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SALBUTAMOL 5MG/2.5ML NEBULISER SOLUTION

Active substance(s): SALBUTAMOL SULFATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Salbutamol 2.5mg/2.5ml and 5mg/2.5ml Nebuliser Solutions
(Salbutamol)
Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Salbutamol Nebuliser Solution is and what it is used for
2. Before you take Salbutamol Nebuliser Solution
3. How to take Salbutamol Nebuliser Solution
4. Possible side effects
5. How to store Salbutamol Nebuliser Solution
6. Further information
1 W
 HAT SALBUTAMOL NEBULISER SOLUTION IS AND WHAT IT
IS USED FOR
Salbutamol belongs to a group of medicines called bronchodilators which help
to open up the air passages in your lungs so that you can breathe more easily.
Salbutamol Nebuliser Solution helps to make breathing easier in patients
who have long-standing breathing difficulties. It is also given to treat
severe attacks of asthma.
2 BEFORE YOU TAKE SALBUTAMOL NEBULISER SOLUTION
Do not take Salbutamol Nebuliser Solution
• If you are allergic (hypersensitive) to salbutamol
• If you are allergic to any of the other ingredients (see section 6 Further
Information)
Some forms of Salbutamol are used to help control premature labour.
Salbutamol Nebuliser Solution is not to be used for this purpose.
Take special care with Salbutamol Nebuliser Solution
Talk to your doctor if any of the following apply to you:
• if you have diabetes
• if you have a heart condition or have recently had a heart attack
• if you have high blood pressure
• if you have an overactive thyroid gland
• if you have a history of heart disease, irregular heartbeat/rhythm
including a very fast pulse or angina
• if you have an aneurysm (a widening of the wall of a blood vessel)
• if you suffer from glaucoma (excessive pressure inside your eyes)
• if you have ever been told that you suffer from pheochromocytoma. This
is a rare tumour which produces chemicals that can cause restlessness,
high blood pressure, and your heart to beat faster.
Taking other medicines
Tell your doctor if you are taking any of the following as they may interact
with Salbutamol Nebuliser Solution:
• steroids including prednisolone
• medicines called xanthines such as theophylline
• medicines called beta blockers, as these can reduce the effectiveness of
your medicine
• diuretic medicines (commonly known as “water tablets” including nonsparing potassium diuretics such as furosemide and indapamide)
• digoxin, which is used in the treatment of heart failure
• tricyclic antidepressants (for depression)
• ipratropium bromide (for asthma)
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant, think you are pregnant or are breast-feeding, you should
not use Salbutamol Nebuliser Solution unless your doctor tells you to.
If you become pregnant whilst taking this medicine you should tell your
doctor as soon as possible.

Driving and using machines
Salbutamol Nebuliser Solution has no known effects on the ability to drive
and use machines.
3 HOW TO TAKE SALBUTAMOL NEBULISER SOLUTION
Always use Salbutamol Nebuliser Solution exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are not sure.
Your doctor may tell you to use your nebuliser at regular times every day or
only when you are wheezy or short of breath. Allow 3-6 hours between
doses. You should always follow your doctor’s instructions.
Adults and adolescents aged 12 years and over
• the usual starting dose is 2.5mg up to four times daily.
Your doctor may increase this to 5mg up to four times daily.
Children aged 4 to 11 years
• the usual dose is 2.5mg to 5mg up to four times a day.
Other pharmaceutical forms may be available that are more appropriate
for children under 4 years old. The effect of Salbutamol Nebuliser Solution
in infants under 18 months is uncertain. Please speak to your doctor for
further information.
General instructions:
Your medicine should be used with a power operated nebuliser. The “mist”
produced is then inhaled through a face mask or mouthpiece. Do not let
the solution or the mist produced by the nebuliser get in your eyes.
1

DETACH
Instructions for use:
HERE
1. P
 repare your nebuliser following the
manufacturer’s instructions and/or the dosing
instructions given by your doctor.
2. T ake a strip of ampoules from the foil sachet.
Remove one or two ampoules (depending on
your dose) [Diagram 1] and put the rest back
in the foil sachet and replace the foil sachet
Diagram 1
in the carton. Never use an ampoule that has
2
been opened already or if the solution is
discoloured.
3. H
 old the ampoule upright and open it by
twisting off the top. [Diagram 2].
4. U
 nless otherwise instructed by your doctor,
squeeze all of the liquid from the plastic
ampoule into the nebuliser chamber.
Diagram 2
5. Throw away the empty plastic ampoule.
6. If your doctor has told you to dilute the solution, this should be carried
out using ONLY sterile sodium chloride 0.9% solution. Use the amount
which your doctor has told you to use.
7. T urn on the nebuliser and breathe in the “mist” calmly and deeply using
a face mask or mouthpiece. If you are using a face mask, make sure it is
fitted correctly. Protect your eyes from the mist produced as it can cause
pain or discomfort if it gets into them. This is especially important if you
suffer from glaucoma.
8. T he length of time it takes your nebuliser to turn your medicine into a
mist will depend on the type of equipment you use. You will know when
your treatment is complete because the fine mist will stop coming out of
your mask or mouthpiece.
9. Y ou must wash your nebuliser, face mask and/or mouthpiece in warm
soapy water and rinse well after each use.

Salbutamol 2.5mg/2.5ml & 5mg/2.5ml PIL - UK
item no: AAAI7544

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origination date: 11.02.16

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originated by: S.Anson
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revision date: 10.03.16

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supplier: Laboratoire Unither

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In most people, Salbutamol Nebuliser Solution will start to give relief from
wheezing and chest tightness within about 5 minutes and the effects
should last for about 4-6 hours. After using your nebuliser a few times you
will know how long the effects normally last for you.

Very rare side effects (probably affecting less than 1 person in 10,000):
• hyperexcitability
• swelling of the
• skin rashes
• sleep disturbances face, lips, eyes and • feeling faint and
throat
collapsing
• hallucinations

Contact your doctor immediately if:
•Y
 ou are not getting relief from your current dose or you are
having to take more inhalations
• Your breathing is not improving or is getting worse
•Y
 our chest feels tight
These are signs that your condition is not being controlled and you
may need different or additional treatment.

Although it is not known exactly how often this happens, some people may
occasionally experience chest pain (due to heart problems such as angina).
Tell your doctor/midwife if you develop these symptoms whilst receiving
treatment with salbutamol, but do not stop using this medicine unless told to do
so.

Your doctor may also prescribe a second type of nebuliser solution to
use at the same time as this medicine. Follow your doctor’s advice on how
to use the nebuliser properly. If you are in any doubt, ask your doctor.
If you use more Salbutamol Nebuliser Solution than you should you
may feel unwell and overtired, shaky, dizzy, have chest pains and feel that
your heart is beating faster than usual. Call your doctor immediately or go
to the nearest hospital casualty department. If you feel shaky you should
not drive. Take this leaflet or an ampoule with you so the hospital will know
what you have taken.
If you forget to use Salbutamol Nebuliser Solution, take the next dose
when it is due or before you become wheezy. Do not take a double dose to
make up for the one you missed.
If you stop using Salbutamol Nebuliser Solution this may make your
condition worse. Do not stop taking your medicine unless your doctor tells
you to do so.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.
4 POSSIBLE SIDE EFFECTS
Like all medicines, Salbutamol Nebuliser Solution 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, lips or throat, or a rash or itching especially affecting the
whole body.
Rarely, inhaled medicines such as salbutamol can cause acute
wheezing and/or shortness of breath. If this occurs, stop using your
medicine immediately and seek medical help.
The following side effects have also been reported:
Common side effects (probably affecting less than 1 person in 10):
• restlessness
• sweating
• headache
• tremor (shaking)
• dizziness
• mouth and throat
irritation
• nausea
• rash
• taste alteration
• hives
• burning sensation
(bad, unpleasant or • itching
of the tongue
unusual taste)
• redness of the skin
Rare side effects (probably affecting less than 1 person in 1,000):
• an awareness of your heartbeat
• hyperactive behaviour
• increase in heart rate
• muscle cramp
• an irregular heart rhythm or
• increased blood flow or pain in
chest pain
the arms and legs
Sometimes this medicine can cause a lowering of potassium levels in the
blood which can make you feel generally unwell and over-tired. You may also
experience frequent urination (passing water). If you notice any of these
effects, tell your doctor who may arrange for you to have a blood test.

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 Yellow Card Scheme
Website: 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 SALBUTAMOL NEBULISER SOLUTION
Keep out of the reach and sight of children.
Store the product below 25°C. Store in the original package.
Do not use Salbutamol Nebuliser Solution after the expiry date which is
stated on the carton and ampoule after Exp. The expiry date refers to the
last day of that month.
Open one foil pack at a time and use all 10 ampoules before opening the
next foil pack. Always replace the foil pack in the carton after use. When
first opening a foil pack, note the date of opening and add 6 months to
this date which will be the “Do not use after” date. Unused ampoules
remaining in an opened foil pack after the “Do not use after” date should
not be used, but should be returned to your pharmacist.
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 FURTHER INFORMATION
What Salbutamol Nebuliser Solution contains
• T he active substance is Salbutamol 2.5mg/2.5ml or 5mg/2.5ml
(as salbutamol sulfate).
• T he other ingredients are sodium chloride, water for injections and
sulfuric acid.
What Salbutamol Nebuliser Solution looks like and contents of
the pack
Salbutamol Nebuliser Solutions are clear, colourless to pale yellow
solutions in clear plastic ampoules.
Salbutamol Nebuliser Solutions are packed in cartons containing 20
or 60 ampoules in foil wrapped strips of 10.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Breath Limited,
Whiddon Valley,
Barnstaple,
North Devon,
EX32 8NS,
United Kingdom.
Manufacturer:
Laboratoire Unither
Espace lndustriel Nord
151 rue André Durouchez- CS 28028
80084 AMIENS CEDEX 2
France.
This leaflet was last revised in February 2016.

Salbutamol 2.5mg/2.5ml & 5mg/2.5ml PIL - UK
item no: AAAI7544

dimensions: 200 x 280

print proof no: 2

pharmacode:

origination date: 11.02.16

min pt size: 9

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 10.03.16

Technical Approval

revised by: S.Anson

date sent: 11.02.16

supplier: Laboratoire Unither

technically app. date: 16.02.16

Non Printing Colours
1.
2.
3.

AAAI7544

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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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