Montelukast Mylan 10 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Montelukast

Available from:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC code:

R03DC; R03DC03

INN (International Name):

Montelukast

Dosage:

10 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Leukotriene receptor antagonists; montelukast

Authorization status:

Marketed

Authorization date:

2010-10-08

Patient Information leaflet

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Montelukast Mylan 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg montelukast, as montelukast sodium.
Excipient with known effect
Each tablet contains 0.003 mg of sunset yellow (E110).
This medicinal product contains less than 1mmol sodium (23 mg) per
tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Blue, round, biconvex, bevelled edge, film-coated tablet, debossed
with ‘MO’ over ‘10’ on one side
and ‘M’ on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Montelukast 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 beta-agonists provide inadequate clinical
control of asthma. In those
asthmatic patients in whom Montelukast Mylan is indicated in asthma,
it can also provide
symptomatic relief of seasonal allergic rhinitis.
Montelukast is also indicated in the prophylaxis of asthma in which
the predominant component is
exercise-induced bronchoconstriction.
Montelukast Mylan 10 mg film-coated tablets are indicated in adults
and adolescents 15 years of age
and older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose for adult patients 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.
Montelukast Mylan should not be used concomitantly with other products
containing the same active
ingredient, montelukast.
_General recommendations_
:
The therapeutic effect of montelukast on parameters of asthma control
occurs within one day. Patients
should be advised to continue taking Montelukast even if their asthma
is under control, as well as
during periods of worsening asthma.
No dosage adjustment is necessary for the elderly, or for p

Summary of Product characteristics

Health Products Regulatory Authority
15 April 2020
CRN0097Y5
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Montelukast Mylan 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg montelukast, as montelukast sodium.
Excipient with known effect
Each tablet contains 0.003 mg of sunset yellow (E110).
This medicinal product contains less than 1mmol sodium (23 mg) per
tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Blue, round, biconvex, bevelled edge, film-coated tablet, debossed
with 'MO' over '10' on one side and 'M' on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Montelukast 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 beta-agonists
provide inadequate clinical control of asthma. In those asthmatic
patients in whom Montelukast Mylan is indicated in asthma, it
can also provide symptomatic relief of seasonal allergic rhinitis.
Montelukast is also indicated in the prophylaxis of asthma in which
the predominant component is exercise-induced
bronchoconstriction.
Montelukast Mylan 10 mg film-coated tablets are indicated in adults
and adolescents 15 years of age and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose for adult patients 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.
Montelukast Mylan should not be used concomitantly with other products
containing the same active ingredient, montelukast.
_General recommendations_:
The therapeutic effect of montelukast on parameters of asthma control
occurs within one day. Patients should be advised to
continue taking Montelukast even if their asthma is under control, as
well as during periods of worsening asthma.
No