Asmalair is indicated in the treatment of asthma as add-on therapy in those patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short acting β-agonists provide inadequate clinical control of asthma. In those asthmatic patients in whom Asmalair is indicated in asthma, Asmalair can also provide symptomatic relief of seasonal allergic rhinitis. Asmalair is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction.

Name of the medicinal product

• Asmalair 10 mg tablets: Each tablet contains 5.2montelukast sodium, which is equivalent to 5 mg montelukast.
• Asmalair 5 mg film-coated tablets: Each tablet contains 10.4montelukast sodium, which is equivalent to10 mg montelukast.

Posology and method of administration

Posology: The recommended dose for adults and adolescents 15 years of age and older with asthma, or with asthma and concomitant seasonal allergic rhinitis , is one 10 mg tablet daily to be taken in the evening.

General recommendations

• The therapeutic effect of Asmalair on parameters of asthma control occurs within one day.
• Asmalair may be taken with or without food.
• Patients should be advised to continue taking Asmalair even if their asthma is under control, as well as during periods of worsening asthma.
• Asmalair should not be used concomitantly with other products containing the same active ingredient, montelukast.
• No dosage adjustment is necessary for the elderly, or for patients with renal insufficiency, or mild to moderate hepatic impairment. There are no data on patients with severe hepatic impairment.
• The dosage is the same for both male and female patients.
• Paediatric population: Do not give Asmalair 10 mg tablets to children less than 15 years of age. The safety and efficacy of Asmalair 10 mg tablets in children less than 15 years has not been established.
• Method of administration: Oral use.

Therapy with Asmalair in relation to other treatments for asthma

• Asmalair can be added to a patient’s existing treatment regimen.
• Inhaled corticosteroids: Treatment with Asmalair can be used as add-on therapy in patients when inhaled corticosteroids plus “as needed” short acting β-agonists provide inadequate clinical control.
• Asmalair should not be abruptly substituted for inhaled corticosteroids.

Special warnings and precautions for use

• Patients should be advised never to use oral montelukast to treat acute asthma attacks and to keep their usual appropriate rescue medication for this purpose readily available. If an acute attack occurs, a short-acting inhaled β-agonist should be used. Patients should seek their doctors’ advice as soon as possible if they need more inhalations of short-acting β-agonists than usual.
• Montelukast should not be substituted abruptly for inhaled or oral corticosteroids. There are no data demonstrating that oral corticosteroids can be reduced when montelukast is given concomitantly.
• In rare cases, patients on therapy with anti-asthma agents including montelukast may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy. These cases have been sometimes associated with the reduction or withdrawal of oral corticosteroid therapy. Although a causal relationship with leukotriene receptor antagonism has not been established. physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and or neuropathy presenting in their patients. Patients who develop these symptoms should be reassessed and their treatment regimens evaluated.
• Treatment with montelukast does not alter the need for patients with aspirin–sensitive asthma to avoid taking aspirin and other non-steroidal anti-inflammatory drugs.
• Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Asmalair – Information Leaflet

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