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SALAMOL EASI-BREATHE 100 MICROGRAMS/ACTUATION INHALER

Active substance(s): SALBUTAMOL SULPHATE

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PATIENT INFORMATION LEAFLET

2447
29.06.15[8]

Salamol Easi-Breathe®
100 micrograms/actuation Inhaler
(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.
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 in this
medicine.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Salamol EasiBreathe
 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 betablockers (e.g. propranolol);

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

 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.
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 EasiBreathe.
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 breathoperated inhaler. This means it only releases a dose when you breathe in.

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?
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.

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.

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,







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):

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

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 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 Salamol Easi-Breathe 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.

POM

PL 20636/2447

you may notice an irregular heartbeat, muscle weakness or cramp);

 Increase in lactate levels and acid levels in the blood (you may

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

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

Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.

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. Protect from heat.
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.
Product Licence Holder and Manufacturer
Manufactured by
Norton Waterford (IVAX Pharmaceuticals Ireland), Waterford, Ireland.
Teva Czech Industries s.r.o., Opava-Komarov, Czech Republic.

Leaflet Revision date Ref: 29.06.15[8]
Salamol Easi- Breathe is a trademark of Norton Healthcare Limited.

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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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