Astepro 1.5 mg/ml nasal spray, solution

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Azelastine hydrochloride

Dostupné z:

Mylan IRE Healthcare Limited

ATC kód:

R01AC; R01AC03

INN (Medzinárodný Name):

Azelastine hydrochloride

Dávkovanie:

1.5 milligram(s)/millilitre

Forma lieku:

Nasal spray, solution

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Antiallergic agents, excl. corticosteroids; azelastine

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

2013-09-13

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
ASTEPRO 0.15% NASAL SPRAY
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 0.15% 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 Astepro.
CHILDREN
Astepro Nasal Spray is not recommended for use in children below 6
years of age.
OTHER MEDICINES AND ASTEPRO
Even if Astepro is not known to be affected by other medicines, tell
your doctor or pharmacist if you
are taking,

Súhrn charakteristických

Health Products Regulatory Authority
30 March 2022
CRN00CJ6K
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Astepro 1.5 mg/ml nasal spray, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml solution contains 1.5 mg azelastine hydrochloride.
One 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 seasonal allergic rhinitis (hayfever) 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.
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
_Precautions to be taken before handling or administering the
medicinal product:_
Spray with head held upright.
Before the first use, the pump must be primed by pressing down and
releasing the pump six times. When Astepro 1.5 mg/m