Special Warning : אזהרת שימוש

4.4   Special Warnings and Precautions for Use
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 patients are at risk of severe attacks and even death. Physicians should consider using oral corticosteroid therapy and/or the maximum recommended dose of inhaled corticosteroid in those patients.

Patients should seek medical advice if treatment with Ventolin syrup becomes less effective.

The dosage or frequency of administration should only be increased on medical advice.

Patients taking Ventolin syrup may also be receiving short-acting inhaled bronchodilators to relieve symptoms.

The management of asthma should normally follow a stepwise programme, and patient response should be monitored clinically and by lung function tests.

Increasing use of bronchodilators in particular short-acting inhaled beta2- 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 they need more inhalations than usual.

In this situation patients should be reassessed and consideration given to the need for increased anti-inflammatory therapy (e.g. higher doses of inhaled corticosteroids or a course of oral corticosteroid). Severe exacerbations of asthma must be treated in the normal way.

Patients should be warned that if either the usual relief with Ventolin oral preparations is diminished or the usual duration of action reduced, they should not increase the dose or its frequency of administration, but should seek medical advice.

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. Patients with underlying severe heart disease (e.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.

Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis.

Potentially serious hypokalaemia may result from beta-2 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 derivatives, steroids, diuretics and by hypoxia. It is recommended that serum potassium levels are monitored in such situations.

In common with other β-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 corticosteroids can exaggerate this effect.

Ventolin Syrup contains 5.6 mg sodium per 5 ml dose, equivalent to 0.28% of the WHO recommended maximum daily intake of 2 g sodium in an adult.

Ventolin syrup is sugar free.
Ventolin Syrup contains 10.00 mg sodium benzoate per 5 ml dose.
Ventolin Syrup contains 1.9 mg of propylene glycol in each 5 ml dose.
Ventolin Syrup contains 0.00003325 mg benzyl alcohol in each dosage unit.
Benzyl alcohol may cause allergic reactions. Patients with liver or kidney disease and pregnant or breastfeeding patients should be advised that large amounts of benzyl alcohol can build up in the body and may cause metabolic acidosis.

Effects on Driving

4.7   Effects on Ability to Drive and Use Machines
None known.