DAREQ 5MG FILM COATED TABLETS

Country: Cyprus

Language: Greek

Source: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Active ingredient:

DESLORATADINE

Available from:

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

ATC code:

R06AX27

INN (International Name):

DESLORATADINE

Dosage:

5MG

Pharmaceutical form:

FILM COATED TABLETS

Composition:

DESLORATADINE (8000001892) 5MG

Administration route:

ORAL USE

Prescription type:

Εθνική Διαδικασία

Therapeutic area:

DESLORATADINE

Product summary:

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

Patient Information leaflet

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

Summary of Product characteristics

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