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SALBUTAMOL EASI-BREATHE CFC-FREE INHALER 100MICROGRAMS PRESSURISED INHALATION SUSPENSION

Active substance(s): SALBUTAMOL

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Salamol Easi-Breathe® CFC-Free Inhaler 100micrograms Pressurised Inhalation Suspension
(salbutamol sulphate)
Package leaflet: Information for the patient

What is in this leaflet
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,
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.
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.
The name of your
medicine is
Salamol
Easi-Breathe
CFC-Free Inhaler
100micrograms
Pressurised
Inhalation
Suspension but
will be referred to
as Salamol
Easi-Breathe
throughout 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 heart beat, 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.

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.

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.

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.

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.

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.

Do not take more than eight puffs in 24 hours.
Wait 4 hours between doses.

Using the Inhaler
Opening
To open the inhaler, fold down the cap which
fits over the mouthpiece.

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.

Open

Closed
Air holes
Top

Cap

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.

Do not take more than eight puffs in 24 hours.
Wait 4 hours between doses.

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.

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.

1. Shake the inhaler
vigorously.

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.

7. What to do if your inhaler stops working
properly?
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.

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

If you use more Salamol Easi-Breathe than
you should
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.
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
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):

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.

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):
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 heart beat, 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;
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.
Very rare (may affect up to 1 in 10,000
people):
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
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
metal can 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.
The metal container is under pressure. Do
not puncture, break or burn, even when it is
seemingly empty container.
Do not take your medicine after the expiry
date which is stated on the label after ‘Exp’.
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. Contents of the pack and other
information
What Salamol Easi-Breathe contains
The active ingredient is salbutamol sulphate
equivalent to 100micrograms of salbutamol in
each puff (metered dose).
The other ingredients are ethanol anhydrous
(alcohol) and the propellant norflurane
(HFA-134a). This medicine does not contain
any CFCs.
What Salamol Easi-Breathe looks like and
contents of the pack
Salamol Easi-Breathe is a pressurised metered
dose inhaler, with an aluminium canister,
containing suspension. The inhaler has a dark
blue plastic cap.
Each pack of Salamol Easi-Breathe contains a
single inhaler which supplies 200 actuations.
Manufactured by:
Merckle GmbH, Ludwig-Merckle-Str.3, 89143,
Blaubeuren, Germany.
Or
Ivax Pharmaceuticals Ireland, IDA Industrial
park, Waterford, Ireland.

Salamol Easi-Breathe® CFC-Free Inhaler
100micrograms Pressurised Inhalation
Suspension, PL: 18799/2397
Leaflet date: 22.07.2015

POM

Salamol Easi-Breathe is a registered trademark
of Norton Healthcare Limited.

Package leaflet: Information for the patient
Salamol EAsi-Breathe® CFC-Free Inhaler 100micrograms Pressurised Inhalation
Suspension
(salbutamol sulphate)

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.

Procured from within EU and repackaged by
the Product Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.

SAL100/200/GE/LT

Salbutamol Easi-Breathe® CFC-Free Inhaler 100micrograms Pressurised Inhalation
Suspension
(salbutamol sulphate)
Package leaflet: Information for the patient

What is in this leaflet
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,
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.
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.
The name of your
medicine is
Salbutamol
Easi-Breathe
CFC-Free Inhaler
100micrograms
Pressurised
Inhalation
Suspension but
will be referred to
as Salbutamol
Easi-Breathe
throughout 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 EasiBreathe
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 heart beat, 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 EasiBreathe
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.

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.
Test spray the inhaler by firing two shots into
Closed

Open

Air holes
Top

Cap

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.

Do not take more than eight puffs in 24 hours.
Wait 4 hours between doses.

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.

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.

1. Shake the inhaler
vigorously.

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.

7. What to do if your inhaler stops working
properly?
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.

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

If you use more Salbutamol Easi-Breathe
than you should
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.
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
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):
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 heart beat, 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;
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.
Very rare (may affect up to 1 in 10,000
people):
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
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not refrigerate or freeze.
If this medicinal product is exposed to
extreme cold, please refer to the metal box
from the metered dose inhaler and warm it
for a few minutes in hand before you use it.
Do not heat the container in a different way.

The metal container is under pressure. Do
not puncture, break or burn, even when it is
seemingly empty container.
Do not take your medicine after the expiry
date which is stated on the label after ‘Exp’.
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. Contents of the pack and other
information
What Salbutamol Easi-Breathe contains
The active ingredient is salbutamol sulphate
Each actuation contains 100micrograms
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 looks like
and contents of the pack
Salbutamol Easi-Breathe is a pressurised
metered dose inhaler, with an aluminium
canister, containing suspension. The inhaler
has a dark blue plastic cap.
Each pack of Salbutamol Easi-Breathe contains
a single inhaler which supplies 200 actuations.
Manufactured by:
Merckle GmbH, Ludwig-Merckle-Str.3, 89143,
Blaubeuren, Germany.
Or
Ivax Pharmaceuticals Ireland, IDA Industrial
park, Waterford, Ireland.
Procured from within EU and repackaged by
the Product Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Salbutamol Easi-Breathe CFC-Free Inhaler
100micrograms Pressurised Inhalation
Suspension, PL: 18799/2397
Leaflet date: 22.07.2015

POM

Package leaflet: Information for the patient
Salbutamol Easi-Breathe CFC-Free Inhaler 100micrograms Pressurised Inhalation
Suspension
(salbutamol sulphate)

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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