Χώρα: Κύπρος
Γλώσσα: Ελληνικά
Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
LEVOCETIRIZINE DIHYDROCHLORIDE
DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629
R06AE09
LEVOCETIRIZINE
5MG
FILM COATED TABLETS
LEVOCETIRIZINE DIHYDROCHLORIDE (8000001832) 5MG
ORAL USE
Εθνική Διαδικασία
LEVOCETIRIZINE
Νομικό καθεστώς: Χωρίς Ιατρική Συνταγή Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 1 TABS IN BLISTER(S) (300012801) 1 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή; PACK WITH 2 TABS IN BLISTER(S) (300012802) 2 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή; PACK WITH 4 TABS IN BLISTER(S) (300012803) 4 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή; PACK WITH 5 TABS IN BLISTER(S) (300012804) 5 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή; PACK WITH 7 TABS IN BLISTER(S) (300012805) 7 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή; PACK WITH 10 TABS IN BLISTER(S) (300012806) 10 TABLET - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή; PACK WITH 28 TABS IN BLISTER(S) (300012809) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται
COMPARATIVE TABLE ENGLISH VS GREEK PIL PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZOBRAL 5 MG FILM-COATED TABLETS For adults and children aged 6 years and above levocetirizine dihydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. 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. You must talk to a doctor if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET 1. What Zobral is and what it is used for 2. What you need to know before you take Zobral 3. How to take Zobral 4. Possible side effects 5. How to store Zobral 6. Contents of the pack and other information 1. WHAT ZOBRAL IS AND WHAT IT IS USED FOR Levocetirizine dihydrochloride is the active ingredient of Zobral. Zobral is an antiallergic medication. ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ: ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ ΤΟΝ ΑΣΘΕΝΉ ZOBRAL 5 MG ΕΠΙΚΑΛΥΜΜΈΝΑ ΜΕ ΛΕΠΤΌ ΥΜΈΝΙΟ ΔΙΣΚΊΑ Για ενήλικες και παιδιά ηλικίας 6 ετών και άνω διϋδροχλωρική λεβοσετιριζίνη ΔΙΑΒΆΣΤΕ ΠΡΟΣΕΚΤΙΚΆ ΟΛΌΚΛΗΡΟ ΤΟ ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ ΠΡΙΝ ΑΡΧΊΣΕΤΕ ΝΑ ΠΑΊΡΝΕΤΕ ΑΥΤΌ ΤΟ ΦΆΡΜΑΚΟ, ΔΙΌΤΙ ΠΕΡΙΛΑΜΒΆΝΕΙ ΣΗΜΑΝΤΙΚΈΣ ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ ΣΑΣ. Πρέπει πάντοτε να παίρνετε αυτό το φάρμακο ακριβώς όπως περιγράφεται στο παρόν φύλλο οδηγιών χρήσης ή σύμφωνα με τις οδηγίες του γιατρού, του φαρμακοποιού ή του νοσ Διαβάστε το πλήρες έγγραφο
1. NAME OF THE MEDICINAL PRODUCT Zobral 5 mg Film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride. Excipient with known effect: 79.00 mg lactose monohydrate / tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Round, biconvex, white in colour, film-coated tablets with smooth surface without spots and chips. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zobral 5 mg film-coated tablets are indicated in the symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and urticaria in adults and children aged 6 years and above. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and adolescents 12 years and above: The daily recommended dose is 5 mg (1 film-coated tablet). _Older people_ Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see Patients with renal impairment below). 1 SUMMARY OF PRODUCT CHARACTERISTICS Patients with renal impairment: The dosing intervals must be individualized according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed. The CLcr (ml/min) may be estimated from serum creatinine (mg/dl) determination using the following formula: Dosing Adjustments for Patients with Impaired Renal Function: Group Creatinine clearance (ml/min) Dosage and frequency Normal 80 1 tablet once daily Mild 50 – 79 1 tablet once daily Moderate 30 – 49 1 tablet once every 2 days Severe < 30 1 tablet once every 3 days End-stage renal disease - Patients undergoing dialysis < 10 Contra-indicated In pediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient and his body weight. There are no specific data for children with renal impairment. Patients with hepatic impairmen Διαβάστε το πλήρες έγγραφο