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TERBUTALINE SULFATE 0.5MG/DOSE DRY POWDER INHALER

Active substance(s): TERBUTALINE SULFATE

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Package leaflet: Information for the user
®

Bricanyl 0.5mg/dose Turbohaler®
(terbutaline sulfate)
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
0.5mg/dose Turbohaler 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.

6. Contents of the pack and other
information
What Bricanyl Turbohaler contains
The active ingredient in Bricanyl Turblhaler is
terbutaline sulfate.
Each actuation delivers 0.5mg terbutaline
sulfate.
Bricanyl Turbohaler does not contain any other
excepients.
What Bricanyl Turbohaler looks like and the
contents of the pack
Bricanyl Turbohaler is a metered dose, dry
powder inhaler which contains white inhalation
powder.
Each pack contains a metered dose inhaler with
a blue turn grip and white body which provides
100 doses.
A Braille code and ‘Terbutaline sulfate
0.5mg/dose’ is embossed at the bottom of the
turning grip. The inhaler contains a counter
window and tamper evident seal.
Manufactured by: AstraZeneca Dunkerque
Production, Dunkerque, France.
Or

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.

AstraZeneca AB, Sodertalje, Sweden.

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.

Bricanyl® 0.5mg/dose Turbohaler®;
PL 18799/2843

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,
pharmacist or nurse. 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 store above 30°C.
When not in use, Bricanyl Turbohaler
should be stored with the cover tightened.
Do not use Bricanyl Turbohaler after the
expiry date which is stated on the
carton/inhaler label after ‘Exp’. 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 no
longer required. These measures will help
to protect the environment.

Procured from within the EU and repackaged
by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.

Leaflet date: 03.05.2016

POM

Package leaflet: Information for the user

Terbutaline sulfate 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
sulfate 0.5mg/dose dry powder inhaler but will
be referred to as Terbutaline sulfate inhaler or
inhaler throughout this leaflet.
What is in this leaflet
1. What Terbutaline sulfate inhaler is and what
it is used for
2. What you need to know before you use
Terbutaline sulfate inhaler
3. How to use Terbutaline sulfate inhaler
4. Possible side effects
5. How to store Terbutaline sulfate inhaler
6. Contents of the pack and other
information1.
1. What Terbutaline sulfate inhaler is
and what it is used for
Terbutaline sulfate inhaler 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 sulfate 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 sulfate inhaler
Do not use Terbutaline sulfate inhaler:
• If you are allergic to terbutaline.
Warnings and precautions
Talk to your doctor or pharmacist before using
Terbutaline sulfate inhaler if:
• You have diabetes. If so, you may need
some extra blood sugar tests when you start
using Terbutaline sulfate 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 sulfate inhaler.
Other medicines and Terbutaline sulfate
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 sulfate inhaler can affect the way
that some medicines work and some medicines
can have an effect on Terbutaline sulfate
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).

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 sulfate
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
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.

If you are to undergo surgery with general
anaesthetics it is important that you inform your
doctor about all medicines you use, including
Terbutaline sulfate inhaler to protect you from
adverse effects (e.g. irregular heart beat).

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.

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 sulfate inhaler, talk to your
doctor straight away.

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.

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

7. If you are to take a
second inhalation,
repeat steps 2 to 6.

3. How to use Terbutaline sulfate 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 sulfate inhaler is to be used by a
child, make sure that they use it correctly.

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 sulfate inhaler.

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.

5. How to store Terbutaline sulfate inhaler




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.

Keep out of the sight and reach of children.
Do not store above 30°C.
When not in use, Terbutaline sulfate inhaler
should be stored with the cover tightened.
Do not use Terbutaline sulfate inhaler after
the expiry date which is stated on the
carton/inhaler label after ‘Exp’. 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 no
longer required. These measures will help
to protect the environment.
6. Contents of the pack and other
information

What Terbutaline sulfate inhaler contains
The active ingredient is terbutaline sulfate.
Each actuation delivers 0.5mg terbutaline
sulfate.
Terbutaline sulfate inhaler does not contain any
other excepients.
What Terbutaline sulfate inhaler looks like
and the contents of the pack
Terbutaline sulfate inhaler is a metered dose,
dry powder inhaler which contains white
inhalation powder.
Each pack contains a metered dose inhaler with
a blue turn grip and white body which provides
100 doses.
A Braille code and ‘Terbutaline sulfate
0.5mg/dose’ is embossed at the bottom of the
turning grip. The inhaler contains a counter
window and tamper evident seal.

If you use more Terbutaline sulfate inhaler
than you should
If you use more Terbutaline sulfate inhaler than
you should, contact your doctor or pharmacist
for advice.

Manufactured by: AstraZeneca Dunkerque
Production, Dunkerque, France.

If you forget to use Terbutaline sulfate
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.

Procured from within the EU and repackaged
by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.

If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

Leaflet date: 03.05.2016

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 sulfate inhaler and see
a doctor straight away.
Sudden wheezing soon after inhaling your
dose of Terbutaline sulfate inhaler. It is not
known exactly how often this happens. If
this happens to you, stop using
Terbutaline sulfate 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 sulfate 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,
pharmacist or nurse. 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.

Or
AstraZeneca AB, Sodertalje, Sweden.

Terbutaline sulfate 0.5mg/dose dry powder
inhaler;
POM
PL 18799/2843

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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