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SALBUTAMOL 2MG /ML NEBULISER SOLUTION

Active substance(s): SALBUTAMOL SULPHATE / SALBUTAMOL SULPHATE

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Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines including
medicines obtained without a prescription. It is important that you tell your doctor if you are taking the
following medicines, as they may decrease or increase the effect of Salbutamol Nebuliser Solution
and vice versa.
• are taking any other beta-adrenergic agonists (these are medicines used to treat severe asthma
and other lung conditions)
• beta blockers such as propranolol. These are not usually taken with salbutamol
• xanthine derivatives and steroids (used in other asthma treatments)
• diuretics (water tablets)
• laxatives.
Pregnancy and breast-feeding
Do not use Salbutamol Nebuliser Solution if you are in premature labour or have a threatened
miscarriage.
Do not breast-feed unless your doctor advises you to as salbutamol passes into breast milk.
The safety of salbutamol during pregnancy has not been established. Tell your doctor if you are
pregnant, likely to be pregnant or are trying to become pregnant.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
It is unlikely that Salbutamol Nebuliser Solution will affect your ability to drive or use machines.

PATIENT INFORMATION LEAFLET
SALBUTAMOL 1MG/ML AND 2MG/ML NEBULISER SOLUTION

(salbutamol sulphate)
The name of this medicine is Salbutamol 1mg/ml or 2mg/ml Nebuliser Solution, which will be referred to as
Salbutamol Nebuliser Solution throughout this leaflet.
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 your 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 gets serious, or if you notice any side effects not listed in the 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 use Salbutamol Nebuliser Solution
3. How to use Salbutamol Nebuliser Solution
4. Possible side effects
5. How to store Salbutamol Nebuliser Solution
6. Further Information

2. BEFORE YOU USE SALBUTAMOL NEBULISER SOLUTION
Do not use Salbutamol Nebuliser Solution if you are:
• allergic (hypersensitive) to salbutamol, salbutamol sulphate, or any of the other ingredients in
Salbutamol Nebuliser Solution (these are listed in section 6, Further Information)
• in premature labour or have a threatened miscarriage
Take special care with Salbutamol Nebuliser Solution if you:
• suffer from severe or unstable asthma:
• your doctor should monitor you frequently, and you should be treated with additional drugs and not just
salbutamol or other bronchiodilating (‘reliever’) drugs
• potentially serious low levels of potassium in the blood (hypokalaemia) have been reported when
salbutamol is given, particularly when it is taken with other drugs such as xanthine derivatives and
steroids (used in other asthma treatments), diuretics (water tablets) and laxatives
• use another nebuliser solution such as ipratropium bromide, you need to make sure the mist doesn’t get in
your eyes as it can aggrevate glaucoma (a potentially serious and painful condition of the eyes)
• are being treated for an overactive thyroid, salbutamol may interfere with your thyroid medication
• are a diabetic
• if you have existing heart disease such as angina or heart failure you must seek immediate medical
advice especially if you experience any chest pain or other symptoms of heart disease
• if you have been taking laxatives for a long time
This solution is for inhalation only and it should not be swallowed or used for injection.
You should tell your doctor if your asthma seems to be getting worse, or if this medicine stops working.
You should not increase the dose without advice from your doctor.
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This product is for inhalation use only. It should not be injected or swallowed.
Your doctor may tell you to use your nebuliser at a regular time each day or may tell you only to use it
when you are very wheezy or short of breath.
Always use the nebuliser exactly as your doctor or asthma nurse has told you and use the
recommended dose. Make sure that you know how to use your nebuliser properly. You should check
with your doctor or pharmacist if you are not sure.
Adults, Elderly and Children aged over 18 months
The usual dose is 2.5mg to 5mg salbutamol used up to 4 times a day, as described in “How to use
your Nebuliser”.
For severe attacks in hospital a higher dose may be given.
Paediatric Population
Children aged 12 years and over: Dose as per adult population.
Children aged 4 to 11 years: 2.5mg to 5mg up to four times a day.
Other pharmaceutical forms may be more appropriate for administration in children under
4 years old.
Clinical efficacy of nebulised salbutamol in infants under 18 months is uncertain. As transient
hypoxaemia may occur, supplemental oxygen therapy should be considered.
Read and follow the instructions on the pharmacist’s label. Do not take more doses than your
doctor has prescribed or use your nebuliser more often then you are told. It is very important
that you inhale each dose exactly as instructed.
If you need to take more inhalations than usual, or you find the dose is becoming less effective, or
your asthma is getting worse tell your doctor or asthma nurse immediately as you may need other
medicines.
If you need to go into hospital take your Salbutamol Nebuliser with you.
How to use your Salbutamol Nebuliser:
1.
2.
3.

Salbutamol Nebuliser Solution is a liquid which, when used in a nebulising device, is converted into a mist
which can then be inhaled. It contains the active ingredient salbutamol (salbutamol sulphate) which belongs
to a group of medicines called bronchodialators. These are used to make breathing easier by relaxing and
opening up the airways in the lungs.
Salbutamol is used for the management of the symptoms of severe wheeziness or other chest conditions
(such as asthma or bronchitis) particularly when no other treatment seem to work.
They are also used to treat severe attacks of asthma.

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3. HOW TO USE SALBUTAMOL NEBULISER SOLUTION

1. WHAT SALBUTAMOL NEBULISER SOLUTION IS AND WHAT IT IS USED FOR

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PACKAGING DEVELOPMENT
Product Name : Salbutamol PIL
Cordinator : Kanchan

Item Code : D970 D
Artist : Atul

Item : PIL

Date : 20-09-12 (25-03-13)
Software : Illustrator CS5

Fonts : Convert to curve

FOR FANNIN COA ARTWORK

Colours :
Black

BLUE WOOL TEST VALUE 5-8
(LIGHT FASTENING DATA)

New Add Change

Spectro-Densitometer Delta-E reading
( E) for colour: NOT MORE THAN dE2.5

Supersedes / Reference:

Glossmeter reading
(for white surface): NOT LESS THAN 80 %

Screen : # 175

Tuck flap:

Unwinding Direction :

Font: Arial / Arial Bold

Side / Collar flap overlap:

Links :
Pharmacode: 2908_STD

Design : Folded

Material : 54 GSM JK Maplitho Paper.

Varnish :

Actual Size : 297 x 210mm

Size after Folding : 75 x 53mm

Body text : 9pt
Sub Heading : 10pt

Print repeat length :
Artwork Print Size:

actual

Main Heading : 12pt

scaled

Grain Direction : Perpendicular to Crease / Perpendicular to Pasting Flap / Parallel to length
Reference / Instructions / Remark / Braille Text Embossing:
Path : F:atul/Pawan/Fannin/Salbutamol 2mg Nebuliser Fannin COA/D970 D Salbutamol 2mg ml Nebuliser Fannin COA (Add change) PIL.ai
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Artist

Cordinator

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File Copied by:

file loaded in BCT HO

Pharma Code
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Date:

NOTE TO THE PRINTER :

Return approved artwork alongwith the proof.

The proof must be verified against the approved hardcopy, should be certified and signed by an
authorised QA person. The unsigned proof will not be accepted.

Colour scheme must be as approved by packaging development co-ordinator.

Any deviation must be brought to the notice of packaging development co-ordinator immediately.

For any clarification, please contact packaging development co-ordinator immediately.

4. POSSIBLE SIDE EFFECTS
Like all medicines, salbutamol can cause side effects, although not everybody gets them.
If after using this medicine you immediately experience a worsening of your asthma symptoms or your
wheezing gets worse then stop using this medicine and contact your doctor immediately.
If you get any of the following very rare side effects after taking this medicine you should contact
your doctor or hospital emergency department immediately:
• any sudden wheeziness, difficulty in breathing or dizziness
• swelling of the eyelids, face, lips or throat
• itching, raised bumps on the skin
• collapse i.e. fainting
The following side effects have also been reported:
Common (seen in less than 1 in 10 people and more than 1 in 100 people)
• tremor
• headaches
• rapid heartbeat
Uncommon (seen in less than 1 in 100 people and more than 1 in 1000 people)
• palpitations
• mouth and throat irritation
• muscle cramps
Rare (seen in less than 1 in 1000 people and more than 1 in 10,000 people)
• low blood potassium level in blood (feeling weak or may cause heart problems to people taking
other drugs)
• flushing
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Very rare (occurring in less than 1 in 10,000 people)
• hyperactivity in children
• low blood pressure
• restlessness or excitability
• irregular or rapid heartbeat
The following side effects can also happen but the frequency of these is unknown:
• chest pain, especially if you have existing heart disease. See your doctor if this happens
• build up of lactic acid in your blood, your doctor will know this from a blood test. This may cause
stomach pain, hyperventilation, shortness of breath, cold feet and hands, irregular heartbeat and
thirst.
Patients who are also taking anticolinergic medicines, (such as ipratropium) mixed with salbutamol in
their nebulizers, may suffer from an eye condition called glaucoma (an increased pressure in the
eyes), which can cause severe pain in the eye and damage to your vision. It is important to avoid
getting the nebuliser mist in your eyes. This can be avoided by using a mouthpiece instead of a face
mask or using protective eye goggles to prevent the mist from getting in the eyes if a face mask is
preferred.
If any of these side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE SALBUTAMOL NEBULISER SOLUTION
Keep out of the reach and sight of children.
Do not take this medicine after the expiry date (Exp.) stated. The expiry date refers to the last day of
that month.
Store in the original package to protect the ampoules from light. Always return the unopened
ampoules to the foil over-wrap and place back into the box after use to protect from the light. Use the
ampoules within 3 months of first opening.
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:
The active ingredient is salbutamol sulphate. Each nebule contains 2.5mg or 5mg of salbutamol
sulphate in 2.5mls of liquid
The other ingredients are sodium chloride, sulphuric acid (as a pH adjuster) and water.
What Salbutamol Nebuliser Solution looks like and the contents of the pack:
Salbutamol Nebuliser Solution is a liquid which when used in a nebulising device is converted into a
mist to be inhaled.
The solutions are available in two strengths, 1mg per ml or 2mg per ml. Each pack contains 20
ampoules, and each ampoule contains 2.5ml of solution.
Salbutamol Nebuliser Solution comes in plastic polythene ampoules in strips of 5, with over wrap. Your
medicine is available in boxes of 20 ampoules.
Marketing Authorisation Holder:
Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough,
Northamptonshire, NN8 6GT, UK
Manufacturer responsible for batch release:
Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough,
Northamptonshire, NN8 6GT, UK
This leaflet was last approved in March 2013.
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1. Set up the nebuliser and get it ready for filling.
2. Open the foil wrapping by cutting along the side. Only open when you are ready to use the first
ampoule.
3. Take the ampoule strip out of the wrapping and remove the end ampoule by twisting
downwards and away from you. Replace the unused ampoules back into the foil over-wrap
and place them back into their box.
4. To open the ampoule. Hold the body and top of the ampoule securely and then twist the
body.
5. Carefully place the open end of the ampoule into the nebuliser container and empty the contents
by squeezing slowly.
6. Set up and use the nebuliser as you have been shown.
7. Ensure that any remaining solution left in your nebuliser after use is discarded and your nebuliser
is cleaned as recommended.
8. Nebulisers should always be used in a well ventilated room.
Salbutamol Nebuliser Solution is intended to be used undiluted.
If you have been told by your doctor to dilute Salbutamol Nebuliser Solution, empty the contents of the
ampoule into the nebuliser container, add the amount of sterile normal saline that your doctor has told
you to and shake gently to mix before using.
If you use more Salbutamol Nebuliser Solution than you should
If you have accidentally taken more than the prescribed dose, contact your nearest hospital casualty
department or tell your doctor or pharmacist immediately. Remember to take your nebuliser with you.
You may develop a condition where you have low levels of potassium in your blood if you overdose
with salbutamol
If you forget to use your Salbutamol Nebuliser
If you miss a dose do not worry. Just inhale the next dose when it is due or before if you become
wheezy. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

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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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