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BUDESONIDE 0.5MG NEBULISER SUSPENSION

Active substance(s): BUDESONIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Budesonide 0.5mg and 1mg Nebuliser Suspension
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 antibiotic medicines, erythromycin and
clarithromycin
• Other medicines which help you to breathe
• Oestrogens and contraceptive steroids

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

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Pregnancy and breast-feeding
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 taking
this medicine. If you become pregnant whilst taking
this medicine you should tell your doctor as soon as
possible.

1. What Budesonide Nebuliser Suspension is
and what it is used for
Budesonide belongs to a group of steroids called
glucocorticoids which can be used to reduce or
prevent inflammatory reactions (inflammation) in the
lungs.

Driving and using machines
Inhaled budesonide has no or negligible influence on
the ability to drive and use machines.
3. How to use Budesonide Nebuliser
Suspension

Your medicine is used for the treatment of asthma. It
is used in patients where other types of inhaler, such
as a pressurised inhaler or an inhaler containing a dry
powder are unsatisfactory or inappropriate.

Always use this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.

This medicine may also be used for the treatment
in hospitals of very serious cases of pseudocroup
(a disease of the throat that may cause difficulty in
breathing).

Your doctor will advise you of the correct dose which
will depend on how bad your asthma is.

2. What you need to know before you use
Budesonide Nebuliser Suspension
Do not use Budesonide Nebuliser Suspension:
• If you are allergic to budesonide or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions:
Talk to your doctor or pharmacist before using
Budesonide Nebuliser Suspension if any of the
following apply to you:
• If you have or have had tuberculosis
• If you have or have had a liver disease or problems
with your liver
• If you have a fungal, viral or other infection of the
airways, e.g. a cold or chest infection.
If you are switching from corticosteroid tablets
(such as prednisolone) to Budesonide Nebuliser
Suspension, you may feel generally unwell during the
switch. It is also possible that you may get symptoms
that were suppressed by the corticosteroid tablets,
such as allergic rhinitis (itchy, blocked or runny nose),
eczema (dry, itchy skin), muscle and joint pain. You
should talk to your doctor if this happens to you.
Budesonide Nebuliser Suspension is not suitable for
use in an attack of acute shortness of breath. The
sudden attack of breathlessness should be treated
with a short-acting bronchodilator agent.

Asthma
You may find that your asthma improves within 3 days
but it can take between 2-4 weeks before the full effect
is achieved. It is important that you keep taking your
medicine as instructed by your doctor even if you feel
better.
Adults (including the elderly) and adolescents of 12
years and over:
The usual dose is 0.5-2.0mg of budesonide daily. This
dose will normally be taken on two separate occasions
during the day although if your asthma is stable and
not severe your doctor may advise you to take this
medicine once a day. Your doctor will tell you how and
when it is best to take your medicine and you should
always follow their instructions.
Infants and children (aged 6 months to 11 years):
The usual dose is 0.25-1.0mg of budesonide daily. The
doctor will advise you on how your child should take
their medicine but this will usually be on two separate
occasions during the day. However if their asthma is
stable and not severe your doctor may advise that they
should take this medicine once a day.
Pseudocroup:
The usual dose for infants and children with
pseudocroup is 2 mg. This is given as a single dose
or as two 1 mg doses separated by 30 minutes.
The treatment can be repeated every 12 hours as
necessary until improvement is seen, for a maximum
of 36 hours.

If you experience more wheezing and/or shortness of
breath immediately after using Budesonide Nebuliser
Suspension, you should immediately stop using
Budesonide Nebuliser Suspension and seek medical
advice.

Instructions for use:
Your medicine must be used with a jet nebuliser. The
“mist” produced is then inhaled through a mouthpiece
or face mask. Ultrasound nebulisers should not be
used with this medicine.

To reduce your risk of getting oral thrush (white
patches on the tongue or in the mouth), rinse your
mouth with water (spit out the water – do not swallow
it) and brush your teeth after using Budesonide
Nebuliser Suspension. Tell your doctor if you do get
oral thrush.

To take your medicine follow these steps:

Children and adolescents
In rare cases, long term treatment with budesonide
can slow down the normal growth of children and
adolescents. If your child uses this medicine for a long
time, it is normal that the doctor will want to monitor
their height on a regular basis.
Budesonide is a steroid. You should be aware that you
could fail an anti-doping test as a result of using this
medicine. You should discuss this with your doctor if
you have any concerns.
Other medicines and Budesonide Nebuliser
Suspension
Tell your doctor if you are taking any of the following as
they may interact with your medicine:
• Medicines for the treatment of a fungal infection
such as ketoconazole or itraconazole
• Medicines for the treatment of HIV called ritonavir
or saquinavir

1. Break off a single ampoule from the strip, leaving
the rest in the
1 DETACH
foil sachet
HERE
(see diagram 1)
2. Shake the
ampoule gently
3. Open the
ampoule by
twisting off
the top (see
diagram 2)
4. Squeeze all of
2
the liquid from
the ampoule into
TWIST
the nebuliser
cup. Replace
the top of the
nebuliser cup
and dispose
of the empty
ampoule
carefully
Continued overleaf

Budesonide 0,5mg and 1mg ampoules PIL - UK
item no:

AAAI1478

print proof no:

awstudio@actavis.co.uk

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approved for print/date

revision date:

Technical Approval

25.11.15
dje

Catalent

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dje

revised by:
supplier:

pharmacode:
min pt size: 8pt

origination date: 20.07.15
originated by:

dimensions: 120x315

colours/plates:

date sent: 20.07.15
technically app. date*:

Non Printing Colours
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* Please note the technical approval is provided by the supplier and is valid on the date indicated.
Any technical changes madeby the supplier after approval are not the responsibility of the Artwork Studio.

5. Connect one end of the cup to the mouthpiece or
face mask and the other end to the air pump
6. Gently shake the cup once more then turn on the
nebuliser. Breathe in the “mist” calmly and deeply
using the mouthpiece or face mask
7. When no more mist comes out of the mouthpiece
or face mask, your treatment is complete
8. Rinse your mouth with water (spit out the water
– do not swallow it) and brush your teeth. If you
have used a face mask, you should also wash your
face well. It is important to do this as it can reduce
the risk of some side effects associated with this
medicine
9. You should clean the nebuliser after each use.
Wash the nebuliser container and mouthpiece or
face mask in warm water using a mild detergent in
accordance with the manufacturer’s instructions.
The nebuliser should then be rinsed well and dried
by connecting the nebuliser container to the air
pump.

Suppression of your adrenal gland (a small gland next
to the kidney) can also occur. The major symptoms of
adrenal suppression include headaches, tiredness,
feeling and being sick, weight loss, stomach pain and
lack of appetite.
Feeling restless, nervous, over-excited, irritable or
depressed (these effects are more likely to occur in
children)
Very rare: may affect up to 1 in 10,000 people
Decrease in bone mineral density (thinning of the
bones).
Not known: frequency cannot be estimated from the
available data
Cataracts (clouding of the lens in the eye), glaucoma
(increased pressure in the eye), aggression, increased
motor activity (difficulty to stay still), sleeping problems
or feeling anxious.
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

It is important that you always follow the
manufacturer’s instructions that come with the
nebuliser. If you are not sure about how to use the
nebuliser, talk to your doctor or pharmacist.
Your doctor may also prescribe the following:
• Your doctor may consider adding steroid tablets to
your treatment during periods of stress (e.g. if you
have an infection), or if you have been taking a high
dose of an inhaled steroid for a long time, or before
an operation.
• If you have been taking steroid tablets for your
asthma, your doctor may reduce the number
of tablets that you take once you start to use
Budesonide Nebuliser Suspension. You might
experience some symptoms as a result of this
including a stuffy or runny nose, a lack of energy,
depression, eczema (a type of skin rash) and joint
and/or muscle pain. If any of these symptoms
bother you or persist, please contact your doctor.
• Your doctor may ask you to mix this medicine with
solutions containing other active substances which
work on the respiratory system such as salbutamol,
terbutaline, sodium cromoglicate and ipratropium
bromide. If so follow their instructions carefully.
You must not mix this medicine unless specifically
instructed by your doctor.

By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Budesonide Nebuliser
Suspension
Keep this medicine out of the sight and reach of
children.
• Do not use this medicine after the expiry date
which is stated on the carton and foil sachet after
Exp. The expiry date refers to the last day of that
month
• Store the ampoules in their foil sachet and their
original carton in order to protect from light and
moisture
• Once you have opened a single ampoule it should
be used within 12 hours. After this time, the
ampoule and any remaining contents should be
thrown away
• Once a foil sachet has been opened, the ampoules
inside should be used within 3 months (it is a good
idea to mark the opening date on the foil sachet to
help you remember).

If you use more Budesonide Nebuliser Suspension
than you should
Contact your doctor or pharmacist as soon as possible.
Remember to take the pack and any remaining
ampoules with you. 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.

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

If you forget to use your Budesonide Nebuliser
Suspension
Do not take a double dose to make up for a forgotten
dose. Simply take your next dose on time.

• The active substance is budesonide
• The other ingredients are disodium edetate, sodium
chloride, polysorbate 80, citric acid, sodium citrate
and water for injection.

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

Budesonide 0.5mg Nebuliser Suspension contains
0.5mg of budesonide (0.25mg/ml) as the active
substance in each 2ml ampoule.

4. Possible side effects

6. Contents of the pack and other information
What Budesonide Nebuliser Suspension contains

Budesonide 1mg Nebuliser Suspension contains 1.0mg
of budesonide (0.5mg/ml) as the active substance in
each 2ml ampoule.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
All medicines can cause allergic reactions, although
serious allergic reactions are very rare. Tell your
doctor immediately if you get any sudden wheeziness,
difficulty in breathing, swelling of the eyelids, face or
lips, rash or itching (especially affecting your whole
body).

What Budesonide Nebuliser Suspension looks like
and contents of the pack

Rarely, inhaled drugs such as budesonide can cause
acute wheezing and/or shortness of breath. If this
occurs, stop using this medicine immediately and
seek medical advice.

The ampoules are packed in strips of 4, 5, 8, 10 or 12
inside a foil sachet which is then packed into a carton.
The cartons are available in pack sizes containing 5,
20, 24, 40 (2 x 20) or 60 ampoules. Not all pack sizes may
be marketed.

The following side effects have been reported.

Your medicine comes in the form of plastic ampoules
containing 2ml of a white to off-white suspension to be
nebulised (made into a fine mist for inhalation).

Marketing Authorisation Holder:
Breath Limited, Whiddon Valley, Barnstaple, North Devon, EX32
8NS, United Kingdom.

Common: may affect up to 1 in 10 people
Soreness and/or irritation in the mouth (including
oral thrush), hoarseness, throat irritation, difficulty in
swallowing and cough.

Manufacturer:
Qualiti (Burnley) Limited, Talbot Street, Briercliffe, Burnley,
BB10 2JY, United Kingdom

Rare: may affect up to 1 in 1,000 people
Skin reactions including itching, rash, bruising,
inflammation, redness of the skin and/or skin
eruptions, swelling, slowing of growth in children
and adolescents, hypersensitivity (an allergy to the
medicine) and bronchospasm (tightening of the
muscles in the airways resulting in wheezing), voice
problems.

This leaflet was last revised in November 2015.

AAAI1478

Budesonide 0,5mg and 1mg ampoules PIL - UK
item no:

AAAI1478

print proof no:

awstudio@actavis.co.uk

2

approved for print/date

revision date:

Technical Approval

25.11.15
dje

Catalent

1.black
2.
3.
4.
5.
6.

dje

revised by:
supplier:

pharmacode:
min pt size: 8pt

origination date: 20.07.15
originated by:

dimensions: 120x315

colours/plates:

date sent: 20.07.15
technically app. date*:

Non Printing Colours
1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated.
Any technical changes madeby the supplier after approval are not the responsibility of the Artwork Studio.

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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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