Dareq

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

desloratadine

Available from:

Delorbis Pharmaceuticals Ltd.

INN (International Name):

desloratadine

Dosage:

5mg

Pharmaceutical form:

tablets film-coated

Prescription type:

Prescription

Patient Information leaflet

1
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 control your allergic
reaction and its symptoms.
WHEN DAREQ SHOULD BE USED
Dareq relieves symptoms associated with allergic rhinitis
(inflammation of the nasal passages
caused by an allergy, for example, hay fever or allergy to dust mites)
in adults and adolescents 12
years of age and older. These symptoms include sneezing, runny or
itchy nose, itchy palate and
itchy, red or watery eyes.
Dareq is also used to relieve the symptoms associated with urticaria
(a skin condition caused by
an allergy). These symptoms include itching and hives.
Relief of these symptoms lasts a full day and helps you to resume your
normal daily activities and
sleep.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DAREQ
DO NOT TAKE DAREQ
- if you are allergic to desloratadine, or any of the other
ingredients of this medicine (listed in
section 6) or to loratadine.
2
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Dareq:
- if you have poor kidney function.
USE

Summary of Product characteristics

1
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.
2
Method of administration
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).
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No clinically