Montelukast 10mg film-coated Tablets

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

MONTELUKAST

Διαθέσιμο από:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

Φαρμακολογική κατηγορία (ATC):

R03DC03

INN (Διεθνής Όνομα):

MONTELUKAST 10 mg

Φαρμακοτεχνική μορφή:

FILM-COATED TABLET

Σύνθεση:

MONTELUKAST 10 mg

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Καθεστώς αδειοδότησης:

Withdrawn

Ημερομηνία της άδειας:

2011-11-08

Φύλλο οδηγιών χρήσης

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.
•
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 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
WHAT MONTELUKAST 10 MG FILM-COATED TABLETS IS
Montelukast 10 mg film-coated tablets
are leukotriene receptor antagonist that blocks substances
called leukotrienes.
HOW MONTELUKAST 10 MG FILM-COATED TABLETS WORKS
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).
WHEN MONTELUKAST 10 MG FILM-COATED TABLETS SHOULD BE USED
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 adults and adolescents 15
years of age and older who are not adequately controlled on their
medication and need additional
therapy.
• Montelukast 10 mg film-coated tablets
also h

Αρχείο Π.Χ.Π.

1
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 those patientswith 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
Montelukast 10 mg f ilm-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 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 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-
2
coated tablets should not be used concomitantly with other products
containing the same active
ingredient, montelukast.
No dosage adjustmen