Desallergan solution oral

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

desloratadine

Available from:

Vetprom AD

ATC code:

R06AX27

INN (International Name):

desloratadine

Dosage:

0.5mg/ml

Pharmaceutical form:

solution oral

Units in package:

glass bottle 120ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-05-12

Patient Information leaflet

1
LEAFLET: INFORMATION FOR THE PATIENT
DESALLERGAN 0,5 MG/ML PERORAL SOLUTION
Desloratadine
READ ATTENTIVELY THE ENTIRE LEAFLET BEFORE STARTING TO TAKE THIS DRUG
SINCE IT CONTAINS INFORMATION
IMPORTANT FOR YOU.
-
Keep this leaflet. It may become useful to read it again.
-
In case you have some additional question, ask your physician or
pharmacist.
-
This drug has been prescribed personally to you. Do not ced it to
other people. It may harm them
regardless of the fact that they have the same disease symptoms as
yours.
-
If you experience any undesired drug effects, notify your physician or
pharmacist. This includes
also all possible undesired effects not described in this leaflet. See
point 4.
WHAT DOES THIS LEAFLET CONTAIN
1.
What is DESALLERGAN and what is it used for
2.
What do you have to know before using DESALLERGAN
3.
How to use DESALLERGAN
4.
Possible undesired effects
5.
How to store DESALLERGAN
6.
Content of the packaging and additional information
1.
WHAT IS DESALLERGAN AND WHAT IS IT USED FOR
The active substance in DESALLERGAN peroral solution is desloratadine.
It is antiallergic drug
which does not provoke somnolence. It helps to control the allergic
reactions and to master their
manifestations.
DESALLERGAN IS APPLIED AT:

Allergic rhinitis (inflammation of the nasal ways caused by allergy,
for instance hay fever or
allergy to domestic dust) for relieving of the sneezing and itching,
the nose secretion, the palate
itching, the reddening of the eyes or epiphora;

Urticaria (condition of the skin running along with itching, rashes
and reddening provoked by
allergy)
Desloratadine has prolonged effect which lasts the entire day, thus
this drug will help you restore your
normal daily activity and your sleep.
This drug is intended for children from 1 to 11 years of age,
adolescents and teenagers (12 years and
up) and adults, incl. old people.
2.
WHAT DO YOU HAVE TO KNOW BEFORE USING DESALLERGAN
DO NOT TAKE DESALLERGAN:

If you are allergic to desloratadine, to some of the other components
of this

Summary of Product characteristics

2
1.
NAME OF THE DRUG PRODUCT
DESALLERGAN 0,5 mg/ml oral solution
2.
QUALITATIVE AND QUANTITATIVE CONTENT
1 ml peroral solution contains 0,5 mg desloratadine.
Excipients with known effect: sorbitol 105 mg/ml.
For the complete list of the excipients, see point 6.1.
3.
PHARMACEUTICAL FORM
Peroral solution.
Appearance – clear, colourless solution with fruity aroma.
4.
CLINICAL DATA
4.1.
THERAPEUTIC INDICATIONS
DESALLERGAN is indicated at adults, adolescents and children above 1
year for alleviation of the
symptoms of:

allergic rhinitis (see point 5.1)

urticaria (see point 5.1)
4.2.
DOSAGE AND MODE OF APPLLICATION
Dosage
_Adults and adolescents (≥ 12 years)_
The recommended dose is 10 ml (5 mg) peroral solution once a day.
_Paediatric population_
It is necessary to bear in mind that in most cases of rhinitis at
children below 2 years have infection
genesis (see point 4.4), as well as there are no data which justify
the application of desloratadine at
infection rhinitis.
Chldren aged from 1 to 5 years: 2,5 ml (1,25 mg) peroral solution once
a day.
Children aged from 6 to 11 years: 5 ml (2,5 mg) peroral solution once
a day.
There is no data about the application of desloratadine at children
aged less than 1 year. The efficacy
and the safety in that age group are not established.
There is limited experience about the efficacy and the use of
desloratadine at children aged between 1
and 11 years and adolescents aged 12 – 17 years (see points 4.8 and
5.1).
Allergic rhinitis with intermittent course (presence of symptoms for
less than 4 days a week or for less
than 4 weeks) should be treated in accordance with the anamnesis of
the specific patient; the
treatment may be stopped after mastering of the symptoms and to start
again at their recurring.
At persisting allergic rhinitis (presence of symptoms for 4 or more
days a week and for more than 4
weeks) is recommended a permanent administering of the product during
the whole period of
exposition with the allergen.
3
Mode of application
Peroral application.
The p