País: Chipre
Língua: grego
Origem: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
DESLORATADINE
DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629
R06AX27
DESLORATADINE
5MG
FILM COATED TABLETS
DESLORATADINE (8000001892) 5MG
ORAL USE
Εθνική Διαδικασία
DESLORATADINE
Νομικό καθεστώς: Χωρίς Ιατρική Συνταγή; PACK WITH 1 TABS IN BLISTER(S) ALU/ALU (310009701) 1 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή; PACK WITH 5 TABS IN BLISTER(S) ALU/ALU (310009702) 5 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή; PACK WITH 7 TABS IN BLISTER(S) ALU/ALU (310009703) 7 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή; PACK WITH 10 TABS IN BLISTER(S) ALU/ALU (310009704) 10 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή; PACK WITH 15 TABS IN BLISTER(S) ALU/ALU (310009705) 15 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή; PACK WITH 20 TABS IN BLISTER(S) ALU/ALU (310009706) 20 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή; PACK WITH 30 TABS IN BLISTER(S) ALU/ALU (310009707) 30 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή; PACK WITH 1 TABS IN BLISTER(S) ALU/PVC/PE/PVDC (310009710) 1 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή; PACK WITH 5 TABS IN BLISTER(S) ALU/PVC/PE/PVDC (310009711) 5 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή; PACK WITH 7 TABS IN BLISTER(S) ALU/PVC/PE/PVDC (310009712) 7 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή; PACK WITH 10 TABS IN BLISTER(S) ALU/PVC/PE/PVDC (310009713) 10 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή; PACK WITH 15 TABS IN BLISTER(S) ALU/PVC/PE/PVDC (310009714) 15 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή; PACK WITH 20 TABS IN BLISTER(S) ALU/PVC/PE/PVDC (310009715) 20 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή; PACK WITH 30 TABS IN BLISTER(S) ALU/PVC/PE/PVDC (310009716) 30 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή
COMPARATIVE TABLE ENGLISH VS GREEK PIL PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DAREQ 5 MG FILM-COATED TABLETS desloratadine 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, 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Dareq is and what it is used for 2. What you need to know before you take Dareq 3. How to take Dareq 4. Possible side effects 5. How to store Dareq 6. Contents of the pack and other information 1. WHAT DAREQ IS AND WHAT IT IS USED FOR WHAT DAREQ IS Dareq contains desloratadine which is an antihistamine. HOW DAREQ WORKS Dareq is an antiallergy medicine that does not make you drowsy. It helps ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ: ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ ΤΟΝ ΑΣΘΕΝΉ DAREQ 5 MG ΕΠΙΚΑΛΥΜΜΈΝΑ ΜΕ ΛΕΠΤΌ ΥΜΈΝΙΟ ΔΙΣΚΊΑ δεσλοραταδίνη ΔΙΑΒΆΣΤΕ ΠΡΟΣΕΚΤΙΚΆ ΟΛΌΚΛΗΡΟ ΤΟ ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ ΠΡΙΝ ΑΡΧΊΣΕΤΕ ΝΑ ΠΑΊΡΝΕΤΕ ΑΥΤΌ ΤΟ ΦΆΡΜΑΚΟ, ΔΙΌΤΙ ΠΕΡΙΛΑΜΒΆΝΕΙ ΣΗΜΑΝΤΙΚΈΣ ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ ΣΑΣ. - Φυλάξτε αυτό το φύλλο οδηγιών χρήσης. Ίσως χρειαστεί να το διαβάσετε ξανά. - Εάν έχετε περαιτέρω απορίες, ρωτήστε τον γιατρό, τον φαρμακοποιό ή τον νοσοκόμο σας. - Η συνταγή γι’ αυτό το φάρμακο χορηγήθηκε αποκλειστικά για σας. ∆εν πρέπει να δώσετε το φάρμακ Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dareq 5 mg Film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg desloratadine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets Dareq 5 mg film-coated tablets are light blue colored, round, biconvex film-coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dareq is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with: - allergic rhinitis (see section 5.1) - urticaria (see section 5.1) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and adolescents (12 years of age and over)_ The recommended dose of Dareq is one tablet once a day. Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4 weeks) should be managed in accordance with the evaluation of patient’s disease history and the treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance. In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods. _Paediatric population_ There is limited clinical trial efficacy experience with the use of desloratadine in adolescents 12 through 17 years of age (see sections 4.8 and 5.1). The safety and efficacy of desloratadine 5 mg film-coated tablets in children below the age of 12 years have not been established. No data are available. Method of administration 1 Oral use. The dose can be taken with or without food. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or to loratadine. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE In the case of severe renal insufficiency, Dareq should be used with caution (see section 5.2). CONVULSIONS Desloratadine should be administered with caution in patients with medical or fa Leia o documento completo