ZOBRAL 5MG FILM COATED TABLETS

מדינה: קפריסין

שפה: יוונית

מקור: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

מרכיב פעיל:

LEVOCETIRIZINE DIHYDROCHLORIDE

זמין מ:

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

קוד ATC:

R06AE09

INN (שם בינלאומי):

LEVOCETIRIZINE

כמות:

5MG

טופס פרצבטיות:

FILM COATED TABLETS

הרכב:

LEVOCETIRIZINE DIHYDROCHLORIDE (8000001832) 5MG

מסלול נתינה (של תרופות):

ORAL USE

סוג מרשם:

Εθνική Διαδικασία

איזור תרפויטי:

LEVOCETIRIZINE

leaflet_short:

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

עלון מידע

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�

מאפייני מוצר

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