EASYHALER SALBUTAMOL SULFATE

Posology Adults and Older people:

For the relief of acute bronchospasm and for managing intermittent episodes of asthma one inhalation (200 micrograms) may be administered as a single starting dose, this may be increased to two inhalations (400 micrograms). To prevent exercise-induced bronchospasm or allergen bronchospasm one inhalations (200 micrograms) should be taken before challenge, this dose (200 micrograms) may be repeated if necessary.

Paediatric Population:

Relief of acute bronchospasm Children aged 4 to 11 years 200 micrograms as required.

Children aged 12 years and over:

Dose as per adult population. Prevention of allergen or exercise-induced bronchospasm Children aged 4 to 11 years 200 micrograms before challenge or exertion.

Children aged 12 years and over:

Dose as per adult population. Chronic therapy Children aged 4 to 11 years 200 micrograms four times a day. On-demand use of Easyhaler Salbutamol Sulfate should not exceed four times daily. 4).

Children aged 12 years and over:

Dose as per adult population. On demand use of Easyhaler Salbutamol Sulfate should not exceed four inhalations (800 micrograms) in any 24 hour period. For optimum results in most patients Easyhaler Salbutamol Sulfate inhaler should be used regularly during asthmatic attacks.

The bronchodilator effect of each administration of inhaled salbutamol lasts for four hours, except in patients whose asthma is becoming worse. Such patients should be warned not to increase their usage of salbutamol, but should seek medical advice in case treatment with an inhaled and/or systemic glucocorticosteroid is indicated.

Method of administration For oral inhalation only. This preparation is particularly useful for patients unable to use metered dose inhalers properly and for patients in whom the use of an inhalation aerosol causes irritation of airways.

Inhaled salbutamol should be used only on as-needed basis at the lowest dose and frequency required. Precautions to be taken before handling or administering the medicinal product Instructions for use: The protective cover of the inhaler should be opened and the dust cap removed immediately prior to use.

The inhaler should be shaken vigorously up and down 3-5 times. Whilst holding the inhaler in an upright position, between the finger and thumb, press once until a click is heard. Let inhaler click back again whilst continuing to hold in an upright position.

Inhalation should take place from either a sitting or standing position. The patient should breathe out normally and place the mouthpiece between their teeth whilst using their lips to form a seal around the mouthpiece. Patients are instructed to perform a rapid and forced inhalation through the Easyhaler device.

After holding their breath for at least 5 seconds the patient can resume normal breathing. Patients should not to exhale into the device. The mouthpiece of the inhaler should be cleaned once a week using a dry cloth or tissue. Patients should be instructed in the proper use of their inhaler (see patient information leaflet) and children should always have adult supervision when using the device.

Illustrated instructions for use accompany each package.

The undesirable effects caused by normally used inhaled doses of Salbutamol are mild, typical for sympathomimetic agents, and they usually disappear with continued treatment. Adverse events are listed below by system organ class and frequency.

Frequencies are defined as: very common (≥1/10), common, (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data). 4), cough, irritation of mouth and throat which may be prevented by rinsing the mouth after inhalation.

Musculoskeletal and connective tissue and bone disorders: tremor muscle cramps, Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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, inhaled corticosteroids) should be advised to continue taking their anti-inflammatory medication even when symptoms decrease, and they do not require Salbutamol. Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma.

Severe asthma requires regular medical assessment including lung function testing as the patients are at risk of severe attacks and even death. Physicians should consider using oral corticosteroid therapy or the maximum use of inhaled corticosteroids.

Increasing use of bronchodilators, particularly short-acting inhaled ß2-agonists to relieve symptoms indicates deteriorating asthma control (especially if the peak expiratory flow rate value falls and/or becomes irregular), and patients should be warned to seek medical advice as soon as possible.

Overuse of short-acting beta-agonists may mask the progression of the underlying disease and contribute to deteriorating asthma control, leading to an increased risk of severe asthma exacerbations and mortality. , daytime symptoms, night-time awakening, and activity limitation due to asthma) for proper treatment adjustment as these patients are at risk for overuse of salbutamol.

In the event of a previous effective dose of inhaled salbutamol failing to give relief for at least three hours or if they need more inhalations than usual, the patient should be advised to seek medical advice as soon as possible. g.

higher doses of inhaled corticosteroids or a course of oral corticosteroids). A regular anti-inflammatory controller medication taken on a daily basis is required as soon as the patient needs inhaled Beta2-agonists more than twice a week.

Severe episodes of asthma must be treated in the normal way. As there may be adverse effects associated with excessive dosing, the dosage and frequency of administration should only be increased on medical advice. Salbutamol should be administered with caution in patients with thyrotoxicosis, cardiac insufficiency, hypokalaemia, myocardial ischaemia, tachyarrhythmia and hypertrophic obstructive cardiomyopathy.

Potentially serious hypokalaemia may result from ß2-agonist therapy, mainly from parenteral and nebulised therapy. Particular caution is advised in acute severe asthma, as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics and by hypoxia.

5). Rarely inhalation therapy may cause bronchospasm after dosing. In this event, treatment with Salbutamol must be immediately discontinued and, if need be, replaced with another therapy. Cardiovascular effects may be seen with sympathomimetic drugs, including salbutamol.

There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with salbutamol. g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving salbutamol should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease.

Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin. In common with other beta-adrenoceptor agonists, salbutamol can induce reversible metabolic changes such as increased blood glucose levels.

Diabetic patients may be unable to compensate for the increase in blood glucose and the development of ketoacidosis has been reported. Concurrent administration of glucocorticoids can exaggerate this effect. One dose contains less than 10 mg lactose, which probably does not cause symptoms in lactose intolerant patients.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1 (lactose monohydrate, which contains small amounts of milk proteins). Salbutamol inhalation is contraindicated in treatment of threatened abortion or premature labour.