Otrivine Extra Dual Relief 0.5mg/ml + 0.6mg/ml nasal spray, solution

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Xylometazoline hydrochloride; Ipratropium bromide

Beszerezhető a:

Haleon Ireland Limited

ATC-kód:

R01AB; R01AB06

INN (nemzetközi neve):

Xylometazoline hydrochloride; Ipratropium bromide

Adagolás:

0.5mg /ml + 0.6mg/ml milligram(s)/millilitre

Gyógyszerészeti forma:

Nasal spray, solution

Recept típusa:

Product not subject to medical prescription

Terápiás terület:

Sympathomimetics, combinations excl. corticosteroids; xylometazoline

Engedélyezési státusz:

Marketed

Engedély dátuma:

2012-12-18

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE USER
Otrivine Extra Dual Relief 0.5 mg/ml + 0.6 mg/ml Nasal Spray
Xylometazoline hydrochloride/Ipratropium bromide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
This medicine should not be used for more than 7 consecutive days.
-
You must talk to a doctor or pharmacist if you do not feel better or
if you feel worse.
-
This medicine has been recommended for you only. Do not pass it onto
others. It may harm
them, even if their signs of illness are the same as yours.
WHAT IS IN THIS LEAFLET
1.
What Otrivine Extra Dual Relief Nasal spray is and what it is used for
2.
What you need to know before you use Otrivine Extra Dual Relief Nasal
spray
3.
How to use Otrivine Extra Dual Relief Nasal spray
4.
Possible side effects
5
How to store Otrivine Extra Dual Relief Nasal spray
6.
Contents of the pack and other information
1. WHAT OTRIVINE EXTRA DUAL RELIEF NASAL SPRAY
IS AND WHAT IT IS USED FOR
Otrivine Extra Dual Relief Nasal spray is a combination medicinal
product consisting of two different
substances (xylometazoline hydrochloride and ipratropium bromide). One
of the active ingredients
(ipratropium bromide) helps with the runny nose, the other
(xylometazoline hydrochloride) has a
decongesting effect.
Otrivine Extra Dual Relief Nasal spray is used for the treatment of
nasal congestion with runny nose
(rhinorrhea) in connection with common colds.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OTRIVINE EXTRA DUAL RELIEF NASAL SPRAY
DO NOT USE OTRIVINE EXTRA DUAL RELIEF NASAL SPRAY
-
In children below 18 years of age, as adequate information on safety

Termékjellemzők

Health Products Regulatory Authority
15 March 2024
CRN00DX10
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Otrivine Extra Dual Relief 0.5mg/ml + 0.6mg/ml nasal spray, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 0.5 mg xylometazoline hydrochloride and 0.6 mg
ipratropium bromide.
1 puff (approx. 140 microliters) contains 70 micrograms xylometazoline
hydrochloride and 84 micrograms ipratropium bromide.
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 nasal congestion and rhinorrhea in connection
with common colds.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults:_ 1 puff in each nostril up to 3 times daily. At least 6 hours
should elapse between two doses. Do not exceed
3 applications daily into each nostril.
The treatment duration should not exceed 7 days (see section 4.4).
Do not exceed the stated dose. The lowest dose necessary to achieve
efficacy should be used for the shortest duration of
treatment.
It is recommended to stop treatment, when the symptoms have
diminished, even before the maximum duration of treatment
of 7 days, in order to minimize the risk of adverse reactions (see
section 4.8).
_Paediatric population_
Otrivine Extra Dual Relief is not recommended for use in children and
adolescents below 18 years of age due to lack of
sufficient documentation.
_Geriatrics_
There is only limited experience of use in patients above 70 years of
age.
Method of administration
Two fingers vertically actuated pump:
Before the first application, prime the pump by actuating 4 times.
Once primed the pump will normally remain charged
throughout regular daily treatment periods.
1.
Clear the nose.
2.
Hold the bottle upright with thumb under base and nozzle between two
fingers.
Health Products Regulatory Authority
15 March 2024
CRN00DX10
Page 2 of 7
3.
Lean forward slightly and insert the nozzle into a nostril.
4.