Deslorasam 5 mg filmomhulde tabletten

Quốc gia: Hà Lan

Ngôn ngữ: Tiếng Hà Lan

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

Thành phần hoạt chất:

DESLORATADINE

Sẵn có từ:

Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)

Mã ATC:

R06AX27

INN (Tên quốc tế):

DESLORATADINE

Dạng dược phẩm:

Filmomhulde tablet

Thành phần:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CITROENZUUR 1-WATER (E 330) ; CROSCARMELLOSE NATRIUM (E 468) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAÏSZETMEEL ; POLOXAMEER 188 ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Tuyến hành chính:

Oraal gebruik

Khu trị liệu:

Desloratadine

Tóm tắt sản phẩm:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CITROENZUUR 1-WATER (E 330); CROSCARMELLOSE NATRIUM (E 468); INDIGOKARMIJN ALUMINIUMLAK (E 132); LACTOSE 1-WATER; MACROGOL 3350; MAÏSZETMEEL; POLOXAMEER 188; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); TALK (E 553 B); TITAANDIOXIDE (E 171);

Ngày ủy quyền:

2012-06-27

Tờ rơi thông tin

Desloratadine, NL/H/2330/001, August 2020
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DESLORASAM 5 MG FILMOMHULDE TABLETTEN
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 Deslorasam is and what it is used for
2.
What you need to know before you take Deslorasam
3.
How to take Deslorasam
4.
Possible side effects
5.
How to store Deslorasam
6.
Contents of the pack and other information
1.
WHAT DESLORASAM IS AND WHAT IT IS USED FOR
WHAT DESLORASAM IS
Deslorasam contains desloratadine which is an antihistamine.
HOW DESLORASAM WORKS
Deslorasam is an antiallergy medicine that does not make you drowsy.
It helps control your allergic
reaction and its symptoms.
WHEN DESLORASAM SHOULD BE USED
Deslorasam 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.
Deslorasam 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 DESLORASAM
DO NOT TAKE DESLORASAM
•
if you are allergic to desloratadine or any of the other ingredients
of this medicine (listed in section
6) or to loratadine.
WARNINGS AND PRECAUTIO

Đặc tính sản phẩm

Desloratadine, NL/H/2330/001, August 2020
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Deslorasam 5 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg desloratadine.
Excipient with known effect:
15 mg of lactose monohydrate per film-coated tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Round, biconvex, blue film-coated tablets and 6.5 mm in diameter
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Desloratadine 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): _
T
he recommended dose of Desloratadine 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 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.
Desloratadine, NL/H/2330/001, August 2020
2
4.3
CONTRAINDICATIONS
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 insufficienc