Aerinaze

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

desloratadine, pseudophedrine sulfate

Saatavilla:

N.V. Organon

ATC-koodi:

R01BA52

INN (Kansainvälinen yleisnimi):

desloratadine, pseudoephedrine

Terapeuttinen ryhmä:

Nasal preparations

Terapeuttinen alue:

Rhinitis, Allergic, Seasonal

Käyttöaiheet:

Symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion.

Tuoteyhteenveto:

Revision: 22

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2007-07-30

Pakkausseloste

19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AERINAZE 2.5 MG/120 MG MODIFIED-RELEASE TABLETS
desloratadine/pseudoephedrine sulphate
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, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs or illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. SEE SECTION 4.
WHAT IS IN THIS LEAFLET
:
1.
What Aerinaze is and what it is used for
2.
What you need to know before you take Aerinaze
3.
How to take Aerinaze
4.
Possible side effects
5.
How to store Aerinaze
6.
Contents of the pack and other information
1.
WHAT AERINAZE IS AND WHAT IT IS USED FOR
WHAT AERINAZE IS
Aerinaze tablets contain a combination of two active ingredients,
desloratadine which is an
antihistamine and pseudoephedrine sulphate which is a decongestant.
HOW AERINAZE WORKS
Antihistamines help to reduce allergic symptoms by preventing the
effects of a substance called
histamine, which is produced by the body. Decongestants help to clear
nasal congestion
(blocked/stuffy nose).
WHEN AERINAZE SHOULD BE USED
Aerinaze tablets relieve symptoms associated with seasonal allergic
rhinitis (hay fever), such as,
sneezing, runny or itchy nose, and eyes, when accompanied by nasal
congestion in adults and
adolescents 12 years of age and older.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AERINAZE
DO NOT TAKE AERINAZE
:
-
if you are allergic to desloratadine, pseudoephedrine sulphate,
adrenergic medicines, or any of
the other ingredients of this medicine (listed in section 6) or to
loratadine
-
if you have high blood pressure, heart or blood vessel disease or a
history of stroke
-
if you have glaucoma, difficulty in urinating, ur

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Aerinaze 2.5 mg/120 mg modified-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each tablet contains 2.5 mg desloratadine and 120 mg pseudoephedrine
sulphate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified-release tablet.
Blue and white bilayer oval tablet with “D12” branded to blue
layer.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aerinaze is indicated in adults and adolescents 12 years and older for
the symptomatic treatment of
seasonal allergic rhinitis when accompanied by nasal congestion.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Aerinaze is one tablet twice a day.
The recommended dosage and the duration of treatment should not be
exceeded.
The duration of treatment should be kept as short as possible and
should not be continued after the
symptoms have disappeared. It is advisable to limit treatment to about
10 days, as during chronic
administration the activity of pseudoephedrine sulphate may diminish.
After improvement of the
congestive condition of the mucosae of the upper airway, treatment may
be maintained with
desloratadine alone, if necessary.
_ _
_Elderly patients _
Patients of 60 years or older are more likely to experience adverse
reactions to sympathomimetic
medicinal products, such as pseudoephedrine sulphate. The safety and
efficacy of Aerinaze have not
been established in this population, and there are insufficient data
to give adequate dose
recommendations. Therefore Aerinaze should be used with caution in
patients above 60 years of age.
_Patients with renal or hepatic impairment _
The safety and efficacy of Aerinaze have not been established in
patients with impaired renal or
hepatic function, and there are insufficient data to give adequate
dose recommendations. Aerinaze is
not recommended for use in patients with impaired renal or hepatic
function.
_ _
_Paediatric population _
The safety and efficacy of Aerinaze in c