Desloratadine 2.5mg5ml oral solution sugar free

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Desloratadine

Disponible depuis:

Rosemont Pharmaceuticals Ltd

Code ATC:

R06AX27

DCI (Dénomination commune internationale):

Desloratadine

Dosage:

500microgram/1ml

forme pharmaceutique:

Oral solution

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: ; GTIN: 5016119312892

Notice patient

212
DESLORATADINE 0.5MG/ML ORAL SOLUTION
14.10.15
TEN
1 of 2
0.5MG/ML
N/A
Rosemont
YES
-
210 x 300mm (folded 150 x 30mm)
1
Black
Keyline
150ML
P0723
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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 USER
_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

Résumé des caractéristiques du produit

OBJECT 1
DESLORATADINE 0.5MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 01-Apr-2016 | Rosemont
Pharmaceuticals Limited
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
disease history and the treatment could
be discontinued after symptoms are resolved and reinitiated upon their
reappearance.
In persistent allergic rhinitis (presence