VENTOLIN

Posology Adults The minimum starting dose is 2mg three times a day given as 5ml syrup. The usual effective dose is 4mg (10ml syrup) three or four times a day, which may be increased to a maximum of 8mg (20ml syrup) three or four times a day if adequate bronchodilation is not obtained.

Elderly In elderly patients or in those known to be unusually sensitive to beta- adrenergic stimulant drugs, it is advisable to initiate treatment with the minimum starting dose. 5ml of syrup three times daily. This may be increased to 2mg as 5ml of syrup three or four times daily.

6 - 12 years: the minimum starting dose is 2mg as 5ml syrup three times daily. This may be increased to four times daily. Over 12 years: the minimum starting dose is 2mg three times daily given as 5ml syrup. This may be increased to 4mg as 10ml syrup three or four times daily.

Ventolin is well tolerated by children so that, if necessary, these doses may be cautiously increased to the maximum dose. For lower doses the syrup may be diluted with freshly prepared purified water BP. Method of administration Route of administration: oral

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, very rare and unknown 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 beta agonist therapy.

Nervous system disorders Very common:

Tremor.

Common:

Headache.

Very rare:

Hyperactivity.

Cardiac disorders Common:

Tachycardia, palpitations. 4) Vascular disorders Rare: Peripheral vasodilatation.

Musculoskeletal and connective tissue disorders Common:

Muscle cramps.

Very rare:

Feeling of muscle tension. * reported spontaneously in post-marketing data therefore frequency regarded as unknown Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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.

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. 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. v. formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion.