1. Name of the medicinal product
Singulair® Paediatric 5 mg chewable Tablets
2. Qualitative and quantitative composition
One chewable tablet contains montelukast sodium, which is equivalent to 5 mg montelukast.
Excipients with known effect: This medicine contains 1.5 mg aspartame (E 951) per tablet.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Pink, round, biconvex, diameter 9.5 mm with SINGULAIR engraved on one side and MSD 275 on the other.
4. Clinical particulars
4.1 Therapeutic indications
Singulair 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.
Singulair may also be an alternative treatment option to low-dose inhaled corticosteroids for patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids (see section 4.2).
Singulair is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction.
4.2 Posology and method of administration
The recommended dose for paediatric patients 6-14 years of age is one 5 mg chewable tablet daily to be taken in the evening. If taken in connection with food, Singulair should be taken 1 hour before or 2 hours after food. No dosage adjustment within this age group is necessary.
The therapeutic effect of Singulair on parameters of asthma control occurs within one day. Patients should be advised to continue taking Singulair even if their asthma is under control, as well as during periods of worsening asthma.
No dosage adjustment is necessary 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.
Singulair as an alternative treatment option to low-dose inhaled corticosteroids for mild persistent asthma
Montelukast is not recommended as monotherapy in patients with moderate persistent asthma. The use of montelukast as an alternative treatment option to low-dose inhaled corticosteroids for children with mild persistent asthma should only be considered for patients who do not have a recent history of serious asthma attacks that required oral corticosteroid use and who have demonstrated that they are not capable of using inhaled corticosteroids (see section 4.1). Mild persistent asthma is defined as asthma symptoms more than once a week but less than once a day, nocturnal symptoms more than twice a month but less than once a week, normal lung function between episodes. If satisfactory control of asthma is not achieved at follow-up (usually within one month), the need for an additional or different anti-inflammatory therapy based on the step system for asthma therapy should be evaluated. Patients should be periodically evaluated for their asthma control.
Therapy with Singulair in relation to other treatments for asthma
When treatment with Singulair is used as add-on therapy to inhaled corticosteroids, Singulair should not be abruptly substituted for inhaled corticosteroids (see section 4.4).
10 mg tablets are available for adults and adolescents 15 years of age and older.
Do not give Singulair 5 mg chewable tablets to children less than 6 years of age. The safety and efficacy of Singulair 5 mg chewable tablets in children less than 6 years of age has not been established.
4 mg chewable tablets are available for paediatric patients 2 to 5 years of age.
4 mg granules are available for paediatric patients 6 months to 5 years of age.
Method of administration
The tablets are to be chewed before swallowing.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.