MEDOLIN Tablet Ref.[28250] Active ingredients: Salbutamol

Cardiovascular effects may be seen with sympathomimetic drugs, including Medolin. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with beta agonists. Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving Medolin 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 given with caution in hyperthyroidism, myocardial insufficiency, arrhythmias, susceptibility to QT-interval prolongation, hypertension, and diabetes mellitus since ketoacidosis has been reported. In common with other beta-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. Concomitant administration of corticosteroids can exaggerate this effect.

In severe asthma particular caution is also required to avoid inducing hypokalaemia as this effect may be potentiated by hypoxia or by concomitant administration of other anti-asthma drugs; plasma-potassium concentrations should be monitored. Beta(2) agonists such as salbutamol are not appropriate for use alone in the treatment of more than mild asthma. Increasing need for, or decreased duration of effect of, inhaled salbutamol and other short-acting beta(2) agonists indicates deterioration of asthma control and the likely requirement for increased anti-inflammatory therapy.

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

Salbutamol should be administered cautiously to patients with thyrotoxicosis.

Medolin contains lactose.

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

• Salbutamol and non selective beta-blocking drugs like propranolol are not to be administered together.
• 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.
• 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.

Pregnancy

Salbutamol crosses the placental barrier and hence drug therapy should be considered if the expected benefit is greater than any possible risk to the mother.

Breast-feeding

Salbutamol is excreted in breast milk, therefore, its use in nursing mothers needs careful consideration.

No reports.

In common with other beta-agonists cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extra systoles) have been reported in association with the use of salbutamol usually in susceptible patients.

Unknown (cannnot be estimated from the available data): Myocardial ischaemia* (see section 4.4)

^* reported spontaneously in post-marketing data therefore frequency regarded as unknown

Salbutamol and other beta agonists may cause fine tremor of skeletal muscle (particularly the hands), palpitations, tachycardia, nervous tension, headaches, peripheral vasodilatation, and rarely muscle cramps.

Inhalation causes fewer side-effects than systemic administration, and the more selective beta(2) agonists cause fewer side-effects than less selective beta agonists.

Potentially serious hypokalaemia has been reported after large doses.

Hypersensitivity reactions have occurred, including paradoxical bronchospasm, angioedema, urticaria, hypotension, and collapse.

As with other beta₂-agonists hyperactivity in children is being reported rarely.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.

None reported.