Montelukast 10mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MONTELUKAST

Available from:

Accord Healthcare Limited

ATC code:

R03DC03

INN (International Name):

MONTELUKAST

Pharmaceutical form:

FILM-COATED TABLET

Composition:

MONTELUKAST 10 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Authorization status:

Authorised

Authorization date:

2011-11-08

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
MONTELUKAST 10 MG FILM-COATED TABLETS
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 or
nurse.

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 or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Montelukast 10 mg film-coated tablets are and what they are used
for
2.
What you need to know before you take Montelukast 10 mg film-coated
tablets
3.
How to take Montelukast 10 mg film-coated tablets
4.
Possible side effects
5.
How to store Montelukast 10 mg film-coated tablets
6.
Contents of the pack and other information
1. WHAT MONTELUKAST 10 MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED
FOR
Montelukast 10 mg film-coated tablets are leukotriene receptor
antagonist that blocks substances called
leukotrienes. Leukotrienes cause narrowing and swelling of airways in
the lungs and also cause allergy
symptoms.
By
blocking
leukotrienes,
Montelukast
10
mg
film-coated
tablets
improves
asthma
symptoms, helps control asthma and improves seasonal allergy symptoms
(also known as hay fever or
seasonal allergic rhinitis).
Your doctor has prescribed Montelukast 10 mg film-coated tablets to
treat asthma, preventing your
asthma symptoms during the day and night.
• Montelukast 10 mg film-coated tablets are used for the treatment
of patients who are not adequately
controlled on their medication and need additional therapy.
• Montelukast 10 mg film-coated tablets also helps prevent the
narrowing of airways triggered by
exercise.
• In those asthmatic patients in whom Montelukast 10 mg film-coated
tablets are indicated in asthma

Summary of Product characteristics

Page 1 of 11
1.
NAME OF THE MEDICINAL PRODUCT
Montelukast 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains montelukast sodium 10.4 mg equivalent
to 10 mg montelukast.
Excipient(s) with known effect:
Contain 130.95 mg of Lactose monohydrate per tablet
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
7.9 x 7.9 mm beige coloured, rounded square, biconvex, film coated
tablet debossed “M10” on one side
and plain on other side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Montelukast 10 mg film-coated tablets is indicated in the treatment of
asthma as add-on therapy in
adults and adolescents from 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 beta-agonists
provide inadequate clinical control of asthma. In those asthmatic
patients in whom Montelukast 10 mg
film-coated tablets is indicated in asthma, Montelukast 10 mg
film-coated tablets can also provide
symptomatic relief of seasonal allergic rhinitis.
Montelukast 10 mg film-coated tablets 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 dosage 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:
Page 2 of 11
The therapeutic effect of Montelukast 10 mg film-coated tablets on
parameters of asthma control
occurs within one day. Montelukast 10 mg film-coated tablets may be
taken with or without food.
Patients should be advised to continue taking Montelukast 10 mg
film-coated tablets even if their
asthma is under control, as well as during periods of worsening
asthma. Montelukast 10 mg film-coated
tablets should not be used concomitantly with other products
containing the same