DESLORATADINE CLONMEL 0.5 Mg/Ml Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DESLORATIDINE

Available from:

Clonmel Healthcare Ltd

ATC code:

R06AX27

INN (International Name):

DESLORATIDINE

Dosage:

0.5 Mg/Ml

Pharmaceutical form:

Oral Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other antihistamines for systemic use

Authorization status:

Authorised

Authorization date:

2012-05-25

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DESLORATADINE CLONMEL 0.5 MG/ML ORAL SOLUTION
desloratadine
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Desloratadine Clonmel is and what it is used for
2. What you need to know before you take Desloratadine Clonmel
3. How to take Desloratadine Clonmel
4. Possible side effects
5. How to store Desloratadine Clonmel
6. Contents of the pack and other information
1. WHAT DESLORATADINE CLONMEL IS AND WHAT IT IS USED FOR
WHAT DESLORATADINE CLONMEL IS
Desloratadine Clonmel contains desloratadine which is an
antihistamine.
HOW DESLORATADINE CLONMEL WORKS
Desloratadine Clonmel oral solution is an antiallergy medicine that
does not make you drowsy. It helps
control your allergic reaction and its symptoms.
WHEN DESLORATADINE CLONMEL SHOULD BE USED
Desloratadine Clonmel 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 Clonmel 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
normal daily activities and sleep.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESLORATADINE CLONMEL
DO NOT TAKE DESLOR

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Desloratadine Clonmel 0.5mg/ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains 0.5 mg desloratadine.
Excipient with known effect
The medicinal product contains 103 mg/ml sorbitol (E420).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
Desloratadine Clonmel is a clear, colourless solution free from
foreign matter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Desloratadine Clonmel 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 Clonmel is 10 ml (5 mg) oral
solution once a day.Desloratadine
Clonmel_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 Clonmeldesloratadine.
Children 1 through 5 years of age: 2.5 ml (1.25 mg) Desloratadine
Clonmel oral solution once a day.
Children 6 through 11 years of age: 5 ml (2.5 mg) Desloratadine
Clonmel 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.
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