Astepro 1 mg/ml Nasal Spray, Solution

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Azelastine hydrochloride

Disponible depuis:

Meda Health Sales Ireland Limited

Code ATC:

R01AC; R01AC03

DCI (Dénomination commune internationale):

Azelastine hydrochloride

Dosage:

1 milligram(s)/millilitre

forme pharmaceutique:

Nasal spray, solution

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

Antiallergic agents, excl. corticosteroids; azelastine

Statut de autorisation:

Not marketed

Date de l'autorisation:

2012-10-05

Notice patient

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
ASTEPRO 1MG/ML NASAL SPRAY SOLUTION
Azelastine hydrochloride
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
-
In this leaflet Astepro 1 mg/ml Nasal Spray, Solution is called
Astepro.
_ _
IN THIS LEAFLET:
1.
What Astepro is and what it is used for
2.
Before you use Astepro
3.
How to use Astepro
4.
Possible side effects
5.
How to store Astepro
6.
Further 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.
BEFORE YOU USE ASTEPRO
_ _
DO NOT USE ASTEPRO IF
-
if you are allergic (hypersensitive) to azelastine hydrochloride or
any of the other ingredients of Astepro
(see section 6).
If this applies to you, talk to your doctor_ _or pharmacist_._
CHECK WITH YOUR DOCTOR, OR PHARMACIST BEFORE USING ASTEPRO
- if you are taking any other medicines obtained without a
prescription
USING OTHER MEDICINES
Astepro is not known to be affected by other medicines.
PREGNANCY AND BREAST-FEEDING
There are only limited information on the effects of Astepro on the
unborn or breast fed child.
If you are pregnant, trying to be

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Astepro 1 mg/ml Nasal Spray, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Solution containing 1 mg /ml azelastine hydrochloride.
The delivered dose per actuation (0.14 ml) contains 0.14 mg azelastine
hydrochloride equivalent to 0.13 mg azelastine
For a 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
Adults and adolescents 12 years and older:
2 applications in each nostril twice daily.
This dose should not be exceeded.
Children 6 to 11 years:
1 application in each nostril twice daily.
Astepro Nasal Spray is not recommended for use in children below 6
years of age due to a lack of data on safety and/or
efficacy
Astepro Nasal Spray is suitable for long-term use. There is no
restriction regarding duration of use.
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 first use, the pump must be primed by pressing down and
releasing the pump six times. When Astepro Nasal
Spray has not been used for 3 or more days, the pump must be reprimed
by pressing down and releasing the pump a
sufficient number of times until a fine mist emerges.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance azelastine hydrochloride or
to any of the excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Nothing relevant.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
__