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

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

XYLOMETAZOLINE HYDROCHLORIDE, IPRATROPIUM BROMIDE

Tilgængelig fra:

Haleon Hellas Single Member Societe Anonyme, under the distinctive title of Haleon Hellas, 274, Kifissias Ave, 15232 chalandri, Athens, Greece

ATC-kode:

R01AB06

INN (International Name):

IPRATROPIUM BROMIDE 0.6 mg/ml XYLOMETAZOLINE HYDROCHLORIDE 0.5 mg/ml

Lægemiddelform:

NASAL SPRAY, SOLUTION

Sammensætning:

IPRATROPIUM BROMIDE 0.6 mg/ml XYLOMETAZOLINE HYDROCHLORIDE 0.5 mg/ml

Recept type:

POM

Terapeutisk område:

NASAL PREPARATIONS

Autorisation status:

Authorised

Autorisation dato:

2013-02-13

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
Otrivine Extra Dual Relief 0.5 mg/ml + 0.6 mg/ml nasal spray, solution
Xylometazoline hydrochloride/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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Otrivine Extra Dual Relief is and what it is used for
2.
What you need to know before you use Otrivine Extra Dual Relief
3.
How to use Otrivine Extra Dual Relief
4.
Possible side effects
5
How to store Otrivine Extra Dual Relief
6.
Contents of the pack and other information
1. WHAT OTRIVINE EXTRA DUAL RELIEF
IS AND WHAT IT IS USED FOR
Otrivine Extra Dual Relief is a combination medicinal product
consisting of two different substances.
One of the active ingredients helps against runny nose, the other has
a decongesting effect.
Otrivine Extra Dual Relief 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
DO NOT USE OTRIVINE EXTRA DUAL RELIEF
-
In children below 18 years of age, as adequate information on safety
and efficacy is not
available
-
If you are allergic to xylometazoline hydrochloride or ipratropium
bromide or any of the other
ingredients of this medicine (listed in section 6)
-
If you are allergic to atropine or atropine like substances such as
hyoscyamine and scopolamine
-
If you had your pituitary gland removed by surgery carried out through
the nose
-
If you have had brain surgery where the operation was carried out
through the nose or mouth
-
If you suf

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Otrivine Extra Dual Relief 0.5 mg/ml + 0.6 mg/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.
3.
Lean forward slightly and insert the nozzle into a nostril.
4.
Spray and breathe in gently through the nose at the same time.
5. Repeat this procedure in the other nostril.
6. Clean and dry the nozzl