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PATIENT INFORMATION LEAFLET
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. Salamol Easi-Breathe®
Salamol Easi-Breathe should only be used if recommended by a doctor. 2. Hold the inhaler upright and open it by folding down the cap which fits over the mouthpiece. 100 micrograms/actuation Inhaler
Driving and using machines
Salamol Easi-Breathe does not affect the ability to drive or to use 3. Breathe out normally as far as you comfortably This medicine is available using the above name but will be referred to as Then hold the mouthpiece firmly between your Salamol Easi-Breathe throughout this leaflet. 3. How to use Salamol Easi-Breathe
lips. Hold the inhaler upright and make sure that Always use this medicine exactly as your doctor has told you to. You your hand is not blocking the airholes. Breathe in Read all of this leaflet carefully before you start using this medicine.
should check with your doctor or pharmacist if you are not sure. slowly and deeply through the mouthpiece. Don't  Keep this leaflet. You may need to read it again. The dosage is individually adjusted according to your doctor's stop breathing when the inhaler puffs the dose into  If you have any further questions, ask your doctor or pharmacist. instructions, based on previous asthma therapy. your mouth. Carry on until you have taken a deep  This medicine has been prescribed for you. Do not pass it on to others. The usual dose for Salamol Easi-Breathe is: It may harm them, even if their symptoms are the same as yours.  If any of the side effects gets serious, or if you notice any side effects Adults and the elderly:
4. Take the inhaler out of your mouth and hold not listed in this leaflet, please tell your doctor or pharmacist. For the best results with this medicine you should use it when required to your breath for 10 seconds or for as long as you relieve symptoms of asthma and other chest conditions with similar comfortably can. Then breathe out slowly. In this leaflet
symptoms, such as wheezing, breathlessness and tightness in your 1. What Salamol Easi-Breathe is and what it is used for
chest. Take one puff as a starting dose. This may be increased to two 5. After you have used your inhaler, hold it upright 2. Before you use Salamol Easi-Breathe
3. How to use Salamol Easi-Breathe
To prevent asthma caused by exercise or allergens (e.g. house dust, 4. Possible side effects
pollen etc.), take two puffs 10-15 minutes before you exercise or before 6. If you need to take more than one puff, close 5. How to store Salamol Easi-Breathe
the cap, wait about one minute and then start 6. Further information
Do not take more than eight puffs in 24 hours. Wait 4 hours between doses. 1. What Salamol Easi-Breathe is and what it is used for
7. What to do if your inhaler stops working Children:
Salamol Easi-Breathe contains salbutamol sulphate, which belongs to a To relieve asthma symptoms such as wheezing, breathlessness and If your inhaler does not work properly, unscrew the group of medicines called beta agonists. Salbutamol is a bronchodilator tightness in your chest, take one puff as a starting dose. This may be top and press the can down. It is important to and works by widening the airways in your lungs to allow air in and out. clean your inhaler regularly to prevent deposits This helps you to feel less breathless, wheezy or tight-chested. To prevent asthma caused by exercise or allergens (e.g. house dust, pollen from the aerosol building up and blocking the etc.), take one puff 10-15 minutes before you exercise or before exposure inhaler. If your inhaler does not seem to be to known allergens. This can be increased to two puffs if necessary. working, it may be that your inhaler has become Salamol Easi-Breathe is used to treat asthma. It can also be used to blocked and you should clean your inhaler as prevent asthma caused by exercise or asthma caused by a reaction to Do not take more than four puffs in 24 hours. Wait 4 hours between doses. allergens (substances to which you are allergic to e.g. house dust, pollen, If your inhaler still does not work, return it to your dog hair, cat hair, cigarette smoke, etc.) or to treat breathing difficulties Instructions for use
associated with reversible airways obstruction (e.g. chronic obstructive Important
pulmonary disease [COPD]). This type of medicine is known as a Before using this medicine, please read this leaflet carefully and follow 'reliever'. You may be using another medicine to prevent you from having an asthma attack ("controller medication"). You can safely use your An adult should always supervise children when they use Salamol Easi- controller medication with this medicine. Cleaning the inhaler
You must keep your inhaler clean, especially in the 2. Before you use Salamol Easi-Breathe
mouthpiece. This will prevent deposits from the Do not use Salamol Easi-Breathe
aerosol building up. To prevent your inhaler  If you are allergic to salbutamol (active ingredient) or any of the other  Tell your doctor if your asthma gets worse or if this medicine does not becoming blocked you must clean it once a week. provide as much relief from your asthma as before.  You should sit or stand upright while taking this medicine. It is important A. To clean your inhaler unscrew and remove the Take special care with Salamol Easi-Breathe
when using this medicine to hold the inhaler upright as it will not work if top of the inhaler. Keep this top dry at all times. Let your doctor know if you suffer from thyroid problems, diabetes, serious heart disease, fast irregular heart rhythms or high blood pressure. This inhaler is designed to make it easier for you to use. It is a breath- Tell your doctor if you have a condition known as hypoxia (a disorder operated inhaler. This means it only releases a dose when you breathe in. B. Remove the metal can from the bottom of the where the oxygen level in the blood is low and may cause inhaler. Do not put the metal can into water. breathlessness) or if you have a history of heart disease or angina. Using the Inhaler
Consult a doctor immediately if your usual treatment is not working or you To open the inhaler, fold down the cap which fits over the mouthpiece. 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 Taking other medicines
C. Rinse the bottom of the inhaler with warm running Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines that you obtained without D. Shake off any excess water and dry the bottom of If you are having treatment that requires a general anaesthetic, please tell the inhaler thoroughly (leave to dry overnight if your anaesthetist that you are taking Salamol Easi-Breathe. Do not use possible) but do not use direct heat. Put the can this medicine for at least six hours before the intended anaesthetic. back into the bottom of the inhaler. Close the cap and screw the top and bottom parts of your inhaler 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 Failure to allow the mouthpiece to dry properly
will result in an increase in blockage problems.
The following medicines may influence the effect of Salamol Easi-Breathe:  Some medicines for the treatment of high blood pressure such as beta-  Medicines used to treat heart disease (e.g. digoxin); Medicines for the treatment of depression (from the monoamine Test spray the inhaler by firing two shots into the air before you use it for If you need to use your inhaler before it is dry, shake off any water from oxidase inhibitor group e.g. phenelzine or tricyclic antidepressants e.g. the first time and also if you have not used it for a period of five days or the bottom of the inhaler and put the can back in. Test spray the inhaler more. To test spray your inhaler, unscrew the top of it so you can see the by firing two puffs in the air as previously described above. 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 Screw the top and bottom parts of your inhaler together and take your Medicines for the treatment of chronic alcoholism (e.g. disulfiram); usual dose. When you have taken your usual dose, wash and dry your If you use more Salamol Easi-Breathe than you should
6. FURTHER INFORMATION
What Salamol Easi-Breathe contains
It is important that you take your dose as stated on the pharmacist's
 The active substance is salbutamol sulphate. label or as advised by your doctor. You should not increase or
Each actuation contains100 micrograms salbutamol (as salbutamol decrease your dose without seeking medical advice.
The other ingredients are ethanol anhydrous and the propellant If you accidentally take a larger dose than recommended, you may notice norflurane. This medicine does not contain any CFCs. 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. What Qvar Easi-Breathe Inhaler looks like and contents of the pack:
These effects usually wear off in a few hours, but you should tell your A pressurised metal canister enclosed in a blue plastic casing with a dark doctor as soon as possible. Your doctor may want to check your blood Each pack contains single Inhaler which supplies 200 actuations. 4. Possible side effects
Product Licence Holder and Manufacturer
Like all medicines Salamol Easi-Breathe can cause side effects, although Norton Waterford (IVAX Pharmaceuticals Ireland), Waterford, Ireland. Contact your doctor immediately if you experience allergic (hypersensitivity) reactions. These include Teva Czech Industries s.r.o., Opava-Komarov, Czech Republic.  Wheezing, coughing and difficulty in breathing;  Rash, swelling of the face and throat, and a fall in blood pressure. Procured from within the EU by Product Licence holder Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, 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). Common (less than 1 in 10 patients, but more than 1 in 100):
 Feeling tense and getting headaches (which are more likely with higher Salamol Easi- Breathe is a trademark of Norton Healthcare Limited. Uncommon (less than 1 in 100 patients, but more than 1 in 1,000):
Rare (less than 1 in 1,000, but more than 1 in 10,000):
 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 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; Very rare (less than 1 in 10,000):
 Trembling (particularly your hands). Not known:
 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 If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist, but do not stop using this medicine unless you are told to do so. 5. How to store Salamol Easi-Breathe
Keep out of the sight and reach of children.
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 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 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.

Source: http://doctorfox.multipharmacy.com/pdf/salbutamol-inhalers/PIL-Salamol-Easi-Breathe-inhaler.pdf