Desloratadine 0.5mg/ml Oral Solution
Country: United Kingdom
Language: English
Source: myHealthbox
Patient Information leaflet
(PIL)
23-04-2024
Summary of Product characteristics
(SPC)
23-04-2024
Active ingredient:
desloratadine
Available from:
Rosemont Pharmaceuticals Ltd
ATC code:
R06AX27
INN (International Name):
desloratadine
Dosage:
0.5mg/ml
Pharmaceutical form:
Oral Solution
Administration route:
Oral use
Units in package:
150ml
Prescription type:
POM - Prescription Only Medicine
Manufactured by:
Rosemont Pharmaceuticals Ltd
Therapeutic group:
antihistamines – H1 antagonist
Therapeutic indications:
It is indicated in adults, adolescents and children over the age of 1 year for the relief of symptoms associated with: - allergic rhinitis - urticaria
Authorization status:
Authorised
Authorization date:
2015-04-17
Patient Information leaflet
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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
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Summary of Product characteristics
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
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