Desloratadine 2.5mg5ml oral solution sugar free

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Desloratadine

Saatavilla:

Actavis UK Ltd

ATC-koodi:

R06AX27

INN (Kansainvälinen yleisnimi):

Desloratadine

Annos:

500microgram/1ml

Lääkemuoto:

Oral solution

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: ; GTIN: 5012617025036 5012617025043

Pakkausseloste

DESLORATADINE 0.5MG/ML
ORAL SOLUTION
PACKAGE LEAFLET: INFORMATION FOR THE USER
_Continued over page_
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE.
• 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.
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
Desloratadine Oral Solution is an anti-allergy
medicine that does not make you drowsy. It
helps control your allergic reaction and its
symptoms.
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 normal daily
activities and sleep.
2 WHAT YOU NEED TO KNOW BEFORE YOU
TAKE DESLORATADINE ORAL SOLUTION
DO NOT TAKE DESLORATADINE ORAL
SOLUTION
• if you are ALLERGIC (hypersensitive) to
desloratadine, loratadine, or to any of the
other ingredients of Desloratadine Oral
Solution (listed in section 6).
WARNINGS AND PRECAUTIONS
TAKE

Valmisteyhteenveto

OBJECT 1
DESLORATADINE 0.5MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 07-Mar-2018 | Accord-UK Ltd
1. Name of the medicinal product
Desloratadine 0.5mg/ml Oral Solution
2. Qualitative and quantitative composition
Each ml of oral solution contains 0.5 mg desloratadine.
Excipients with known effect
Sorbitol (E420)
Sodium citrate
Disodium edentate
Propylene glycol (E1520)
For a 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 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
Desloratadine may be taken without regard to mealtime for the relief
of symptoms associated with
allergic rhinitis (including intermittent and persistent allergic
rhinitis) and urticaria (see section 5.1).
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.
In adults and adolescents (12 years of age and over): 10 ml (5 mg)
Desloratadine oral solution once a day.
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 of symptoms for 4 days or
more