AERIUS TABLETS

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

DESLORATADINE

Disponibil de la:

ORGANON PHARMA ISRAEL LTD., ISRAEL

Codul ATC:

R06AX27

Forma farmaceutică:

TABLETS

Compoziție:

DESLORATADINE 5 MG

Calea de administrare:

PER OS

Tip de prescriptie medicala:

Required

Produs de:

ORGANON LLC, USA

Grupul Terapeutică:

DESLORATADINE

Zonă Terapeutică:

DESLORATADINE

Indicații terapeutice:

Aerius tablet is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with:- allergic rhinitis - urticaria

Data de autorizare:

2017-05-31

Prospect

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
This medicine can be sold under doctor's prescription only
AERIUS
® TABLETS
FILM-COATED TABLETS
EACH FILM COATED TABLET CONTAINS:
Desloratadine 5 mg
For a list of inactive ingredients please refer to section 6 “WHAT
AERIUS TABLETS CONTAINS?”
See also section 2.8 “IMPORTANT INFORMATION ABOUT SOME OF THE
INGREDIENTS OF THE MEDICINE".
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
This leaflet contains concise information about AERIUS TABLETS. If you
have any further
questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their ailment seems similar to yours.
•
This medicine is intended for adults and adolescents 12 years of age
and older.
1. WHAT IS AERIUS TABLETS INTENDED FOR?
AERIUS TABLETS is an antiallergy medicine that does not make you
drowsy. It helps control your
allergic reaction and its symptoms.
This medicine 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.
AERIUS TABLETS 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.
THERAPEUTIC GROUP:
H
1
receptor antagonists - antihistamines.
2. BEFORE YOU USE AERIUS TABLETS
2.1 DO NOT USE AERIUS TABLETS IF YOU:
•
are allergic (hypersensitive) to desloratadine, or any of the other
ingredients of AERIUS
TABLETS (for a list of inactive ingredients, see section 6.1) or to
loratadine.
2.2 SPECIAL WARNINGS CONCERNING USE OF AERIUS TABLETS
BEFORE STARTING TREATMENT WITH AERIUS TABLETS, TELL THE

Caracteristicilor produsului

1.
NAME OF THE MEDICINAL PRODUCT
Aerius
®
Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 5 mg desloratadine.
Excipient(s) with known effect:
This medicinal product contains lactose (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
Light blue, round and embossed film-coated tablets with elongated
letters “S” and “P” on one side and
plain on the other.
The diameter of the film-coated tablet is 6.5 mm.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Aerius 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 Aerius 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 Aerius 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
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
Renal function impairment
In the case of severe renal insufficiency, Aerius should be