Deslor 0.5mg/ml Oral Solution

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

DESLORATADINE

Prieinama:

Rowex Ltd Newtown Bantry, Co. Cork, , Ireland

ATC kodas:

R06AX27

INN (Tarptautinis Pavadinimas):

DESLORATADINE 0.5 mg/ml

Vaisto forma:

ORAL SOLUTION

Sudėtis:

DESLORATADINE 0.5 mg/ml

Recepto tipas:

POM

Gydymo sritis:

ANTIHISTAMINES FOR SYSTEMIC USE

Produkto santrauka:

Licence number in the source country: NOT APPLICAPABLE

Autorizacija statusas:

Authorised

Leidimo data:

2020-04-01

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DESLOR 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, 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.
WHAT IS IN THIS LEAFLET
1.
What Deslor is and what it is used for
2.
What you need to know before you take Deslor
3.
How to take Deslor
4.
Possible side effects
5.
How to store Deslor
6.
Contents of the pack and other information
1.
WHAT DESLOR IS AND WHAT IT IS USED FOR
WHAT DESLOR IS
Deslor contains desloratadine which is an antihistamine.
HOW DESLOR WORKS
Deslor oral solution is an anti-allergy medicine that does not make
you drowsy. It helps control your
allergic reaction and its symptoms.
WHEN DESLOR SHOULD BE USED
Deslor 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.
Deslor 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 DESLOR
DO NOT TAKE DESLOR
-
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 nur

Prekės savybės

Page 1 of 9
1.
NAME OF THE MEDICINAL PRODUCT
Deslor 0.5 mg/ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains 0.5 mg of desloratadine.
Excipients with known effect
Each ml of oral solution contains up to 97.5 mg of sorbitol, 102.30 mg
of propylene glycol and 0.167 mmol
(3.85 mg) of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Deslor 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 Deslor is 10 ml (5 mg) oral solution once a
day.
_Pediatric 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 Deslor.
Children 1 through 5 years of age: 2.5 ml (1.25 mg) Deslor oral
solution once a day.
Children 6 through 11 years of age: 5 ml (2.5 mg) Deslor oral solution
once a day.
The safety and efficacy of Deslor 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.
Page 2 of 9
In persistent allergic rhinitis (presence of symptoms for 4 days or
more per week and for more than 4 weeks),
continued treatment m