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TERBUTALINE SULPHATE 0.5 MG/DOSE TURBOHALER

Active substance(s): TERBUTALINE SULPHATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Bricanyl® Turbohaler®
(terbutaline sulphate)
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.

3. How to use Bricanyl Turbohaler
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. If Bricanyl
Turbohaler is to be used by a child, make sure
that they use it correctly.

How much to take




The recommended dose is one inhalation as
required.
Do not take more than four inhalations in any
24 hour period.
One inhalation from your Bricanyl Turbohaler
should last for up to six hours.

In this leaflet:

Talk to your doctor straight away if:

1. What Bricanyl Turbohaler is and what it is
used for
2. What you need to know before you use
Bricanyl Turbohaler
3. How to use Bricanyl Turbohaler
4. Possible side effects
5. How to store Bricanyl Turbohaler
6. Contents of the pack and other information1.






1. What
Bricanyl
is and
What
Oxis Turbohaler
is Turbohaler
and what it is used
f

Please read the complete instructions
carefully before you start to take your
medication
Cover
Mouthpiece
Turbohaler is
a multidose
Indicator
inhaler from
window
which very
small amounts
Grip
of powder are
Figure 1
administered

what

it is used for
Bricanyl Turbohaler is an inhaler. It contains a
medicine called terbutaline. This belongs to a
group of medicines called ‘beta-agonists’. These
work by relaxing certain muscles and opening up
the airways in the lungs.
Bricanyl Turbohaler is used for asthma and other
breathing problems where you have a tight chest
and difficulty breathing.2.
B

2. What you need to know before you
use Bricanyl Turbohaler
Do not use Bricanyl Turbohaler:


If you are allergic to terbutaline.

Warnings and precautions
Talk to your doctor or pharmacist before using
Bricanyl Turbohaler if:
 You have diabetes. If so, you may need some
extra blood sugar tests when you start using
Bricanyl Turbohaler.
 You have a history of heart disease, irregular
heart rhythm or angina.
 You have an overactive thyroid gland.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before using
Bricanyl Turbohaler.

Other medicines and Bricanyl Turbohaler
Tell your doctor or pharmacist if you are taking, or
have recently taken or might take any other
medicines. This includes medicines that you buy
without a prescription and herbal medicines.
Bricanyl can affect the way that some medicines
work and some medicines can have an effect on
Bricanyl.
In particular, tell your doctor or pharmacist if you
are taking any of the following medicines:
 Steroid medicines (such as prednisolone).
 Medicines called ‘xanthines’ (such as
theophylline).
 Medicines called ‘beta-blockers’ (such as
atenolol or propranolol) including eye drops
(such as timolol).
 Water tablets (diuretics) such as furosemide
(also known as frusemide).
If you are to undergo surgery with general
anaesthetics it is important that you inform your
doctor about all medicines you use, including
Bricanyl to protect you from adverse effects (e.g.
irregular heart beat).

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 or pharmacist for
advice before using this medicine.
If you become pregnant while you are using
Bricanyl Turbohaler, talk to your doctor
straight away.

Driving and using machines
Bricanyl is not likely to affect you being able to
drive or use any machines.

Your breathing is getting worse.
You often wake at night with asthma.
You start getting a tight chest.
You are not getting relief from your current
dose.
These are signs that your asthma is not being
controlled. You may need a different or
additional treatment straight away.

(Figure 1). When you breathe in through
Turbohaler the powder is delivered to your
lungs. It is therefore important that you
inhale forcefully and deeply through the
mouthpiece.
How to prepare a new Turbohaler for use
Before using Turbohaler for the first time you
need to prepare the inhaler for use.
Unscrew and lift off the white cover.
Hold the Turbohaler upright
with the blue grip downwards
(Figure 2). Do not hold the
mouthpiece when you turn the
blue grip. Turn the blue grip
Figure 2
as far as it will go in one
direction, and then back again in the opposite
direction as far as it will go. It does not matter
which way you turn first. During this procedure
you will hear a click. Perform the procedure twice.
The turbohaler is now prepared for use, and you
should not repeat the above procedure again.
To take a dose, please continue according to the
instructions below.

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 blue grip
at the bottom.
3. Do not hold the mouthpiece
when you load your Turbohaler. To load your
Turbohaler with a dose, turn the blue 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
by screwing it back on
tightly.
With each inhalation some medication may stick
to the inside of your mouth and throat. To reduce
the risk of side effects it is advised that you, when
possible, rinse your mouth with water after
using Bricanyl Turbohaler.
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.

Common (may affect up to 1 in 10 people)




Pounding or rapid heart beat (palpitations).
Cramp or feeling tense.
Low levels of potassium in your blood which
may cause muscle weakness, thirst, or ‘pins
and needles’.

Not known (frequency cannot be estimated
from the available data)

Unusual or irregular heart beats.

Chest pain (due to heart problems such as
angina). Tell your doctor if you develop this
symptom whilst receiving treatment with
Bricanyl Turbohaler, but do not stop using this
medicine unless told to.

Feeling sick (nausea).

Mouth and throat irritation.

Changes in sleeping patterns and changes in
behaviour, such as feeling agitated, restless
or hyperactive.
Do not be concerned by this list of side effects.
You may not get any of them.
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 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

When to start using a new Turbohaler




When a red mark first appears in the indicator
window under the mouthpiece, there are about
20 doses left. You will need to see your doctor
for another prescription.
When the red mark reaches the bottom of the
indicator window, your Turbohaler is empty
and you must start using your new Turbohaler.

5. 5.
H







RED

RED

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 Turbohaler more than once by
mistake before taking your dose, you will still
only receive one dose.

If you use more Bricanyl Turbohaler than
you should
If you use more Bricanyl Turbohaler than you
should, contact your doctor or pharmacist for
advice.
If you forget to use Bricanyl 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.
1.

4. Possible
side effects
2. e effects

How to store Bricanyl Turbohaler

KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
Do not store above 30°C.
Replace the cover properly after use.
Do not use Bricanyl Turbohaler after the expiry
date printed on the carton or on the side of
your Turbohaler. The expiry date refers to the
last day of that month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines that
are no longer required. This will help to protect
the environment.

6. Contents of the pack and other
Information
3.

Fu

What Bricanyl Turbohaler contains
Each actuation delivers 500 micrograms of
terbutaline Sulphate.
What Bricanyl Turbohaler looks like and the
contents of the pack
Bricanyl Turbohaler is a metered dose inhaler,
with a white mouth piece and cover with a blue
turn grip. The base of the turning grip has a Braille
code embossed.
Each Turbohaler contains 100 doses.
Manufactured by:
AstraZeneca AB, S-151 85 Sodertalje, Sweden.
or
AstraZeneca Dunkerque Production, 224, Avenue
de la Dordogne, 59640 Dunkerque, France.
Procured from within the EU & repackaged by
PL holder:
Kosei Pharma UK Ltd., 956 Buckingham Avenue,
Slough Trading Estate, SL1 4NL.

Bricanyl® Turbohaler®
PL: 39352/0289
®

®

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

Bricanyl and Turbohaler are registered
trademarks of the AstraZeneca group.

Important side effects to look out for:
 Allergic reactions. The signs may include a
swollen face, skin rash, breathing problems,
low blood pressure (feeling faint) and collapse.
It is not known exactly how often this happens.
If this happens to you, stop using Bricanyl
Turbohaler and see a doctor straight away.
 Sudden wheezing soon after inhaling your
dose of Bricanyl Turbohaler. It is not known
exactly how often this happens. If this
happens to you, stop using Bricanyl
Turbohaler and see a doctor straight away.

Leaflet date: 22.09.2015

Other possible side effects:
Very Common (may affect more than 1 in 10
people)
 Trembling or shaking.
 Headache.

POM

PACKAGE LEAFLET: INFORMATION FOR THE USER

Terbutaline Sulphate 0.5mg/dose Turbohaler
(terbutaline sulphate)
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. 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.
The name of your medicine is Terbutaline
Sulphate 0.5mg/dose Turbohaler, but it will be
referred as Terbutaline Sulphate Turbohaler
throughout the leaflet.
In this leaflet:
1. What Terbutaline Sulphate Turbohaler is and
what it is used for
2. What you need to know before you use
Terbutaline Sulphate Turbohaler
3. How to use Terbutaline Sulphate Turbohaler
4. Possible side effects
5. How to store Terbutaline Sulphate Turbohaler
6. Contents of the pack and other information1.
1.

What Terbutaline Sulphate Turbohaler is
and what it is used for

What Oxis Turbohaler is and what it is used f

Terbutaline Sulphate Turbohaler is an inhaler. It
contains a medicine called terbutaline. This
belongs to a group of medicines called ‘betaagonists’. These work by relaxing certain muscles
and opening up the airways in the lungs.
Terbutaline Sulphate Turbohaler is used for
asthma and other breathing problems where you
have a tight chest and difficulty breathing.2.
B

2.

Before you use Terbutaline Sulphate
Turbohaler

Do not use Terbutaline Sulphate Turbohaler if:
 You are allergic to terbutaline.
Warnings and precautions
Talk to your doctor or pharmacist before using
Terbutaline Sulphate Turbohaler if:
 You have diabetes. If so, you may need some
extra blood sugar tests when you start using
Terbutaline Sulphate Turbohaler.
 You have a history of heart disease, irregular
heart rhythm or angina.
 You have an overactive thyroid gland.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before using
Terbutaline Sulphate Turbohaler.
Other medicines and Terbutaline Sulphate
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.
Terbutaline Sulphate can affect the way that some
medicines work and some medicines can have an
effect on Terbutaline Sulphate.
In particular, tell your doctor or pharmacist if you
are taking any of the following medicines:
 Steroid medicines (such as prednisolone).
 Medicines called ‘xanthines’ (such as
theophylline).
 Medicines called ‘beta-blockers’ (such as
atenolol or propranolol) including eye drops
(such as timolol).
 Water tablets (diuretics) such as furosemide
(also known as frusemide).
If you are to undergo surgery with general
anaesthetics it is important that you inform your
doctor about all medicines you use, including
Terbutaline sulphate to protect you from adverse
effects (e.g. irregular heart beat).
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 or pharmacist for advice before
using this medicine.
 If you become pregnant while you are using
Terbutaline Sulphate Turbohaler, talk to your
doctor straight away

Driving and using machines
Terbutaline Sulphate Turbohaler is not likely to
affect you being able to drive or use any
machines.

3. How to use Terbutaline Sulphate
Turbohaler
4.

How to

5.

Always use Terbutaline Sulphate Turbohaler
exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are
not sure. If Terbutaline Sulphate Turbohaler is to
be used by a child, make sure that they use it
correctly.
How much to take
 The recommended dose is one inhalation as
required.
 Do not take more than four inhalations in any 24
hour period.
 One inhalation from your Terbutaline Sulphate
Turbohaler should last for up to six hours.
Talk to your doctor straight away if:
 Your breathing is getting worse.
 You often wake at night with asthma.
 You start getting a tight chest.
 You are not getting relief from your current
dose.
These are signs that your asthma is not being
controlled. You may need a different or
additional treatment straight away.
Please read the complete instructions
carefully before you start to take your
medication
Cover
Mouthpiece
Turbohaler is
a multidose
Indicator
inhaler from
window
which very
small amounts
Grip
of powder are
Figure 1
administered
(Figure 1). When you breathe in through
Turbohaler the powder is delivered to your lungs.
It is therefore important that you inhale forcefully
and deeply through the mouthpiece.
How to prepare a new Turbohaler for use
Before using Turbohaler for the first time you need
to prepare the inhaler for use.
Unscrew and lift off the white cover.
Hold the Turbohaler upright
with the blue grip downwards
(Figure 2). Do not hold the
mouthpiece when you turn the
blue grip. Turn the blue grip
as far as it will go in one
Figure 2
direction, and then back
again in the opposite direction as far as it will
go. It does not matter which way you turn first.
During this procedure you will hear a click.
Perform the procedure twice.
The turbohaler is now prepared for use, and you
should not repeat the above procedure again.
To take a dose, please continue according to the
instructions below.

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 blue grip
at the bottom.
3. Do not hold the mouthpiece
when you load your Turbohaler. To load your
Turbohaler with a dose, turn the blue 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
by screwing it back on
tightly.
With each inhalation some medication may stick
to the inside of your mouth and throat. To reduce
the risk of side effects it is advised that you, when
possible, rinse your mouth with water after
using Terbutaline Sulphate Turbohaler.
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
 When a red mark first appears in the indicator
window under the mouthpiece, there are about
20 doses left. You will need to see your doctor
for another prescription.
 When the red mark reaches the bottom of the
indicator window, your Turbohaler is empty
and you must start using your new Turbohaler.

Other possible side effects:
Very Common (may affect more than 1 in 10
people)
 Trembling or shaking.
 Headache.

Common (may affect up to 1 in 10 people)




Not known (frequency cannot be estimated
from the available data)

Unusual or irregular heart beats.

Chest pain (due to heart problems such as
angina). Tell your doctor if you develop this
symptom whilst receiving treatment with
Terbutaline Sulphate Turbohaler, but do not
stop using this medicine unless told to.

Feeling sick (nausea).

Mouth and throat irritation.

Changes in sleeping patterns and changes in
behaviour, such as feeling agitated, restless
or hyperactive.
Do not be concerned by this list of side effects.
You may not get any of them.
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 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. 6. How
H to store Terbutaline Sulphate
Turbohaler







RED

RED

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 Turbohaler more than once by
mistake before taking your dose, you will still
only receive one dose.
If you use more Terbutaline Sulphate
Turbohaler than you should
If you use more Terbutaline Sulphate Turbohaler
than you should, contact your doctor or
pharmacist for advice.
If you forget to use Terbutaline Sulphate
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.
7.
8.4. e Possible
effects

side effects

Like all medicines, Terbutaline Sulphate
Turbohaler can cause side effects, although not
everybody gets them.
Important side effects to look out for:
 Allergic reactions. The signs may include a
swollen face, skin rash, breathing problems,
low blood pressure (feeling faint) and collapse.
It is not known exactly how often this happens.
If this happens to you, stop using
Terbutaline Sulphate Turbohaler and see a
doctor straight away.
 Sudden wheezing soon after inhaling your
dose of Terbutaline Sulphate Turbohaler. It is
not known exactly how often this happens. If
this happens to you, stop using Terbutaline
Sulphate Turbohaler and see a doctor
straight away.

Pounding or rapid heart beat (palpitations).
Cramp or feeling tense.
Low levels of potassium in your blood which
may cause muscle weakness, thirst, or ‘pins
and needles’.

KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
Do not store above 30°C.
Replace the cover properly after use.
Do not use Terbutaline Sulphate Turbohaler
after the expiry date printed on the carton or
on the side of your Turbohaler. The expiry
date refers to the last day of that month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines that
are no longer required. This will help to protect
the environment.

6. Further Information
9.

Fu

What Terbutaline Sulphate Turbohaler
contains
Each actuation delivers 500 micrograms of
terbutaline Sulphate.
What Terbutaline Sulphate Turbohaler looks
like and the contents of the pack
Terbutaline Sulphate Turbohaler is a metered
dose inhaler, with a white mouth piece and cover
with a blue turn grip. The base of the turning grip
has a Braille code embossed.
Each Turbohaler contains 100 doses.
Manufactured by:
AstraZeneca AB, S-151 85 Sodertalje, Sweden.
or
AstraZeneca Dunkerque Production, 224, Avenue
de la Dordogne, 59640 Dunkerque, France.
Procured from within the EU & repackaged by
PL holder:
Kosei Pharma UK Ltd., 956 Buckingham Avenue,
Slough Trading Estate, SL1 4NL.

Terbutaline Sulphate 0.5mg/dose
Turbohaler
POM
PL: 39352/0289
®

Turbohaler is registered trademarks of the
AstraZeneca group.
Leaflet date: 22.09.2015

Expand view ⇕

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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