Rhinolast S, 1 mg/ml Nasal Spray, Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Azelastine hydrochloride

Available from:

Meda Health Sales Ireland Limited

ATC code:

R01AC; R01AC03

INN (International Name):

Azelastine hydrochloride

Dosage:

1 milligram(s)/millilitre

Pharmaceutical form:

Nasal spray, solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Antiallergic agents, excl. corticosteroids; azelastine

Authorization status:

Not marketed

Authorization date:

2012-10-26

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
RHINOLAST S 1 MG/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 Rhinolast S
1 mg/ml Nasal Spray, Solution is called Rhinolast S.
_ _
IN THIS LEAFLET
:
1.
What Rhinolast S is and what it is used for
2.
Before you use Rhinolast S
3.
How to use Rhinolast S
4.
Possible side effects
5.
How to store Rhinolast S
6.
Further information
1.
WHAT RHINOLAST S IS AND WHAT IT IS USED FOR
RHINOLAST S
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.
Rhinolast S 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. Rhinolast S should help
control these symptoms.
2.
BEFORE YOU USE RHINOLAST S
_ _
DO NOT USE RHINOLAST S IF
-
if you are allergic (hypersensitive) to azelastine hydrochloride or
any of the other ingredients of
Rhinolast S (see section 6).
If this applies to you, talk to your doctor
_ _
or pharmacist
_._
CHECK WITH YOUR DOCTOR, OR PHARMACIST BEFORE USING RHINOLAST S
- if you are taking any other medicines obtained without a
prescription
USING OTHER MEDICINES
Rhinolast S is not known to be affected by other medicines.
PREGNANCY AND BREAST-FEEDING
There are only limited information on the effects of Rhinol

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rhinolast S, 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.
Rhinolast S 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
Rhinolast S 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 Rhinolast S
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.
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