Krajina: Cyprus
Jazyk: gréčtina
Zdroj: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
MONTELUKAST SODIUM
DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629
R03DC03
MONTELUKAST
4MG
TABLET,CHEWABLE
MONTELUKAST SODIUM (8000001574) 4,16MG
ORAL USE
Εθνική Διαδικασία
MONTELUKAST
Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 TABS IN BLISTER(S) (300011907) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται
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 Prečítajte si celý dokument
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 Prečítajte si celý dokument