DAREQ 5MG FILM COATED TABLETS

Nchi: Kuprosi

Lugha: Kigiriki

Chanzo: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
03-06-2022
Tabia za bidhaa Tabia za bidhaa (SPC)
15-03-2018

Viambatanisho vya kazi:

DESLORATADINE

Inapatikana kutoka:

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

ATC kanuni:

R06AX27

INN (Jina la Kimataifa):

DESLORATADINE

Kipimo:

5MG

Dawa fomu:

FILM COATED TABLETS

Tungo:

DESLORATADINE (8000001892) 5MG

Njia ya uendeshaji:

ORAL USE

Dawa ya aina:

Εθνική Διαδικασία

Eneo la matibabu:

DESLORATADINE

Bidhaa muhtasari:

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

Taarifa za kipeperushi

                                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
                                
                                Soma hati kamili
                                
                            

Tabia za bidhaa

                                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
                                
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