VIBROCIL-S NASAL DROPS

Country: Cyprus

Language: Greek

Source: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Active ingredient:

DIMETINDENE MALEATE; PHENYLEPHRINE

Available from:

GLAXOSMITHKLINE ΚΑΤΑΝΑΛΩΤΙΚΑ ΠΡΟΙΟΝΤΑ ΥΓΕΙΑΣ ΕΛΛΑΣ ΜΟΝΟΠΡΟΣΩΠΗ ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ (GSK CH ΕΛΛΑΣ ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.) (0000011419) 274

ATC code:

R01AB

INN (International Name):

SYMPATHOMIMETICS,COMBINATIONS EXCL CORTICOSTEROIDS

Pharmaceutical form:

NASAL DROPS

Composition:

DIMETINDENE MALEATE (0003614695) 0.025% W/V; PHENYLEPHRINE (0000059427) 0.25% W/V

Administration route:

NASAL USE

Prescription type:

Εθνική Διαδικασία

Therapeutic area:

PHENYLEPHRINE

Product summary:

Νομικό καθεστώς: Χωρίς Ιατρική Συνταγή; PACK WITH 1 BOTTLE X 15ML (900019301) 15 MILLILITRE - Εγκεκριμένο - Χωρίς Ιατρική Συνταγή

Patient Information leaflet

ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΓΙΑ ΤΟ ΧΡΗΣΤΗ
1.1.
Vibrocil-S

διάλυμα ρινικό (σταγόνες) (0.025+0.25)% w/v
Vibrocil-S

εκνέφωμα ρινικό (0.025+0.25)% w/v
Vibrocil-S

εκνέφωμα ρινικό σταθερών δόσεων
(microdoser)
(0.035+0.35)mg/dose
Vibrocil-S

γέλη ρινική (0.025+0.25)% w/w
Dimetindene maleate + phenylephrine
(ΜηλεΪνική διμεθινδένη + φαινυλεφρίνη)
1.2.
ΣΎΝΘΕΣΗ
VIBROCIL-S
 ΔΙΆΛΥΜΑ ΡΙΝΙΚΌ (ΣΤΑΓΌΝΕΣ), ΕΚΝΈΦΩΜΑ
ΡΙΝΙΚΌ ΚΑΙ ΕΚΝΈΦΩΜΑ
ΡΙΝΙΚΌ ΣΤΑΘΕΡΏΝ ΔΌΣΕΩΝ (MICRODOSER) :
Δραστικές ουσίες : Dimetindene maleate, phenylephrine
Έκδοχα : Benzalkonium chloride (συντηρητικό), sodium
phosphate dibasic
anhydrous, citric acid monohydrate, sorbitol, lavender oil
(deterpenized),
purified water.
VIBROCIL-S
 ΓΈΛΗ ΡΙΝΙΚΉ :
Δραστικές ουσίες : Dimetindene maleate, phenylephrine
Έκδοχα : Benzalkonium chloride (συντηρητικό), sodium
phosphate dibasic
anhydrous, citric acid monohydrate, sorbitol, lavender oil
(deterpenized),
hypromellose, purified water.
1.3.
ΦΑΡΜΑΚΟΤΕΧΝΙΚΈΣ ΜΟΡΦΈΣ
Διάλυμα ρινικό (σταγόνες)
Εκνέφωμα ρινικό
Εκνέφωμα ρινικό σταθερών δόσεων
(microdoser)
Γέλη ρινική
1.4.
ΠΕΡΙΕΚΤΙΚΌΤΗΤΑ ΣΕ ΔΡΑΣΤΙΚΈΣ ΟΥΣΊΕΣ
VIBROCIL-S
 ΔΙΆΛΥΜΑ ΡΙΝΙΚΌ (ΣΤΑΓΌΝΕΣ) ΚΑΙ
ΕΚΝΈΦΩΜΑ ΡΙΝΙΚΌ :
1 ml περιέχει :
Dimetindene maleate
0.25 mg
Phenylephrine
2.50 mg
_1/7_
VIBROCIL-S
 ΕΚΝΈΦΩΜΑ ΡΙΝΙΚΌ ΣΤΑΘΕΡΏΝ ΔΌΣΕΩΝ
(MICRODOSER) :
Κάθε δόση περιέχει 0.035mg dimetindene maleate και
0.35mg phenylephrine
1 ml περιέχει :
Dimetindene maleate
0.25 mg
Phenylephrine
2.50 mg
VIBROCIL-S
 ΓΈΛΗ ΡΙΝΙΝΙΚΉ :
1 g περιέχει :
Dimetindene maleate
0.25 mg
Phenylephrine

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vibrocil-S

2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Phenylephrine base and Dimethindene (INN).
Chemical designation:
Phenylephrine: (S)-1-(3-Hydroxyphenyl)-2-methylaminoethanol
Dimetindene:
2-(2-dimethylaminoethyl)-3-[2-(2-pyridyl)ethyl]-(1H)-indene maleate.
Vibrocil
®
Nasal Drops:
Phenylephrine 0.25% w/v, dimetindene 0.025% w/v
For excipients, see 6.1
3.
PHARMACEUTICAL FORM
Vibrocil
®
Nasal Drops
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Acute and chronic rhinitis, seasonal (hay fever) and non-seasonal
allergic rhinitis.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Nasal drops:
_Infants up to 1 year of age (with medical advice):_
1 drop into each nostril 3 to 4 times a day_ _
_Children 1 to 6 years of age_:
1 to 2 drops into each nostril 3 to 4 times a day
_Adults and children over 6 years of age_:
3 to 4 drops into each nostril 3 to 4 times a day
4.3.
CONTRA-INDICATIONS
Known hypersensitivity to any of the ingredients.
Like other vasoconstrictors, phenylephrine is contra-indicated in case
of atrophic rhinitis and
in patients who are receiving monoamine oxidase inhibitors or who have
received them in the
previous 14 days.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Vibrocil-S

should not be used continuously for more than 2 weeks. Prolonged or
excessive
use may induce tachyphylaxis and rebound congestion (rhinitis
medicamentosa).
As with other topical vasoconstrictors, do not exceed the recommended
dosage; excessive
use may lead, especially in small children and in the elderly, to
systemic effects of
vasoconstrictors.
Caution is recommended in patients with cardiovascular disease,
hypertension, thyroid
disease or closed angle glaucoma.
Vibrocil drops should not be used without medical advice in infants
and children below 6
years of age.
4.5.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Phenylephrine is contra-indicated in patients taking tricyclic
antidepressants and monoamin