What it is and what it is used for

for should be ensured that, wherever possible, Salamol Easi-Breathe® is 2. What you need to know before you use Salamol Easi-Breathe® • have phaeochromocytoma (a certain disease of the adrenal medulla – the inner part of the adrenal gland). no longer used for at least 6 hours before the start of anaesthesia. 3. How to use Salamol Easi-Breathe® 4. Possible side effects Your inhaler does not have a dose counter. Your inhaler contains The blood sugar level can rise if Salamol Easi-Breathe® is inhaled 5. How to store Salamol Easi-Breathe® enough medicine for 200 puffs only (whether inhaled and/or at high doses. In patients with diabetes, blood sugar levels 6. Contents of the pack and other information released into the air for testing) and it contains a propellant gas should be closely monitored. 1. What Salamol Easi-Breathe® is and what it is to deliver the medicine. However, after 200 puffs, your inhaler Hypokalaemia (a reduction in blood potassium levels) may occur can continue to spray the gas but without the right dose of during high-dose treatment with Salamol Easi-Breathe®. This can used for salbutamol, so you cannot be sure you will receive any medicine be made even worse if used at the same time as other Effect after using 200 puffs. Methods of telling that the inhaler is especially methylxanthines (e.g. theophylline), Salamol Easi-Breathe® contains salbutamol sulfate, which belongs empty like shaking it, weighing it, or floating it in water, are not medicines, corticosteroids (cortisone-like medicines), diuretics (used to to a group of medicines called beta agonists. Salbutamol is a reliable. You should consider recording the number of puffs used. increase urine output) or digitalis glycosides (medicines used to bronchodilator and works by widening the airways in your lungs to You could also consider keeping a back-up inhaler. If you are heart failure), or if you also have hypoxaemia (low blood allow air in and out. This helps you to feel less breathless, wheezy using more than one inhaler, it is recommended to keep track of treat oxygen levels). Blood electrolyte monitoring is indicated, so that or tight-chested. the number of puffs used for each inhaler separately. potassium can be administered if necessary. Usage Special treatment instructions As with other inhaled treatments, a bronchial spasm (paradoxical Salamol Easi-Breathe® is used to treat asthma in adults, Treatment of asthma should follow a stepwise approach in bronchospasm) may occur after using Salamol Easi-Breathe®, with adolescents and children aged 4 to 11 years. It can also be used accordance with disease severity. an immediate increase in wheezing. In this case, a fast-acting to prevent asthma caused by exercise or asthma caused by a may be dangerous for patients to increase the use of bronchodilator should be inhaled immediately. Treatment with reaction to allergens (substances to which you are allergic to e.g. It Easi-Breathe® should be stopped at once and the treating house dust, pollen, dog hair, cat hair, cigarette smoke, etc.) or to beta2-agonists, such as Salamol Easi-Breathe®, of their own accord. Salamol If your breathlessness should suddenly get worse after inhalation doctor should be informed. He/she will decide whether further treat breathing difficulties associated with reversible airways measures are required. obstruction (e.g. chronic obstructive pulmonary disease [COPD]). (paradoxical bronchospasm), treatment should be discontinued Children This type of medicine is known as a 'reliever'. You may be using immediately and your treatment plan revised by the doctor. another medicine to prevent you from having an asthma attack Salbutamol should not be used as monotherapy in patients with The specific dosage recommendations for children aged 4 to 11 years should be observed (see section 3). persistent asthma. ("controller medication"). You can safely use your controller Elderly medication with this medicine. An increasing need for beta2-agonists, such as Salamol No special dosage adjustment is required in the elderly. In asthma, fast-acting bronchodilators including Salamol Inhaler Easi-Breathe®, is a sign of worsening disease. Other medicines and Salamol Easi-Breathe® should not be the main or only treatment. It is recommended that If, despite treatment, there is no satisfactory improvement or Tell your doctor or pharmacist if you are taking/using, have Salamol Inhaler should always be prescribed with an inhaled even worsening of the disease, the treatment plan must be corticosteroid (anti-inflammatory) medicine. reviewed by the doctor and, if necessary, reworked by combining recently taken/used or might take/use any other medicines. it with anti-inflammatories, adjusting the dose of pre-existing If you are having treatment that requires a general anaesthetic,

What you need to know before you take it

e anti-inflammatory therapy or co-administering other medicines. If please tell your anaesthetist that you are taking Salamol Salamol Easi-Breathe® breathlessness should develop suddenly or rapidly get worse, Easi-Breathe®. Do not use this medicine for at least six hours Do not use Salamol Easi-Breathe® you must seek medical help at once. before the intended anaesthetic.

• if you are allergic to salbutamol or any of the other Significantly exceeding the recommended doses (in particular Salbutamol can reduce the amount of potassium in your blood. If ingredients of this medicine (listed in section 6) single doses used in an acute attack, but also the total daily this happens, you may notice an irregular heartbeat, muscle
• if you unexpectedly go into early labour (premature labour) or the dose) can be dangerous because of possible cardiac side effects, weakness or cramp. This is more likely to happen if you use threatened abortion. especially in association with electrolyte imbalances (e.g., salbutamol with some medicines used to treat high blood Warnings and precautions hypokalaemia), and must therefore be avoided. pressure, other medicines used to treat breathing problems (e.g. Talk to your doctor, pharmacist or nurse before using Salamol steroids), stimulants (e.g. xanthines) and long-term laxatives. Effects on the heart and blood circulation system (cardiovascular Easi-Breathe® if you: effects) can occur with the use of sympathomimetics, including The following medicines may influence the effect of Salamol
• are hypersensitive to other sympathomimetics salbutamol. Based on data from post-marketing observational Easi-Breathe®:
• have any severe heart conditions, especially recent heart studies and from published literature, there is evidence to
• water tablets (diuretics) attack, coronary heart disease (coronary artery disease), suggest that myocardial ischaemia (a lack of oxygen to the heart • medicines for the treatment of chronic alcoholism (e.g. hypertrophic obstructive cardiomyopathy (chronic heart muscle) may rarely occur in association with salbutamol. disulfiram) muscle disease), tachycardia (increase in heart rate above Patients with underlying severe heart disease receiving
• the anti-microbial drug metronidazole. 100 beats per minute) and tachyarrhythmias (heart rhythm salbutamol should seek urgent medical help if they notice chest Beta-receptor blockers (used to lower blood pressure) disorders with increased heart rate) pain or symptoms of worsening heart disease. used at the same time, Salamol Easi-Breathe® and beta-receptor
• have severe and untreated hypertension (high blood pressure) To assess progression of disease and your response to treatment, If blockers will mutually weaken their respective effects, with the or an aneurysm (abnormal bulging of the blood vessel wall) administration of beta-receptor blockers posing a risk of causing daily self-monitoring as instructed by the doctor is important.
• are taking cardiac glycosides This is done, for example, by routinely measuring peak expiratory severe bronchospasms (bronchial spasms).

Antidiabetic agents (used to treat diabetes) The blood sugar-lowering effect of antidiabetics can be reduced during treatment with Salamol Easi-Breathe®. However, this is generally only to be expected at higher doses that are usual in systemic administration (as tablets or injection/infusion). Digitalis glycosides (cardiac glycosides) and antiarrhythmic agents An increased risk of side effects is possible if Salamol Easi-Breathe® is given at the same time as antiarrhythmic agents (e.g. digitalis/quinidine). Anaesthetics The use of halogenated anaesthetics (used in general anaesthesia), such as halothane, methoxyflurane or enflurane, must be expected to increase the risk of severe heart rhythm disorders and hypotension (reduction in blood pressure) in patients treated with Salamol Easi-Breathe® (see 2. 'What you need to know before you use Salamol Easi-Breathe®'). Sympathomimetics (medicines that act on the autonomic nervous system) If given at the same time, Salamol Easi-Breathe® and theophylline or other sympathomimetics may mutually enhance their respective effects, with an increased risk of side effects. In addition, substances which themselves enhance sympathomimetic effects, such as L dopa, L thyroxine, oxytocin or alcohol, can have an effect on cardiovascular regulation in interaction with Salamol Easi-Breathe®. Hypokalaemia (reduction in blood potassium levels) possibly triggered by Salamol Easi-Breathe® can be made even worse if you are also taking methylxanthines (e.g. theophylline), corticosteroids, diuretics or digitalis glycosides. Caution is required if you are being treated with ergot alkaloid-type substances, such as ergotamine, at the same time as Salamol Easi-Breathe®, as the mutual effect on the vasomotor system (vasodilatory regulation) is difficult to predict individually and may also lead to vasoconstrictor and vasodilator reactions (narrowing or widening of the blood vessels). If used at the same time, Salamol Easi-Breathe® and monoamine oxidase inhibitors or tricyclic antidepressants can trigger an increased effect of salbutamol on the cardiovascular system. Hypertensive reactions, causing a rise in blood pressure, may occur if procarbazine is given at the same time. 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. Salbutamol crosses the placental barrier. For humans, there is insufficient experience with regard to use during pregnancy. An increase in heart rate (tachycardia) and low blood sugar levels (hypoglycaemia) have been described in newborns with the use of salbutamol as a tocolytic agent. Animal studies have shown reproductive toxicity in rats at very high doses. The potential risk for humans is unknown.

Salamol Easi-Breathe® should not be used during pregnancy, especially during the first three months, unless strictly indicated. The same applies to its use at the end of pregnancy, due to the tocolytic effect, which delays labour. As salbutamol probably passes into human milk, its use during breast-feeding is recommended only after a careful risk/benefit assessment. Driving and using machines No studies have been carried out on the effects on the ability to drive and operate machinery. Salamol Easi-Breathe® contains ethanol This medicine contains 3.93 mg of alcohol (ethanol) in each metered dose. The amount in each metered dose of this medicine is equivalent to less than 0.1 ml beer or wine. The small amount of alcohol in this medicine will not have any noticeable effects.

How to take it

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. Salamol Easi-Breathe® should be used as required rather than regularly. If your asthma is active (for example you have frequent symptoms or flare ups, such as breathlessness that makes speaking, eating or sleeping difficult, cough, wheezing, tight chest or limited physical ability), you should tell your doctor right away who may start or increase a medicine to control your asthma such as an inhaled corticosteroid. Tell your doctor as soon as possible if your medicine does not seem to be working as well as usual (for example you need higher doses to relieve your breathing problems or your inhaler fails to give relief for at least 3 hours) as your asthma may be getting worse and you may need a different medicine. If you use Salamol Easi-Breathe® more than twice a week to treat your asthma symptoms, not including preventive use before exercise, this indicates poorly controlled asthma and may increase the risk of severe asthma attacks (worsening of asthma) that can have serious complications and may be life-threatening or even fatal. You should contact your doctor as soon as possible to review your asthma treatment.

If you use a medicine against inflammation of your lungs daily, Closed Open e.g., "inhaled corticosteroid", it is important to continue using it regularly, even if you feel better. Air Holes Use in children and adolescents Top The usual dose for children under the age of 12 years to relieve asthma symptoms such as wheezing, breathlessness and tightness in the chest, is one puff as a starting dose. This may be Cap 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 (along with regular asthma anti-inflammatory medicine – inhaled corticosteroid) is up to 2 puffs, 4 times a day. 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 Do not take more than eight puffs in 24 hours. Wait 4 hours period of five days or more. To test spray your inhaler, unscrew between doses. the top of it so you can see the metal can inside. Open the cap, Instructions for use shake the inhaler and spray the aerosol by The inhaler does not have a dose counter, you can consider pressing the can with your finger or thumb. recording the number of puffs you are taking. If you are using Close the cap and put the top back on. more than one inhaler, it is recommended to keep track of the 1 1. Shake the inhaler vigorously. number of doses for each inhaler separately. 2. Hold the inhaler upright and open it by Important folding down the cap which fits over the Before using this medicine, please read this leaflet carefully and mouthpiece. follow the instructions. 3. Breathe out normally as far as you An adult should always supervise children when they use comfortably can. Then hold the Salamol Easi-Breathe®. mouthpiece firmly between your lips. Always remember the following: Hold the inhaler upright and make sure

• Wait four hours between doses. that your hand is not blocking the
• Tell your doctor if your asthma gets worse or if this medicine 2 airholes. Breathe in slowly and deeply does not provide as much relief from your asthma as before. through the mouthpiece. Don't stop
• You should sit or stand upright while taking this medicine. It breathing when the inhaler puffs the is important when using this medicine to hold the inhaler dose into your mouth. Carry on until you upright as it will not work if it is not held in this position. have taken a deep breath. This inhaler is designed to make it easier for you to use. It is a 4. Take the inhaler out of your mouth and breath-operated inhaler. This means it only releases a dose when hold your breath for 10 seconds or for you breathe in. as long as you comfortably can. Then breathe out slowly. Using the Inhaler 5. After you have used your inhaler, hold it 3 Opening upright and close the cap immediately. To open the inhaler, fold down the cap which fits over the 6. If you need to take more than one puff, mouthpiece. 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 4 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 A 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.

B

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

C

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.

D

Failure to allow the mouthpiece to dry properly will result in an increase in blockage problems.

happens, you may notice an irregular heartbeat, muscle If you need to use your inhaler before it is dry, shake off any weakness or cramp) 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 • Increase in lactate levels and acid levels in the blood (you may experience symptoms such as persistent nausea and described above. Screw the top and bottom parts of your inhaler vomiting, unexplained tiredness, shortness of breath and together and take your usual dose. When you have taken your rapid breathing, cold or blue hands and feet) usual dose, wash and dry your inhaler again as described above.

• sleep disturbances and sensing things that are not real If you use more Salamol Easi-Breathe® than you should
• increased blood flow to your extremities (peripheral It is important that you take your dose as stated on the dilatation) pharmacist's label or as advised by your doctor. You should • nausea, vomiting and dry and sore mouth. not increase or decrease your dose without seeking Very rare: may affect up to 1 in 10,000 people: medical advice.
• hypersensitivity reactions including itching, hives (urticaria), If you accidentally take a larger dose than recommended, you swelling of the mouth and throat region (angioedema), skin may notice that your heart is beating faster than usual, that you rash (exanthema), bronchial spasm (bronchospasm), drop in feel shaky or tense, you may have a headache and your skin may blood pressure and collapse. look flushed and feel hot. These effects usually wear off in a few
• difficulty in sleeping (insomnia); hours, but you should tell your doctor as soon as possible. Your
• heart rhythm disorders, including atrial fibrillation, increase in doctor may want to check your blood potassium levels. heart rate (supraventricular tachycardia) and irregular pulse

Possible side effects

(ventricular extrasystoles) and chest tightness (anginal complaints). Like all medicines, this medicine can cause side effects, although

• bronchial spasm (paradoxical bronchospasm) not everybody gets them.
• itching of your skin; Contact your doctor immediately if you experience allergic
• trembling (particularly your hands). (hypersensitivity) reactions. These include Rarely, micturition (urination) disorders, heartburn and increases
• wheezing, coughing and difficulty in breathing; or decreases in blood pressure can occur.
• rash, swelling of the face and throat, and a fall in blood Additional side effects in children pressure.
• Sleep disturbances and sensing things that are not real have You might collapse in very rare circumstances. been reported. If you experience any of these side effects or if they occur
• Hyperactivity. suddenly after using salbutamol you should stop using your Reporting of side effects medication straightaway and tell your doctor immediately. If you get any side effects, talk to your doctor, pharmacist or Allergic reactions to salbutamol are very rare (occurring in less nurse. This includes any possible side effects not listed in this than 1 in 10,000 patients). leaflet. You can also report side effects directly via the Yellow Other side effects: Card Scheme at: www.mhra.gov.uk/yellowcard or search for Common: may affect up to 1 in 10 people MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on
• high blood glucose levels the safety of this medicine.
• feeling tense and getting headaches (which are more likely with higher doses)

How to store it

Salamol Easi-Breathe®

• feeling shaky (muscle tremors) Keep this medicine out of the sight and reach of children.
• dizziness Do not use this medicine after the expiry date which is stated on
• rapid heartbeat. the label and carton after EXP. The expiry date refers to the last Uncommon: may affect up to 1 in 100 people day of that month.
• restlessness Do not store above 25°C.
• forceful heartbeat that may be rapid or irregular Do not refrigerate or freeze. If this medicine gets very cold,
• poor blood circulation to the heart muscle (myocardial remove the metal can from the inhaler and warm it in your hands ischaemia) (see also 2. 'Warnings and precautions')
• irritation of the mouth or throat region, change in the sense for a few minutes before you use it. Do not warm the can in any other way. of taste Pressurised container. Do not puncture, break or burn the can,
• muscle pain (myalgia), muscle cramps. even if it seems empty. Rare: may affect up to 1 in 1,000 people Do not throw away any medicines via wastewater or household
• reduction in the amount of potassium in your blood (if this waste. Ask your pharmacist how to throw away medicines you

no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Salamol Easi-Breathe® contains

• The active substance is salbutamol sulfate equivalent to 100 micrograms of salbutamol in each puff (metered dose).
• The other ingredients are ethanol anhydrous (alcohol) and the propellant norflurane (HFA-134a). This medicine does not contain any CFCs. This medicine contains fluorinated greenhouse gases. Each inhaler contains 7.5 g of norflurane (HFA-134a) corresponding to 0,010725 tonne CO2 equivalent (global warming potential GWP = 1430). What Salamol Easi-Breathe® looks like and contents of the pack
• The name of your medicine is Salamol Easi-Breathe®CFC-Free Inhaler 100 micrograms Pressurised Inhalation Suspension.
• Each pack of Salamol Easi-Breathe® contains a single inhaler and can which supplies 200 metered doses.
• Twin pack with one Salamol Easi-Breathe® and one refill container, each containing 200 metered doses (2 x 200). Not all pack sizes may be marketed. Marketing Authorisation Holder: Norton Healthcare Ltd., T/A IVAX Pharmaceuticals UK, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom Manufacturer: IVAX Pharmaceuticals Ireland, IDA Industrial Park, Waterford, Ireland This leaflet was last revised in January 2026.

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