Desloratadine Denk 0,5 mg/ml drank

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DESLORATADINE 0,5 mg/ml

Beschikbaar vanaf:

Denk Pharma GmbH & Co. KG Prinzregentenstrasse 79 81675 MÜNCHEN (DUITSLAND)

INN (Algemene Internationale Benaming):

DESLORATADINE 0,5 mg/ml

farmaceutische vorm:

Drank

Samenstelling:

CITROENZUUR 0-WATER (E 330) ; HYPROMELLOSE (E 464) ; PROPYLEENGLYCOL (E 1520) 150 mg/ml ; PROPYLEENGLYCOL (E 1520) ; SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420) ; SUCRALOSE (E 955) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; TUTTI-FRUTTI SMAAKSTOF ; WATER, GEZUIVERD, CITROENZUUR 0-WATER (E 330) ; HYPROMELLOSE (E 464) ; PROPYLEENGLYCOL (E 1520) ; PROPYLEENGLYCOL (E 1520) 150 mg/ml ; SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420) ; SUCRALOSE (E 955) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; TUTTI- FRUTTI SMAAKSTOF ; WATER, GEZUIVERD, CITROENZUUR 0-WATER (E 330) ; HYPROMELLOSE (E 464) ; PROPYLEENGLYCOL (E 1520) 150 mg/ml ; PROPYLEENGLYCOL (E 1520) ; SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420) ; SUCRALOSE (E 955) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; TUTTI- FRUTTI SMAAKSTOF ; WATER, GEZUIVERD

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2020-02-10

Bijsluiter

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

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Desloratadine Denk 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:
This medicinal product contains 150 mg/ml of sorbitol and 150.51 mg/ml
of propylene glycol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Desloratadine Denk 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 Denk 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 Desloratadine
Denk.
Children 1 through 5 years of age: 2.5 ml (1.25 mg) Desloratadine Denk
oral solution once a day.
Children 6 through 11 years of age: 5 ml (2.5 mg) Desloratadine Denk
oral solution once a day.
The safety and efficacy of Desloratadine Denk 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.
In persistent allergic rhinitis (presence of symptoms for 4 days or
more per week and for more than
4 w