VENTOLIN Syrup Ref.[28325] Active ingredients: Salbutamol

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.

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 (eg. 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. It is recommended that serum potassium levels are monitored is 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.

This medicine contains less than 1 mmol sodium (23 mg) in each 5 mL dose, that is to say essentially ‘sodium-free’.

This medicine contains 10 mg sodium benzoate in each 5 mL dose.

This medicine contains 0.00000004 mg benzyl alcohol in each 5 mL dose. Benzyl alcohol may cause allergic reactions.

Ventolin syrup is sugar free.

Ventolin syrup and non-selective beta-blocking drugs, such as propranolol, should not usually be prescribed together.

Pregnancy

Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
As with the majority of drugs, there is little published evidence of its safety in the early stages of human pregnancy, but in animal studies there was evidence of some harmful effects on the foetus at very high dose levels.

Breast-feeding

As salbutamol is probably secreted in breast milk its use in nursing mothers requires 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).

None known.

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.

Rare: Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles

Unknown: Myocardial ischaemia* (see section 4.4)

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. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia, Fax: +357 22608649, Website: www.moh.gov.cy/phs.

None known.

Ventolin syrup is sugar free. Dilution of Ventolin syrup with syrup BP or sorbitol solution is not recommended as this may result in the precipitation of the cellulose thickening agent. If dilution is required freshly prepared Purified Water BP should be used. The diluted mixture must be protected from light and stored below 25°C.