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SALBUTAMOL 100 MICROGRAMS EASI-BREATHE CFC-FREE INHALER

Active substance(s): SALBUTAMOL SULPHATE

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Transcript
 Keep this leaflet. You
may need to read it
again.
 If you have any
further questions, ask
your doctor,
pharmacist or nurse.
 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.

Package leaflet: information for the user

100 micrograms Pressurised Inhalation Suspension

(salbutamol sulphate)

Salamol Easi-Breathe® CFC-Free Inhaler

Read all of this
leaflet carefully
before you
start using this
medicine because it
contains important
information for you.

 If you get any side
effects, talk to your
doctor, pharmacist or
nurse. This includes
any possible side
effects not listed in
this leaflet. See
section 4.

This medicine is available using the above name but
will be referred to as Salamol Easi-Breathe throughout
this leaflet.

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

1. What Salamol Easi-Breathe is and what
it is used for
Effect
Salamol Easi-Breathe® contains salbutamol sulphate,
which belongs to a group of medicines called beta
agonists. Salbutamol is a bronchodilator and works by
widening the airways in your lungs to allow air in and
out. This helps you to feel less breathless, wheezy or
tight-chested.
Usage
Salamol Easi-Breathe® is used to treat asthma in
adults, adolescents and children aged 4 to 11 years.
It can also be used to prevent asthma caused by
exercise or asthma caused by a reaction to allergens
(substances to which you are allergic to e.g. house
dust, pollen, dog hair, cat hair, cigarette smoke, etc.) or
to treat breathing difficulties associated with reversible
airways obstruction (e.g. chronic obstructive pulmonary
disease [COPD]). This type of medicine is known as a
‘reliever’. You may be using another medicine to
prevent you from having an asthma attack (“controller
medication”). You can safely use your controller
medication with this medicine.

2. What you need to know before you
use Salamol Easi-Breathe®
Do not use Salamol Easi-Breathe®
- if you are allergic to salbutamol or any of the other
ingredients of this medicine.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using
Salamol Easi-Breathe®
- if you suffer from thyroid problems, diabetes,
serious heart disease, fast irregular heart rhythms
or high blood pressure.
- if you have a condition known as hypoxia (a
disorder where the oxygen level in the blood is low
and may cause breathlessness) or if you have a
history of heart disease or angina.
Consult a doctor immediately if your usual treatment is
not working or you need more than 8 puffs per day (for
adults) or 4 puffs per day (for children) or in case of
worsening asthma symptoms. Your dosage should only
be increased on medical advice.

Other medicines and Salamol Easi-Breathe®
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
If you are having treatment that requires a general
anaesthetic, please tell your anaesthetist that you are
taking Salamol Easi-Breathe®. Do not use this medicine
for at least six hours before the intended anaesthetic.
Salbutamol can reduce the amount of potassium in your
blood. If this happens, you may notice an irregular
heartbeat, muscle weakness or cramp.
This is more likely to happen if you use salbutamol with
some medicines used to treat high blood pressure,
other medicines used to treat breathing problems (e.g.
steroids), stimulants (e.g. xanthines) and long-term
laxatives.
The following medicines may influence the effect of
Salamol Easi-Breathe®:
 Some medicines for the treatment of high blood
pressure such as beta-blockers (e.g. propranolol);
 Medicines used to treat heart disease (e.g. digoxin);
 Medicines for the treatment of depression (from the
monoamine oxidase inhibitor group e.g. phenelzine
or tricyclic antidepressants e.g. amitriptyline or
trazodone);
 Water tablets (diuretics);
 Medicines for the treatment of chronic alcoholism
(e.g. disulfiram);
 The anti-microbial drug metronidazole.
Pregnancy and breast-feeding
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
Salamol Easi-Breathe® does not affect the ability to
drive or to use machinery.

3. How to use Salamol Easi-Breathe®
Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The dosage is individually adjusted according to your
doctor’s instructions, based on previous asthma
therapy.
For the best results with this medicine you should use it
when required to relieve symptoms of asthma and other
chest conditions with similar symptoms, such as
wheezing, breathlessness and tightness in your chest.
Take one puff as a starting dose. This may be
increased to two puffs if necessary.
To prevent asthma caused by exercise or allergens
(e.g. house dust, pollen etc.), take two puffs 10-15
minutes before you exercise or before exposure to
known allergens.
Do not take more than eight puffs in 24 hours.
Wait 4 hours between doses.

Use in children and adolescents
The usual dose for children under the age of 12 years
to relieve asthma symptoms such as wheezing,
breathlessness and tightness in your chest, take one
puff as a starting dose. This may be increased to two
puffs if necessary.
Children over the age of 12 should refer to the adult
dosage instructions above.
The usual dose for children under the age of 12 years
to prevent asthma caused by exercise or allergens (e.g.
house dust, pollen etc.), is one puff 10-15 minutes
before exercise or before exposure to known allergens.
This can be increased to two puffs if necessary.

Test spray the inhaler by firing two shots into the air
before you use it for the first time and also if you have
not used it for a period of five days or more. To test
spray your inhaler, unscrew the top of it so you can see
the metal can inside. Open the cap, shake the inhaler
and spray the aerosol by pressing the can with your
finger or thumb. Close the cap and put the top back on.
1.

Shake the inhaler
vigorously.

2.

Hold the inhaler upright
and open it by folding
down the cap which fits
over the mouthpiece.

3.

Breathe out normally as far
as you comfortably can.
Then hold the mouthpiece
firmly between your lips.
Hold the inhaler upright and
make sure that your hand is
not blocking the airholes.
Breathe in slowly and
deeply through the
mouthpiece. Don’t stop
breathing when the inhaler
puffs the dose into your
mouth. Carry on until you
have taken a deep breath.

4.

Take the inhaler out of your
mouth and hold your breath
for 10 seconds or for as long
as you comfortably can. Then
breathe out slowly.

5.

After you have used your
inhaler, hold it upright and
close the cap immediately.

6.

If you need to take more
than one puff, close the cap,
wait about one minute and
then start again from step 1.

7.

What to do if your inhaler
stops working properly?

Children over the age of 12 should refer to the adult
dosage instructions above.
The usual dose for children under the age of 12 years
for regular treatment of asthma is up to 2 puffs, 4 times
a day.
Do not take more than eight puffs in 24 hours.
Wait 4 hours between doses.
Instructions for use
Important
Before using this medicine, please read this leaflet
carefully and follow the instructions.
An adult should always supervise children when they
use Salamol Easi-Breathe®.
Always remember the following:
 Wait four hours between doses.
 Tell your doctor if your asthma gets worse or if this
medicine does not provide as much relief from your
asthma as before.
 You should sit or stand upright while taking this
medicine. It is important when using this medicine to
hold the inhaler upright as it will not work if it is not
held in this position.
This inhaler is designed to make it easier for you to use.
It is a breath-operated inhaler. This means it only
releases a dose when you breathe in.
Using the Inhaler
Opening
To open the inhaler, fold down the cap which fits over
the mouthpiece.
Open

Closed
Air Holes
Top

Cap

If your inhaler does not work properly, unscrew the top and
press the can down. It is important to clean your inhaler
regularly to prevent deposits from the aerosol building up
and blocking the inhaler. If your inhaler does not seem to
be working, it may be that your inhaler has become blocked
and you should clean your inhaler as detailed below.
If your inhaler still does not work, return it to your doctor or
pharmacist.

If you accidentally take a larger dose than
recommended, you may notice that your heart is
beating faster than usual, that you feel shaky or tense,
you may have a headache and your skin may look
flushed and feel hot. These effects usually wear off in a
few hours, but you should tell your doctor as soon as
possible. Your doctor may want to check your blood
potassium levels.

4. Possible side effects
B. Remove the metal can
from the bottom of the
inhaler. Do not put the
metal can into water.

C. Rinse the bottom of
the inhaler with warm
running water for at
least 30 seconds.

D. Shake off any excess
water and dry the bottom
of the inhaler thoroughly
(leave to dry overnight if
possible) but do not use
direct heat. Put the can
back into the bottom of
the inhaler. Close the cap
and screw the top and
bottom parts of your
inhaler back together.

Failure to allow the mouthpiece to dry properly
will result in an increase in blockage problems.
If you need to use your inhaler before it is dry, shake off
any water from the bottom of the inhaler and put the
can back in. Test spray the inhaler by firing two puffs in
the air as previously described above. Screw the top
and bottom parts of your inhaler together and take your
usual dose. When you have taken your usual dose,
wash and dry your inhaler again as described above.

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Contact your doctor immediately if you experience
allergic (hypersensitivity) reactions. These include
 Wheezing, coughing and difficulty in breathing;
 Rash, swelling of the face and throat, and a fall in
blood pressure.
If you experience any of these side effects or if they
occur suddenly after using salbutamol you should stop
using your medication straightaway and tell your
doctor immediately. Allergic reactions to salbutamol
are very rare (occurring in less than 1 in 10,000
patients).
Other side effects:

Common (may affect up to 1 in 10 people):




Feeling tense and getting headaches (which are
more likely with higher doses);
Feeling shaky (muscle tremors);
Dizziness.

Uncommon (may affect up to 1 in 100 people):









Very rare (may affect up to 1 in 10,000 people):




Reduction in the amount of potassium in your blood
(if this happens, you may notice an irregular
heartbeat, muscle weakness or cramp);
Increase in lactate levels and acid levels in the
blood (you may experience symptoms such as
persistent nausea and vomiting, unexplained
tiredness, shortness of breath and rapid breathing,
cold or blue hands and feet);
Sleep disturbances and sensing things that are not
real;

Difficulty in sleeping (insomnia);
Itching of your skin;
Trembling (particularly your hands).

Not known (frequency cannot be estimated from
the available data):


Chest pain (due to heart problems such as angina).

Additional side effects in children
You might collapse in very rare circumstances.
 Sleep disturbances and sensing things that are not
real have been reported.
 Hyperactivity.

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 the Yellow Card Scheme at:
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 Salamol Easi-Breathe®







Muscle pain (myalgia).

Rare (may affect up to 1 in 1,000 people):




Rapid or irregular heart beat (tachycardia or
palpitations);
Increased blood flow to your extremities (peripheral
dilatation)
Mouth and throat irritations, nausea, vomiting and
dry and sore mouth;
Muscle cramps.





Keep out of the sight and reach of children.
Do not store above 25°C.
Do not refrigerate or freeze.
If this medicine gets very cold, remove the canister
from the inhaler and warm it in your hands for a few
minutes before you use it. Do not warm the can in
any other way.
Pressurised container. Do not puncture, break or
burn, even when apparently empty.
Do not use this medicine after the expiry date which
is stated on the label and carton.
If your inhaler fails to work properly or shows any
signs of deterioration, you should seek the advice of
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. Contents of the pack and other
information
What Salamol Easi-Breathe® contains
- The active substance is salbutamol sulphate.
Each actuation contains 100 micrograms
salbutamol (as salbutamol sulphate).
-

The other ingredients are ethanol anhydrous
(alcohol) and the propellant norflurane (HFA-134a).
This medicine does not contain any CFCs.

What Salamol Easi-Breathe® Inhaler looks like and
contents of the pack:
A pressurised metal canister enclosed in a blue plastic
casing with a dark blue cap.
Each pack contains single Inhaler which supplies 200
actuations.
Manufacturers:
IVAX Pharmaceuticals Ireland,
IDA Industrial Park,
Waterford, Ireland.
Or
Merckle GmbH,
Ludwig-Merckle-Str. 3,
89143, Blaubeuren,
Germany.
Procured from within the EU and repackaged by the
Product License holder:
Kosei Pharma UK Limited, 956 Buckingham Avenue,
Slough Trading Estate, Slough, SL1 4NL, UK

Salamol Easi-Breathe® CFC-Free
Inhaler
PL: 39352/0313
Salamol Easi-Breathe® is a registered trademark of
Norton Healthcare Limited.

POM
Leaflet date: 03/03/2016

Salamol Easi-Breathe® CFC-Free Inhaler (salbutamol sulphate)

It is important that you take your dose as stated on
the pharmacist’s label or as advised by your doctor.
You should not increase or decrease your dose
without seeking medical advice.



100 micrograms Pressurised Inhalation Suspension

A. To clean your inhaler
unscrew and remove
the top of the inhaler.
Keep this top dry at
all times.

If you use more Salamol Easi-Breathe® than you
should

Package leaflet: information for the user

Cleaning the inhaler
You must keep your inhaler
clean, especially in the
mouthpiece. This will prevent
deposits from the aerosol
building up. To prevent your
inhaler becoming blocked you
must clean it once a week.

 Keep this leaflet. You
may need to read it
again.
 If you have any
further questions, ask
your doctor,
pharmacist or nurse.

Package leaflet: information for the user

 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.

(salbutamol sulphate)
Pressurised Inhalation Suspension

Salbutamol 100 micrograms Easi-Breathe® CFC-Free Inhaler

Read all of this
leaflet carefully
before you
start using this
medicine because it
contains important
information for you.

 If you get any side
effects, talk to your
doctor, pharmacist or
nurse. This includes
any possible side
effects not listed in
this leaflet. See
section 4.

This medicine is available using the above name but
will be referred to as Salbutamol Easi-Breathe
throughout this leaflet.

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

1. What Salbutamol Easi-Breathe is and
what it is used for
Effect
Salbutamol Easi-Breathe® contains salbutamol
sulphate, which belongs to a group of medicines called
beta agonists. Salbutamol is a bronchodilator and works
by widening the airways in your lungs to allow air in and
out. This helps you to feel less breathless, wheezy or
tight-chested.
Usage
Salbutamol Easi-Breathe® is used to treat asthma in
adults, adolescents and children aged 4 to 11 years.
It can also be used to prevent asthma caused by
exercise or asthma caused by a reaction to allergens
(substances to which you are allergic to e.g. house
dust, pollen, dog hair, cat hair, cigarette smoke, etc.) or
to treat breathing difficulties associated with reversible
airways obstruction (e.g. chronic obstructive pulmonary
disease [COPD]). This type of medicine is known as a
‘reliever’. You may be using another medicine to
prevent you from having an asthma attack (“controller
medication”). You can safely use your controller
medication with this medicine.

2. What you need to know before you
use Salbutamol Easi-Breathe®
Do not use Salbutamol Easi-Breathe®
- if you are allergic to salbutamol or any of the other
ingredients of this medicine.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using
Salbutamol Easi-Breathe®
- if you suffer from thyroid problems, diabetes,
serious heart disease, fast irregular heart rhythms
or high blood pressure.
- if you have a condition known as hypoxia (a
disorder where the oxygen level in the blood is low
and may cause breathlessness) or if you have a
history of heart disease or angina.
Consult a doctor immediately if your usual treatment is
not working or you need more than 8 puffs per day (for
adults) or 4 puffs per day (for children) or in case of
worsening asthma symptoms. Your dosage should only
be increased on medical advice.

Other medicines and Salbutamol Easi-Breathe®
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
If you are having treatment that requires a general
anaesthetic, please tell your anaesthetist that you are
taking Salbutamol Easi-Breathe®. Do not use this
medicine for at least six hours before the intended
anaesthetic.
Salbutamol can reduce the amount of potassium in your
blood. If this happens, you may notice an irregular
heartbeat, muscle weakness or cramp.
This is more likely to happen if you use salbutamol with
some medicines used to treat high blood pressure,
other medicines used to treat breathing problems (e.g.
steroids), stimulants (e.g. xanthines) and long-term
laxatives.
The following medicines may influence the effect of
Salbutamol Easi-Breathe®:
 Some medicines for the treatment of high blood
pressure such as beta-blockers (e.g. propranolol);
 Medicines used to treat heart disease (e.g. digoxin);
 Medicines for the treatment of depression (from the
monoamine oxidase inhibitor group e.g. phenelzine
or tricyclic antidepressants e.g. amitriptyline or
trazodone);
 Water tablets (diuretics);
 Medicines for the treatment of chronic alcoholism
(e.g. disulfiram);
 The anti-microbial drug metronidazole.
Pregnancy and breast-feeding
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
Salbutamol Easi-Breathe® does not affect the ability to
drive or to use machinery.

3. How to use Salbutamol Easi-Breathe®
Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The dosage is individually adjusted according to your
doctor’s instructions, based on previous asthma
therapy.
For the best results with this medicine you should use it
when required to relieve symptoms of asthma and other
chest conditions with similar symptoms, such as
wheezing, breathlessness and tightness in your chest.
Take one puff as a starting dose. This may be
increased to two puffs if necessary.
To prevent asthma caused by exercise or allergens
(e.g. house dust, pollen etc.), take two puffs 10-15
minutes before you exercise or before exposure to
known allergens.
Do not take more than eight puffs in 24 hours.
Wait 4 hours between doses.

Use in children and adolescents
The usual dose for children under the age of 12 years
to relieve asthma symptoms such as wheezing,
breathlessness and tightness in your chest, take one
puff as a starting dose. This may be increased to two
puffs if necessary.
Children over the age of 12 should refer to the adult
dosage instructions above.
The usual dose for children under the age of 12 years
to prevent asthma caused by exercise or allergens (e.g.
house dust, pollen etc.), is one puff 10-15 minutes
before exercise or before exposure to known allergens.
This can be increased to two puffs if necessary.

Test spray the inhaler by firing two shots into the air
before you use it for the first time and also if you have
not used it for a period of five days or more. To test
spray your inhaler, unscrew the top of it so you can see
the metal can inside. Open the cap, shake the inhaler
and spray the aerosol by pressing the can with your
finger or thumb. Close the cap and put the top back on.
1.

Shake the inhaler
vigorously.

2.

Hold the inhaler upright
and open it by folding
down the cap which fits
over the mouthpiece.

3.

Breathe out normally as far
as you comfortably can.
Then hold the mouthpiece
firmly between your lips.
Hold the inhaler upright and
make sure that your hand is
not blocking the airholes.
Breathe in slowly and
deeply through the
mouthpiece. Don’t stop
breathing when the inhaler
puffs the dose into your
mouth. Carry on until you
have taken a deep breath.

4.

Take the inhaler out of your
mouth and hold your breath
for 10 seconds or for as long
as you comfortably can. Then
breathe out slowly.

5.

After you have used your
inhaler, hold it upright and
close the cap immediately.

6.

If you need to take more
than one puff, close the cap,
wait about one minute and
then start again from step 1.

7.

What to do if your inhaler
stops working properly?

Children over the age of 12 should refer to the adult
dosage instructions above.
The usual dose for children under the age of 12 years
for regular treatment of asthma is up to 2 puffs, 4 times
a day.
Do not take more than eight puffs in 24 hours.
Wait 4 hours between doses.
Instructions for use
Important
Before using this medicine, please read this leaflet
carefully and follow the instructions.
An adult should always supervise children when they
use Salbutamol Easi-Breathe®.
Always remember the following:
 Wait four hours between doses.
 Tell your doctor if your asthma gets worse or if this
medicine does not provide as much relief from your
asthma as before.
 You should sit or stand upright while taking this
medicine. It is important when using this medicine to
hold the inhaler upright as it will not work if it is not
held in this position.
This inhaler is designed to make it easier for you to use.
It is a breath-operated inhaler. This means it only
releases a dose when you breathe in.
Using the Inhaler
Opening
To open the inhaler, fold down the cap which fits over
the mouthpiece.
Open

Closed
Air Holes
Top

Cap

If your inhaler does not work properly, unscrew the top and
press the can down. It is important to clean your inhaler
regularly to prevent deposits from the aerosol building up
and blocking the inhaler. If your inhaler does not seem to
be working, it may be that your inhaler has become blocked
and you should clean your inhaler as detailed below.
If your inhaler still does not work, return it to your doctor or
pharmacist.

If you accidentally take a larger dose than
recommended, you may notice that your heart is
beating faster than usual, that you feel shaky or tense,
you may have a headache and your skin may look
flushed and feel hot. These effects usually wear off in a
few hours, but you should tell your doctor as soon as
possible. Your doctor may want to check your blood
potassium levels.

4. Possible side effects
F. Remove the metal can
from the bottom of the
inhaler. Do not put the
metal can into water.

G. Rinse the bottom of
the inhaler with warm
running water for at
least 30 seconds.

H. Shake off any excess
water and dry the bottom
of the inhaler thoroughly
(leave to dry overnight if
possible) but do not use
direct heat. Put the can
back into the bottom of
the inhaler. Close the cap
and screw the top and
bottom parts of your
inhaler back together.

Failure to allow the mouthpiece to dry properly
will result in an increase in blockage problems.
If you need to use your inhaler before it is dry, shake off
any water from the bottom of the inhaler and put the
can back in. Test spray the inhaler by firing two puffs in
the air as previously described above. Screw the top
and bottom parts of your inhaler together and take your
usual dose. When you have taken your usual dose,
wash and dry your inhaler again as described above.

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Contact your doctor immediately if you experience
allergic (hypersensitivity) reactions. These include
 Wheezing, coughing and difficulty in breathing;
 Rash, swelling of the face and throat, and a fall in
blood pressure.
If you experience any of these side effects or if they
occur suddenly after using salbutamol you should stop
using your medication straightaway and tell your
doctor immediately. Allergic reactions to salbutamol
are very rare (occurring in less than 1 in 10,000
patients).
Other side effects:

Common (may affect up to 1 in 10 people):




Feeling tense and getting headaches (which are
more likely with higher doses);
Feeling shaky (muscle tremors);
Dizziness.





Very rare (may affect up to 1 in 10,000 people):




Muscle pain (myalgia).

Rare (may affect up to 1 in 1,000 people):





Reduction in the amount of potassium in your blood
(if this happens, you may notice an irregular
heartbeat, muscle weakness or cramp);
Increase in lactate levels and acid levels in the
blood (you may experience symptoms such as
persistent nausea and vomiting, unexplained
tiredness, shortness of breath and rapid breathing,
cold or blue hands and feet);
Sleep disturbances and sensing things that are not
real;

Difficulty in sleeping (insomnia);
Itching of your skin;
Trembling (particularly your hands).

Not known (frequency cannot be estimated from
the available data):


Chest pain (due to heart problems such as angina).

Additional side effects in children
You might collapse in very rare circumstances.
 Sleep disturbances and sensing things that are not
real have been reported.
 Hyperactivity.

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 the Yellow Card Scheme at:
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 EasiBreathe®





Uncommon (may affect up to 1 in 100 people):


Rapid or irregular heart beat (tachycardia or
palpitations);
Increased blood flow to your extremities (peripheral
dilatation)
Mouth and throat irritations, nausea, vomiting and
dry and sore mouth;
Muscle cramps.






Keep out of the sight and reach of children.
Do not store above 25°C.
Do not refrigerate or freeze.
If this medicine gets very cold, remove the canister
from the inhaler and warm it in your hands for a few
minutes before you use it. Do not warm the can in
any other way.
Pressurised container. Do not puncture, break or
burn, even when apparently empty.
Do not use this medicine after the expiry date which
is stated on the label and carton.
If your inhaler fails to work properly or shows any
signs of deterioration, you should seek the advice of
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. Contents of the pack and other
information
What Salbutamol Easi-Breathe® contains
- The active substance is salbutamol sulphate.
Each actuation contains 100 micrograms
salbutamol (as salbutamol sulphate).
-

The other ingredients are ethanol anhydrous
(alcohol) and the propellant norflurane (HFA-134a).
This medicine does not contain any CFCs.

What Salbutamol Easi-Breathe® Inhaler looks like
and contents of the pack:
A pressurised metal canister enclosed in a blue plastic
casing with a dark blue cap.
Each pack contains single Inhaler which supplies 200
actuations.
Manufacturers:
IVAX Pharmaceuticals Ireland,
IDA Industrial Park,
Waterford, Ireland.
Or
Merckle GmbH,
Ludwig-Merckle-Str. 3,
89143, Blaubeuren,
Germany.
Procured from within the EU and repackaged by the
Product License holder:
Kosei Pharma UK Limited, 956 Buckingham Avenue,
Slough Trading Estate, Slough, SL1 4NL, UK

Salbutamol 100 micrograms
Easi-Breathe® CFC-Free Inhaler
PL: 39352/0313
Leaflet date: 03/03/2016

POM

Salbutamol 100 micrograms Easi-Breathe® CFC-Free Inhaler

It is important that you take your dose as stated on
the pharmacist’s label or as advised by your doctor.
You should not increase or decrease your dose
without seeking medical advice.



(salbutamol sulphate)
Pressurised Inhalation Suspension

E. To clean your inhaler
unscrew and remove
the top of the inhaler.
Keep this top dry at
all times.

If you use more Salbutamol Easi-Breathe® than you
should

Package leaflet: information for the user

Cleaning the inhaler
You must keep your inhaler
clean, especially in the
mouthpiece. This will prevent
deposits from the aerosol
building up. To prevent your
inhaler becoming blocked you
must clean it once a week.

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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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