Montelair 10 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Montelukast

Available from:

Clonmel Healthcare Ltd

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:

2010-10-29

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
MONTELAIR 10 MG FILM-COATED TABLETS
FOR ADOLESCENTS AND ADULTS FROM 15 YEARS
Montelukast
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Montelair 10 mg is and what it is used for
2. What you need to know before you take Montelair 10 mg
3. How to take Montelair 10 mg
4. Possible side effects
5. How to store Montelair 10 mg
6. Contents of the pack and other information
1. WHAT MONTELAIR 10 MG IS AND WHAT IT IS USED FOR
WHAT MONTELAIR IS
Montelair is a leukotriene receptor antagonist that blocks substances
called leukotrienes.
HOW MONTELAIR WORKS
Leukotrienes cause narrowing and swelling of airways in the lungs and
also cause allergy symptoms.
By blocking leukotrienes, Montelair improves asthma symptoms, helps
control asthma and improves
seasonal allergy symptoms (also known as hay fever or seasonal
allergic rhinitis).
WHEN MONTELAIR SHOULD BE USED
Your doctor has prescribed Montelair to treat asthma, preventing your
asthma symptoms during the day
and night.
•
Montelair is used for the treatment of adults and adolescents 15 years
of age and older who are not
adequately controlled on their medication and need additional therapy.
•
Montelair also helps prevent the narrowing of airways triggered by
exercise.
•
In those asthmatic patients in whom Montelair is indicated in asthma,
Montelair can also provide
symptomatic relief of seasonal allergic rhinitis.
Your doctor will determine how Montelair should be used depending on
the symptoms and se

Summary of Product characteristics

Health Products Regulatory Authority
21 March 2024
CRN00F29D
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Montelair 10 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains montelukast sodium, which is
equivalent to 10 mg of montelukast.
Excipient(s) with known effect:
Each tablet contains 100 mg of lactose monohydrate and 0.83 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
_Film-coated tablet. _Beige coloured, round, biconvex-shaped
film-coated tablets
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Montelair is indicated in the treatment of asthma as add-on therapy in
those patients 15 years of age and older 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 Montelair is indicated in asthma,
Montelair can also provide symptomatic relief of
seasonal allergic rhinitis.
Montelair is also indicated in the prophylaxis of asthma in which the
predominant component is exercise-induced
bronchoconstriction.
4.2 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 Montelair on parameters of asthma control
occurs within one day. Montelair may be taken with or
without food. Patients should be advised to continue taking Montelair
even if their asthma is under control, as well as during
periods of worsening asthma. Montelair 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 se