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FORMOTEROL FUMARATE DIHYDRATE 6 MICROGRAM TURBOHALER

Active substance(s): FORMOTEROL FUMARATE DIHYDRATE

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S0047 LEAFLET Oxis 20151102

PACKAGE LEAFLET: INFORMATION FOR THE USER

OXIS TURBOHALER 6
FORMOTEROL FUMARATE DIHYDRATE 6 microgram
TURBOHALER
(formoterol fumarate)
Your medicine is known by one of the above names but will be
referred to as Oxis Turbohaler in this leaflet.
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 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 or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

What is in this leaflet:
1. What Oxis Turbohaler is and what it is used for
2. What you need to know before you use Oxis Turbohaler

Pregnancy and breast-feeding




If you get pregnant while using Oxis Turbohaler, do not stop
using Oxis Turbohaler but talk to your doctor immediately.
Driving and using machines
Oxis Turbohaler is not likely to affect you being able to drive or use
any tools or machines.
Oxis Turbohaler contains lactose
Oxis Turbohaler contains lactose, which is a type of sugar. If you
have been told by your doctor that you have an intolerance to some
sugars, talk to your doctor before using this medicine. The amount
of lactose in this medicine does not normally cause problems in
people who are lactose intolerant.
The excipient lactose contains small amounts of milk proteins,
which may cause allergic reactions.
3. HOW TO USE OXIS TURBOHALER


Always use this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are
not sure.



Do not increase the dose of Oxis Turbohaler prescribed by your
doctor without talking to your doctor first.



If you are using Oxis Turbohaler regularly for asthma or COPD
you should continue to use your medicine, even if you have no
symptoms.

3. How to use Oxis Turbohaler
4. Possible side effects
5. How to store Oxis Turbohaler
6. Contents of the pack and other information

If you are pregnant or breastfeeding, think you may be
pregnant, or are planning to have a baby, ask your doctor for
advice before taking this medicine - do not use Oxis Turbohaler
unless your doctor tells you to.

1. WHAT OXIS TURBOHALER IS AND WHAT IT IS USED FOR

Important information about your asthma or COPD symptoms

Oxis Turbohaler is an inhaler. It contains a medicine called
formoterol. This belongs to a group of medicines called ‘long-acting
beta-agonists’ or ‘bronchodilators’.

If you feel you are getting breathless or wheezy while using Oxis
Turbohaler, you should continue to use Oxis Turbohaler but go to
see your doctor as soon as possible, as you may need additional
treatment.

It works by relaxing the muscles in your airways. This helps you to
breathe more easily. It starts to work within 1 to 3 minutes and the
effects last up to 12 hours.
Your doctor has prescribed this medicine to treat asthma or chronic
obstructive pulmonary disease (COPD).
Asthma
Oxis Turbohaler is used to treat asthma in adults, adolescents and
children 6 years and older. For asthma, your doctor will prescribe
two asthma inhalers: Oxis Turbohaler and a separate
‘corticosteroid’ inhaler. These should be used together.


Oxis Turbohaler is used to help prevent asthma symptoms from
happening.



Some people also use Oxis Turbohaler when they need extra
doses for relief of asthma symptoms, to make it easier to
breathe again.



Oxis Turbohaler can also be used before exercise to prevent
asthma symptoms caused by exercise.

Chronic obstructive pulmonary disease (COPD)

Contact your doctor immediately if:


Your breathing is getting worse or you often wake up at night
with asthma.



You start getting chest tightness.



You are not getting relief from your current dose.



You need to take more than your usual dose for more than two
days in a week.



You need to use your Turbohaler more often than usual before
exercise.

These signs could mean that your asthma or COPD is not being
properly controlled and you may need different or additional
treatment immediately.
Asthma
Oxis Turbohaler should not be used in children under 6 years of
age.
Adults (18 years and above)

Oxis Turbohaler can also be used to treat the symptoms of COPD
in adults. COPD is a long-term disease of the airways in the lungs,
which is often caused by cigarette smoking.



The recommended dose is 1 or 2 inhalations, once or twice a
day.



Your doctor may increase this to 4 inhalations, once or twice a
day.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE OXIS
TURBOHALER



Some people also use Oxis Turbohaler as a ‘reliever inhaler’. If
you get asthma symptoms, the usual dose is 1 or 2 inhalations
when they happen.



A total daily dose of more than 8 inhalations is not normally
needed. This includes the inhalations that you take every day,
when you get asthma symptoms and before exercise. However,
your doctor may allow you to take up to 12 inhalations a day.
Do not use more than 12 inhalations in total in 24 hours.

Do not use Oxis Turbohaler:


If you are allergic (hypersensitive) to formoterol, or any of the
other ingredients of this medicine (listed in section 6).

Warnings and Precautions
Talk to your doctor or pharmacist before using Oxis Turbohaler if:


You are diabetic. You may need some additional blood sugar
tests while you are using Oxis Turbohaler.

• Do not take more than 6 inhalations at any one time.
Children and adolescents (6 to 17 years)



You have high blood pressure or you have ever had a heart
problem.



The recommended dose is 2 inhalations, once or twice a day.



Some children also use Oxis Turbohaler as a ‘reliever inhaler’.
If your child gets asthma symptoms, the usual dose is 1 or 2
inhalations when they happen.



A total daily dose of more than 4 inhalations is not normally
needed. This includes the inhalations that your child takes
every day, when they get asthma symptoms and before
exercise. However, your doctor may allow your child to take up
to 8 inhalations a day. Your child should not use more than 8
inhalations in total in 24 hours.



Your child should not have more than 2 inhalations at any one
time.



You have problems with your thyroid gland.



You have low levels of potassium in your blood. Your doctor
may take blood samples to check the levels of potassium in
your blood.



You have severe liver problems such as liver cirrhosis.

If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before using Oxis Turbohaler.
Other medicines and Oxis Turbohaler
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. This includes medicines that you
buy without a prescription and herbal medicines. This is because
Oxis Turbohaler can affect the way some medicines work and some
medicines can have an effect on Oxis Turbohaler.
In particular, tell your doctor or pharmacist if you are taking any of
the following medicines:

Your doctor (or asthma nurse) will help you to manage your
asthma. Once your asthma is well controlled your doctor may
consider it appropriate to gradually reduce the dose of Oxis
Turbohaler.
Asthma caused by exercise
If you or your child have asthma symptoms caused by exercise,
your doctor may advise you or your child to use Oxis Turbohaler
before exercise as well. Oxis Turbohaler should not be used in
children under 6 years of age.



Beta-blocker medicines (such as atenolol or propranolol for high
blood pressure), including eyedrops (such as timolol for
glaucoma).



Medicines for a fast or uneven heart beat (such as quinidine).



Medicines like digoxin, often used to treat heart failure.





The recommended dose is 2 inhalations before exercise.

Diuretics, also known as ‘water tablets’ (such as furosemide).
These are used to treat high blood pressure.





Steroid medicines that you take by mouth (such as
prednisolone).



Xanthine medicines (such as theophylline or aminophylline).
These are often used to treat asthma.

A total daily dose of more than 8 inhalations is not normally
needed. This includes the inhalations that you take every day,
when you get asthma symptoms and before exercise. However,
your doctor may allow you to take up to 12 inhalations a day.
Do not use more than 12 inhalations in total in 24 hours.



Erythromycin (used to treat infections).

• Do not take more than 6 inhalations at any one time.
Children and adolescents (6 to 17 years)



Anti-histamines (such as terfenadine).



The recommended dose is 1 or 2 inhalations before exercise.



Other substances that dilate the airways (bronchodilators, such
as salbutamol).





Ephedrine (used to treat asthma or as a decongestant).



Tricyclic anti-depressants (such as amitriptyline).

A total daily dose of more than 4 inhalations is not normally
needed. This includes the inhalations that your child takes
every day, when they get asthma symptoms and before
exercise. However, your doctor may allow your child to take up
to 8 inhalations a day. Your child should not use more than 8
inhalations in total in 24 hours.



Your child should not have more than 2 inhalations at any one
time.

If any of the above applies to you, or if you are not sure, talk to your
doctor or pharmacist before using Oxis Turbohaler.
Also tell your doctor or pharmacist if you are going to have a
general anaesthetic for an operation or for dental work.
The addition of anticholinergics (such as tiotropium or ipratropium
bromide) to the treatment with Oxis Turbohaler, can help to open
your airways even more.

Adults (18 years and above)

Chronic obstructive pulmonary disease (COPD)

4. POSSIBLE SIDE EFFECTS



Only to be used by adults (aged 18 years and above).



The recommended dose is 2 inhalations once or twice a day.

Like all medicines, this medicine can cause side effects, although
not everybody gets them.



Your doctor may advise you to take extra doses for relief of
your COPD symptoms.

If the following happens to you, stop using Oxis Turbohaler
and talk to your doctor immediately:



You should not have more than 8 inhalations a day.





Do not take more than 4 inhalations at any one time.

Bronchospasm (tightening of the muscles in the airways which
causes sudden wheezing) after inhaling your medicine. This
happens very rarely, may affect up to 1 in 10,000 people.

Other possible side effects:
Preparing your new Oxis Turbohaler Inhaler
Before using your new Oxis Turbohaler for the first time, you need
to prepare it for use as follows.


Unscrew the white cover and lift it off.
You may hear a rattling sound.



Hold your Oxis Turbohaler upright
with the turquoise grip at the bottom.



Turn the turquoise grip as far as it will
go in one direction. Then turn it as far as it
will go in the other direction (it does not
matter which way you turn it first). You should
hear a click sound.



Do this again, turning the turquoise grip in
both directions.

Common (may affect up to 1 in 10 people)


Palpitations (awareness of your heart beating), trembling or
shaking. If these effects occur, they are usually mild and usually
disappear as you continue to use Oxis Turbohaler.

• Headache.
Uncommon (may affect up to 1 in 100 people)


Feeling restless or agitated.



Disturbed sleep.



Fast heart beat.

• Muscle cramps.
Rare (may affect up to 1 in 1,000 people)


Uneven heart beat.

• Your Oxis Turbohaler is now ready for use.
How to take an inhalation



Nausea (feeling sick).



Low level of potassium in your blood.

Every time you need to take an inhalation, follow the instructions
below.

• Allergic reactions such as rash, itching and bronchospasm.
Very rare (may affect up to 1 in 10,000 people)

1. Unscrew the white cover and lift it off. You may hear a rattling
sound.



Chest pain or tightness in the chest (angina pectoris).



An increase in the amount of sugar (glucose) in your blood.



Taste changes, such as an unpleasant taste in the mouth.



Changes in your blood pressure.



Feeling dizzy.

2. Hold your Turbohaler upright with the turquoise grip at the
bottom.
3. Do not hold the mouthpiece when you load your Turbohaler. To
load your Turbohaler with a dose, turn the turquoise grip as far
as it will go in one direction. Then turn it as far as it will go in the
other direction (it does not matter which way you turn it first).
You should hear a click sound. Your Turbohaler is now loaded
and ready to use. Only load your Turbohaler when you need to
use it.
4. Hold your Turbohaler away from your mouth. Breathe out gently
(as far as is comfortable). Do not breathe out through your
Turbohaler.
5. Place the mouthpiece gently between
your teeth. Close your lips. Breathe in
as deeply and as hard as you can
through your mouth. Do not chew or
bite on the mouthpiece.
6. Remove your Turbohaler from your
mouth. Then breathe out gently. The amount of medicine that
is inhaled is very small. This means you may not be able to
taste it after inhalation. If you have followed the instructions,
you can still be confident that you have inhaled the dose and
the medicine is now in your lungs.

If any of the side effects get serious or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
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 at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on
the safety of this medicine.
5. HOW TO STORE OXIS TURBOHALER


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Store Oxis Turbohaler with the cover tightly closed. Do not store
above 30°C.



Do not use the inhaler after the date shown on the pack.



If you are told to stop taking this medicine take any inhalers
which you haven’t finished back to your pharmacist for safe
disposal.



If the inhaler doesn’t work properly or shows any signs of
deterioration you should consult your pharmacist who will tell
you what to do.

7. If you are to take a second inhalation, repeat steps 2 to 6.
8. Replace the cover tightly after use.
Do not try to remove or twist the mouthpiece. It is fixed to your
Turbohaler and must not be taken off. Do not use your Turbohaler if
it has been damaged or if the mouthpiece has come apart from your
Turbohaler.
As with all inhalers, caregivers should ensure that children
prescribed Oxis Turbohaler use correct inhalation technique, as
described above.
Cleaning your Turbohaler
Wipe the outside of the mouthpiece once a week with a dry tissue.
Do not use water or liquids.
When to start using a new Turbohaler


The dose indicator tells you how many doses
are left in the Turbohaler, starting with 60
doses when it is full.



The dose indicator is marked in intervals of
10 doses. Therefore, it does not show every
dose. When you first see a red mark at the
edge of the indicator window, there are
approximately 20 doses left. For the last 10
doses, the background of the dose indicator
is red. When the ‘0’ on the red background
has reached the middle of the window, you
must start using your new Turbohaler.

Note:


The grip will still twist and ‘click’ even when your Turbohaler is
empty.



The sound that you hear as you shake your Turbohaler is
produced by a drying agent and not the medicine. Therefore the
sound does not tell you how much medicine is left in your
Turbohaler.



If you load your Oxis Turbohaler more than once by mistake
before taking your dose, you will still only receive one dose.
However, the dose indicator will register all the loaded doses.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Oxis Turbohaler contains


The active substance is formoterol fumarate dihydrate. Each
actuation contains 6 micrograms of formoterol fumarate
dihydrate of which you can inhale 4.5 micrograms.



The inhalers also include lactose monohydrate.

What Oxis Turbohaler looks like and contents of the pack
Oxis Turbohaler is a metered dose, inspiratory flow driven, dry
powder inhaler, consisting of a turquoise turning grip and white
cover. On the bottom of the turning grip a braille code for
identification of eformoterol is embossed.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
Oxis Turbohaler are manufactured by


AstraZenca AB, S-15185 Sodertalje, Sweden



AstraZeneca GmbH, Wedel, Germany



Biofabri S.L., La Relva s/n, 36400 Porrino, Pontevedra, Spain



AstraZeneca UK Limited, Silk road business park, Macclesfield,
Cheshire, SK10 2NA.

POM

PL 19488/0047

Leaflet revision date: 02 November 2015
Oxis is a registered trade mark of AstraZeneca AB, Sweden.

If you use more Oxis Turbohaler than you should
If you use more Oxis Turbohaler than you should, contact your
doctor or pharmacist for advice immediately. The following effects
may happen: trembling, headache or a rapid heart beat.
If you forget to use Oxis Turbohaler


If you forget to take a dose, take it as soon as you remember.
However, if it is nearly time for your next dose, skip the missed
dose.



Do not take a double dose to make up for a forgotten dose.

If you stop using Oxis Turbohaler
Do not stop using Oxis Turbohaler without talking to your doctor.
If you have any further questions on using your Turbohaler, ask
your doctor, nurse or pharmacist.

S0047 LEAFLET Oxis 20151102

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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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