Aerius 5mg tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

desloratadine

Available from:

Schering-Plough Labo N.V.

ATC code:

R06AX27

INN (International Name):

desloratadine

Dosage:

5mg

Pharmaceutical form:

tablets film-coated

Units in package:

(10/1x10/) blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-07-30

Summary of Product characteristics

Page 1 of 6
Summary of Product Characteristics
Aerius
®
tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Aerius tablets 5 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of desloratadine.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Coated tablets
4.
CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
For the relief of symptoms associated with allergic rhinitis such as
sneezing, nasal
discharge and itching, as well as ocular itching, tearing and redness,
and itching of
palate. For relief of symptoms associated with urticaria such as
itching and rash.
_4.2 _
_POSOLOGY AND METHOD OF ADMINISTRATION _
For relief of symptoms associated with allergic rhinitis (including
intermittent and
persistent) and urticaria, Aerius
®
is taken with or without meal.
Adults and adolescents (12 years of age and over) take one tablet (5
mg) 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. The treatment should 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.
The safety and efficacy of Aerius 5 mg tablets in children below the
age of
12 years have not been established. No data are available.
_Additional information for special populations _
_Geriatric population: _
The safety and efficacy of Aerius
®
has not been established for geriatric population.
_Renal impairment: _
Aerius
®
should be used with caution in patients with severe renal failure.
_Hepatic impairment: _
There is no data regarding administration of Aerius
®
in