Azomyr

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

desloratadine

Available from:

N.V. Organon

ATC code:

R06AX27

INN (International Name):

desloratadine

Therapeutic group:

Antihistamines for systemic use,

Therapeutic area:

Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal

Therapeutic indications:

Azomyr is indicated for the relief of symptoms associated with:allergic rhinitis (see section 5.1)urticaria (see section 5.1)

Product summary:

Revision: 52

Authorization status:

Authorised

Authorization date:

2001-01-15

Patient Information leaflet

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AZOMYR 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, 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 of 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 Azomyr is and what it is used for
2.
What you need to know before you take Azomyr
3.
How to take Azomyr
4.
Possible side effects
5.
How to store Azomyr
6.
Contents of the pack and other information
1.
WHAT AZOMYR IS AND WHAT IT IS USED FOR
WHAT AZOMYR IS
Azomyr contains desloratadine which is an antihistamine.
HOW AZOMYR WORKS
Azomyr is an antiallergy medicine that does not make you drowsy. It
helps control your allergic
reaction and its symptoms.
WHEN AZOMYR SHOULD BE USED
Azomyr 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.
Azomyr 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 AZOMYR
DO NOT TAKE AZOMYR
-
if you are allergic to desloratadine, or any of the other ingredients
of this medicine (listed in
section 6) or to loratadine.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Azomyr:
-

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Azomyr 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 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
Azomyr 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 Azomyr 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 Azomyr 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.
3
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 ca