Rhinolast S nasal spray, solution

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Azelastine hydrochloride

Boleh didapati daripada:

Mylan IRE Healthcare Limited

Kod ATC:

R01AC; R01AC03

INN (Nama Antarabangsa):

Azelastine hydrochloride

Dos:

1.5 milligram(s)/millilitre

Borang farmaseutikal:

Nasal spray, solution

Jenis preskripsi:

Product subject to prescription which may be renewed (B)

Kawasan terapeutik:

Antiallergic agents, excl. corticosteroids; azelastine

Status kebenaran:

Not marketed

Tarikh kebenaran:

2013-09-13

Risalah maklumat

Rhinolast Hay Fever
Allergy Nasal Spray
Azelastine hydrochloride 01.w/v
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.

This medicine is available without prescription. However, you still
need to use it carefully to
get the best results.

Keep this leaflet. You may need to read it again.

Ask your doctor or pharmacist if you need more information or advice.

You must contact your doctor if your symptoms do not improve.
IN THIS LEAFLET:
1.
What Rhinolast Hayfever Nasal Spray is for
2.
Before you use Rhinolast Hayfever Nasal Spray
3.
How to use Rhinolast Hayfever Nasal Spray
4.
Possible side effects
5.
How to store Rhinolast Hayfever Nasal Spray
6.
Further information
1.
WHAT RHINOLAST HAYFEVER NASAL SPRAY IS FOR
Rhinolast Hayfever Nasal Spray belongs to a group of medicines called
antihistamines. These work by
preventing the effects of histamine that the body produces as part of
an allergic reaction. Rhinolast
Allergy is used to treat seasonal allergic rhinitis. This is an
allergy which may affect you only at
certain times of the year (for example, allergy to pollen called
Hayfever).
Hayfever usually affects you by causing a runny nose, sneezing,
itching or blocked nose. Rhinolast
Allergy should help control these symptoms. If you are not sure that
you are suffering from an
allergy consult your pharmacist before using this medicine. Do not use
it to relieve the symptoms of
colds or flu.
This product may be used by adults and children aged 12 years and
over.
2.
BEFORE YOU TAKE RHINOLAST NASAL SPRAY
DO NOT USE RHINOLAST HAYFEVER NASAL SPRAY IF:

You are allergic to azelastine hydrochloride or any of the other
ingredients of Rhinolast
Hayfever Nasal Spray. If this applies to you, talk to your doctor or
pharmacist.

You are not sure that you are suffering from an allergy. Consult your
pharmacist.

Your have cold or flu symptoms
PREGNANCY AND BREAST-FEEDING
If you are pregnant, trying to become pregnant or are breast-feeding
ask your doctor or p

Ciri produk

Health Products Regulatory Authority
26 November 2020
CRN00C1Y6
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rhinolast S 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.
Rhinolast S Nasal Sprayis 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
Rhinolast S Nasal Spray 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 first use, the pump must be primed by pressing down and
releasing the pump six times. When Rhinolast S Nasal
Spray has no