MONTOL 4MG TABLET,CHEWABLE

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

MONTELUKAST SODIUM

Διαθέσιμο από:

DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629

Φαρμακολογική κατηγορία (ATC):

R03DC03

INN (Διεθνής Όνομα):

MONTELUKAST

Δοσολογία:

4MG

Φαρμακοτεχνική μορφή:

TABLET,CHEWABLE

Σύνθεση:

MONTELUKAST SODIUM (8000001574) 4,16MG

Οδός χορήγησης:

ORAL USE

Τρόπος διάθεσης:

Εθνική Διαδικασία

Θεραπευτική περιοχή:

MONTELUKAST

Περίληψη προϊόντος:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 TABS IN BLISTER(S) (300011907) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Φύλλο οδηγιών χρήσης

COMPARATIVE TABLE ENGLISH VS GREEK PIL
PACKAGE LEAFLET: INFORMATION FOR THE USER
MONTOL 4 MG CHEWABLE TABLETS
montelukast
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU GIVE THIS MEDICINE TO
YOUR
CHILD BECAUSE IT CONTAINS IMPORTANT INFORMATION.

Keep this leaflet. You may need to read it again.

If you have any further questions, please ask your doctor or
pharmacist.

This medicine has been prescribed for your child only. Do not pass it
on to others. It may harm them, even if their signs of illness are the
same
as your child’s.

If your child gets 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 Montol 4 mg is and what it is used for
2. What you need to know before your child takes Montol 4 mg
3. How to take Montol 4 mg
4. Possible side effects
5. How to store Montol 4 mg
6. Contents of the pack and other information
1.
WHAT MONTOL 4 MG IS AND WHAT IT IS USED FOR
ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ: ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ
ΤΟ ΧΡΉΣΤΗ
MONTOL 4 MG ΜΑΣΏΜΕΝΑ ΔΙΣΚΊΑ
μοντελουκάστη
ΔΙΑΒΆΣΤΕ ΠΡΟΣΕΚΤΙΚΆ ΟΛΌΚΛΗΡΟ ΤΟ ΦΎΛΛΟ
ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ ΠΡΙΝ
ΔΏΣΕΤΕ ΤΟ ΦΆΡΜΑΚΟ ΑΥΤΌ ΣΤΟ ΠΑΙΔΊ ΣΑΣ
ΔΙΌΤΙ ΠΕΡΙΛΑΜΒΆΝΕΙ
ΣΗΜΑΝΤΙΚΈΣ ΠΛΗΡΟΦΟΡΊΕΣ.

Φυλάξτε αυτό το φύλλο οδηγιών χρήσης.
Ίσως χρειαστεί να το
διαβάσετε ξανά.

Εάν έχετε περαιτέρω απορίες, ρωτήστε
τον γιατρό ή τον φαρμακοποιό
σας.

Η συνταγή για αυτό το φάρμακο
χορηγήθηκε αποκλειστικά για το
παιδί σας. Δεν πρέπει να δώσετε το
φάρμακο σε άλλους. Μπορεί να
τους προκαλέσει βλάβη, ακόμα και όταν
τα συμπτώματα της
ασθένειάς τ�

Αρχείο Π.Χ.Π.

1.
NAME OF THE MEDICINAL PRODUCT
Montol 4 mg Chewable tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One chewable tablet contains montelukast sodium, which is equivalent
to 4 mg of montelukast.
Excipient(s) with known effect: This medicine contains 4.80 mg
aspartame per tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablets
Pink, oval, biconvex tablets with “M4” engraved on one side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Montol is indicated in the treatment of asthma as add-on therapy in
those 2 to 5 year old 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.
Montol may also be an alternative treatment option to low-dose inhaled
corticosteroids for 2 to 5 year
old patients with mild persistent asthma who do not have a recent
history of serious asthma attacks
that required oral corticosteroid use and who have demonstrated that
they are not capable of using
inhaled corticosteroids (see section 4.2).
Montol is also indicated in the prophylaxis of asthma from 2 years of
age and older in which the
predominant component is exercise-induced bronchoconstriction.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
This medicinal product is to be given to a child under adult
supervision. The recommended dose for
paediatric patients 2-5 years of age is one 4 mg chewable tablet daily
to be taken in the evening. If
1
SUMMARY OF PRODUCT CHARACTERISTICS
taken in connection with food, Montol should be taken 1 hour before or
2 hours after food. No dosage
adjustment within this age group is necessary.
General recommendations
The therapeutic effect of montelukast on parameters of asthma control
occurs within one day. Patients
should be advised to continue taking Montol even if their asthma is
under control, as well as during
periods of worsening asthma.
No dosage adjustment is necessary for patients with renal
ins