Skip to Content

UK Edition. Click here for US version.

SALAMOL EASI-BREATHE CFC-FREE INHALER

Active substance(s): SALBUTAMOL / SALBUTAMOL SULPHATE

View full screen / Print PDF » Download PDF ⇩
Transcript
PATIENT INFORMATION LEAFLET

Salamol Easi-Breathe® CFC-Free
Inhaler
100 micrograms Pressurised
Inhalation

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.

(salbutamol sulphate)
This medicine is available using the above name but
will be referred to as Salamol Easi-Breathe®
throughout 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.
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.

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.

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.

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.

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.

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.

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? 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.

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

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.

1. Shake the inhaler vigorously.

Assessed against UK PIL dated April 2014
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.

Final draft mock up

By kariri at 9:30 am, May 06, 2015

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.
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 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.

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

4. Possible side effects

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

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

Additional side effects in children

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).

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 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.

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;
 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.

 Difficulty in sleeping (insomnia);
 Itching of your skin;
 Trembling (particularly your hands).
Not known (frequency cannot be estimated from
the available data):

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 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 pierce or burn container
even when 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 and the
propellant norflurane. 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.
Merckle GmbH, Ludwig-Merckle-Str. 3, 89143,
Blaubeuren, Germany.
Procured from within the EU by Product Licence holder
PilsCo Ltd, 10-16 Colvilles Place, East Kilbride, G75
0SN.
PL 39467/0214 Salamol Easi-Breathe® CFC-Free
Inhaler 100 micrograms Pressurised Inhalation
Leaflet last revised 27/04/2015

POM

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

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.

Hide