Skip to Content

BUDESONIDE 200 MICROGRAMS DRY POWDER INHALER

Active substance(s): BUDESONIDE / BUDESONIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
S0937 LEAFLET Pulmicort 20170206

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
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.



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.

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:


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).

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:

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



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.



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 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.

If you load your Turbohaler more than once by mistake before
taking your dose, you will still only receive one dose.



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.



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.

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.

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

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.

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

Manufacturer

4. POSSIBLE SIDE EFFECTS





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)

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

PL: 19488/0937

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.



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.

Leaflet revision date: 06 February 2017



Pneumonia (infection of the lung) in COPD patients.

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

Tell your doctor if you have any of the following while taking
budesonide they could be symptoms of a lung infection:

®

®

S0937 LEAFLET Pulmicort 20170206

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.

Hide