Desloratadine 0.5 mg/ml oral solution

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Desloratidine

Beszerezhető a:

Accord Healthcare Ireland Ltd.

ATC-kód:

R06AX; R06AX27

INN (nemzetközi neve):

Desloratidine

Adagolás:

0.5 milligram(s)/millilitre

Gyógyszerészeti forma:

Oral solution

Terápiás terület:

Other antihistamines for systemic use; desloratadine

Engedélyezési státusz:

Marketed

Engedély dátuma:

2020-10-30

Betegtájékoztató

DESLORATADINE 0.5 MG/ML
ORAL SOLUTION
desloratadine
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_Continued over page_
_Continued top of next column_
BBBA8815
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 DESLORATADINE ORAL SOLUTION IS
AND WHAT IT IS USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU
TAKE DESLORATADINE ORAL SOLUTION
3 HOW TO TAKE DESLORATADINE ORAL
SOLUTION
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE DESLORATADINE ORAL
SOLUTION
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1 WHAT DESLORATADINE ORAL SOLUTION IS
AND WHAT IT IS USED FOR
WHAT DESLORATADINE ORAL SOLUTION IS
Desloratadine Oral Solution contains
desloratadine which is an antihistamine.
HOW DESLORATADINE ORAL SOLUTION WORKS
Desloratadine Oral Solution oral solution is an
anti-allergy medicine that does not make you
drowsy. It helps control your allergic reaction and
its symptoms.
WHEN DESLORATADINE ORAL SOLUTION SHOULD
BE USED
Desloratadine Oral Solution 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, adolescents and children 1 year of age and
older. These symptoms include sneezing, runny or
itchy nose, itchy palate, and itchy, red or watery
eyes.
Desloratadine Oral Solution 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 no

Termékjellemzők

Health Products Regulatory Authority
19 November 2020
CRN008LL0
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Desloratadine 0.5 mg/ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains 0.5 mg desloratadine.
Excipient with known effect:
Each ml of oral solution contains 148 mg sorbitol (E420) and 103 mg
propylene glycol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
Desloratadine is a clear, colourless solution free from foreign
matter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Desloratadine 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 desloratadine 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) desloratadine oral
solution once a day.
Children 6 through 11 years of age: 5 ml (2.5 mg) desloratadine oral
solution once a day.
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