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

Active substance(s): SALBUTAMOL

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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

Package leaflet: Information for the patient

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

Salbutamol Sulphate

100 micrograms Pressurised Inhalation Suspension

Salamol Easi-Breathe® CFC-Free Inhaler

PE2843

What is in this leaflet

- 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.

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 breat-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.

Product Name: SAL HFA E/B 100MCG 200 IUK
Date: 15/04/2014

Perigord Premedia Job No: 228226

Component: Leaflet

Template: LF15.2

Barcode: N/A

Pharmacode: 1323

Dimensions (mm): 369 x 160

Draft: 01

Signature: .........................................

Date:

/

/

Date:

/

/

Packaging Technologist:

Other Information: Black coding panel on labels are varnish free areas

Signature: .........................................

FONT INFORMATION

COLOURS USED
PMS 2768

PMS Warm Red

PMS 5483

Black
Keyline (DO NOT PRINT)

Bliss Light
Bliss Light Italic
Bliss Regular
Bliss Bold
Bliss Extra bold

Version 4.2

Closed

Open
Air Holes
Top

Signature: .........................................

Date:

/

/

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.

Philip
Murphy

Digitally signed by Philip
Murphy
DN: cn=Philip Murphy,
o=Perigord Premedia,
ou=Quality, email=philip.
murphy@perigordgroup.
com, c=IE
Date: 2014.04.16 14:12:15
+01'00'

H/0450/001/IB/049

The approval of all text including Braille contained in this artwork
is the responsibility of the Regulatory Affairs Department

Divya Jain

Final Review:
PAGE NO:

Approved

1 of 2

Page 1 of 3

Signature: .........................................

Date:

/

/

1

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.

2

3

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.

4

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

Submitted to authority as UK/

Subject to Regulatory Authority Approval
Approved by Reg. Dept. for print

1. Shake the inhaler
vigorously.

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

Cap

Regulatory:

PMS 5483 - 10%

PMS 2768 - Various tints used within illustrations
Black - Various tints used within illustrations
PMS Warm Red - Various tints used within illustrations

REG0048269

12:57

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.

FP code: FA0778

Artwork Co-ordinator:

Job No.: 272449

TINTS USED

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.
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.

SAP CODE: PE2843

TEVA Pharmaceuticals Ireland, IDA Industrial Park, Cork Road, Waterford, Ireland.

Software Used: Adobe Indesign CS4

3. How to use Salamol
Easi-Breathe®

Digitally signed by Divya Jain
DN: cn=Divya Jain, o, ou,
email=Divya.Jain@tevauk.com,
c=GB
Date: 2014.04.22 09:35:51 +01'00'

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.

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.

D

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):
• 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);

TEVA Pharmaceuticals Ireland,
IDA Industrial Park, Cork Road, Waterford, Ireland.
SAP:

PE2843

JOB NO:

REG0048269

272449

DRAFT:

Version 4.2

DATE:
01

15/04/2014

Approved

5. How to store Salamol
Easi-Breathe®
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 after EXP.
The expiry date refers to the last day of that
month.

PAGE NO:
12:57

2 OF 2

Page 2 of 3

What Salamol Easi-Breathe® contains
- The active substance is salbutamol sulphate
equivalent to 100 micrograms 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
• The name of your medicine is Salamol
Easi-Breathe® CFC-Free Inhaler 100 micrograms
Pressurised Inhalation Suspension.
• Each pack of Salamol Easi-Breathe® contains
a single inhaler and can which supplies
200 metered doses.
Marketing Authorisation Holder:
Norton Healthcare Ltd.,
T/A IVAX Pharmaceuticals UK,
Ridings Point,
Whistler Drive,
Castleford,
West Yorkshire,
WF10 5HX,
United Kingdom
Manufacturer:
IVAX Pharmaceuticals Ireland,
IDA Industrial Park,
Waterford,
Ireland

This leaflet was last revised in April 2014

Salamol Easi-Breathe® CFC-Free Inhaler

C

6. Contents of the pack and other
information

This medicinal product is authorised in the
Member States of the EEA under the following
names:
UK: Salamol Easi-Breathe® CFC-Free Inhaler
100 micrograms Pressurised Inhalation
Suspension.
Germany: Salbulair N 100 mikrogramme
Easi-Breathe Druckgasinhalation, Suspension.
The Netherlands: Salbutamol 100 Redihaler
100 microgram/dosis aërosol, suspensie.
Denmark: Salamol.

100 micrograms Pressurised Inhalation Suspension

4. Possible side effects

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.
Pressurised aerosol can. Do not puncture, break or
burn the can, even if it seems empty.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

Salbutamol Sulphate

B Remove the metal can from
the bottom of the inhaler. Do
not put the metal can into
water.

B

• 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.

Package leaflet: Information for the patient

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
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.

A

PE2843

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.

Pharma Code
(TBC)

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

Package leaflet: Information for the patient

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

Salbutamol Sulphate

100 micrograms Pressurised Inhalation Suspension

Salamol Easi-Breathe® CFC-Free Inhaler

SAP Code (TBC)

What is in this leaflet

- 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.

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 breat-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.

Product Name: SAL HFA E/B 100MCG 200 IUK
Date: 15/04/2014

Perigord Premedia Job No: 228224

Component: Leaflet

Template: LF15.2

Barcode: N/A

Pharmacode: N/A

Dimensions (mm): 369 x 160

11:00

Draft: 01

Signature: .........................................

Date:

/

/

Date:

/

/

Date:

/

/

Packaging Technologist:

Other Information: Black coding panel on labels are varnish free areas

Signature: .........................................

FONT INFORMATION

COLOURS USED
PMS 2768

PMS Warm Red

PMS 5483

Black
Keyline (DO NOT PRINT)

Bliss Light
Bliss Light Italic
Bliss Regular
Bliss Bold
Bliss Extra bold

Version 0.1

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.
Closed

Open
Air Holes
Top

Cap

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.

Philip
Murph
y

Digitally signed by Philip
Murphy
DN: cn=Philip Murphy,
o=Perigord Premedia,
ou=Quality,
email=philip.
murphy@perigordgroup.
com, c=IE
Date: 2014.04.16
11:07:11 +01'00'

Subject to Regulatory Authority Approval
Approved by Reg. Dept. for print
Signature: .........................................

The approval of all text including Braille contained in this artwork
is the responsibility of the Regulatory Affairs Department

Submitted to authority as
UK/H/0450/001/IB/049

Final Review:
PAGE NO:

Approved

1 of 2

Page 1 of 3

Signature: .........................................

Date:

/

/

1. Shake the inhaler
vigorously.

1

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.

2

3

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.

4

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

Regulatory:

PMS 5483 - 10%

PMS 2768 - Various tints used within illustrations
Black - Various tints used within illustrations
PMS Warm Red - Various tints used within illustrations

REG0121737

FP code: N/A

Artwork Co-ordinator:

Job No.: 272752

TINTS USED

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.
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.

SAP CODE: N/A

TEVA Pharmaceuticals Ireland, IDA Industrial Park, Cork Road, Waterford, Ireland.

Software Used: Adobe Indesign CS4

3. How to use Salamol
Easi-Breathe®

Divya Jain

Digitally signed by Divya Jain
DN: cn=Divya Jain, o, ou, email=Divya.
Jain@tevauk.com, c=GB
Date: 2014.04.22 09:37:16 +01'00'

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.

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.

D

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):
• 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);

TEVA Pharmaceuticals Ireland,
IDA Industrial Park, Cork Road, Waterford, Ireland.
SAP:

N/A

JOB NO:

REG0121737

272752

DRAFT:

Version 0.1

DATE:
01

15/04/2014

Approved

5. How to store Salamol
Easi-Breathe®
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 after EXP.
The expiry date refers to the last day of that
month.

PAGE NO:
11:00

2 OF 2

Page 2 of 3

What Salamol Easi-Breathe® contains
- The active substance is salbutamol sulphate
equivalent to 100 micrograms 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
• The name of your medicine is Salamol
Easi-Breathe® CFC-Free Inhaler 100 micrograms
Pressurised Inhalation Suspension.
• Each pack of Salamol Easi-Breathe® contains
a single inhaler and can which supplies
200 metered doses.
Marketing Authorisation Holder:
Norton Healthcare Ltd.,
T/A IVAX Pharmaceuticals UK,
Ridings Point,
Whistler Drive,
Castleford,
West Yorkshire,
WF10 5HX,
United Kingdom
Manufacturer:
Merckle GmbH,
Ludwig-Merckle-Straße 3,
89143 Blaubeuren,
Germany

This leaflet was last revised in April 2014

Salamol Easi-Breathe® CFC-Free Inhaler

C

6. Contents of the pack and other
information

This medicinal product is authorised in the
Member States of the EEA under the following
names:
UK: Salamol Easi-Breathe® CFC-Free Inhaler
100 micrograms Pressurised Inhalation
Suspension.
Germany: Salbulair N 100 mikrogramme
Easi-Breathe Druckgasinhalation, Suspension.
The Netherlands: Salbutamol 100 Redihaler
100 microgram/dosis aërosol, suspensie.
Denmark: Salamol.

100 micrograms Pressurised Inhalation Suspension

4. Possible side effects

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.
Pressurised aerosol can. Do not puncture, break or
burn the can, even if it seems empty.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

Salbutamol Sulphate

B Remove the metal can from
the bottom of the inhaler. Do
not put the metal can into
water.

B

• 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.

Package leaflet: Information for the patient

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
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.

A

SAP Code (TBC)

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.

Expand view ⇕

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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