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OXIS TURBOHALER 6 INHALATION POWDER

Active substance(s): FORMOTEROL FUMARATE DIHYDRATE

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PS07260

Package Leaflet: Information for the user

Oxis Turbohaler 6 micrograms per dose Inhalation Powder
(Formoterol fumarate dihydrate)

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.
• 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
3. How to use Oxis Turbohaler
4. Possible side effects
5. How to store Oxis Turbohaler
6. Contents of the pack and other information
1. What Oxis Turbohaler is and what it is used for
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’.
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)
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.
2. What you need to know before you use
Oxis Turbohaler
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.
• You have high blood pressure or you have ever had a heart
problem.
• 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:
• 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.
• 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.
• Erythromycin (used to treat infections).
• Anti-histamines (such as terfenadine).
• 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).
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.
Pregnancy, breast-feeding and fertility
• 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.
• 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.
Important information about your asthma or COPD
symptoms
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.
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)
• 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.
• 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 take more than 6 inhalations at any one time.
Children and adolescents (6 to 17 years)
• 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.
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.
Adults (18 years and above)
• The recommended dose is 2 inhalations before exercise.
• 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 take more than 6 inhalations at any one time.
Children and adolescents (6 to 17 years)
• The recommended dose is 1 or 2 inhalations before
exercise.
• 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.
Chronic obstructive pulmonary disease (COPD)
• Only to be used by adults (aged 18 years and above).
• The recommended dose is 2 inhalations once or
twice a day.
• Your doctor may advise you to take extra doses for relief of
your COPD symptoms.
• You should not have more than 8 inhalations a day.
• Do not take more than 4 inhalations at any one time.
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
Mouthpiece
off. You may hear a rattling sound.
• Hold your Oxis Turbohaler upright
Indicator
with the turquoise grip at the
bottom.
• Turn the turquoise grip as far as it
Grip
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.
• Your Oxis Turbohaler is now ready for use.

How to take an inhalation
Every time you need to take an inhalation, follow the
instructions below.
1. Unscrew the white cover and lift it off. You may hear a
rattling sound.
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.
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.
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.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If the following happens to you, stop using Oxis Turbohaler
and talk to your doctor immediately:
• 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:
Common (may affect up to 1 in 10 people)
• Trembling or shaking. If these effects occur, they are
usually mild and usually disappear as you continue to use
Oxis Turbohaler.
• Headache.
• Feeling dizzy.
• Nausea (feeling sick).
• Muscle cramps.
Uncommon (may affect up to 1 in 100 people)
• Palpitations (awareness of your heart beating). If this effect
occurs, it is usually mild and usually disappear as you
continue to use Oxis Turbohaler.
• Disturbed sleep.
• Fast heart beat.
• Allergic reactions such as rash, itching and bronchospasm.
• Low level of potassium in your blood.
• 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.
• Uneven heart beat.
• Chest pain or tightness in the chest (angina pectoris).
Rare (may affect up to 1 in 1,000 people)
• Feeling restless or agitated.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly (see details
below). By reporting side effects you can help provide more
information on the safety of this medicine.

United Kingdom
Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
Malta
ADR Reporting. Website: www.medicinesauthority.gov.mt/
adrportal
5. How to store Oxis Turbohaler
• Keep this medicine out of the sight and reach of children.
• This medicinal product does not require any special storage
conditions.
• When not in use, Oxis Turbohaler should be stored with the
cover tightened.
• Do not use this medicine after the expiry date which is
stated on the carton or on the side of your Turbohaler.
The expiry date refers to the last day of that month.
• Always be sure to dispose of your used Turbohaler
responsibly, since some of the medicine will remain inside
it. Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.
6. Contents of the pack and other information
What Oxis Turbohaler 6 contains
The active substance is formoterol fumarate dihydrate. Each
dose contains 6 micrograms of formoterol fumarate dihydrate
of which you can inhale 4.5 micrograms.
The other ingredient is lactose monohydrate (which contains
milk proteins). See section 2 Oxis Turbohaler contains lactose.
What Oxis Turbohaler 6 looks like and contents
of the pack
Oxis Turbohaler 6 is an inhaler containing your medicine. The
inhalation powder is white in colour. Each Turbohaler contains
60 doses and has a white body with a turquoise turning grip.
Oxis Turbohaler 6 is available in the following pack sizes:
60 doses (1 inhaler), 3x60 doses (3 inhalers), 10x60 doses
(10 inhalers), 18x60 doses (18 inhalers) or 20x60 doses
(20 Inhalers).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Oxis Turbohaler 6 in
United Kingdom, Ireland and Malta is held by AstraZeneca UK Ltd,
600 Capability Green, Luton LU1 3LU, UK.
Oxis Turbohaler 6 is manufactured by AstraZeneca AB, S-151 85
Södertälje, Sweden.
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria
Oxis Turbohaler 6 μg – Dosier Pulverinhalator
Belgium
Oxis Turbohaler 4,5 μg/dose
Denmark
Oxis Turbuhaler
Finland
Oxis Turbuhaler
France
Oxis Turbuhaler 6 μg par dose
Germany
Oxis Turbohaler 6 Mikrogramm Pulver
zur Inhalation
Greece
Oxez Turbuhaler
Ireland
Oxis Turbohaler 6, inhalation powder
Italy
Oxis Turbohaler 4.5
Luxembourg
Oxis Turbohaler 4.5 μg/dose
The Netherlands
Oxis 6 Turbuhaler
Portugal
Oxis Turbohaler
Spain
Oxis Turbuhaler 4.5 microgramos polvo
para inhalación
Sweden
Oxis Turbuhaler
UK
Oxis Turbohaler 6, inhalation powder

To listen to or request a copy of
this leaflet in Braille, large print or
audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the
following information:
Product name
Oxis Turbohaler 6 
Reference number
17901/0154
This is a service provided by the
Royal National Institute of Blind
People.
This leaflet was last revised in March 2016.
© AstraZeneca 2016
Oxis and Turbohaler are trade marks of the AstraZeneca
group of companies.
RSP 15 0039a

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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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