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Salamol Easi-Breathe Cfc-Free Inhaler

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Document: leaflet MAH BRAND_PLPI 16369-1634 change

2.


What you need to know before you use Salamol Easi-Breathe®



Salamol Easi-Breathe® CFC-Free Inhaler

(salbutamol sulphate)

Package leaflet: Information for the patient

Your medicine is known as the above but will be referred to as Salamol Easi-Breathe® throughout the remainder of 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.

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®

T ell 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.

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 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 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.