Oxymetazoline Uriach Nasal Spray Solution 0.5mg/ml

País: Malta

Idioma: anglès

Font: Medicines Authority

ingredients actius:

OXYMETAZOLINE HYDROCHLORIDE

Disponible des:

Uriach Consumer Healthcare SL Av. Cami Reial, 51-57, 08184 Palau- solita I Plegamans, Barcelona, Spain

Codi ATC:

R01AA05

Designació comuna internacional (DCI):

OXYMETAZOLINE HYDROCHLORIDE 0.5 mg/ml

formulario farmacéutico:

NASAL SPRAY, SOLUTION

Composición:

OXYMETAZOLINE HYDROCHLORIDE 0.5 mg/ml

tipo de receta:

OTC

Área terapéutica:

NASAL PREPARATIONS

Estat d'Autorització:

Withdrawn

Data d'autorització:

2015-01-02

Informació per a l'usuari

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
OXYMETAZOLINE URIACH
0.5 MG/ML
NASAL SPRAY, SOLUTION
Oxymetazoline hydrochloride
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 7 days or in case of your
child after 3-5 days.
WHAT IS IN THIS LEAFLET
1.
What Oxymetazoline Uriach is and what it is used for
2.
What you need to know before you use Oxymetazoline Uriach
3.
How to use Oxymetazoline Uriach
4.
Possible side effects
5.
How to store Oxymetazoline Uriach
6.
Contents of the pack and other information
1.
WHAT OXYMETAZOLINE URIACH IS AND WHAT IT IS USED FOR
Oxymetazoline Uriach belongs to a group of medicines called
sympathomimetics which acts producing local
vasoconstriction and nasal decongestion.
This medicine is indicated for local and temporary relief of nasal
congestion produced by rhinitis.
You must talk to a doctor if you do not feel better or if you feel
worse after 7 days or in case of your child after
3- 5 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OXYMETAZOLINE URIACH
DO NOT USE OXYMETAZOLINE URIACH
-
if you are allergic to oxymetazoline or any of the other ingredients
of this medicine (listed in section 6);
-
if you are taking and have taken antidepressant drugs (depression
treatment) in last 14 days;
-
if you are using other sympathomimetic decongestants;
-
if you have high fluid pressure inside the eye (narrow-angle
glaucoma);
-
if you have recently had neurosurgery (trans-sphenoidal hypophysectomy
or other surgery exposing
meninx);
-
if you suffer from heart disease or circulator

Fitxa tècnica

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Oxymetazoline Uriach 0.5 mg/ml
Nasal spray, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The nasal solution contains
1 ml of nasal spray contains 0.5 mg oxymetazoline hydrochloride
1 dose (0.07 ml) contains 35 μg oxymetazoline hydrochloride.
Excipient(s) with known effect:
Benzalkonium chloride
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
Local and temporary relief of nasal congestion produced by rhinitis
Oxymetazoline Uriach is indicated in adults and children over 12
years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and children over 12 years: one spray in each nostril every 12
hours.
Oxymetazolin in spray should not be used for more than a week without
seeking medical advice.
_Paediatric population _
_ _
The product should not be administered to children below 12 years (see
section 4.3).
_ _
Method of administration
Nasal administration.
Before use the protective cap needs to be removed. Before using this
product for the first time, it is
necessary to load the spray. For this purpose, hold the bottle away
your body, push the spray several
times pointing down until pulverised liquid comes out.
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Nasal fluids should be eliminated by blowing the nose before the
application. A spray bottle should be
held upright during application. The end portion of the dispenser
should be inserted into the nostril and
easily and rapidly presses the circular portion of the dispenser to
spray the product. Immediately after
the injection, it is advisable to breathe through the nose. The same
process should be used for other
nostril. After each use and before closing the bottle, the applicator
should be cleaned with a clean and
damp cloth and closed with the cap.
4.3
CONTRAINDICATIONS

Hypersensitivity to the active substance or other adrenergic
decongestant products or to any of
the excipients listed in