Desloratadine Teva 0,5 mg/ml, drank

Krajina: Holandsko

Jazyk: holandčina

Zdroj: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktívna zložka:

DESLORATADINE

Dostupné z:

Teva Nederland B.V. Swensweg 5 2031 GA HAARLEM

ATC kód:

R06AX27

INN (Medzinárodný Name):

DESLORATADINE

Forma lieku:

Drank

Zloženie:

CITROENZUUR 0-WATER (E 330) ; HYPROMELLOSE (E 464) ; KAUWGOMSMAAKSTOF #15864 ; PROPYLEENGLYCOL (E 1520) 100 mg/ml ; SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420) ; SUCRALOSE (E 955) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER, GEZUIVERD,

Spôsob podávania:

Oraal gebruik

Terapeutické oblasti:

Desloratadine

Prehľad produktov:

Hulpstoffen: CITROENZUUR 0-WATER (E 330); HYPROMELLOSE (E 464); KAUWGOMSMAAKSTOF #15864; PROPYLEENGLYCOL (E 1520) 100 mg/ml; SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420); SUCRALOSE (E 955); TRINATRIUMCITRAAT 2-WATER (E 331); WATER, GEZUIVERD;

Dátum Autorizácia:

2013-09-04

Príbalový leták

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DESLORATADINE TEVA 0,5 MG/ML, DRANK
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
WHAT IS
contains desloratadine which is an antihistamine.
HOW WORKS
is an antiallergy medicine that does not make you
drowsy. It helps control your
allergic reaction and its symptoms.
WHEN SHOULD BE USED
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.
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
DO NOT TAKE
•
if you are allergic to desloratadine, loratadine or any of the other
ingredients of this medicine
(listed in secti

Súhrn charakteristických

1
1.
NAME OF THE MEDICINAL PRODUCT
Desloratadine Teva 0,5 mg/ml, drank
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains 0.5 mg desloratadine.
Excipient(s) with known effect
Each ml of oral solution contains 150 mg sorbitol (E 420),
approximately 0.01-0.04 mg benzylalcohol
and 100.2 mg propylene glycol (E 1520).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
Clear, colorless aqueous solution with a bubble-gum odour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 is 10 ml (5 mg) 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 .
Children 1 through 5 years of age: 2.5 ml (1.25 mg)
oral solution once a day.
Children 6 through 11 years of age: 5 ml (2.5 mg) oral
solution once a day.
The safety and efficacy of 0.5 mg/ml oral solution in
children below the age of
1 year have not been established.
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
2
treatment could be discontinued after symptoms are resolved and
reinitiated upon their reappearance.
In persistent allergic rhinitis (presence of symptoms for 4 days or
mo