Monkasta 10 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MONTELUKAST SODIUM

Available from:

TAD Pharma GmbH Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany

ATC code:

R03DC03

INN (International Name):

MONTELUKAST SODIUM 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

MONTELUKAST SODIUM 10 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-02-17

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
MONKASTA 10 MG FILM-COATED TABLETS
FOR ADULTS AND ADOLESCENTS 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 Monkasta is and what it is used for
2.
What you need to know before you take Monkasta
3.
How to take Monkasta
4.
Possible side effects
5.
How to store Monkasta
6.
Contents of the pack and other information
1.
WHAT MONKASTA IS AND WHAT IT IS USED FOR
WHAT MONKASTA IS
Monkasta is a leukotriene receptor antagonist that blocks substances
called leukotrienes.
HOW MONKASTA WORKS
Leukotrienes cause narrowing and swelling of airways in the lungs and
also cause allergy symptoms.
By blocking leukotrienes, Monkasta improves asthma symptoms, helps
control asthma and improves
seasonal allergy symptoms (also known as hay fever or seasonal
allergic rhinitis).
WHEN MONKASTA SHOULD BE USED
Your doctor has prescribed Monkasta to treat asthma, preventing your
asthma symptoms during the
day and night.
-
Monkasta 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.
-
Monkasta also helps prevent the narrowing of airways triggered by
exercise.
-
In those asthmatic patients in whom Monkasta is indicated in asthma,
Monkasta can also
provide symptomatic relief of seasonal allergic rhinitis.
Your doctor will determine how Monkasta should be used depending on
the symptoms and severity of
your asthma.
WHAT IS ASTHMA?
Asthma is

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Monkasta 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg montelukast (as montelukast
sodium).
Excipient(s) with known effect
Each film-coated tablet contains 81.94 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
The film-coated tablets are apricot-coloured, round, slightly
biconvex, with bevelled edges.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Monkasta 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 β-agonists provide inadequate clinical
control of asthma. In those asthmatic
patients in whom Monkasta is indicated in asthma, Monkasta can also
provide symptomatic relief of
seasonal allergic rhinitis.
Monkasta 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 Monkasta on parameters of asthma control
occurs within one day. Monkasta
may be taken with or without food. Patients should be advised to
continue taking Monkasta even if
their asthma is under control, as well as during periods of worsening
asthma. Monkasta 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 severe
hepatic impairment. The
dosage is the same for both male and female patients.
Therapy with Monkasta in re