AIROMIR AUTOHALER PRESSURISED INHALATION

Based on the MedDRA system organ class and frequencies, adverse reactions are listed in the table below. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to < 1/100), rare (≥1/10 000 to <1/1 000), very rare (≤1/10 000 including isolated reports) and not known (cannot be estimated from the available data).

4) Vascular disorders Rare Peripheral vasodilatation Rare Throat irritationRespiratory, thoracic and mediastinal disorders Very rare Paradoxical bronchospasm (with an immediate increase in wheezing after dosing) (As with other inhalation therapy, paradoxical bronchospasm may occur immediately after dosing.

) Gastrointestinal disorders Rare Mouth irritation, nausea, vomiting, dry mouth, sore mouth Skin and subcutaneous tissue disorders Very rare Pruritus Uncommon Myalgia, muscle crampsMusculoskeletal and connective tissue disorders Very rare Fine tremor (particularly of hands) 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Patients should be instructed in the proper use of the inhaler and their technique checked, to ensure that the active substance reaches the target areas within the lungs. Patients should be warned they may experience a different taste on inhalation compared to their previous inhaler.

The management of asthma should normally follow a stepwise programme, and the patient’s response should be monitored clinically and by lung function tests. Increasing use of short- acting bronchodilators, in particular ß2-agonists to control symptoms, indicates deterioration of asthma control.

Under these conditions, the patient’s therapy plan should be reassessed. Patients with persistent asthma should receive optimal anti-inflammatory basic therapy with corticosteroids. Sudden and progressive deterioration in asthma control is potentially life threatening and consideration should be given to increasing or starting oral and/or inhaler corticosteroid therapy.

In patients considered at risk, daily peak flow monitoring may be instituted. The dosage or frequency of administration should only be increased on medical advice. The patient should be advised to seek medical advice if a previously effective dose ceases to be effective for at least three hours, and/or their asthma seems to be worsening.

Patients requiring long-term management with Airomir Autohaler device should be kept under regular surveillance. Salbutamol should be administered cautiously to patients with thyrotoxicosis, coronary insufficiency, hypertrophic obstructive cardiomyopathy, arterial hypertension, tachyarrhythmias, in concomitant use of cardiac glycosides or diabetes mellitus.

Potentially serious hypokalaemia has been reported in patients taking ß2-agonist therapy mainly from parenteral and nebulised administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics, long-term laxatives and by hypoxia.

Extra care should therefore be taken if ß2-agonists are used in these groups of patients and it is recommended that serum potassium levels should be monitored in such situations. Care should be taken when treating acute asthma attacks or exacerbation of severe asthma as increased serum lactate levels, and rarely, lactic acidosis have been reported after high doses of salbutamol have been used in emergency situations.

9 Overdose). Unwanted stimulation of cardiac adrenoceptors can occur in patients taking ß2-agonist 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 ß-agonists.

g. ischaemic heart disease, arrhythmias 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 either respiratory or cardiac in origin.

As with other inhalation therapy, the potential for paradoxical bronchospasm should be considered. If this occurs, the Airomir Autohaler should be discontinued immediately and alternative therapy given. Solutions which are not of neutral pH may rarely cause paradoxical bronchospam in some patients.

Salbutamol and non-selective ß-antagonists such as propranolol should not usually be prescribed together. In common with other ß-agonists, salbutamol can induce reversible metabolic changes such as increased blood glucose levels. Patients with diabetes 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. Severe exacerbations of asthma must be treated in the normal way. Excipient(s) Ethanol The small amount of alcohol in this medicine will not have any noticeable effects.

1. Airomir Autohaler device is contraindicated for use in the management of premature labour and threatened abortion.