SALBULIN Inhalation powder Ref.[50248] Active ingredients: Salbutamol

Bronchodilators should not be the only or main treatment in patients with persistent asthma. Severe asthma requires regular medical assessment, including lung function testing, as patients are at risk of severe attacks and even death. The use of brochodilators such as Salbulin MDPI Novolizer 100 micrograms should not delay the introduction and regular use of inhaled corticosteroid therapy.

Daily patient self assessment of asthma control following instructions on the use of Salbulin MDPI Novolizer 100 micrograms and any other drugs required for the management of asthma is important in order that the course of the disease can be followed and the success of both bronchodilator and anti-inflammatory therapy monitored. The patient should be instructed in the regular measurement of peak expiratory flow rate (PEFR) using a portable peak flow meter.

If asthma control does not improve satisfactorily or deteriorates, or if the short-acting relief bronchodilator treatment becomes less effective, or more inhalations than usual are required, medical advice must be sought in order that the clinical condition can be re-assessed and therapeutic management revised appropriately. In this situation anti-inflammatory therapy may be required, the dose of anti-inflammatory therapy may need to be increased, or a short course of oral glucocorticoids may be needed. Increasing use of bronchodilators and in particular short-acting inhaled beta₂ adrenergic agonists to relieve symptoms indicates deterioration of asthma control. Patients should be advised that a sudden and increasing deterioration of asthma symptoms can be life-threatening. Therefore, medical assistance must be sought immediately.

The dose and frequency of inhalation of short-acting beta₂ agonists should only be increased following medical advice and if a previously effective dose fails to give the expected relief the patient should seek medical advice. Exceeding the prescribed dose can be dangerous (see section 4.9). If acute asthma symptoms are not relieved or gets even worse following a second inhalation, or if patients are unable to trigger the Novolizer device during an acute asthma attack, medical assistance should be sought immediately.

Potentially serious hypokalaemia may result from beta₂-agonist therapy, mainly from parenteral and nebulised administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment with xanthine derivates, steroids, and diuretics. Serum potassium levels should be monitored in such situations.

Inhalation of high doses of salbutamol can increase the blood glucose level. Therefore, blood glucose levels in diabetic patients should be monitored closely.

In the following cases, salbutamol should only be used with caution and if strictly indicated:

• serious cardiac disorders, in particular recent myocardial infarction
• coronary heart disease, hypertrophic obstructive cardiomyopathy and tachyarrhythmia
• severe and untreated hypertension
• aneurysm
• hyperthyroidism
• diabetes which is difficult to control
• pheochromocytoma

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

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 the use of high doses of salbutamol. This is reversible on reducing the dose of salbutamol.

This medicinal product contains lactose. The amount of lactose contained in Salbulin MDPI Novolizer does not normally cause problems in lactose intolerant people.

However, in patients with profound enzyme deficiency, lactose intolerance has been reported very rarely following inhalation of powder containing lactose.

Inhaled salbutamol preparations are not indicated for threatened abortion.

Salbutamol and non-selective beta-receptor blocking drugs should not usually be prescribed together. Administration of beta -receptor blocking drugs to patients with asthma may cause severe bronchoconstriction.

When administering halogenated anaesthetics, e.g. halothane, methoxyflurane or enflurane, to patients treated with salbutamol there is an increased risk of severe dysrhythmia and hypotension. Salbutamol should not used for at least 6 hours prior to the use of halogenated anaesthetics.

Treatment with salbutamol can lead to hypokalaemia (see 4.4 Special warning and precautions for use and 4.8 Undesirable effects). This effect may be potentiated by the concomitant administration of other drugs, in particular xanthine derivatives, glucocorticoids, diuretics and cardiac glycosides (digoxin). Serum potassium levels should be monitored in these situations.

Monoamine oxidase inhibitors and tricyclic antidepressants may increase the risk of cardiovascular side effects.

Pregnancy

Studies in animals have shown reproductive toxicity (see section 5.3). Safety in pregnant women has not been established. No controlled clinical trials with salbutamol have been conducted in pregnant women. Rare reports of various congenital anomalies following intrauterine exposure to salbutamol (including cleft palate, limb defects and cardiac disorders) have been received. Some of the mothers were taking multiple medications during their pregnancies. Salbutamol MDPI Novolizer should not be used during pregnancy unless clearly necessary.

Breast-feeding

As salbutamol is probably secreted in breast milk, its use in nursing mothers required careful consideration. It is not known whether salbutamol has a harmful effect on the neonate, and so its use should be restricted to situations where it is felt that the expected benefit to the mother is likely to outweigh any potential risk to the neonate.

Fertility

There is no information on the effects of salbutamol on human fertility. There were no adverse effects on fertility in animals (see section 5.3).

No studies on the effects on the ability to drive and use machines have been performed.

Up to 10% of patients may experience adverse reactions. These reactions are dose-dependent.

The most commonly reported adverse reactions are: taste alteration (bad, unpleasant and unusual taste), mouth and throat irritation, fine tremor (usually of the hands), nausea, sweating, restlessness, headache and dizziness. These undesirable effects may subside on continuation of treatment within 1-2 weeks.

As with other inhalation therapies, in rare cases paradoxical bronchospasm may occur, with an immediate increase in wheezing after dosing. Paradoxical bronchospasm should be treated immediately with an alternative fast-acting inhaled bronchodilator and Salbulin MDPI Novolizer 100 micrograms discontinued immediately The patient should be assessed and, if necessary, alternative therapy instituted.

Hypersensitivity reactions such as rash, urticaria, dermatitis, pruritus and erythema have been observed. There have been very rare reports of angioedema (oedema of the face, lips, eyes and throat), bronchospasm, hypotension, collapse, thrombopenia and nephritis.

Tachycardia, with or without peripheral vasodilatation, may occur. In common with other β2 agonists, cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles), palpitations, angina pectoris, and blood pressure effects have been reported in association with the use of salbutamol, usually in susceptible patients.

There are also reports of the stimulating effects on the central nervous system after inhalation of salbutamol which manifest themselves in hyperactive behaviour, sleeping disturbances and hallucinations. These observations were predominantly made in children up to 12 years of age.

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, <1/1,000); Very rare (<1/10,000), Not known (cannot be estimated from the available data).

Lactose-monohydrate contains small amounts of milk proteins and can therefore cause allergic reactions.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Not applicable.