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OXIS TURBOHALER 12

Active substance(s): EFORMOTEROL FUMARATE DIHYDRATE / FORMOTEROL FUMARATE DIHYDRATE

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PS07261

Package Leaflet: Information for the user

Oxis Turbohaler 12 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 aged 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 breast-feeding, 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 inhalation, once or
twice a day.
• Your doctor may increase this to 2 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 inhalation when they happen.
• A total daily dose of more than 4 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 6 inhalations a day. Do not use more than
6 inhalations in total in 24 hours.
• Do not take more than 3 inhalations at any one time.
Children and adolescents (6 to 17 years)
• The recommended dose is 1 inhalation 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 inhalation when they happen.
• A total daily dose of more than 2 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 4 inhalations a day.
Your child should not use more than 4 inhalations in
total in 24 hours.
• Your child should not have more than 1 inhalation 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 1 inhalation before exercise.
• A total daily dose of more than 4 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 6 inhalations a day. Do not use more than
6 inhalations in total in 24 hours.
• Do not take more than 3 inhalations at any one time.
Children and adolescents (6 to 17 years)
• The recommended dose is 1 inhalation before exercise.
• A total daily dose of more than 2 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 4 inhalations a day.
Your child should not use more than 4 inhalations in
total in 24 hours.
• Your child should not have more than 1 inhalation at
any one time.
Chronic obstructive pulmonary disease (COPD)
• Only to be used by adults (aged 18 years and above).
• The recommended dose is 1 inhalation 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 4 inhalations a day.
• Do not take more than 2 inhalations at any one time.
Preparing your new Oxis Turbohaler
Before using your new Oxis Turbohaler for the first time,
you need to prepare it for use as follows:
• Unscrew the white cover
Mouthpiece
and lift it off. You may hear a
Indicator
rattling sound.
• Hold your Oxis Turbohaler
upright with the turquoise grip at
the bottom.
Grip
• 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
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 12 contains
The active substance is formoterol fumarate dihydrate.
Each dose contains 12 micrograms of formoterol fumarate
dihydrate of which you can inhale 9 micrograms.
The other ingredient is lactose monohydrate (which contains
milk proteins). See section 2 Oxis Turbohaler contains
lactose.
What Oxis Turbohaler 12 looks like and contents
of the pack
Oxis Turbohaler 12 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 12 is available in the following pack sizes:
60 doses (1 inhaler), 3x60 doses (3 inhaler), 10x60 doses
(10 inhaler), 18x 60 doses (18 inhalers) or 20x60 doses
(20 inhaler).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Oxis Turbohaler 12 in
United Kingdom, Ireland and Malta is held by AstraZeneca
UK Ltd, 600 Capability Green, Luton LU1 3LU, UK.
Oxis Turbohaler 12 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 12 μg – Dosier Pulverinhalator
Belgium
Oxis Turbohaler 9 μg/dose
Denmark
Oxis Turbuhaler
Finland
Oxis Turbuhaler
France
Oxis Turbuhaler 12 μg par dose
Germany Oxis Turbohaler 12 Mikrogramm
Pulver zur Inhalation
Greece
Oxez Turbuhaler
Ireland
Oxis Turbohaler 12, inhalation powder
Italy
Oxis Turbohaler 9
Luxembourg
Oxis Turbohaler 9 μg/dose
The Netherlands
Oxis 12 Turbuhaler
Portugal
Oxis Turbohaler
Spain Oxis Turbuhaler 9 microgramos polvo
para inhalación
Sweden
Oxis Turbuhaler
UK
Oxis Turbohaler 12, 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 12
Reference number
17901/0153
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 0038a

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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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