Skip to Content

BUDESONIDE 100 MICROGRAMS TURBOHALER

Active substance(s): BUDESONIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Important information about your asthma symptoms

PACKAGE LEAFLET: INFORMATION FOR THE USER

If you feel you are getting breathless or wheezy while using Budesonide Turbohaler, you should
continue to use Budesonide Turbohaler but go to see your doctor as soon as possible, as you
may need additional treatment.

BUDESONIDE 100 MICROGRAMS TURBOHALER®
(budesonide)

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.

Your medicine is available using the name Budesonide 100 micrograms Turbohaler, but will be
referred to as Budesonide Turbohaler throughout this leaflet. Other strengths (200mcg &
400mcg) are also available.
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.

Use your Budesonide 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 Budesonide Turbohaler twice a day:
Adults and children (13 years and above)


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




Use in Children (5-12 years of age)


WHAT BUDESONIDE TURBOHALER IS AND WHAT IT IS USED FOR

Budesonide 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.

WHAT YOU NEED TO KNOW BEFORE YOU USE BUDESONIDE
TURBOHALER

Only use your Budesonide Turbohaler once a day if your doctor has told you to.
Use your Budesonide Turbohaler at the same time each evening.

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)



Warnings and precautions

Talk to your doctor or pharmacist before using Budesonide 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.

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
Turbohaler to treat asthma symptoms – use your ‘reliever inhaler’.

How to prepare a new Budesonide Turbohaler for use

Before using Budesonide Turbohaler for the first time you need to
prepare the Budesonide Turbohaler for use.

Other medicines and Budesonide 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 Budesonide Turbohaler can affect the way some medicines work and some
medicines can have an effect on Budesonide Turbohaler.

Unscrew the white cover and lift it off.

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).

Hold your Budesonide 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.

Pregnancy, breast-feeding and fertility



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




If you are allergic to budesonide.



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.

Adults and children (13 years and above)

Do not use Budesonide Turbohaler:

In








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

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 Budesonide Turbohaler immediately and talk to your doctor as soon
as possible
• double your dose by taking twice as many inhalations each time.

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

The Budesonide Turbohaler is now ready for use, and you should not
repeat the above procedure again. To take a dose, please follow the
instructions below.

Driving and using machines

Budesonide Turbohaler is not likely to affect you being able to drive or use any tools or
machines.

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.

Information you may have to carry while you are using Budesonide Turbohaler
If you are using a high dose of Budesonide Turbohaler your doctor may ask you to carry a
steroid warning card. This explains to others about your medication.

2.

Hold your Budesonide Turbohaler upright with the brown base at the bottom.

3.

3.

Do not hold the mouthpiece when you load your Budesonide Turbohaler. To load your
Budesonide 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 Budesonide Turbohaler is
now loaded and ready to use. Only load your Budesonide Turbohaler when you need to use
it.

4.

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







HOW TO USE BUDESONIDE 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 Budesonide 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 Budesonide 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.

Page 1 of 2

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).
• 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).

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 Budesonide 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.

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.

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.

Do not try to remove or twist the mouthpiece. It is fixed to your Budesonide Turbohaler and
must not be taken off.

By reporting side effects you can help provide more information on the safety of this medicine.

Do not use your Budesonide Turbohaler if it has been damaged or if the mouthpiece has come
apart from your Budesonide Turbohaler.




5.

Cleaning your Budesonide 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 Budesonide 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 Budesonide Turbohaler.



6.

Note:
• The brown base will still twist and ‘click’ even when your
Budesonide Turbohaler is empty.
• The sound that you hear as you shake your Budesonide
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 Budesonide Turbohaler.
• If you load your Budesonide Turbohaler more than once
by mistake before taking your dose, you will still only
receive one dose.

HOW TO STORE BUDESONIDE TURBOHALER

Keep out of the sight and reach of children.
Do not use your Budesonide Turbohaler after the expiry date printed on the carton or label.
The expiry date refers to the last day of that month.
Do not store above 30°C.
If your doctor tells you to stop using Budesonide Turbohaler, please take it back to the
pharmacist for safe disposal. Only keep the product if your doctor tells you to.
If your medicine appears to be discoloured or show any other signs of deterioration, please
return it to your pharmacist who will advise you further.
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.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Budesonide Turbohaler contains

The active substance is budesonide. There are no other ingredients.

What Budesonide Turbohaler looks like and contents of the pack

Budesonide Turbohaler is one breath-actuated metered dose powder inhaler with a white plastic
body and cover and a light brown turning grip. On the base of the turning grip ‘Budesonide 100’
is embossed and a Braille code. The inhaler comprises of a mouthpiece, a dosing mechanism, an
indicator window and a substance store containing white powder for inhalation.
Budesonide Turbohaler contains 200 actuations.

If you use more Budesonide 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 Budesonide Turbohaler than you should, contact your doctor or pharmacist for
advice.

Each metered dose contains 100 micrograms of budesonide.

Manufacturer

Budesonide Turbohaler is manufactured by AstraZeneca AB., S–151 85 Södertälje, Sweden.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.

If you forget to use Budesonide 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.

Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster, DN3 1QR.

If you stop using Budesonide Turbohaler

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

PL No: 08929/0551

POM

Leaflet revision and issue date: 02.06.16

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

Turbohaler® is a registered trademarks of the AstraZeneca group of companies.

4.

To request a copy of this leaflet in Braille, large print or audio, please call 01302 365000 and
ask for the Regulatory Department.

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 Turbohaler and
talk to your doctor immediately:




Please be ready to give the following information:
Product name:
Budesonide Turbohaler 100
Reference number:
08929/0551

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 Budesonide Turbohaler.
Mild sore throat, coughing and a hoarse voice.

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






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).

Page 2 of 2

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