SINGULAIR Film Coated Tablet 10 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-05-2024
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Active ingredient:
MONTELUKAST SODIUM
Available from:
Profind Wholesale Ltd.
Dosage:
10 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2011-11-25
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Singulair 10mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains montelukast sodium, which is equivalent to 10 mg montelukast.
Excipient: Contains lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from Italy:_
Beige, rounded square, tablet with ‘117’ engraved on one side.
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 -
agonists provide inadequate clinical control of asthma. In those asthmatic patients in whom SINGULAIR is indicated
in asthma, SINGULAIR can also provide symptomatic relief of seasonal allergic rhinitis.
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 dosage for adults 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 SINGULAIR on parameters of asthma control occurs within one
day. SINGULAIR may be taken with or without food. Patients should be advised to continue taking SINGULAIR
even if their asthma is under control, as well as during periods of worsening asthma. SINGULAIR 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,
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