AIRSALB CFC-FREE INHALER 100 MICROGRAM/DOSE

Active substance: SALBUTAMOL SULPHATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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AirSalb CFC-free inhaler 100 microgram/dose

Salbutamol sulphate

CFC-free

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 gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What AirSalb is and what it is used for
2. Before you use AirSalb
3. How to use AirSalb
4. Possible side effects
5. How to store AirSalb
6. Further Information

1

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.

2

Before you use AirSalb

Do not use AirSalb
• if you are allergic (hypersensitive) to
salbutamol or any of the other ingredients
of AirSalb.

Take special care with AirSalb
Ask your doctor for advice 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.
Using other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.

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.
moclobemide)
- tricyclic antidepressants, such as
amitriptyline
• 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
cortisone
• 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 doctorʼs recommendation.
It is unknown whether AirSalb passes into
the motherʼs milk. Therefore, only use
AirSalb if your doctor indicates it is clearly
necessary.
Ask your doctor or pharmacist for advice
before taking any 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.

3

How to use AirSalb

Always use AirSalb exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure. The
usual dose is:
Adults and children from 12 years of age
• Relief of attacks: 1-2 inhalations as
required.
• Prevent symptoms caused by exercise or
triggers: 2 inhalations 10-15 minutes
beforehand.
• Maximum dosage: 8 inhalations per day.

Children below 12 years of age
• Relief of attacks: 1 inhalation as required.
• Symptoms caused by exercise or triggers:
1 inhalation, or 2 if necessary 10-15
minutes beforehand.
• Maximum dosage: 8 doses per day.
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 doctorʼs 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.
1

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

2

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

3

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.

4

Place the mouthpiece in your mouth
between your teeth and close your lips
around it but do not bite it.

Continued on the next page >>

5

6
7
8

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
position.

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.

Cleaning
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
hospital.
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 product, ask your doctor or pharmacist.

4

Possible side effects

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

Stop using AirSalb and contact your
doctor immediately if you develop any of the
following:
• 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 ʻFrequency not
knownʼ 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.
Other side effects can occur with the
following frequencies:
Common, occurs in 1 to 10 per 100 users:
• trembling
• increased heart rate

• headache
• muscle cramps.

Uncommon, occurs in 1 to 10 per 1000
users:
• rapid heartbeat
• irritation in mouth and throat.

Rare, occurs in 1 to 10 per 10,000 users:
• reduced potassium level in the blood
• flushing.

Very rare, occurs in fewer than 1 per
10,000 users:
• allergic reactions, See “Stop using AirSalb
and contact your doctor”
• faintness
• collapse
• increase activity
• increased excitability
• hallucinations
• sleep disturbances
• irregular heart rhythm
• chest pain
• itchy rash
• worsening of breathing immediately after
taking your inhaler.

Frequency not known
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.
If any of the 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 AirSalb

Keep out of the reach and sight of children.
Do not store above 30°C.

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

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 use AirSalb after the expiry date
which is stated on the label and carton. The
expiry date refers to the last day of that month.
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 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
Manufacturer
Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer:
Aeropharm GmbH, François-MitterrandAllee 1, 07407 Rudolstadt, Germany.
+49 (0) 3672 479-0
+49 (0) 3672 479-102
service@aeropharm.de

This leaflet was last revised in 06/2012.

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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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