SALAMOL Pressurised inhalation, suspension Ref.[27689] Active ingredients: Salbutamol

Salbutamol should be administered cautiously to patients with thyrotoxicosis, coronary insufficiency, hypertrophic obstructive cardiomyopathy, arterial hypertension, known tachyarrhythmias, concomitant use of cardiac glycosides or diabetes mellitus.

Patients should be instructed in the proper use of the inhaler and their technique checked, to ensure that the active substance reaches the target areas within the lungs.

The management of asthma should normally follow a stepwise programme, and the patient’s response should be monitored clinically and by lung function tests. Increasing use of short-acting inhaled bronchodilators, in particular ß2-agonists to control symptoms, indicates deterioration of asthma control. Under these conditions, the patient’s therapy plan should be reassessed. Asthmatic patients whose conditions deteriorates despite salbutamol therapy, or where a previously effective dose fails to give relief for at least three hours, should seek medical advice in order that any necessary additional steps may be taken.

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

Patients requiring long term management with Salamol Easi-Breathe CFC-Free Inhaler should be kept under regular surveillance.

Care should be taken when treating acute asthma attacks or exacerbation of severe asthma as increased serum lactate levels, and rarely, lactic acidosis have been reported after the use of high doses of salbutamol have been used in emergency situations this is reversible on reducing the dose of salbutamol

Cardiovscular 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, arrhythmias 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 either respiratory or cardiac in origin.

Potentially serious hypokalaemia may result from ß2-agonist therapy mainly from parenteral and nebulised administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids and diuretics and by hypoxia. It is recommended that serum potassium levels are monitored in such situations.

In common with other beta-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 glucocorticoids can exaggerate this effect.

As with other inhalation therapies, the potential for paradoxical bronchospasm should be considered. If it occurs the preparation should be discontinued immediately and alternative therapy given. Solutions which are not of neutral pH may rarely cause paradoxical bronchospasm in some patients. Salbutamol and non-selective beta blocking drugs such as propranolol should not usually be prescribed together.

Propranolol and other non-cardioselective β-adrenoreceptor blocking agents antagonise the effects of salbutamol, and should not usually be prescribed together.

Monoamine oxidase inhibitors, tricyclic antidepressants, digoxin: risk of increased cardiovascular effects.

Patients should be instructed to discontinue salbutamol at least 6 hours before an intended anaesthesia with halogenic anaesthetics, wherever possible.

Hypokalaemia occurring with β₂-agonist therapy may be exacerbated by treatment with xantines, steroids, diuretics and long-term laxatives.

Because of the content of ethanol, there is theoretical potential for interaction in patients taking disulfiram or metronidazole.

Pregnancy

Salamol Easi-Breathe CFC-Free Inhaler during pregnancy should only be used in situations where the expected benefit to the mother is thought to outweigh any risk to the foetus.

Salbutamol inhalation is contraindicated in treatment of threatened abortion or premature labour.

Salamol Easi-Breathe CFC-Free Inhaler

There is no documented evidence of the use of salbutamol formulated with propellant HFA-134a in pregnant women.

Propellant HFA-134a:

There is no documented evidence of the use of propellant HFA-134a in pregnant women. Pregnant animals exposed to high levels of HFA-134a showed no evidence of any adverse effects.

Salbutamol:

Experience on the use of beta-sympathomimetics during early pregnancy indicates no harmful effect at the doses ordinarily used for inhalation therapy. High systemic doses at the end of pregnancy can cause inhibition of labour and may induce β2-specific foetal/neonatal effects like tachycardia and hypoglycaemia. Inhalation therapy at recommended doses is not expected to induce these harmful side effects at the end of pregnancy.

Breastfeeding

Salamol Easi-Breathe CFC-Free Inhaler should only be used in lactation in situations where the expected benefit to the mother is thought to outweigh any risk to the neonate.

Salamol Easi-Breathe CFC-Free Inhaler

There is no documented evidence of the use of salbutamol formulated with propellant HFA-134a in lactating women.

Propellant HFA-134a:

There is no documented evidence of the use of propellant HFA-134a in lactating women. Lactating animals exposed to high levels of HFA-134a showed no evidence of any adverse effects.

Salbutamol:

Salbutamol may be secreted in breast milk. It is not known whether salbutamol has a harmful effect on the neonate.

Fertility

There is no information on the effects of salbutamol on human fertility.

No studies on the effects on the ability to drive and use machines have been performed.

Based on the MedDRA system organ class and frequencies, adverse events are listed in the table below.

Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000, including isolated reports), not known (cannot be estimated from the available data).

As with other inhalation therapies, paradoxical bronchospasm may occur immediately after dosing. Salamol Easi-Breathe CFC-Free Inhaler should be discontinued immediately, the patient reassessed and treated immediately with another presentation or a different fast-acting inhaled bronchodilator.

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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.