ASMAVENT CFC-FREE

For inhalation use.

ADULTS (including the elderly):

For the relief of acute asthma symptoms including bronchospasm and for the relief of wheezing, shortness of breath and attacks of acute dyspnoea, one inhalation (100 micrograms) may be administered as a single minimum starting dose.

This may be increased to two inhalations if necessary. To prevent exercise-induced or allergen-induced symptoms two inhalations should be taken 10-15 minutes prior to exercise or allergen exposure. For chronic therapy, two inhalations up to four times a day.

CHILDREN:

This product is not recommended for use in children 12 years of age and under. For optimum results, Asmavent® CFC-free Inhaler should be used as required. For all patients, the maximum recommended dose, when Asmavent® CFC-free Inhaler is used on demand as required for the relief of symptoms, should not exceed 8 inhalations in 24 hours.

Each dose should not usually be repeated more often than every 4 hours. However reliance on such frequent supplementary use, or a sudden increase in dose, or if a dose appears to be less effective than usual, indicates poorly controlled or deteriorating asthma.

Asmavent® CFC-free Inhaler cannot be used with any spacing device at this time. If a patient needs a spacing device an alternative product, which can be used with such a device, will need to be prescribed instead of Asmavent® CFC- free Inhaler.

Instructions for Use 1. The mouthpiece cover should be removed and the patient should check inside and outside to make sure that the mouthpiece is clean and that there is no dust, dirt or foreign objects. If it needs cleaning the instructions for cleaning outlined below should be followed.

If the inhaler gets very cold, patients should be instructed to take the metal canister out of the plastic actuator and warm it in their hands for a few minutes before use. Patients should never use anything else to warm it up. The inhaler should be shaken prior to use.

2. The inhaler should be held upright with the thumb on the base, below the mouthpiece. Patients should breathe out as far as is comfortable and then…. 3. Immediately place the mouthpiece in the mouth between the teeth, and close their lips around it.

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) and very rare (<1/10,000) including isolated reports.

Very common and common events were generally determined from clinical trial data. Rare and very rare events were generally determined from spontaneous data.

Immune system disorders Very rare:

Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse.

Metabolism and nutrition disorders Rare:

Hypokalaemia. Potentially serious hypokalaemia may result from β2 agonist therapy.

Psychiatric disorders Rare:

Sleep disturbances Nervous system disorders Common: Fine skeletal muscle tremor most obviously affecting the hands, headache.

Very rare:

Hyperactivity (in children).

Cardiac disorders Common:

Tachycardia with or without peripheral vasodilatation.

Uncommon:

Palpitations, Very rare: Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles) Unknown: Myocardial Ischaemia* Vascular disorders Rare: Peripheral vasodilatation.

Respiratory, thoracic and mediastinal disorders Very rare:

Paradoxical bronchospasm. As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator.

Patients’ inhaler technique should be checked to make sure that aerosol actuation is synchronised with inspiration of breath for optimum delivery of drug to the lungs. Patients should be warned that they may experience a different taste or feel on inhalation compared with their previous inhaler.

Bronchodilators are rarely the only or main treatment in patients with asthma and should not be the only or main treatment in patients with moderate, severe or unstable asthma. Asthma requires regular medical assessment, including pulmonary function tests, as patients with asthma are at risk of severe attacks and even death.

If symptoms persist following the introduction of a short-acting bronchodilator consideration must be given to the need for inhaled and/or oral corticosteroid therapy. Consideration may need to be given to using maximum recommended doses of inhaled corticosteroids and/or oral corticosteroids in patients with more severe disease.

The dose or frequency of administration of salbutamol should only be increased on medical advice. If a previously effective dose of inhaled salbutamol fails to give relief lasting for at least three hours, the patient should be advised to seek medical advice.

Increasing use of bronchodilators, in particular short-acting inhaled β2 agonists, to relieve symptoms, indicates deterioration of asthma control. The patient should be instructed to seek medical advice if short-acting relief bronchodilator treatment becomes less effective, or more inhalations than usual are required.

g. an increase in the dose of inhaled corticosteroids or a course of oral corticosteroids). Severe exacerbations of asthma must be treated in the normal way 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.

1. Unlike intravenous salbutamol and occasionally salbutamol tablets, inhaled salbutamol is not suitable for the treatment of uncomplicated premature labour and should not be used to treat threatened abortion.