly used to treat asthma)



quinidine, disopyramide, procainamide (to can cause changes in the
electrocardiogram (ECG, heart trace).
treat abnormal heart rhythms)
They may also increase the risk of
some antihistamines for example
disturbances of heart rhythm
terfenadine (to treat allergic reactions)
(ventricular arrhythmias.
monoaminoxidase inhibitors or tricyclic
antidepressants for example phenelzine,
isocarboxazid, amitryptiline and
imipramine; phenothiazines (to treat
depression or mental disorders)









2. WHAT YOU NEED TO KNOW BEFORE YOU USE FOSTAIR NEXThaler
Do not use Fostair NEXThaler
if you are allergic to beclometasone dipropionate anhydrous or formoterol fumarate dihydrate
or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Do not use this medicine if you are experiencing acute asthma symptoms such as
shortness of breath, wheezing and cough, your asthma is getting worse or you are
having an acute asthma attack. To relieve your symptoms you should use your
quick-acting “reliever” inhaler which you should carry with you at all times.
Talk to your doctor before using Fostair NEXThaler if you have any of the following:
 heart problems, these include any known disorder of your heart and/or heart function
 disorders of the 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
 high blood pressure
 narrowing of the arteries (also known as arteriosclerosis), or if you know that you have an
aneurysm (an abnormal bulging of the blood vessel wall)
 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 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.
 tumour of the adrenal gland (known as a phaeochromocytoma)
 you are due to have an anaesthetic. Depending on the type of anaesthetic, it may be
necessary to stop taking Fostair NEXThaler at least 12 hours before the anaesthesia.
 you are being, or have ever been, treated for tuberculosis (TB) or if you have a known viral
or fungal infection of your chest.



can increase the effects of formoterol.

3. HOW TO USE FOSTAIR NEXThaler
Always use Fostair NEXThaler exactly as your doctor has told you. You should check with your
doctor, nurse or pharmacist if you are not sure.
Fostair NEXThaler delivers an extrafine aerosol which results in more of each dose being
delivered to your lungs. Your doctor may, therefore, prescribe a lower dose of this inhaler than
your previous inhalers.
Asthma:
Your doctor will give you a regular check-up to make sure you are taking the correct dose of
Fostair NEXThaler. Once your asthma is well controlled your doctor may consider it
appropriate to gradually reduce the dose of Fostair NEXThaler. Under no circumstances
should you change the dose without first speaking to your doctor.
How much Fostair NEXThaler to use:
Adults and the elderly:
The recommended dose of this medicine is 1 or 2 inhalations twice daily.
The maximum daily dose is 4 inhalations.
Do not increase the dose.
If you feel that the medicine is not effective, always talk to your doctor before increasing the
dose.
Chronic obstructive pulmonary disease (COPD):
Adults and the elderly:
The recommended dose is two puffs in the morning and two puffs in the evening.
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.
How to use Fostair NEXThaler:
Fostair NEXThaler is for inhalation use.
In this pack, you will find in a sealed protective pouch an inhaler called NEXThaler that
contains your medicine in the form of a powder. The NEXThaler inhaler enables you to inhale
your medicine. Please read the instructions at the end of this leaflet for more information
about how to use and clean the NEXThaler inhaler.
Whenever possible, stand or sit in an upright position when inhaling.

L-dopa (to treat Parkinson’s Disease)
L-thyroxine (to treat an underactive
thyroid gland)
medicines containing oxytocin (which
causes uterine contraction)

can lower your heart’s tolerance to beta

monoaminoxidase inhibitors (MAOIs) (to
treat mental disorders) including drugs
with similar properties like furazolidone
and procarbazine

can cause a rise in blood pressure.

digoxin (to treat heart disease)

can cause a fall in your blood potassium

adrenergic drugs, such as formoterol.

level. This may increase the likelihood of
abnormal heart rhythms.


Fostair NEXThaler contains lactose monohydrate
The excipient lactose monohydrate contains small amounts of milk proteins, which may cause
reactions in allergic patients.

can cause a fall in your potassium level.



other medicines to treat asthma
theophylline, aminophylline or steroids)
diuretics (water tablets)



some anaesthetics

can increase the risk of abnormal heart

If you have used more Fostair NEXThaler than you should:
 contact your doctor or nearest hospital casualty department immediately for advice. Take
your medicine with you so that the people can see what you have taken;
 side effects may occur. Tell your doctor if you have any unusual symptoms as he/she may
wish to carry out further tests or decide about any measures that may be necessary.
If you forget to use Fostair NEXThaler:
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 NEXThaler:
Even if you are feeling better, do not stop using Fostair NEXThaler or lower the dose. If you
want to do this, talk to your doctor. It is very important for you to use Fostair NEXThaler every
day as prescribed by your doctor even though you may have no symptoms.
If your breathing does not change:
If your symptoms do not improve after inhaling Fostair NEXThaler, you may be using it
incorrectly. Therefore check the instructions for correct use at the end of this leaflet and/or
contact your doctor or nurse to be trained properly again.
If your asthma gets worse:
If your symptoms get worse or are difficult to control (e.g. if you are using your “reliever” inhaler
more frequently) or if your “reliever” inhaler does not improve your symptoms, you should
continue to use Fostair NEXThaler but go to see your doctor as soon as possible. Your doctor
may need to change your dose of Fostair NEXThaler or prescribe an additional or alternative
treatment. If you have any further questions on the use of this product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS

rhythms.
Fostair NEXThaler with alcohol
You should avoid drinking alcohol unless you have talked to your doctor first. Alcohol can lower
your heart‘s tolerance to one of the active ingredients of Fostair NEXThaler, formoterol.

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, cough and
wheezing immediately after using Fostair NEXThaler and this is known as paradoxical
bronchospasm. If this occurs you should STOP using Fostair NEXThaler immediately and
use your quick-acting “reliever” inhaler straightaway to treat the symptoms. You should
contact your doctor straightaway

Pregnancy and breast feeding
There is no clinical data on the use of Fostair NEXThaler during pregnancy. If you think you are
pregnant or are planning to become pregnant please consult your doctor. You should only use
Fostair NEXThaler during pregnancy if you are advised to do so by your doctor. Your doctor
will decide whether you must stop taking Fostair NEXThaler during breastfeeding or you should
take Fostair NEXThaler but refrain from breastfeeding. Always follow the advice of your doctor
strictly.

Tell your doctor immediately if you experience allergic reactions which include skin allergies,
skin itching, skin rash, reddening of the skin, swelling of the skin or of mucous membranes
especially of the eyes, face, lips and throat.

Driving and using machines
Fostair NEXThaler 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.

You should contact your doctor or pharmacist immediately:
 if you experience any of the side effects below and they cause you distress, are severe or
last for several days
 if you are worried in any way or if there is anything you do not understand.

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

Your doctor is likely to assess your asthma and if necessary start you on another course of
treatment. You may be told that you should not use Fostair NEXThaler again.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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