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SALBUTAMOL 2.5MG INHALATION SOLUTION

Active substance(s): SALBUTAMOL SULPHATE

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12 mm

12 mm

Salbutamol Inhalation Solution
2.5mg and 5.0mg

(Salbutamol Sulphate 2.5mg/2.5ml and
5.0mg/2.5ml)
Read all of this leaflet carefully before you start using 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 Inhalation Solution is and what it is used for
2. Before you use Salbutamol Inhalation Solution
3. How to use Salbutamol Inhalation Solution
4. Possible side effects
5. How to store Salbutamol Inhalation Solution
6. Further information

1. WHAT SALBUTAMOL INHALATION SOLUTION IS
AND WHAT IT IS USED FOR
The active substance in Salbutamol Inhalation Solution is called
salbutamol sulphate. Salbutamol sulphate belongs to a group of
medicines known as bronchodilators. It is used to treat asthma
and breathing difficulties associated with wheezing, coughing,
chest tightness or shortness of breath. It works by opening up the
air passages in your lungs so that you can breathe more easily.
Salbutamol Inhalation Solution is usually prescribed to people
who suffer severe cases of these conditions where alternative
treatment has not proved sufficient. It is also given to treat severe
attacks of asthma.

2. BEFORE YOU USE SALBUTAMOL INHALATION
SOLUTION

Do not use Salbutamol Inhalation Solution
- if you are allergic (hypersensitive) to salbutamol sulphate or
any of the other ingredients of Salbutamol Inhalation Solution
- if you are pregnant and go into premature labour
- if you have a history of miscarriages
Talk to your doctor before using this product if this applies to you.
Take special care with Salbutamol Inhalation Solution
- if you are pregnant
- if there is a chance you might become pregnant
- if you are breast-feeding
- if you suffer from an overactive thyroid gland
- if you suffer from heart problems, irregular heart rhythm, high
blood pressure or angina
- if you suffer from diabetes (you may need some additional
blood sugar tests)
If any of the above apply to you, it is important that you tell your
doctor or pharmacist before using Salbutamol Inhalation Solution
and they will decide what to do. It may still be safe for you to use
Salbutamol Inhalation Solution.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have
recently taken, any of the following medicines:
Digoxin (used to treat heart failure and other heart problems);
this medicine may not work as well and your doctor may need to
change your dose.

12 mm

12 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

Beta blockers such as propranolol (used to treat high blood
pressure); taking beta blockers and salbutamol together may
make these medicines less effective and they may not work
properly.
Taking any of the following medicines with Salbutamol Inhalation
Solution can result in low levels of potassium in your blood, which
can make your muscles feel weak or give you muscle aches or
cramps:
• Diuretics (water tablets), including acetazolamide (used in the
treatment of glaucoma, epilepsy and excess water retention)
and other diuretics (used to treat high blood pressure).
• Theophylline or corticosteroids (used in the treatment of
asthma).
Your doctor may therefore ask you to have a blood test from
time to time to check your potassium levels.
If you are using another nebuliser solution e.g. ipratropium
bromide, at the same time as Salbutamol Inhalation Solution, ask
your doctor or pharmacist to advise you on how to make sure
that the mist does not get into your eyes.
Please also tell your doctor or pharmacist if you are taking, or
have recently taken, any other medicines, including medicines
obtained without a prescription.
Using Salbutamol Inhalation Solution with food and drink
Food and drink have no known influence.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before using
Salbutamol Inhalation Solution if you are pregnant, thinking of
becoming pregnant or breast-feeding.
Driving and using machines
Salbutamol Inhalation Solution has no known influence on your
ability to drive and use machines.

If your treatment is less effective than usual
If your treatment is less effective than usual or the effect does not
last as long as usual, do not attempt to exceed your prescribed
dose. You should contact your doctor immediately to discuss the
situation.
If you use more Salbutamol Inhalation Solution than you should
If you have taken a slightly larger dose than recommended, you
may feel short of breath, develop an increased heart rate, feel
shaky or feel muscle weakness and cramps. This usually wears off
after a few hours. However, if you have taken a much larger
dose, you should contact your nearest casualty department or
tell your doctor immediately. Take this leaflet and any remaining
medicine with you.
If you forget to use Salbutamol Inhalation Solution
If you forget an inhalation, take it when you remember. The next
dose should be after your normal interval between doses. Do not
take a double dose to make up for a forgotten dose.
If you stop using Salbutamol Inhalation Solution
Your doctor will advise you when to stop using Salbutamol
Inhalation Solution. Follow your doctor’s instructions.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

3. HOW TO USE SALBUTAMOL INHALATION SOLUTION

4. POSSIBLE SIDE EFFECTS

Always use Salbutamol Inhalation Solution exactly as your doctor
has told you. You should check with your doctor or pharmacist if
you are not sure.
First use of Salbutamol Inhalation Solution
The first time you use Salbutamol Inhalation Solution should be
under close medical supervision.
Adults (including the elderly and children over 12 years)
The usual dose is 2.5mg to 5mg up to four times daily. However,
your doctor may increase the dose to 10mg up to four times daily
if necessary. In these severe cases, you will require strict medical
supervision in hospital.
Children (aged 4 to 11 years)
The usual dose is 2.5mg to 5mg up to four times daily.
Salbutamol Inhalation Solution must only be administered by
inhalation from a suitable nebuliser. (This product should not be
injected or swallowed). A nebuliser is a machine which turns the
nebuliser solution into a fine spray which you can then inhale,
usually through a mask.
Preparing the nebuliser and Salbutamol Inhalation Solution:
1. Make sure that you are fully familiar with the operation of your
nebuliser. Your doctor will instruct you in how to correctly use
the nebuliser and Salbutamol Inhalation Solution. You should
also carefully read the instructions provided with the nebuliser.
2. Prepare the nebuliser for use.
3. Separate an ampoule from the strip by carefully pulling and
twisting (Figure 1). Never use one that is already open.
4. Hold the ampoule upright and twist off the tab (Figure 2). Use
the contents of the ampoule immediately after opening.
5. Squeeze all the ampoule contents into the nebuliser reservoir
(Figure 3). Salbutamol Inhalation Solution should be used
undiluted. However, if dilution is necessary (e.g. if a prolonged
delivery time is required), this should be carried out using only
sterile normal saline solution as instructed by your doctor.
6. Assemble the nebuliser and use it as instructed by your doctor.
Care should be taken to ensure that the nebuliser mist (or the
solution) does not enter your eyes.
7. After nebulisation throw away any solution remaining in the
nebuliser and clean the nebuliser as instructed.

Like all medicines, Salbutamol Inhalation Solution can cause side
effects, although not everybody gets them.
If you experience any of the following very rare side effects
(affecting fewer than 1 in 10,000 people) whilst taking your
medicine, contact your doctor immediately and stop taking this
medicine:
• Severe allergic reaction. You may have a red lumpy skin rash,
difficulty breathing, swelling of face, lips or eyelids,
unexplained high temperature (fever) and feel faint. If the
swelling affects your throat and makes breathing and
swallowing difficult, go to hospital straight away.
• Your breathlessness gets worse.
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 if you develop these
symptoms whilst receiving treatment with salbutamol, but do not
stop using this medicine unless told to do so.
The following side effects have also been reported:
Common side effects (affecting up to 1 in 10 people)
• Headache
• Increase in heart rate
• Trembling
Uncommon side effects (affecting fewer than 1 in 100 people)
• Mouth and throat irritation
• Muscle cramps
• Pounding of the heart
Rare side effects (affecting fewer than 1 in 1000 people)
• Flushing of the skin
• Decrease in the body’s potassium level (which may make your
muscles feel weak, or you may experience muscle aches
and/or cramps)
Very rare side effects (affecting fewer than 1 in 10,000 people)
• Uneven heartbeat, or an extra heartbeat
In children, the following very rare side effects have been
reported:
• Sleep and behaviour disturbances
• Over excitability

(continued overleaf)

Fig 1.
Separation

Fig 2.
Opening

Fig 3.
Squeezing into
nebuliser reservoir

Other side effects (frequency unknown)
• A condition called lactic acidosis which may make you
hyperventilate and feel short of breath
• A condition called acute angle-closure glaucoma which may
cause sudden eye pain, redness of the eyes and blurred vision
If any of the side effects above get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.

5. HOW TO STORE SALBUTAMOL INHALATION SOLUTION
Keep out of the reach and sight of children.
Do not use Salbutamol Inhalation Solution after the expiry date
which is stated on the carton, foil bag and plastic ampoules. The
expiry date refers to the last day of that month.
Store the product below 25°C. Keep the Inhalation Solution
ampoules in the foil bag within the carton in order to protect the
product from light and moisture.
Do not use Salbutamol Inhalation Solution if you notice that the
packaging or any of the plastic ampoules are damaged, or if the
solution in the plastic ampoules is no longer clear and colourless
or slightly yellow.
Do not keep or use an ampoule which has been opened
previously – throw it away.
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 Inhalation Solution contains
The active substance is called salbutamol sulphate. Each 2.5ml
ampoule contains either 2.5mg or 5.0mg of salbutamol as
salbutamol sulphate.
The other ingredients in the Inhalation Solution are: sodium
chloride, dilute sulphuric acid, sodium hydroxide solution and
water for injections.
What Salbutamol Inhalation Solution looks like and the contents
of the pack
Each carton of Salbutamol Inhalation Solution contains 20 plastic
ampoules packed in strips of 10 ampoules. Each strip is
individually wrapped in a foil bag. Each ampoule contains 2.5ml
of a clear and colourless or slightly yellow solution for use only
through a nebuliser.
Marketing Authorisation Holder Focus Pharmaceuticals
Limited, Unit 5, Faraday Court, First Avenue, Centrum 100,
Burton upon Trent, Staffordshire, DE14 2WX
Manufacturer Almac Pharma Services Limited, Almac House, 20
Seagoe Industrial Estate, Craigavon, BT63 5QD, UK
For any information about this medicinal product, please
contact the Marketing Authorisation Holder, details provided
above.

For information in large print, audio CD
or Braille, please telephone 00 44 (0)1283 495 280
or email medinfo@focuspharma.co.uk
This leaflet was last revised in 12/2012.

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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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