SALBUTAMOL Tablets Ref.[7085] Active ingredients: Salbutamol

Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma.

Increasing use of bronchodilators in particular short-acting inhaled beta₂-agonists to relieve symptoms indicates deterioration of asthma control. If patients find that short acting relief bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought.

Salbutamol causes peripheral vasodilation which may result in reflex tachycardia and increased cardiac output

Hyperthyroidism

Salbutamol should only be administered cautiously to patients suffering from thyrotoxicosis after careful evaluation of the benefits and risks of treatment.

Constant monitoring of potassium levels in patients with severe asthma is essential, potentially serious hypokalaemia may result from beta₂-agonist therapy.

Diabetes

Administration of beta agonists is associated with a rise of blood glucose. Therefore blood glucose and lactate levels should be monitored in diabetics and diabetic treatment adjusted accordingly to meet the needs of the diabetic during tocolysis (see section 4.5). 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.

Cardiovascular effects may be seen with sympathomimetic drugs, including salbutamol. There is some evidence from post-marketing data and published literature of myocardial ischaemia associated with beta agonists.

Respiratory indications

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.

Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose – galactose malabsorption should not take this medicine.

Salbutamol tablets contain carmoisine (E122) which may cause allergic reactions

The effects of salbutamol may be altered by guanethidine, reserpine, methyldopa, tricyclic antidepressants and monoamine oxidase inhibitors.

There is an increased risk of hypokalaemia if high doses of theophylline or high doses of corticosteroids are given with higher doses of salbutamol.

Halogenated anaesthetics

Owing to the additional antihypertensive effect, there is increased uterine inertia with risk of haemorrhage; in addition, serious ventricular rhythm disorders due to increased cardiac reactivity, have been reported on interaction with halogenated anaesthetics. Treatment should be discontinued, whenever possible, at least 6 hours before any scheduled anaesthesia with halogenated anaesthetics.

Anti-diabetics

The administration of beta-agonists is associated with a rise of blood glucose, which can be interpreted as an attenuation of anti-diabetic therapy; therefore individual anti-diabetic therapy may need to be adjusted (see section 4.4).

Potassium depleting agents

Owing to the hypokalaemic effect of beta-agonists, concurrent administration of serum potassium depleting agents known to exacerbate the risk of hypokalaemia, such as diuretics, digoxin, methyl xanthines and corticosteroids, should be administered cautiously after careful evaluation of the benefits and risks with special regard to the increased risk of cardiac arrhythmias arising as a result of hypokalaemia (see section 4.4).

Pregnancy

Salbutamol should only be used during pregnancy if it is considered essential by the physician.

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.

None known.

The frequencies of adverse reactions are ranked according to the following MedDRA convention: Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot beestimated from the available data).

Immune system disorders

Very rare: Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse

Metabolism and nutrition disorders

Not known: Lactic acidosis, Hypokalaemia

Nervous system disorders

Not known: Headaches, Myoclonus

Cardiac disorders

Not known: Peripheral vasodilation and compensatory increase in heart rate*, Cardiac arrhythmias, Myocardial ischemia**

Respiratory, thoracic and mediastinal disorders

Not known: Pulmonary oedema

Musculoskeletal and connective tissue disorders

Not known: Skeletal muscle tremor***, Tense feeling****

* With doses of salbutamol higher than those recommended or in patients who are unusually sensitive to beta-adrenergic stimulants.
** There have been spontaneously reports of myocardial ischemia in post-marketing experience (frequency unknown, see section 4.4).
*** A fine tremor, which occurs in some patients, usually the hands and the effects are dose related.
**** Due to the effects on skeletal muscle and not to direct CNS stimulation.

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

None known.