Otirelax drops ear

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

phenazone, lidocaine (lidocaine hydrochloride)

Available from:

Rompharm Company SRL

ATC code:

S02DA30

INN (International Name):

phenazone, lidocaine (lidocaine hydrochloride)

Dosage:

40mg/g+ 10mg/g

Pharmaceutical form:

drops ear

Units in package:

15ml plastic bottle-dropper

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2022-07-26

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
OTIRELAX (40 mg/10 mg)/1 g, ear drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g of solution contains 40 mg of phenazone and 10 mg of lidocaine
hydrochloride.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ear drops, solution.
Clear, colourless to slightly brownish-yellow solution, practically
free from particles.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Local symptomatic treatment of certain painful conditions of the
middle ear with intact
tympanic membrane:
- congestive acute otitis media,
- so-called phlyctenular viral otitis,
- barotrauma otitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
In order to avoid unpleasant contact of the cold solution with the
ear, warm the container
between the hands before use.
- Dropper bottle: instill 4 drops in the auditory meatus of the
painful ear, 2 or 3 times a day.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
Tympanic perforation of infectious or traumatic origin (see section
4.4 Special warnings and
special precautions for use).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
WARNINGS
As
a
precautionary
measure,
ensure
that
the
tympanic
membrane
is
intact
before
any
administration.
If there is tympanic destruction, intra-auricular administration may
bring the product into
contact with the structures of the middle ear, with adverse effects
upon them.
2
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
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None.
4.6
FERTILITY, PREGNANCY AND LACTATION
In the absence of any tympanic breach, systemic penetration is
unlikely.
As a result, under normal conditions of use, this medicine can, if
necessary, be used during
pregnancy and lactation.
4.7
EFFECTS ON THE ABILITY