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

Active substance(s): SALBUTAMOL SULPHATE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Salamol Easi-Breathe® CFC-Free Inhaler 100 micrograms
Pressurised Inhalation, Suspension /
Salbutamol Easi-Breathe® CFC-Free Inhaler 100 micrograms
Pressurised Inhalation, Suspension
(salbutamol sulphate)
This product is available using either of the above names but will be referred to as Salamol
Easi-Breathe throughout the following leaflet.
Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.

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.

Keep this leaflet. You may need to read it again.

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.

If you have any further questions, ask your doctor, pharmacist or nurse.

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

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.

Use in children and adolescents

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 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.

What is in this leaflet

Children over the age of 12 should refer to the adult dosage instructions above.

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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.

What Salamol Easi-Breathe is and what it is used for
What you need to know before you use Salamol Easi-Breathe
How to use Salamol Easi-Breathe
Possible side effects
How to store Salamol Easi-Breathe
Contents of the pack and other information

1. What Salamol Easi-Breathe is and what it is used for

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.

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

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

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.

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

Open

Air Holes

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.

Top

Cap

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.

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.

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.

1. Shake the inhaler vigorously.

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.

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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.

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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.

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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.

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Cleaning the inhaler

Reporting of side effects

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.

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.

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

5. How to store Salamol Easi-Breathe

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.




Keep 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.
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.
If your medicine show signs of any deterioration, consult your doctor or pharmacist who
will tell you what to do.

6. Contents of the pack and other information
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.

What Salamol Easi-Breathe contains



The active substance is salbutamol sulphate. Each metered actuation contains
salbutamol sulphate equivalent to 100 micrograms salbutamol.
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
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.



The name of your medicine is Salamol Easi-Breathe CFC-Free Inhaler 100 micrograms
Pressurised Inhalation Suspension.
Salamol Easi-Breathe is a pressurised metered dose inhaler with a metal canister
encased in an actuator with a light blue plastic body and a dark blue cap. The inhaler
does not have a dose counter.
Salamol Easi-Breathe is available in:
− Single pack: a single inhaler and can which supplies 200 metered doses
− Double pack: a single inhaler, a can and a refill can; each can supply 200 metered
doses.

If you use more Salamol Easi-Breathe than you should
POM
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 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.

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.

PL: 15814/1190

This product is manufactured by IVAX Pharmaceuticals Ireland, Waterford, Ireland or
Merckle GmbH, Blaubeuren, Germany.
Procured from within the EU and repackaged by the Product Licence holder:
O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 03.09.2015.
Salamol Easi-Breathe is a registered trademark of Norton Healthcare Ltd.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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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