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BUDESONIDE 200 MICROGRAMS DRY POWDER INHALER

Active substance(s): BUDESONIDE

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S0937 LEAFLET Pulmicort 20160620

PACKAGE LEAFLET: INFORMATION FOR THE USER

PULMICORT® 200 TURBOHALER®
(budesonide)
Your medicine is known as Pulmicort 200 Turbohaler but will be
referred to as Pulmicort Turbohaler throughout the following patient
information leaflet.

3. HOW TO USE PULMICORT 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 Pulmicort Turbohaler is to be used by your child, make sure
they use it correctly as your doctor has told you.



Information for other strengths of Pulmicort Turbohaler may also be
present in this leaflet.

It is important to use Pulmicort Turbohaler every day, even if
you have no asthma symptoms at the time.



Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.

Your breathing may improve within 2 days. However it can take
up to 4 weeks for the medicine to have its full effect.

Important information about your asthma symptoms



Keep this leaflet. You may need to read it again.



If you have any further questions, ask your doctor or
pharmacist.



This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.



If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

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

If you feel you are getting breathless or wheezy while using
Pulmicort Turbohaler, you should continue to use Pulmicort
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.



Your chest starts to feel tight in the morning or your chest
tightness lasts longer than usual.

These signs could mean that your condition is not being properly
controlled and you may need different or additional treatment
immediately.
Use your Pulmicort Turbohaler every day.
This helps to prevent asthma symptoms from happening. Your
doctor will advise you of the correct dose to treat your asthma. Your
doctor will reduce your medication to the lowest dose needed to
control your asthma.
If your doctor has told you to use your Turbohaler twice a day:

1. WHAT PULMICORT TURBOHALER IS AND WHAT IT IS USED
FOR
Pulmicort Turbohaler is an inhaler. It contains a medicine called
budesonide. This belongs to a group of medicines called
‘corticosteroids’. It works by reducing and preventing swelling and
inflammation in your lungs.

Adults and children (13 years and above)


The recommended dose is 1 or 2 inhalations, twice a day (in
the morning and in the evening).



Your doctor may increase this to a maximum of 1600
micrograms a day.



If your asthma is getting worse and you are using your ‘reliever
inhaler’ more often or you have more symptoms:

Your doctor has prescribed this medicine to treat asthma. Your
doctor will prescribe two asthma inhalers: Pulmicort Turbohaler and
a separate ‘reliever inhaler’.


Use Pulmicort Turbohaler every day, as your doctor has told
you to. This helps to prevent asthma symptoms from
happening.



Use your ‘reliever inhaler’ when you get asthma symptoms, to
make it easier to breathe again.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE
PULMICORT TURBOHALER
Do not use Pulmicort Turbohaler:

-

double your dose of Pulmicort Turbohaler immediately and
talk to your doctor as soon as possible

-

double your dose by taking twice as many inhalations each
time.

Use in Children (5 - 12 years of age)


The recommended dose is 1 or 2 inhalations, twice a day (in
the morning and in the evening).



The doctor may increase this to a maximum of 800 micrograms
a day.

If your doctor has told you to use your Turbohaler once a day:


Only use your Turbohaler once a day if your doctor has told you
to.

Warnings and precautions



Use your Turbohaler at the same time each evening.

Talk to your doctor or pharmacist before using

Adults and children (13 years and above)

Pulmicort Turbohaler if:



The recommended dose is 1 or 2 inhalations, in the evening.



You have a lung infection.





You have a cold or chest infection or any problems with your
breathing.

If your asthma is getting worse and you are using your ‘reliever
inhaler’ more often or you have more symptoms:



You have or have ever had tuberculosis (TB).



You have liver problems.

If you are allergic to budesonide.

Other medicines and Pulmicort Turbohaler
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. This includes medicines that you
buy without a prescription and herbal medicines. This is because
Pulmicort Turbohaler can affect the way some medicines work and
some medicines can have an effect on Pulmicort Turbohaler.
In particular, tell your doctor or pharmacist if you are taking any of
the following medicines:


Steroid medicines.



Medicines to treat fungal infections (such as itraconazole and
ketoconazole).



HIV protease inhibitors (such as ritonavir and nelfinavir).

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. Do not use
Pulmicort Turbohaler unless your doctor tells you to.



If you get pregnant while using Pulmicort Turbohaler, do not
stop using Pulmicort Turbohaler but talk to your doctor
immediately.

Driving and using machines
Pulmicort Turbohaler is not likely to affect you being able to drive or
use any tools or machines.
Information you may have to carry while you are using
Pulmicort Turbohaler
If you are using a high dose of Pulmicort Turbohaler your doctor
may ask you to carry a steroid warning card. This explains to others
about your medication.

-

double your dose immediately and talk to your doctor as
soon as possible

-

double your dose by taking the same number of inhalations
your doctor has told you twice a day (once in the morning
and once in the evening).

Use in Children (5 - 12 years of age)


The recommended dose is 1 or 2 inhalations, in the evening.



The maximum dose is 400 micrograms a day.

Use your separate ‘reliever inhaler’ to treat asthma symptoms
when they happen.
Always keep your ‘reliever inhaler’ with you to use when you need
it. Do not use Pulmicort Turbohaler to treat asthma symptoms - use
your ‘reliever inhaler’.
How to prepare a new Turbohaler for use
Before using Pulmicort Turbohaler for the first
time you need to prepare the Turbohaler for
use.
Unscrew the white cover and lift it off.
Hold your Turbohaler upright with brown
base at the bottom. Do not hold the
mouthpiece when you turn the grip. Turn the
brown base as far as it will go in one
direction. Then turn it back as far as it will
go in the other direction. It does not matter
which way you turn first. You should hear a
click sound. Perform the procedure twice.
The Turbohaler is now ready for use, and you should not repeat
the above procedure again. To take a dose, please follow the
instructions below.

How to take an inhalation

Other possible side effects:

Every time you need to take an inhalation, follow the instructions
below.

Common (may affect up to 1 in 10 people)


Thrush (a fungal infection) in the mouth. This is less likely if you
rinse your mouth out with water after using your Turbohaler.



Mild sore throat, coughing and a hoarse voice.

1. Unscrew the white cover and lift it off.
2. Hold your Turbohaler upright with the brown base at the
bottom.

Rare (may affect up to 1 in 1,000 people)

3. Do not hold the mouthpiece when you load your Turbohaler. To
load your Turbohaler with a dose, turn the brown base 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.



Sleeping problems, depression or feeling worried, restless,
nervous, over-excited or irritable. These effects are more likely
to occur in children.



Bruising of the skin.



Loss of voice.



Hoarse voice (in children).

4. Hold your Turbohaler away from your mouth. Breathe out
gently (as far as is comfortable). Do not breathe out through
your Turbohaler.

Inhaled corticosteroids can affect the normal production of steroid
hormones in your body, particularly if you use high doses for a long
time, for example 400 micrograms or more daily for several years.

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.

The effects include:

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 after use.
9. Rinse your mouth out with water after
inhaling your prescribed dose.
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 you first see a red mark (depicted as
grey) in the indicator window, there are
about 20 doses left. You will then need to
see your doctor for another prescription.
When the red mark has reached the
bottom of the indicator window, you must
start using your new Turbohaler.
Note:


The brown base 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 Pulmicort Turbohaler than you should
It is important that you take your dose as stated on the pharmacist’s
label or as advised by your doctor. You should not increase or
decrease your dose without seeking medical advice. If you use
more Pulmicort Turbohaler than you should, contact your doctor or
pharmacist for advice.
If you forget to use Pulmicort Turbohaler
If you forget to take a dose, skip the missed dose and take the next
dose as usual. Do not take a double dose to make up for a
forgotten dose.
If you stop using Pulmicort Turbohaler
Do not stop using this medicine even when your asthma gets better,
unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.



changes in bone mineral density (thinning of the bones).



cataract (clouding of the lens in the eye).



glaucoma (increased pressure in the eye)



a slowing of the rate of growth of children and adolescents
(rare). If high doses are given over several years, final adult
height may be reduced by about 1 cm.



an effect on the adrenal gland (a small gland next to the kidney)
(rare).

These effects are much less likely to happen with inhaled
corticosteroids than with corticosteroid tablets.
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 PULMICORT TURBOHALER


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not use after the expiry date printed on the pack.



Pulmicort Turbohaler should be stored below 30°C. Replace the
cover properly after use.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If your Pulmicort Turbohaler is not working properly or shows
any other signs of deterioration, you should seek the advice of
your pharmacist who will tell you what to do.



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
What Pulmicort Turbohaler contains


Pulmicort Turbohaler contains 100 actuations each delivering
200 micrograms of the active ingredient budesonide. There are
no other ingredients.

What Pulmicort Turbohaler looks like and contents of the pack
Pulmicort Turbohaler is a breath actuated metered dose powder
inhaler with a white cap and a dark brown base and turning grip. A
braille code for the identification of Pulmicort Turbohaler and
‘Budesonide 200’ are embossed on the bottom of the turning grip.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by AstraZeneca AB, S-15185
Sodertalje, Sweden.

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

POM

PL: 19488/0937

If either of the following happen to you, stop using Pulmicort
Turbohaler and talk to your doctor immediately:

Leaflet revision date: 20 June 2016



Pulmicort and Turbohaler are registered trade mark of
AstraZeneca AB, Sweden.



Swelling of your face, particularly around your mouth (with
possible swelling of the lips, tongue, eyes and ears), rash,
itching, contact dermatitis (a skin problem), hives and
bronchospasm (tightening of the muscles in the airways which
causes wheezing). This may mean that you are having an
allergic reaction. This happens rarely, affecting less than 1 in
1,000 people.
Sudden wheezing after inhaling your medicine. If this happens,
also use your ‘reliever’ inhaler straight away. This happens very
rarely, affecting less than 1 in 10,000 people.

®

®

S0937 LEAFLET Pulmicort 20160620

S0937 LEAFLET Budesonide 20160620

PACKAGE LEAFLET: INFORMATION FOR THE USER

3. HOW TO USE BUDESONIDE 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 Budesonide Inhaler is to be used by your child, make sure
they use it correctly as your doctor has told you.

BUDESONIDE 200 micrograms DRY POWDER INHALER
(budesonide)
Your medicine is known as Budesonide 200 micrograms Dry
Powder Inhaler but will be referred to as Budesonide Inhaler
throughout the following patient information leaflet.



Information for other strengths of Budesonide Inhaler may also be
present in this leaflet.

It is important to use Budesonide Inhaler every day, even if you
have no asthma symptoms at the time.



Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.

Your breathing may improve within 2 days. However it can take
up to 4 weeks for the medicine to have its full effect.

Important information about your asthma symptoms



Keep this leaflet. You may need to read it again.



If you have any further questions, ask your doctor or
pharmacist.



This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.



If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

What is in this leaflet
1. What Budesonide Inhaler is and what it is used for
2. What you need to know before you use Budesonide Inhaler
3. How to use Budesonide Inhaler
4. Possible side effects
5. How to store Budesonide Inhaler
6. Contents of the pack and other information

If you feel you are getting breathless or wheezy while using
Budesonide Inhaler, you should continue to use Budesonide Inhaler
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.



Your chest starts to feel tight in the morning or your chest
tightness lasts longer than usual.

These signs could mean that your condition is not being properly
controlled and you may need different or additional treatment
immediately.
Use your Budesonide Inhaler every day.
This helps to prevent asthma symptoms from happening. Your
doctor will advise you of the correct dose to treat your asthma. Your
doctor will reduce your medication to the lowest dose needed to
control your asthma.
If your doctor has told you to use your Inhaler twice a day:

1. WHAT BUDESONIDE INHALER IS AND WHAT IT IS USED
FOR
Budesonide Inhaler is an inhaler. It contains a medicine called
budesonide. This belongs to a group of medicines called
‘corticosteroids’. It works by reducing and preventing swelling and
inflammation in your lungs.

Adults and children (13 years and above)


The recommended dose is 1 or 2 inhalations, twice a day (in
the morning and in the evening).



Your doctor may increase this to a maximum of 1600
micrograms a day.



If your asthma is getting worse and you are using your ‘reliever
inhaler’ more often or you have more symptoms:

Your doctor has prescribed this medicine to treat asthma. Your
doctor will prescribe two asthma inhalers: Budesonide Inhaler and a
separate ‘reliever inhaler’.


Use Budesonide Inhaler every day, as your doctor has told you
to. This helps to prevent asthma symptoms from happening.



Use your ‘reliever inhaler’ when you get asthma symptoms, to
make it easier to breathe again.

-

double your dose of Budesonide Inhaler immediately and
talk to your doctor as soon as possible

-

double your dose by taking twice as many inhalations each
time.

Use in Children (5 - 12 years of age)


The recommended dose is 1 or 2 inhalations, twice a day (in
the morning and in the evening).

2. WHAT YOU NEED TO KNOW BEFORE YOU USE
BUDESONIDE INHALER



The doctor may increase this to a maximum of 800 micrograms
a day.

Do not use Budesonide Inhaler:

If your doctor has told you to use your Inhaler once a day:

If you are allergic to budesonide.



Only use your Inhaler once a day if your doctor has told you to.

Warnings and precautions



Use your Inhaler at the same time each evening.

Talk to your doctor or pharmacist before using

Adults and children (13 years and above)

Budesonide Inhaler if:



The recommended dose is 1 or 2 inhalations, in the evening.



You have a lung infection.





You have a cold or chest infection or any problems with your
breathing.

If your asthma is getting worse and you are using your ‘reliever
inhaler’ more often or you have more symptoms:



You have or have ever had tuberculosis (TB).



You have liver problems.

Other medicines and Budesonide 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. This is because
Budesonide Inhaler can affect the way some medicines work and
some medicines can have an effect on Budesonide Inhaler.
In particular, tell your doctor or pharmacist if you are taking any of
the following medicines:


Steroid medicines.



Medicines to treat fungal infections (such as itraconazole and
ketoconazole).



HIV protease inhibitors (such as ritonavir and nelfinavir).

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. Do not use
Budesonide Inhaler unless your doctor tells you to.
If you get pregnant while using Budesonide Inhaler, do not stop
using Budesonide Inhaler but talk to your doctor immediately.

Driving and using machines
Budesonide Inhaler is not likely to affect you being able to drive or
use any tools or machines.
Information you may have to carry while you are using
Budesonide Inhaler
If you are using a high dose of Budesonide Inhaler your doctor may
ask you to carry a steroid warning card. This explains to others
about your medication.

-

double your dose immediately and talk to your doctor as
soon as possible

-

double your dose by taking the same number of inhalations
your doctor has told you twice a day (once in the morning
and once in the evening).

Use in Children (5 - 12 years of age)


The recommended dose is 1 or 2 inhalations, in the evening.



The maximum dose is 400 micrograms a day.

Use your separate ‘reliever inhaler’ to treat asthma symptoms
when they happen.
Always keep your ‘reliever inhaler’ with you to use when you need
it. Do not use Budesonide Inhaler to treat asthma symptoms - use
your ‘reliever inhaler’.
How to prepare a new Inhaler for use
Before using Budesonide Inhaler for the first
time you need to prepare the Inhaler for use.
Unscrew the white cover and lift it off.
Hold your Inhaler upright with brown base at
the bottom. Do not hold the mouthpiece when
you turn the grip. Turn the brown base as far
as it will go in one direction. Then turn it
back as far as it will go in the other
direction. It does not matter which way you
turn first. You should hear a click sound.
Perform the procedure twice.
The Inhaler is now ready for use, and you
should not repeat the above procedure
again. To take a dose, please follow the instructions below.

How to take an inhalation

Other possible side effects:

Every time you need to take an inhalation, follow the instructions
below.

Common (may affect up to 1 in 10 people)


Thrush (a fungal infection) in the mouth. This is less likely if you
rinse your mouth out with water after using your Inhaler.



Mild sore throat, coughing and a hoarse voice.

1. Unscrew the white cover and lift it off.
2. Hold your Inhaler upright with the brown base at the bottom.
3. Do not hold the mouthpiece when you load your Inhaler. To
load your Inhaler with a dose, turn the brown base 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.

Rare (may affect up to 1 in 1,000 people)

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.



Sleeping problems, depression or feeling worried, restless,
nervous, over-excited or irritable. These effects are more likely
to occur in children.



Bruising of the skin.



Loss of voice.



Hoarse voice (in children).

Inhaled corticosteroids can affect the normal production of steroid
hormones in your body, particularly if you use high doses for a long
time, for example 400 micrograms or more daily for several years.
The effects include:


changes in bone mineral density (thinning of the bones).



cataract (clouding of the lens in the eye).



glaucoma (increased pressure in the eye)

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.



a slowing of the rate of growth of children and adolescents
(rare). If high doses are given over several years, final adult
height may be reduced by about 1 cm.



an effect on the adrenal gland (a small gland next to the kidney)
(rare).

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

These effects are much less likely to happen with inhaled
corticosteroids than with corticosteroid tablets.

8. Replace the cover by screwing it back
on tightly after use.

Reporting of side effects

9. Rinse your mouth out with water after
inhaling your prescribed dose.
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.

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.

Cleaning your Inhaler

5. HOW TO STORE BUDESONIDE INHALER

Wipe the outside of the mouthpiece once a week with a dry tissue.
Do not use water or liquids.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not use after the expiry date printed on the pack.



Budesonide Inhaler should be stored below 30°C. Replace the
cover properly after use.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If your Budesonide Inhaler is not working properly or shows any
other signs of deterioration, you should seek the advice of your
pharmacist who will tell you what to do.



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.

When to start using a new Inhaler
When you first see a red mark (depicted as
grey) in the indicator window, there are
about 20 doses left. You will then need to
see your doctor for another prescription.
When the red mark has reached the
bottom of the indicator window, you must
start using your new Inhaler.
Note:


The brown base 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 Budesonide Inhaler than you should
It is important that you take your dose as stated on the pharmacist’s
label or as advised by your doctor. You should not increase or
decrease your dose without seeking medical advice. If you use
more Budesonide Inhaler than you should, contact your doctor or
pharmacist for advice.
If you forget to use Budesonide Inhaler
If you forget to take a dose, skip the missed dose and take the next
dose as usual. Do not take a double dose to make up for a
forgotten dose.
If you stop using Budesonide Inhaler
Do not stop using this medicine even when your asthma gets better,
unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Budesonide Inhaler contains


Budesonide Inhaler contains 100 actuations each delivering
200 micrograms of the active ingredient budesonide. There are
no other ingredients.

What Budesonide Inhaler looks like and contents of the pack
Budesonide Inhaler is a breath actuated metered dose powder
inhaler with a white cap and a dark brown base and turning grip. A
braille code for the identification of Budesonide Inhaler and
‘Budesonide 200’ are embossed on the bottom of the turning grip.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer

4. POSSIBLE SIDE EFFECTS
Like all medicines this medicine can cause side effects, although
not everybody gets them.
If either of the following happen to you, stop using Budesonide
Inhaler and talk to your doctor immediately:




Swelling of your face, particularly around your mouth (with
possible swelling of the lips, tongue, eyes and ears), rash,
itching, contact dermatitis (a skin problem), hives and
bronchospasm (tightening of the muscles in the airways which
causes wheezing). This may mean that you are having an
allergic reaction. This happens rarely, affecting less than 1 in
1,000 people.
Sudden wheezing after inhaling your medicine. If this happens,
also use your ‘reliever’ inhaler straight away. This happens very
rarely, affecting less than 1 in 10,000 people.

This product is manufactured by AstraZeneca AB, S-15185
Sodertalje, Sweden.
POM

PL: 19488/0937

Leaflet revision date: 20 June 2016
S0937 LEAFLET Budesonide 20160620

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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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