Desloratadine ratiopharm
País: Unión Europea
Idioma: inglés
Fuente: EMA (European Medicines Agency)
Información para el usuario
(PIL)
24-06-2022
Ficha técnica
(SPC)
24-06-2022
Informe de Evaluación Pública
(PAR)
03-02-2021
Ingredientes activos:
desloratadine
Disponible desde:
Ratiopharm GmbH
Código ATC:
R06AX27
Designación común internacional (DCI):
desloratadine
Grupo terapéutico:
Antihistamines for systemic use,
Área terapéutica:
Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
indicaciones terapéuticas:
Desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with:allergic rhinitischronic idiopathic urticaria as initially diagnosed by a physician
Resumen del producto:
Revision: 12
Estado de Autorización:
Authorised
Fecha de autorización:
2012-01-13
Información para el usuario
19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DESLORATADINE RATIOPHARM 5 MG FILM-COATED TABLETS
desloratadine
For adults
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 7 days.
WHAT IS IN THIS LEAFLET
1.
What Desloratadine ratiopharm is and what it is used for
2.
What you need to know before you take Desloratadine ratiopharm
3.
How to take Desloratadine ratiopharm
4.
Possible side effects
5.
How to store Desloratadine ratiopharm
6.
Contents of the pack and other information
1.
WHAT DESLORATADINE RATIOPHARM IS AND WHAT IT IS USED FOR
WHAT DESLORATADINE RATIOPHARM IS
Desloratadine ratiopharm contains desloratadine which is an
antihistamine.
HOW DESLORATADINE RATIOPHARM WORKS
Desloratadine ratiopharm is an antiallergy medicine that does not make
you drowsy. It helps control
your allergic reaction and its symptoms.
WHEN DESLORATADINE RATIOPHARM SHOULD BE USED
Desloratadine ratiopharm 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. These
symptoms include sneezing, runny or itchy nose, itchy palate, and
itchy, red or watery eyes.
Desloratadine ratiopharm is also used to relieve the symptoms
associated with chronic idiopathic
urticaria (a skin condition with unknown cause), initially diagnosed
by your doctor. 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.
You
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Ficha técnica
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Desloratadine ratiopharm 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg desloratadine.
Excipient(s) with known effect:
Each tablet contains 14.25 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Round, biconvex, blue film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Desloratadine ratiopharm is indicated in adults for the relief of
symptoms associated with:
-
allergic rhinitis (see section 5.1)
-
chronic idiopathic urticaria as initially diagnosed by a physician
(see section 5.1)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one tablet once a day.
Duration of treatment
The duration of treatment depends on the type, duration and course of
symptoms.
If symptoms persist for more than 7 days or deteriorate, patients
should seek medical advice in order
to minimise the risk of masking an underlying disease.
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 weeks), continued treatment may be proposed to the patients during
the allergen exposure periods.
For chronic idiopathic urticaria the symptoms may persist more than 6
weeks it is characterised by
recurrent episodes and continued treatment may be necessary.
_Paediatric population _
Desloratadine ratiopharm is not recommended for use in children and
adolescents below 18 years of
age.
There is limited clinical trial efficacy experience with the use of
desloratadine in adolescents
12 through 17 years of age (see sections 4.8 and 5.1).
3
The safety and efficacy of Desloratadine
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