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Active substance(s): SALBUTAMOL SULPHATE

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AirSalb CFC-free inhaler 100 microgram/dose

Salbutamol sulphate


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.

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


What AirSalb is and what it is
used for

The name of your medicine is AirSalb
CFC-free inhaler 100 microgram/dose. It will
be referred to as AirSalb throughout this leaflet.

AirSalb contains the active ingredient
salbutamol. AirSalb is used to treat breathing
difficulties caused by the following diseases:
• asthma
• chronic obstructive pulmonary disease
(COPD) including
- chronic bronchitis
- emphysema
AirSalb is additionally used to prevent
asthma symptoms caused by:
• exercise or
• triggers, such as house dust, pollen, cats,
dogs and cigarette smoke

AirSalb expands the airways, allowing the
air to flow more freely.
AirSalb should primarily be used to relieve
symptoms rather than as a regular treatment.
AirSalb is indicated for adults, adolescent
and children from 4 to 11 years.


What you need to know before
you take AirSalb

Do not use AirSalb
• if you are allergic to salbutamol or any of
the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Talk to your doctor before using AirSalb if
any of the following conditions apply to you:
• severe heart disease
• a history of heart disease, irregular heart
rhythm or angina
• severe and untreated high blood pressure
• an overactive thyroid gland
• too little potassium in the blood
• enlarged artery (aneurysm)
• diabetes (extra checks of blood glucose
levels are recommended when beginning
treatment with AirSalb)
• tumour of the adrenal medulla
(pheochromocytoma). The adrenal medulla
are two glands situated above the kidneys.
Other medicines and AirSalb
Tell your doctor or pharmacist if you are
using, have recently used or might use any
other medicines.

The following medicines can influence or
be influenced by AirSalb:
• heart and vascular medicines which can
narrow the airways and containing active
substances ending in “-ol” such as
propranolol (betablockers). This may
cause spasms in the lung airways.
• certain medicines to treat depression:
- monoamine oxidase inhibitors (e.g.
- tricyclic antidepressants, such as
• anaesthetics (agents that induce partial or
total loss of sensation), such as halothane
• medicines against irregular heartbeat,
such as digoxin
• xanthine derivatives (used to help
breathing), such as theophylline
• steroids (group of hormones), such as
• diuretics (water tablets), such as furosemide

Pregnancy and breast-feeding
Limited knowledge exists regarding use
during pregnancy but there also is a risk for
the unborn child, if your asthma is untreated
during pregnancy. Therefore, you should use

AirSalb only if your doctor indicates it is
clearly necessary. Do not change the
dosage by yourself, but always use it
according to your doctor’s recommendation.
It is unknown whether AirSalb passes into
the mother’s milk. Therefore, only use
AirSalb if your doctor indicates it is clearly
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.
Driving and using machines
No studies on the effects on the ability to
drive and use machines have been
performed. Therefore, do not drive or
operate machines until you know how this
medicine affects you.


How to use AirSalb

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

The recommended dose is:

Adults and adolescents aged 12 years
and over
• Relief of attacks: 1-2 inhalations as
• Prevent symptoms caused by exercise or
triggers: 2 inhalations 10-15 minutes
• Maximum dosage: 8 inhalations per day.

Children below (4-11 years)
• Relief of attacks: 1 inhalation as required.
The dose may be increased to two
inhalations if required.
• Symptoms caused by exercise or triggers:
1 inhalation, or 2 if necessary 10-15
minutes beforehand.
• Maximum dosage: 8 doses per day.

Children below 4 years of age
No recommendations can be made for
dosage since the effect has not yet been

Contact your doctor if the treatment is not
effective enough or if you need more doses
per day than usual. Never increase your
dose or change the duration of use without
your doctor’s approval.

Inhaler test before use:
Check that the inhaler is functioning, if you use
a new inhaler or if it has not been used for
7 days or more. Remove the protective cap,
shake the inhaler and spray twice into the air.
Instructions for use:
Inhale sitting or standing, wherever possible.

Remove the protective cap. Check inside
and outside to make sure that the
mouthpiece is clean.


Shake the inhaler thoroughly for a couple
of seconds before use.

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Hold the inhaler upright with the bottom
of the container upwards, put your thumb
on the base, below the mouthpiece.
Breathe out as far as is comfortable, but
do not breathe into the mouthpiece.
Place the mouthpiece in your mouth
between your teeth and close your lips
around it but do not bite it.

Just after starting to breathe in through
your mouth press down on the top of the
inhaler to release a puff while still
breathing in steadily and deeply.

Hold your breath for 5-10 seconds. Take
the inhaler from your mouth and your
finger from the top of the inhaler.

If you need another puff keep the inhaler
upright and wait about half a minute
before repeating steps 2 to 6.

After use always replace the mouthpiece
cover to keep out dust and fluff. Replace
mouthpiece cover firmly and snap into

Some people find it difficult to release a puff
of medicine just after they start to breathe in.
In this case, as well as for children, the
Vortex® or AeroChamber® Plus spacer
device can be used. Please refer to the
product information of the spacer device for
its correct handling.

To prevent the inhaler blocking up or if it
does block up, clean it at least once a week,
as follows:
1 Pull the metal canister out of the plastic
case of the inhaler and remove the
mouthpiece cover.
2 Rinse the plastic case and the
mouthpiece cover in lukewarm water. Do
not attempt to remove any build up of
medicine around the mouthpiece with a
sharp object, such as a pin. A mild
detergent may be added to the water,
then rinse thoroughly with clean water
before drying. Do not put the metal
canister into water.
3 Leave the plastic case and the
mouthpiece cover to dry in a warm place.
Avoid excessive heat.
4 Replace the canister and mouthpiece cover.
Inhaler content:
Shake the inhaler to check the remaining
amount of medicine in your inhaler. Do not
use AirSalb if you do not detect any liquid in
the inhaler while shaking.

Cold temperature use:
If the inhaler has been stored beneath 0°C,
warm it in your hands for 2 minutes, shake it
and spray into the air twice before use.
If you use more AirSalb than you should
In this case always contact your doctor or
Typical symptoms of overdose are:
• trembling
• headache
• rapid heart beat
• nausea or vomiting
• inability to keep still
• irritability, excitation
• seizures
• sleepiness.

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


Possible side effects

Like all medicines, this medicine can cause
side effects, although not everybody gets them.

Stop using AirSalb and contact your
doctor immediately if you develop any of the
• allergic reaction symptoms such as
- swelling of the face, tongue or throat
- difficulties in swallowing
- signs which resemble nettle sting
- breathing difficulties
• chest pain, see under ‘Frequency not
known’ below
• breathing immediately becomes worse
after taking AirSalb, although AirSalb
reduces symptoms. This may mean your
disease is worsening and other treatment
is urgently needed.

Side effects can occur with the
following frequencies:

Common, may affect up to 1 in 10 people:
• trembling
• increased heart rate
• headache
• muscle cramps.
Uncommon, may affect up to 1 in 100
• rapid heartbeat
• irritation in mouth and throat.

Rare, may affect up to 1 in 1,000 people:
• reduced potassium level in the blood
• flushing.

Very rare, may affect up to 1 in 10,000
• allergic reactions, See “Stop using AirSalb
and contact your doctor”
• decreased blood pressure
• collapse
• increased activity
• increased excitability
• hallucinations
• sleep disturbances
• irregular heart rhythm
• itchy rash
• worsening of breathing immediately after
taking your inhaler.
Frequency not known (the frequency
cannot be estimated from the available
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 AirSalb, but do not
stop using this medicine unless told to do so.

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


How to store AirSalb

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 label and carton.
The expiry date refers to the last day of that
Do not store above 30°C.

Store the inhaler lying flat or in an inverted
position, with the mouthpiece pointing

The canister contains a pressurised liquid.
Do not expose to temperatures higher than
50°C, even for a short period of time. Protect
from heat, direct sunlight and frost. Do not
pierce or burn the canister even when empty.
Do not throw away any medicines via
wastewater. Ask your pharmacist how to throw
away medicines you no longer use. These
measures will help protect the environment.


Contents of the pack and other

What AirSalb contains
• The active substance is salbutamol.
One metered dose contains 100 micrograms
salbutamol (as sulphate).
The delivered dose through the mouthpiece
is 90 micrograms of salbutamol (as sulphate).
• The other ingredients are norflurane
(HFA134a), anhydrous ethanol, oleic acid

What AirSalb looks like and contents of
the pack
This medicinal product is a white pressurised
inhalation suspension in aluminium containers
with metering valve and plastic applicator.
Packs containing
200 metered doses equal to 8.5 g
pressurised inhalation, suspension.
2 x 200 metered doses equal to 2 x 8.5 g
pressurised inhalation, suspension.
3 x 200 metered doses equal to 3 x 8.5 g
pressurised inhalation, suspension.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Aeropharm GmbH, François-MitterrandAllee 1, 07407 Rudolstadt, Germany.
+49 (0) 3672 479-0
+49 (0) 3672 479-102
This leaflet was last revised
in 05/2016

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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.