Rhinaspray 21 micrograms per metered dose, Nasal Spray Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ipratropium bromide

Available from:

Opella Healthcare France SAS T/A Sanofi

ATC code:

R01AX; R01AX03

INN (International Name):

Ipratropium bromide

Dosage:

21 Mcg/Dose

Pharmaceutical form:

Nasal spray, solution

Therapeutic area:

Other nasal preparations; ipratropium bromide

Authorization status:

Marketed

Authorization date:

1997-03-21

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RHINASPRAY® 21 MICROGRAMS PER METERED DOSE NASAL SPRAY SOLUTION
Ipratropium bromide
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What RHINASPRAY is and what it is used for
2.
What you need to know before you use RHINASPRAY
3.
How to use RHINASPRAY
4.
Possible side effects
5.
How to store RHINASPRAY
6.
Contents of the pack and other information
1.
WHAT RHINASPRAY IS AND WHAT IT IS USED FOR
The name of your medicine is RHINASPRAY 21 micrograms per metered dose
Nasal Spray solution
(called RHINASPRAY in this leaflet). It is a solution that you spray
into your nose. RHINASPRAY
contains a medicine called ipratropium bromide. This belongs to a
group of medicines called
‘anticholinergics’. It is used to help stop a runny nose caused by
Rhinitis. Rhinitis is an inflammation
of the nose which could be because of an allergy (such as hay fever)
or other reasons.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE RHINASPRAY
_ _
DO NOT USE RHINASPRAY
-
You are allergic (hypersensitive) to ipratropium bromide or any of the
other ingredients in
RHINASPRAY (listed in Section 6 below)
-
You are allergic (hypersensitive) to medicines that are similar to
RHINASPRAY, such as
atropine
Do not use this medicine if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before using
RHINASPRAY.
WARNINGS AND PRECAUTIONS
Talk to your doctor, or pharmacist or nurse before using your
medicine if:
•
You have cystic fibrosis
•
You have glauco

Summary of Product characteristics

Health Products Regulatory Authority
15 November 2023
CRN00DRFC
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rhinaspray 21 micrograms per metered dose, Nasal Spray Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each valve actuation (70 microlitres) delivers 21 micrograms of
ipratropium bromide as ipratropium bromide monohydrate.
Excipient(s) with known effect:
Each 70 microlitres of solution contains 17.5 micrograms of
benzalkonium chloride (see section 4.4).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal spray, solution (nasal spray)
A clear, colourless or almost colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rhinaspray is indicated for the symptomatic relief of rhinorrhoea in
allergic and non-allergic rhinitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults:_ Two sprays (42 micrograms) in each nostril administered 2 -
3 times a day.
_Children:_ The use of Rhinaspray has not been evaluated in children,
and therefore is not
recommended for use in patients below the age of 12 years.
ADMINISTRATION
To obtain the best results from your nasal spray follow the simple
instructions given below. If you are unclear about
how to use the nasal spray ask your doctor or pharmacist to explain.
1. Remove the dust cap.
2.The nasal spray pump must be primed before Rhinaspray is used for
the first time. To prime
the pump, hold the bottle with your thumb at the base and your index
and middle fingers on the white
shoulder area. Make sure the bottle points upright and away from your
eyes. Press your thumb firmly and
quickly against the bottle seven times. The pump is now primed and can
be used. Your pump will hold its
prime for up to 24 hours. If you have not used your pump for more than
24 hours, you will need to prime
it again before use. Reprime the pump as before, but this time only
two sprays are required. If you have
not used your pump for more than 7 days reprime using 7 sprays.
3. Blow your nose to clear your nostrils if necessary.