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PULMICORT 100 MICROGRAMS TURBOHALER

Active substance(s): BUDESONIDE / BUDESONIDE / BUDESONIDE

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Package leaflet: Information for the user

Pulmicort® 100 micrograms Turbohaler®
Pulmicort® 200 micrograms Turbohaler®
(budesonide)
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 Pulmicort 100 micrograms Turbohaler
or Pulmicort 200 micrograms Turbohaler but will be referred to as
Pulmicort Turbohaler or Turbohaler throughout this leaflet. Please
note that the leaflet also contains information about other strength
Pulmicort 400 micrograms Turbohaler.
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

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.
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:
If you are allergic to budesonide.
Warnings and precautions
Talk to your doctor or pharmacist before using Pulmicort Turbohaler
if:
 You have a lung infection.
 You have a cold or chest infection or any problems with your
breathing.
 You have or have ever had tuberculosis (TB).
 You have liver problems.
Contact your doctor if you experience blurred vision or other visual
disturbances.
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 and your
doctor may wish to monitor you carefully.
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 medicines (such as ritonavir or cobicistat- containing
products).
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.

3. How to use Pulmicort Turbohaler


Always use this medicine exactly as your doctor or pharmacist

4. 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.
It is important to use Pulmicort Turbohaler every day, even if you
have no asthma symptoms at the time.
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
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:
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:
- 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.
 Use your Turbohaler at the same time each evening.
Adults and children (13 years and above)
 The recommended dose is 1 or 2 inhalations, in the evening.
 If your asthma is getting worse and you are using your ‘reliever
inhaler’ more often or you have more symptoms:
- 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
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 brown base at the
bottom.
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.
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 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 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.

5. How to store Pulmicort 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.




Keep out of the sight and reach of children.
Do not store above 30°C.
When not in use, Pulmicort Turbohaler should be stored with the
cover tightened.
Do not use the Turbohaler after the expiry date which is stated on
the carton and Turbohaler label after ‘Exp’. The expiry date refers
to the last day of that month.
If the Turbohaler does not work properly or shows any signs of
damage, seek the advice of your pharmacist.
Remember if your doctor tells you to stop taking this medicine,
return any unused medicine to your pharmacist for safe disposal.
Only keep this medicine if your doctor tells you to.
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 Pulmicort Turbohaler contains
The active ingredient in Pulmicort Turbohaler is budesonide.
Pulmicort 100 micrograms Turbohaler contains 200 actuations.
Each actuation delivers 100 micrograms budesonide.
Pulmicort 200 micrograms Turbohaler contains 100 actuations.
Each actuation delivers 200 micrograms budesonide.

If you stop using Pulmicort Turbohaler
Do not stop using this medicine even when your asthma gets better,
unless your doctor tells you to.

What Pulmicort Turbohaler looks like and contents of the pack
Pulmicort Turbohaler comes in a white plastic breath actuated
metered dose powder inhaler with a dark brown turning grip.
Pulmicort 100 micrograms Turbohaler has the words ‘Budesonide
100’ and a Braille code is embossed on the base of the turngrip.
Pulmicort 200 micrograms Turbohaler has the words ‘Budesonide
200’ and a Braille code is embossed on the base of the turngrip.

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

Manufactured by: AstraZeneca AB, Sodertalje, Sweden. OR
AstraZeneca Dunkerque Production - Dunkerque, France.

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 Pulmicort
Turbohaler 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.
Other possible side effects:
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.
 Pneumonia (infection of the lung) in COPD patients.
Tell your doctor if you have any of the following while taking
budesonide they could be symptoms of a lung infection:
 Fever or chills.
 Increased mucus production, change in mucus colour.
 Increased cough or increased breathing difficulties.
Uncommon (may affect up to 1 in 100 people)
 Feeling worried, restless and nervous.
 Depression.
 Trembling and shaking.
 Cataract (clouding of the lens in the eye).
 Muscle cramps.
 Blurred vision.
Rare (may affect up to 1 in 1,000 people)
 Sleeping problems, feeling 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).
- 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 1cm.
- 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, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report any 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.

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

®

Pulmicort 100 micrograms Turbohaler ; PL 18799/0532
®
®
Pulmicort 200 micrograms Turbohaler ; PL 18799/0533
Leaflet date: 28.07.2017

POM

PULMICORT & TURBOHALER are trademarks of the AstraZeneca
group of companies.

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Is this leaflet hard to see or read?
Call 0208 515 3763 to obtain the
leaflet in a format suitable for you.

Expand Transcript

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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