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

País: Malta

Idioma: anglès

Font: Medicines Authority

ingredients actius:

XYLOMETAZOLINE HYDROCHLORIDE; IPRATROPIUM BROMIDE

Disponible des:

Novartis Consumer Health UK Limited

Codi ATC:

R01AB06

Designació comuna internacional (DCI):

XYLOMETAZOLINE HYDROCHLORIDE; IPRATROPIUM BROMIDE

formulario farmacéutico:

NASAL SPRAY, SOLUTION

Composición:

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

tipo de receta:

POM

Área terapéutica:

NASAL PREPARATIONS

Estat d'Autorització:

Authorised

Data d'autorització:

2013-02-13

Informació per a l'usuari

Page 1 of 6
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.
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.
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 similar substances, e.g.
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

Fitxa tècnica

Page 1 of 7
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).
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.
Page 2 of 7
_Geriatrics _
There is only limited experience of use in patients above 70 years of
age.
Method of administration
Before the first application, prime the pump by actuating 4 times.
Once primed the pump will
normally remain charged throughout regular daily treatment periods.
Should the spray not be
ejected during the full actuation stroke, or if the product has not
been used for longer than 6 days,
the pump will need to be reprimed with 4 actuations as initially
performed.
4.3 CONTRAINDICATIONS
Otrivine Extra Dual Relief should not be given to children under the
age of 18 due to lack of
sufficient documentation.
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
Known h