VIBROCIL MICRODOSER

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

DIMETINDENE MALEATE; PHENYLEPHRINE

Saatavilla:

GSK CONSUMER HEALTHCARE, ISRAEL LTD

ATC-koodi:

R06AB03

Lääkemuoto:

NASAL SOLUTION

Koostumus:

DIMETINDENE MALEATE 0.025 %W/V; PHENYLEPHRINE 0.25 %W/V

Antoreitti:

NASAL

Prescription tyyppi:

Not required

Valmistaja:

GSK CONSUMER HEALTHCARE SARL, SWITZERLAND

Terapeuttinen ryhmä:

DIMETINDENE

Terapeuttinen alue:

DIMETINDENE

Käyttöaiheet:

Symptomatic treatment of common cold, nasal congestio, acute rhinitis, seasonal (hay fever) and non seasonal allergic rhinitis, acute sinusitis. Adjunctive therapy in case of acute otitis media.

Valtuutus päivämäärä:

2022-10-31

Pakkausseloste

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS
’ REGULATIONS (PREPARATIONS)
– 1986
This medicine is dispensed without a doctor's prescription
VIBROCIL MICRODOSER 0.25% W/V + 0.025% W/V
METERED-DOSE NASAL SPRAY
ACTIVE INGREDIENTS AND THEIR QUANTITY IN A DOSING UNIT:
DIMETHINDENE MALEATE
0.025% W/V
PHENYLEPHRINE
0.25% W/V
Inactive ingredients and allergens in the preparation, please see
section 6 and section 2 under the title
“
Important information about some of the ingredients of the medicine
”
.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains concise information about
the medicine. If you have additional questions, refer to the doctor or
the pharmacist.
Use the preparation according to the instructions in the dosage
section of this leaflet. Consult the
pharmacist if you need more information. Refer to the doctor if signs
of the ailment (symptoms) worsen or
do not improve after 7 days.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Vibrocil Microdoser is intended for temporary relief of nasal
congestion and common cold, acute rhinitis,
seasonal allergic rhinitis (hay fever), non-seasonal allergic rhinitis
and acute sinusitis. Vibrocil Microdoser is
also used as an adjunctive therapy for otitis media (inflammation of
the middle ear).
THERAPEUTIC CLASS:
Dimethindene maleate
–
an anti-allergic agent.
Phenylephrine
–
a sympathomimetic agent, a capillary constrictor.
2.
BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredients or to any of
the other components the medicine
contains (please see section 6 and section 2).
•
You are taking or have taken during the last 14 days antidepressants
of the monoamine oxidase
inhibitors group (MAO inhibitors).
•
You have Atrophic Rhinitis/Ozena that has caused your nasal mucous
membranes to become thinner.
•
You have narrow angle glaucoma.
•
You have undergone resection of the pituitary gland or surgery via the
nose or the mouth in which the
hard, outermost membrane of the cen

Valmisteyhteenveto

1. VIBROCIL MICRODOSER
_2. _
_COMPOSITION _
_Active ingredients:_ Dimetindene maleate 0.025% W/V, Phenylephrine
0.25% W/V.
_3. _
_PHARMACEUTICAL FORM AND AMOUNT OF ACTIVE INGREDIENT PER UNIT _
_Microdoser_
1 mL contains: Dimetindene maleate 0.25 mg, phenylephrine 2.5 mg.
1 spray (=0.14 mL) contains 0.035 mg dimethindene maleate and 0.35 mg
phenylephrine.
A standardized valve enables exact dosing (mean value: 140 µL
solution per spray).
_4. _
_INDICATIONS/APPLICATIONS _
_4.1_
Indication:
Symptomatic treatment of common cold, nasal congestion, acute
rhinitis, seasonal (hay fever) and non
seasonal allergic rhinitis, acute sinusitis. Adjunctive therapy in
case of acute otitis media.
_4.2 DOSING REGIMEN/USE _
Do not exceed the indicated dosage and frequency of use.
The lowest effective dosage should always be used, and the treatment
kept as short as possible.
_Children older than 6 years (under adult supervision) and adults:_
1 to 2 sprays into each nostril 3 to 4 times a day.
Using the microdoser
1.
Thoroughly clean your nose (
e.g. by blowing it
) before use.
2.
Be careful not to get the spray into your eyes.
3.
Remove the protective cap. Before first use, actuate the pump 5 times
to prime it.
The microdoser is now ready for further use.
If the product has not been used for some
time, the pump must be actuated 5 times again before use.
4.
Insert the microdoser into one nostril
and breathe in through your nose as you spray once,
pressing down firmly on the pump. Repeat the process in the other
nostril.
5.
Wipe and dry the nozzle tip before putting the protective cap back on.
Do not share your bottle of Vibrocil metered-dose spray with other
people to avoid any possible
spread of infection.
_4.3 CONTRAINDICATIONS _
Hypersensitivity to one of the active substances (phenylephrine,
dimetindene maleate) or one of
of the excipients listed in section 6.1.
Contraindicated in:

simple atrophic rhinitis, ozena (
rhinitis atrophicans cum foetore)

patients who are on MAO inhibitors or who have taken them in the
preceding