Astepro 1.5 mg/ml Nasal Spray, Solution

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Azelastine hydrochloride

متاح من:

Meda Health Sales Ireland Limited

ATC رمز:

R01AC; R01AC03

INN (الاسم الدولي):

Azelastine hydrochloride

جرعة:

1.5 milligram(s)/millilitre

الشكل الصيدلاني:

Nasal spray, solution

نوع الوصفة الطبية :

Product subject to prescription which may be renewed (B)

المجال العلاجي:

Antiallergic agents, excl. corticosteroids; azelastine

الوضع إذن:

Not marketed

تاريخ الترخيص:

2013-09-13

نشرة المعلومات

MODULE 1.3.1
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
Astepro 1.5 mg/ml Nasal Spray, Solution
Azelastine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
-
In this leaflet Astepro 1.5mg/ml, Nasal Spray is called Astepro
WHAT IS IN THIS LEAFLET
:
1.
What Astepro is and what it is used for
2.
What you need to know before you use Astepro
3.
How to use Astepro
4.
Possible side effects
5.
How to store Astepro
6.
Contents of the pack and other information
1.
WHAT ASTEPRO IS AND WHAT IT IS USED FOR
Astepro contains azelastine hydrochloride which belongs to a group of
medicines called antihistamines.
Antihistamines work by preventing the effects of histamine that the
body produces as part of an allergic
reaction.
Astepro is used to treat allergic rhinitis in adults, adolescents and
children 6 years and older. This is an
allergic reaction to substances such as, for example, pollen, house
dust mites or animal hair.
Usually it affects you by causing a runny nose, sneezing, itching or
blocked nose. Astepro should help
control these symptoms.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ASTEPRO
DO NOT USE ASTEPRO
-
if you are allergic (hypersensitive) to azelastine hydrochloride or
any of the other ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Azelastine S.
CHILDREN
Astepro Nasal Spray is not recommended for use in children below 6
years of age.
OTHER MEDICINES AND AZELASTINE S
Even if Astepro is not known to be affected by other medic

خصائص المنتج

Health Products Regulatory Authority
16 November 2018
CRN008HHF
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Astepro 1.5 mg/ml Nasal Spray, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Solution containing 1.5 mg /ml azelastine hydrochloride.
The delivered dose per actuation (0.14 ml) contains 0.21 mg azelastine
hydrochloride
equivalent to 0.19 mg azelastine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal spray, solution
Clear colourless solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of allergic rhinitis in adults, adolescents and
children 6 years
and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults and adolescents 12 years and older:
2 sprays in each nostril once a day. In some cases 2 sprays in each
nostril twice a day
may be required. The maximum daily dose is 2 sprays in each nostril
twice daily.
Children 6 to 11 years:
1 spray in each nostril twice daily.
Clinical experience of up to 4 weeks duration showed good efficacy and
safety in
children. Longer experiences in children have not been available;
however, clinical
trials of up to one year duration using a double higher daily dose
showed good
safety in adults and adolescents.
Astepro 1.5 mg/ml Nasal Spray, Solution is not recommended for use in
children
below 6 years of age due to a lack of data on safety and/or efficacy.
Health Products Regulatory Authority
16 November 2018
CRN008HHF
Page 2 of 7
Duration of treatment:
Astepro 1.5 mg/ml Nasal Spray, Solution is suitable for long-term use.
The duration
of treatment should be a clinical decision considering the severity of
allergic
symptoms, safety and should correspond to the period of allergenic
exposure.
Use longer than 4 weeks is not recommended in children 6-11 years due
to lack of
clinical data.
Method of administration:
Nasal use (topical – nasal mucosa)
_Precautions to be taken before handling or administering the
medicinal product:_
Spray with head held upright.
Before the firs