OXIS 6 TURBOHALER

Active substance: FORMOTEROL FUMARATE DIHYDRATE

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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, Oxis Turbohaler 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, affecting less than 1 in 10,000 people.
Other possible side effects:
Common (affects less than 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 (affects less than 1 in 100 people)
• Feeling restless or agitated.
• Disturbed sleep
• Fast heart beat
• Muscle cramps
Rare (affects less than 1 in 1,000 people)
• Uneven heart beat
• Nausea (feeling sick)
• Low levels of potassium in your blood
• Allergic reactions such as rash, itching and
bronchospasm.
Very rare (affects less than 1 in 10,000 people)

• 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

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.

5. HOW TO STORE OXIS TURBOHALER
Expiry Date
Do not use this medicine after the expiry date
shown on the Turbohaler label or carton label. If
your doctor tells you to stop taking this medicine,
return any unused medicine to your pharmacist for
safe disposal. Only keep this medicine, if your
doctor tells you to. If your medicine shows any
signs of deterioration contact your pharmacist for
advice.
Storing your medicine
• KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
• Do not store above 30ºC. Replace cap properly
after use.
• Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines that no longer
required. This will help the enviroment.
6. FURTHER INFORMATION
What Oxis Turbohaler 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. Oxis Turbohaler also
contains lactose.
Oxis Turbohaler is a multi-dose dry powder inhaler
which works by breathing through the mouthpiece.
Each Oxis Turbohaler contains 60 actuations.
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicinal product.
What Oxis Turbohaler looks like and contents
of the pack
Oxis Turbohaler is a breath-actuated dry powder
inhaler with a jade green base and a white plastic
body and cover. A Braille code for identification of
formoterol is embossed at the bottom of the turn
grip.
Manufacturer and Licence Holder
The Turbohaler is manufactured by AstraZeneca
AB, S-151 85 Sodertalje, Sweden, and procured
from within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/0620 Oxis 6 Turbohaler

Oxis & Turbohaler are registered trademarks of
AstraZeneca AB.
Revision date: 22/10/13

PATIENT INFORMATION LEAFLET
®

OXIS 6 TURBOHALER
(formoterol fumarate)
Read all of this leaflet carefully before you
start taking this medicine
• 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. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
• 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.
Your medicine is called Oxis 6 Turbohaler but will
be referred to as Oxis Turbohaler throughout this
leaflet.
In
1.
2.
3.
4.
5.
6.

this leaflet:
What Oxis Turbohaler is and what it is used for
Before you use Oxis Turbohaler
How to use Oxis Turbohaler
Possible side effects
How to store Oxis Turbohaler
Further 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
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. BEFORE YOU USE OXIS TURBOHALER

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref: 0620/221013/1/F

®

Do not use Oxis Turbohaler if:
• You are allergic (hypersensitive) to formoterol,
or the other ingredient, lactose (which contains
small amounts of milk proteins).

Take special care with Oxis Turbohaler
Before you use Oxis Turbohaler, tell your doctor or
pharmacist 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.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken 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 and breast-feeding
• If you are pregnant, or planning to get pregnant,
talk to your doctor before using Oxis Turbohaler
- 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.
• If you are breast-feeding, talk to your doctor
before using Oxis Turbohaler.
Driving and using machines
Oxis Turbohaler is not likely to affect you being
able to drive or use any tools or machines.
Important information about some of the
ingredients of Oxis Turbohaler
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 Oxis Turohaler exactly as your
doctor, nurse or pharmacist has told you. Ask
one of them for advice 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 usual 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 usual 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 usual 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 usual 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 usual 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 off. You may hear a
rattling sound.
• Hold your Oxis Turbohaler
upright with the jade
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 jade 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.
2. Hold your Turbohaler
upright with the Jade
green grip at the bottom.
3. Do not hold the mouthpiece
when you load your
Turbohaler.
To load your Turbohaler
with a dose, turn the
Jade green 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. It is not
possible to overload your Turbohaler even if
you turn the grip several times. 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.
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 Turbohaler contains 60 doses (inhalations).
The dose indicator tells you how many doses
are left in the Turbohaler.
• When you first see a red mark at the edge of
the indicator window, there are approximately
20 doses left. When the red mark reaches the
bottom of the indicator 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 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.

Ref: 0620/221013/1/B

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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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