Selective ß2 - agonist

Salbutamol

Each actuation provides salbutamol 200 micrograms (metered dose) or 188 micrograms as emitted dose.

Inhalation powder administered from a multidose powder inhaler.

Pulvinal Salbutamol is indicated for the relief of symptoms of asthma, bronchospasm and/or reversible airways obstruction and for the prevention of exercise-and allergen-induced asthma.

Pulvinal Salbutamol is particularly suitable for the relief of symptoms in mild, moderate and severe asthma. The use of an inhaled 2-agonist must not delay the introduction of regular inhaled corticosteroid therapy.

Pulvinal Salbutamol is for inhalation use only.

Each inhalation of Pulvinal Salbutamol provides 200 micrograms of salbutamol.

Adults:

For the relief of asthma symptoms, including acute bronchospasm, and for managing intermittent episodes of asthma, one inhalation should be administered.

For prevention of exercise-or allergen-induced asthmatic symptoms, one inhalation should be taken 10-15 minutes before challenge.

There is no need to adjust the dosage in elderly patients.

Instructions for use –

Do not remove the cap protecting the inhaler until the moment of use.

Unscrew the protective cap and before twisting the inhaler, hold it upright and tap it gently against a hard surface to level the powder in the chamber.

Holding the inhaler upright press the blue button on the mouth piece and rotate the inhaler body anti-clockwise until the red mark on the body shows through the hole in the mouthpiece (dose-loading position).

While still holding the inhaler upright, rotate the inhaler body clockwise until the green mark on the body shows through the hole in the mouthpiece (dose-delivery position).

Breathe out deeply. While still holding the inhaler upright put the mouthpiece between your lips and breathe in through your mouth. Hold your breath for a few seconds.

To obtain full therapeutic benefit, it is essential that the patient follows the instructions for use (see patient information leaflet) carefully.

Children aged above 6 years:

One inhalation for the relief of asthma symptoms, including acute bronchospasm, for the management of episodic asthma, or 10-15 minutes before allergen exposure or exercise.

Use of Pulvinal Salbutamol should not exceed four inhalations (i.e. 800 micrograms) in 24 hours.

The bronchodilator effect of salbutamol lasts for a minimum of 4 hours, except in those patients whose asthma is worsening. Patients should be warned not to increase the dosage and to seek medical advice in case of worsening of their asthma symptoms. Frequent supplementary use of salbutamol or a sudden increase in dose is likely to indicate poorly controlled or deteriorating asthma.

Pulvinal Salbutamol is contra-indicated in patients with a history of hypersensitivity to either salbutamol or lactose.

Inhaled salbutamol preparations are not appropriate in the management of premature labour and in threatened abortion

The dosage and frequency of administration of inhaled salbutamol should only be increased on medical advice. If a previously effective dose of Pulvinal Salbutamol fails to provide relief lasting for a minimum of three hours, or in the event of increased use of the product, the patient should be advised to seek medical advice, as this may be indicative of deteriorating asthma. In situations where asthma control may appear to be deteriorating, patients should be re-assessed and consideration given to increasing anti-inflammatory therapy.

Patients with severe or unstable asthma are at risk of acute severe episodes and even death and should not be treated only or mainly with bronchodilators. Such patients may require regular medical assessment, including lung function testing, and may require treatment with the maximum recommended dose of inhaled corticosteroids and/or with oral corticosteroids.

Severe exacerbations of asthma must be treated in the usual way.

Salbutamol should be administered cautiously in patients affected by thyrotoxicosis. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Salbutamol should not be administered together with non-selective β-blockers. Concomitant administration of xanthine derivatives, diuretics or steroids may lead to severe hypokalaemia; serum potassium levels should be monitored carefully in such cases.

Tachycardia, with or without peripheral vasodilatation, may occur rarely.

Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles) have been reported in association with β₂–agonists, usually in susceptible patients.

As with all beta-adrenergic agonists administration of inhaled salbutamol may cause dose-related fine tremors of skeletal muscle.

Headaches have occasionally been reported.

There have been rare reports of muscle cramps.

As with any other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator and Pulvinal Salbutamol should be discontinued straightaway. The patient should be assessed and, if necessary, alternative therapy instituted.

Potentially serious hypokalaemia, which can be potentiated by hypoxia and therefore be worse in acute severe asthma, may result from β₂-agonist therapy. Therefore particular caution is advised in acute severe asthma.

As with other β-adrenergic drugs, also with salbutamol there have been rare reports of hyperactivity in children.

Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse have been reported very rarely.

Patients sensitive to the inhalation of a dry powder may occasionally develop throat irritation and cough; this can be minimised by rinsing the mouth after inhalation.

Chiesi Limited

(POM)

12 August 2009