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TERBUTALINE SULPHATE 0.5MG-DOSE DRY POWDER INHALER

Active substance(s): TERBUTALINE SULPHATE

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®

Package leaflet: Information for the user
®

Bricanyl Turbohaler , 0.5mg/dose, inhalation powder
(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.
The name of your medicine is Bricanyl
Turbohaler, 0.5mg/dose, inhalation powder but
will be referred to as Bricanyl Turbohaler or
Turbohaler throughout this leaflet.
What is in this leaflet
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 Turbohaler is and 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
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,
have recently taken or might take any other
medicines. This includes medicines that you buy
without a prescription and herbal medicines.
Bricanyl Turbohaler can affect the way that some
medicines work and some medicines can have an
effect on Bricanyl Turbohaler.
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 Turbohaler is not likely to affect you
being able to drive or use any machines.
3. How to use Bricanyl 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.

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
Turbohaler is
a multidose
inhaler from
which very
small
amounts of
powder are
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
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.

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.

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.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine 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 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.

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)
• 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.
5. How to store Bricanyl Turbohaler







Keep out of the sight and reach of children.
Do not use Bricanyl Turbohaler after the
expiry date which is stated on the label after
‘Exp’. The expiry date refers to the last day of
that month.
Do not store above 30°C.
Important: replace the cover properly after
use.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. Contents of the pack and other
information
What Bricanyl Turbohaler contains
The active substance is terbutaline sulphate.
Each actuation delivers 500micrograms of
terbutaline sulphate.
This product does not contain propellants or any
other ingredients.
What Bricanyl Turbohaler looks like and the
contents of the pack
Bricanyl Turbohaler is a multi-dose, dry powder
inhaler.
Each pack contains a white inhalation powder in
a metered dose turbohaler, with a white mouth
piece and cover with a blue turn grip.
A Braille code is embossed at the bottom of the
turning grip and ‘Terbutaline Sulfate 0.5mg/dose’.
It provides 100 doses.
Manufactured by: AstraZeneca Dunkerque
Production 224, Avenue de la Dordogne,
F-59640 Dunkerque, France.
Or
AstraZeneca AB-Liquid Production Sweden, S151 85 Sodertalje, Sweden.
Procured from within the EU and repackaged
by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Bricanyl® Turbohaler®, 0.5mg/dose, inhalation
powder;
PL 18799/2453
POM
Leaflet date: 08.02.2016

Package leaflet: Information for the user

Terbutaline sulphate 0.5mg/dose dry powder inhaler
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.
The name of your medicine is Terbutaline
sulphate 0.5mg/dose dry powder inhaler but will
be referred to as Terbutaline sulphate inhaler or
inhaler throughout this leaflet.
What is in this leaflet
1. What Terbutaline sulphate inhaler is and what
it is used for
2. What you need to know before you use
Terbutaline sulphate inhaler
3. How to use Terbutaline sulphate inhaler
4. Possible side effects
5. How to store Terbutaline sulphate inhaler
6. Contents of the pack and other information1.
1. What Terbutaline sulphate inhaler is and
what it is used for
Terbutaline sulphate inhaler 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.
Terbutaline sulphate inhaler is used for asthma
and other breathing problems where you have a
tight chest and difficulty breathing. 2
2. What you need to know before you use
Terbutaline sulphate inhaler
Do not use Terbutaline sulphate inhaler:
• If you are allergic to terbutaline.
Warnings and precautions
Talk to your doctor or pharmacist before using
Terbutaline sulphate inhaler if:
• You have diabetes. If so, you may need some
extra blood sugar tests when you start using
Terbutaline sulphate inhaler.
• 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 inhaler.
Other medicines and Terbutaline sulphate
inhaler
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 inhaler can affect the way
that some medicines work and some medicines
can have an effect on Terbutaline sulphate
inhaler.
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 inhaler, talk to your
doctor straight away.
Driving and using machines
Terbutaline sulphate inhaler is not likely to affect
you being able to drive or use any machines.
3. How to use Terbutaline sulphate inhaler
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
Terbutaline sulphate inhaler 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
inhaler 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
inhaler is a
multidose
inhaler from
which very
small
amounts of
powder are
administered
(Figure 1).
When you breathe in through inhaler 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 inhaler for use
Before using inhaler for the first time you need
to prepare the inhaler for use.
Unscrew and lift off the white cover.
Hold the inhaler 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
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 inhaler 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 inhaler upright
with the blue grip at the
bottom.
3. Do not hold the
mouthpiece when you load your inhaler. To
load your inhaler 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 inhaler is now loaded and ready to use.
Only load your inhaler when you need to use
it.
4. Hold your inhaler away from your mouth.
Breathe out gently (as far as is comfortable).
Do not breathe out through your inhaler.
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 inhaler 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 inhaler.
Do not try to remove or twist the mouthpiece. It is
fixed to your inhaler and must not be taken off. Do
not use your inhaler if it has been damaged or if
the mouthpiece has come apart from your inhaler.
Cleaning your inhaler
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 inhaler
• 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 inhaler is empty and
you must start using your new inhaler.

Note:
• The grip will still twist and ‘click’ even when
your inhaler is empty.
• The sound that you hear as you shake your
inhaler is produced by a drying agent and not
the medicine. Therefore the sound does not
tell you how much medicine is left in your
inhaler.
• If you load your inhaler more than once by
mistake before taking your dose, you will still
only receive one dose.
If you use more Terbutaline sulphate inhaler
than you should
If you use more Terbutaline sulphate inhaler than
you should, contact your doctor or pharmacist for
advice.
If you forget to use Terbutaline sulphate
inhaler
• 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 have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine 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 inhaler and see
a doctor straight away.
Sudden wheezing soon after inhaling your
dose of Terbutaline sulphate inhaler. It is not
known exactly how often this happens. If this
happens to you, stop using Terbutaline
sulphate inhaler and see a doctor straight
away.

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)
• 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
Terbutaline sulphate inhaler, 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. How to store Terbutaline sulphate
inhaler







Keep out of the sight and reach of children.
Do not use Terbutaline Turbohaler after the
expiry date which is stated on the label after
‘Exp’. The expiry date refers to the last day of
that month.
Do not store above 30°C.
Important: replace the cover properly after
use.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. Contents of the pack and other
information
What Terbutaline Turbohaler contains
The active substance is terbutaline sulphate.
Each actuation delivers 500micrograms of
terbutaline sulphate.
This product does not contain propellants or any
other ingredients.
What Terbutaline Turbohaler looks like and
the contents of the pack
Terbutaline Turbohaler is a multi-dose, dry
powder inhaler.
Each pack contains a white inhalation powder in a
metered dose turbohaler, with a white mouth
piece and cover with a blue turn grip.
A Braille code is embossed at the bottom of the
turning grip and ‘Terbutaline Sulfate 0.5mg/dose’.
It provides 100 doses.
Manufactured by: AstraZeneca Dunkerque
Production 224, Avenue de la Dordogne, F-59640
Dunkerque, France.
Or
AstraZeneca AB-Liquid Production Sweden,
S-151 85 Sodertalje, Sweden.
Procured from within the EU and repackaged
by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK
Terbutaline sulphate® 0.5mg/dose dry powder
inhaler,
POM
PL 18799/2453
Leaflet date: 08.02.2016

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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