Skip to Content

PULMICORT 400MICROGRAM TURBOHALER

Active substance(s): BUDESONIDE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Patient Information Leaflet

Pulmicort® 400 microgram 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 400 microgram Turbohaler but will
be referred to as Pulmicort Turbohaler throughout the remainder of the
leaflet.
Pulmicort Turbohaler is also available in 100 microgram and 200 microgram
strengths.
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 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.

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.
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.

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 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, 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 or search for MHRA Yellow card in the
Google Play or Apple App Store. By reporting side effects you can help
provide more information on the safety of this medicine.
5. How to store Pulmicort Turbohaler
Do not store above 30°C.
Store in the original package in order to protect from moisture.
Keep the cover screwed onto your Turbohaler when you are not using it.
The canister must not be punctured, broken or burnt even when empty.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
Do not use your Turbohaler after the expiry date shown on the
packaging. If your doctor decides to stop the treatment return your
Turbohaler to the pharmacist for safe disposal. Only keep it if the doctor
tells you to.
If your Turbohaler fails to work properly or shows signs of deterioration,
take it back to the pharmacist who will tell you what to do.
Medicine should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer
required.
6. Contents of the pack and other information
What Pulmicort Turbohaler contains
Pulmicort Turbohaler contains budesonide and no other ingredient.
What Pulmicort Turbohaler looks like and contents of the pack
Pulmicort Turbohaler is an inhaler containing your medicine which
contains 50 actuations, each containing 400 micrograms of budesonide.
Pulmicort Turbohaler has a white body with a brown base.
Product Licence holder and Manufacturer
This medicine is manufactured by AstraZeneca AB, S – 151 85
Sodertalje, Sweden. Procured from within the EU. Product Licence
Holder: Quadrant Pharmaceuticals Ltd, Lynstock House, Lynstock Way,
Lostock, Bolton, BL6 4SA. Repackaged by Maxearn Ltd, Bolton BL6 4SA
Pulmicort 400 microgram Turbohaler

PL 20774/0207

Pulmicort and turbohaler are registered trademarks of AstraZeneca AB.
th

Date of preparation: 25 October 2017

POM

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Quadrant Pharmaceuticals
Ltd. Tel: 01204 473084

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 lungs) 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.
PP12/0207/V2

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide