Deslora-Denk 5 5mg tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

desloratadine

Available from:

Denk Pharma GmbH & Co. KG

ATC code:

R06AX27

INN (International Name):

desloratadine

Dosage:

5mg

Pharmaceutical form:

tablets film-coated

Units in package:

(10/1x10/) blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-05-15

Patient Information leaflet

_Deslora-Denk 5_
Film-coated tablet – oral use
Antiallergic / antihistaminic agent
Active substance: desloratadine
Package leaflet:
Information for the user
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 or pharmacist.
– 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 or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. WHAT DESLORA-DENK 5 IS AND WHAT IT IS
USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DESLORA-DENK 5
3. HOW TO TAKE DESLORA-DENK 5
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE DESLORA-DENK 5
6. CONTENTS OF THE PACK AND OTHER INFOR-
MATION
1.
What Deslora-Denk 5 is and
what it is used for
What Deslora-Denk 5 is
Deslora-Denk 5 contains desloratadine which
is an antihistamine.
How Deslora-Denk 5 works
Deslora-Denk 5 is an antiallergy medicine
that does not make you drowsy. It helps con-
trol your allergic reaction and its symptoms.
When Deslora-Denk 5 should be
used
Deslora-Denk 5 relieves symptoms associat-
ed with allergic rhinitis (inflammation of the
nasal passages caused by an allergy, for ex-
ample, hay fever or allergy to dust mites) in
adults and adolescents 12 years of age and
older. These symptoms include sneezing, run-
ny or itchy nose, itchy palate, and itchy, red
or watery eyes.
Deslora-Denk 5 is also used to relieve the
symptoms associated with urticaria (a skin
condition caused by an allergy). These symp-
toms include itching and hives.
Relief of these symptoms lasts a full day and
helps you to resume your normal daily activ-
ities and sleep.
2.
What you need to know before
you take Deslora-Denk 5
Do not take Deslora-Denk 5
•
if you are allergic to desloratadine, or any of
the

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Deslora-Denk 5
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: desloradine
Each tablet contains 5 mg desloratadine.
Excipient(s) with known effect
: each film-coated tablet contains 12 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets. Blue, round film-coated tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Deslora-Denk 5 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 desloratadine 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 in children below the age of
12 years have not been
established. No data are available.
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, desloratadine should be
used with caution (see section 5.2).
Patients with rare hereditary problems of galactose intolerance, the