Desloratadine 0.5mg/ml Oral Solution

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: myHealthbox

العنصر النشط:

desloratadine

متاح من:

Rosemont Pharmaceuticals Ltd

ATC رمز:

R06AX27

INN (الاسم الدولي):

desloratadine

جرعة:

0.5mg/ml

الشكل الصيدلاني:

Oral Solution

طريقة التعاطي:

Oral use

الوحدات في الحزمة:

150ml

نوع الوصفة الطبية :

POM - Prescription Only Medicine

المصنعة من قبل:

Rosemont Pharmaceuticals Ltd

المجموعة العلاجية:

antihistamines – H1 antagonist

الخصائص العلاجية:

It is indicated in adults, adolescents and children over the age of 1 year for the relief of symptoms associated with: - allergic rhinitis - urticaria

الوضع إذن:

Authorised

تاريخ الترخيص:

2015-04-17

نشرة المعلومات

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Keep this leaflet. You may need to read it again.
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If you have any further questions, ask your doctor, 
pharmacist or nurse.
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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. 
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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.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_Continued overleaf_
1. WHAT DESLORATADINE ORAL SOLUTION IS AND WHAT IT IS USED FOR
WHAT DESLORATADINE IS
It contains desloratadine which is an antihistamine.
HOW DESLORATADINE WORKS
It is an antiallergy medicine that does not make you drowsy. It helps
control your allergic reaction and 
its symptoms.
WHEN DESLORATADINE SHOULD BE USED
Desloratadine 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 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 DESLORATADINE ORAL SOLUTION
DO NOT TAKE DESLORATADINE ORAL SOLUTION
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if you are allergic to desloratadine, or to any of the other
ingredients of this medicine (listed in section 
6) or to loratadine.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking desloratadine:
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if you have poor kidney function.
USE IN CHILDREN AND ADOLESCENTS
Do not give this medicine to children less than 1 year of age.
Not known: frequency cannot be estimated from the available data. 
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Increased sensitivity of the

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Desloratadine 0.5mg/ml Oral Solution 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each ml contains 0.5mg desloratadine_._ 

Excipient(s) with known effect  

This medicinal product contains 150 mg/ml sorbitol. 

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 

Oral solution 

A clear colourless solution. 

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 oral solution is 10ml
(5mg) 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 oral solution. 
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 0.5mg/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 disea