Desloratadine Teva

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

desloratadine

Dostupné z:

Teva B.V

ATC kód:

R06AX27

INN (Medzinárodný Name):

desloratadine

Terapeutické skupiny:

Antihistamines for systemic use,

Terapeutické oblasti:

Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

Terapeutické indikácie:

Desloratadine Teva is indicated for the relief of symptoms associated with:allergic rhinitis;urticaria.

Prehľad produktov:

Revision: 18

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2011-11-24

Príbalový leták

17
B. PACKAGE LEAFLET
18
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DESLORATADINE TEVA 5 MG FILM-COATED TABLETS
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 Desloratadine Teva is and what it is used for
2.
What you need to know before you take Desloratadine Teva
3.
How to take Desloratadine Teva
4.
Possible side effects
5.
How to store Desloratadine Teva
6.
Contents of the pack and other information
1.
WHAT DESLORATADINE TEVA IS AND WHAT IT IS USED FOR
WHAT DESLORATADINE TEVA IS
Desloratadine Teva contains desloratadine which is an antihistamine.
HOW DESLORATADINE TEVA WORKS
Desloratadine Teva is an antiallergy medicine that does not make you
drowsy. It helps control your allergic
reaction and its symptoms.
WHEN DESLORATADINE TEVA SHOULD BE USED
Desloratadine Teva 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 and adolescents 12 years of
age and older. These symptoms include sneezing, runny or itchy nose,
itchy palate, and itchy, red or watery
eyes.
Desloratadine Teva 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 TEVA
DO NOT TAKE DESLORATADINE TEVA
•
if you are allergic to desloratadine, or any of

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Desloratadine Teva 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg desloratadine.
Excipient(s) with known effect:
Each film-coated tablet contains 1.2 mg of lactose monohydrate (see
section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Blue, round, biconvex film-coated tablet, plain on both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Desloratadine Teva is indicated in adults and adolescents aged 12
years and older 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 Teva 5 mg film-coated tablets is
one tablet once a day.
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.
_Paediatric population _
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).
The safety and efficacy of Desloratadine Teva 5 mg film-coated tablets
in children below the age of 12 years
have not been established.
Method of administration
Oral use.
The dose can be taken with or without food.
4.3
CONTRAINDICATIONS
3
Hypersensitivity to the active substance, to any of the excipients
listed in section 6.1, or to loratadine.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In the case of severe renal insufficiency, Deslorata