DAREQ 0.5MG/ML ORAL SOLUTION

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:

0.5MG/ML

Pharmaceutical form:

ORAL SOLUTION

Composition:

DESLORATADINE (8000001892) 0.5MG

Administration route:

ORAL USE

Prescription type:

Εθνική Διαδικασία

Therapeutic area:

DESLORATADINE

Product summary:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 1 BOTTLE X 50ML (310009601) 50 MILLILITRE - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 1 BOTTLE X 60ML (310009602) 60 MILLILITRE - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 1 BOTTLE X 100ML (310009603) 100 MILLILITRE - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 1 BOTTLE X 120ML (310009604) 120 MILLILITRE - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 1 BOTTLE X 150ML (310009605) 150 MILLILITRE - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Patient Information leaflet

COMPARATIVE TABLE OF PIL-EN VS PIL-GR
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DAREQ 0,5 MG/ML ORAL SOLUTION
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 oral solution is and what it is used for
2. What you need to know before you take Dareq oral solution
3. How to take Dareq oral solution
4. Possible side effects
5. How to store Dareq oral solution
6. Contents of the pack and other information
1. WHAT DAREQ ORAL SOLUTION IS AND WHAT IT IS USED FOR
WHAT DAREQ IS
Dareq contains desloratadine which is an antihistamine.
ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ: ΠΛΗΡΟΦΟΡΊΕΣ ΓΙΑ
ΤΟΝ ΑΣΘΕΝΉ
DAREQ 0,5 MG/ML ΠΌΣΙΜΟ ΔΙΆΛΥΜΑ
Δεσλοραταδίνη
ΔΙΑΒΆΣΤΕ ΠΡΟΣΕΚΤΙΚΆ ΟΛΌΚΛΗΡΟ ΤΟ ΦΎΛΛΟ
ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ ΠΡΟΤΟΎ
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 φάρμακο
σε άλλους. Μπορεί να
τους π

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dareq 0,5 mg/ml Oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains 0,5 mg desloratadine.
Excipient(s) with known effect:
Each ml of solution contains 150.0 mg of liquid sorbitol (non
crystallising).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Dareq 0,5 mg/ml oral solution is a clear colorless solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dareq is indicated in adults, adolescents and children over the age of
1 year 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 10 ml (5 mg) oral solution once a
day.
_Paediatric population_
The prescriber should be aware that most cases of rhinitis below 2
years of age are of
infectious origin (see section 4.4) and there are no data supporting
the treatment of infectious
rhinitis with desloratadine.
Children 1 through 5 years of age: 2.5 ml (1.25 mg) Dareq oral
solution once a day.
Children 6 through 11 years of age: 5 ml (2.5 mg) Dareq oral solution
once a day.
1
The safety and efficacy of desloratadine 0,5 mg/ml oral solution in
children below the age of
1 year have not been established. No data are available.
There is limited clinical trial efficacy experience with the use of
desloratadine in children 1
through 11 years of age and adolescents 12 through 17 years of age
(see sections 4.8 and 5.1).
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 treatm