Vibrocil Nasal Spray Solution with metering pump 2.5mg/0.25mg

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

PHENYLEPHRINE, DIMETINDENE MALEATE

Commercializzato da:

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

Codice ATC:

R01AB

INN (Nome Internazionale):

PHENYLEPHRINE 2.5 mg DIMETINDENE MALEATE 0.25 mg

Forma farmaceutica:

NASAL SPRAY, SOLUTION

Composizione:

PHENYLEPHRINE 2.5 mg DIMETINDENE MALEATE 0.25 mg

Tipo di ricetta:

OTC

Area terapeutica:

NASAL PREPARATIONS

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2007-04-20

Foglio illustrativo

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT/USER
VIBROCIL 0.25% / 0.025%
NASAL SPRAY SOLUTION WITH METERING PUMP
Phenylephrine, dimetindene maleate
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 has
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.
•
You must talk to a doctor if you or your child does not feel better or
feels worse after 7 days.
WHAT IS IN THIS LEAFLET
1
What Vibrocil is and what it is used for
2
What you need to know before you use Vibrocil
3
How to use Vibrocil
4
Possible side effects
5
How to store Vibrocil
6
Contents of the pack and other information
1
WHAT VIBROCIL IS AND WHAT IT IS USED FOR
Vibrocil contains a nasal decongestant (phenylephrine) and an
antihistamine (dimetindene maleate)
as active ingredients.
Vibrocil provides a fast and lasting relief of nasal congestion and
runny nose caused by a wide variety
of infectious or allergic upper respiratory disorders. It helps clear
the nasal passages, relieving from
stuffy or congested nose. Vibrocil does not interfere with the
activity of the nasal cilia.
Vibrocil is used to relieve nasal congestion in case of colds, acute
and chronic rhinitis, hay fever or
other allergic rhinitis (allergies to house dust, animal fur, etc.)
vasomotor rhinitis and sinusitis.
Vibrocil can also be used as additional therapy in case of otitis.
Vibrocil may be prescribed by your doctor for pre- or post-operative
care in case of nasal surgery.
You must talk to a doctor if you do not feel better of if you feel
worse after 7 days.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE VIBROCIL
DO NOT USE VIBROCIL IF YOU OR YOUR CHILD IS:
•
allergic (hypersensitive) to phenylephrine or dimetindene m

Scheda tecnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Vibrocil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of
VIBROCIL NASAL METERED-DOSE SPRAY
contains 2.5 mg of phenylephrine base and
0.25 mg of dimetindene maleate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
_VIBROCIL NASAL SPRAY SOLUTION WITH METERING PUMP: _
Colorless to slightly yellowish, clear solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of common cold, nasal congestion, acute and
chronic rhinitis, seasonal (hay
fever)
and
non-seasonal
allergic
rhinitis,
acute
and
chronic
sinusitis,
and
vasomotor
rhinitis.
Adjunctive therapy in case of acute otitis media.
Pre- and post-operative care (nasal surgery).
Vibrocil is indicated in children 6 years of age and over and in
adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Vibrocil should not be used continuously for more than 7 days.
POSOLOGY
•
_Children below 6 years of age_
: not recommended
•
_Children 6 to 12 years of age (with adult supervision)_
: 1 to 2 sprays into each nostril 3 to 4 times
a day.
•
_Adolescents over 12 years of age and adults_
: 1 to 2 sprays into each nostril 3 to 4 times a day.
METHOD OF ADMINISTRATION
The protective cap should be removed. Before the first application,
several pumping motions should
be performed until an even spray appears in the air. At subsequent
applications the dosing spray will
then be ready for instant use.
The patient should insert the nozzle into the nostril and press once
firmly on the spray head. Then
withdraw the nozzle should be withdrawn before releasing pressure.
Optimal distribution of the spray
is achieved by breathing in a little air through the nose during the
spraying process.
The protective cap should be replaced after use.
The dosing spray ensures that Vibrocil solution is well distributed
over the surface of the nasal
mucosa. The standardised valve with which it is fitted permits
accuracy of dosage (140 micrograms
per spray) and precludes the possibility of