Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Norton Healthcare Ltd., T/A IVAX Pharmaceuticals UK, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom
The symptomatic treatment of asthma and other conditions with associated reversible airways obstruction. For relief of wheezing and shortness of breath, Salamol Easi-Breathe CFC-Free Inhaler should be used on an as required basis.
Prevention of asthma attacks induced by exercise or exposure to allergens.
Salamol Easi-Breathe CFC-Free Inhaler can be used as relief medication to manage mild, moderate and severe asthma, provided its use does not delay the introduction and regular use of inhaled corticosteroid therapy, where necessary.
Salamol Easi-Breathe CFC-Free Inhaler is indicated in adults, adolescents and children aged 4 to 11 years. For infants and children under 4 years of age, see section 5.1.
For optimum results in most patients Salamol Easi-Breathe CFC-Free Inhaler should be used as required.
One inhalation (100 micrograms) may be administered as a single minimum starting dose. This may be increased to two inhalations (200 micrograms) if necessary.
Two inhalations (200 micrograms) should be taken 10-15 minutes before challenge.
On demand use of Salamol Easi-Breathe CFC-Free Inhaler should not exceed 8 inhalations (800 micrograms) in any 24 hours. Inhalations should not usually be repeated more often than every 4 hours. Reliance on such frequent supplementary use, or a sudden increase in dose indicates poorly controlled or deteriorating asthma.
For all patients, four hours should be allowed between each dose.
The usual dosage for children under the age of 12 years: one inhalation (100 micrograms). The dose may be increased to two inhalations (200 micrograms) if required.
Children aged 12 years and over: Dose as per adult population.
The usual dosage for children under the age of 12 years: one inhalation (100 micrograms) before challenge or exertion. The dose may be increased to two inhalations (200 micrograms) if required.
Children aged 12 years and over: Dose as per adult population.
The usual dosage for children under the age of 12 years: up to two inhalations 4 times daily.
Children aged 12 years and over: Dose as per adult population.
No need to adjust the dose.
For Inhalation Use.
Salamol Easi-Breathe administration in children should be supervised by an adult.
Patients should sit wait four hours between doses.
Patients should sit, or stand, upright during inhalation. It is also important that the inhaler should be held in an upright position, as the inhaler works correctly only in a vertical position.
The aerosol spray is inhaled through the mouth into the lungs. The inhaler should be tested by spraying the inhaler by firing two shots into the air before first use, and if the inhaler has not been used for a period of five days or longer.
Use of the Inhaler:
1. Patients should shake the inhaler vigorously.
2. The inhaler must be held upright. Patients should open it by folding down the cap which fits over the mouthpiece.
3. Patients should exhale normally, and place the mouthpiece in their mouth with their lips closed around it. They should hold the inhaler upright and make sure that their hand is not blocking the airholes. Inhalation through the mouthpiece should be slow and deep. Patients should be advised not to stop breathing when the inhaler puffs the dose into their mouth. After that, they should carry on until they have taken a deep breath.
4. Patients should remove the inhaler from their mouth and hold their breath for 10 seconds or as long as they comfortably can. Then, exhale slowly.
5. After using the inhaler, patients should hold it upright and close the cap immediately.
6. If more than one puff is needed, patients should close the cap, wait about one minute and then start again from step 1.
Patients should be advised to clean the inhaler once a week, especially in the mouthpiece to prevent deposits from the aerosol building up.
As with most inhaled medicinal products in pressurised containers, the therapeutic effect of this medicinal product may decrease when the container is cold.
The container should not be punctured, broken or burnt, even when apparently empty.
The metal container must not be put into water.
Full instructions for use are given in the Patient Information Leaflet which should be read carefully by the patient before use.
Cleaning of the Inhaler:
Patients must clean the inhaler once a week.
A. Unscrew and remove the top of the inhaler. Patients should be advised to keep this top dry all the time
B. Remove the metal from the bottom of the inhaler. Patients should be advised not to put the canister into water
C. Rinse the bottom of the inhaler with warm running water for at least 30 seconds
D. Shake off any excess water and dry the bottom of the inhaler thoroughly (overnight if possible). It is important to advise patients not to use direct heat. Patients should put the can back into the bottom of the inhaler. Then, close the cap and screw the top and bottom parts of their inhaler back together.
Overdosage may result in skeletal muscle tremor, tachycardia, tenseness, headache and peripheral vasodilatation. The preferred antidote for overdosage with salbutamol is a cardioselective ß-adrenoceptor blocking agent. Beta-blocking drugs should be used with caution in patients with a history of bronchospasm, as these drugs are potentially life-threatening. Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored.
Hyperglycaemia and agitation have also been reported following overdose with salbutamol.
3 years.
Do not store above 25°C. Do not refrigerate or freeze.
A pressurised aluminium container with a metering valve and breath-operated actuator.
Each pack contains either:
Single pack with one Easi-Breathe MDI with 200 metered doses.
Twin pack with one Easi-Breathe MDI and one refill canister, each containing 200 metered doses (2 × 200, for Germany only).
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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