Otipax drops ear

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

phenazone, lidocaine (lidocaine hydrochloride)

Available from:

Biocodex

ATC code:

S02DA30

INN (International Name):

phenazone, lidocaine (lidocaine hydrochloride)

Dosage:

40mg/g+ 10mg/g

Pharmaceutical form:

drops ear

Units in package:

15ml(16g) glass vial and dropper

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2022-12-23

Summary of Product characteristics

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SUMMARY OF PRODUCTCHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
OTIPAX
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition: 1g solution contain:
Active substances:
Phenazon.....................................40mg
Lidocainehydrochloride.............10 mg
Excipients: sodium thiosulfate, ethanol, glycerol, purified water.
Excipient with known effect: glycerol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ear drops solution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Local symptomatic treatment of certain painful conditions of the
middle ear with intact tympanic membrane:
-
acute otitis media,
-
otitis, as a complication after flue
-
barotrauma otitis.
4.2.
DOSAGE AND METHOD OF ADMINISTRATION
Auricular route.
In order to avoid unpleasant contact of the cold solution with the
ear, warm the container between the hands
before use.
-
Dropper bottle: instil 4 drops in the auditory meatus by applying
gentle pressure to the soft part of
the dropper, 2 or 3 times a day in the painful ear.
4.3.
CONTRAINDICATIONS
-
tympanic perforation of infectious or traumatic origin (see section
4.4),
-
hypersensitivity to the active ingredient or to any of the components
listed in section 6.1.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
SPECIAL WARNINGS
As a precautionary measure, ENSURE THAT THE TYMPANIC MEMBRANE IS
INTACT BEFORE ANY
ADMINISTRATION.
If there is tympanic breach, intra-auricular administration may bring
the product into contact with the
structures of the middle ear, with adverse effects upon them.
This medicine contains an active ingredient which may give a positive
result in the anti-doping tests.
PRECAUTIONS FOR USE
Limit treatment duration to 10 days. Management must be reviewed after
that time.
4.5.
INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTION
The data available to date do not suggest the possibility of
clinically significant interactions.
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4.6.
FERTILITY, PREGNANCY AND LACTATION
In the absence of any tympanic breach, systemic penetration is
unlik