Otipax Ear drops solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PHENAZONE, LIDOCAINE HYDROCHLORIDE

Available from:

Biocodex 7 Avenue Gallieni- 94250 Gentilly, France

ATC code:

S02DA01

INN (International Name):

LIDOCAINE HYDROCHLORIDE 1 % (W/W) PHENAZONE 4 % (W/W)

Pharmaceutical form:

EAR DROPS, SOLUTION

Composition:

LIDOCAINE HYDROCHLORIDE 1 % (W/W) PHENAZONE 4 % (W/W)

Prescription type:

OTC

Therapeutic area:

OTOLOGICALS

Authorization status:

Authorised

Authorization date:

2006-02-28

Patient Information leaflet

Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OTIPAX SOLUTION, EAR DROPS
PHENAZONE / LIDOCAINE HYDROCHLORIDE
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 your pharmacist.
This includes any
possible side effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 10 days.
WHAT IS IN THIS LEAFLET
1.
What OTIPAX solution, ear drops is and what it is used for
2.
What you need to know before you use OTIPAX solution, ear drops
3.
How to use OTIPAX solution, ear drops
4.
Possible side effects
5
How to store OTIPAX solution, ear drops
6.
Contents of the pack and other information
1.
WHAT OTIPAX SOLUTION, EAR DROPS IS AND WHAT IT IS USED FOR
Pharmacotherapeutic group:
local analgesic / anti-inflammatory for otological use. (S: Sensory
organs).
Therapeutic indications:
OTIPAX is indicated for the local symptomatic treatment of certain
painful conditions of the
middle ear with intact tympanic membrane:
- Congestive acute otitis media
- Flu otitis so-called phlyctenular viral otitis
- Barotrauma otitis
You must talk to a doctor if you do not feel better or if you feel
worse after 10 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OTIPAX SOLUTION, EAR DROPS
DO NOT USE OTIPAX SOLUTION, EAR DROPS:
-
If you are allergic to lidocaine or phenazone or any of the other
ingredients of this
medicine (listed in section 6).
-
If you have a tympanic perforation of infectious or traumatic origin.
2
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Otipax solution, ear
drops.
- If there is an opening in the tympanic membrane (ear drum), this
medicine may cause
adverse effects in the middle

Summary of Product characteristics

Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
OTIPAX
®
solution, ear drops.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenazone
................................................................................................
4g
Lidocaine hydrochloride
...........................................................................
1g
for 100g of solution, ear drops.
Excipient with known effect: glycerol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for ear drops.
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,
-
flu otitis so-called phlyctenular viral otitis,
-
barotrauma otitis.
4.2.
Posology and method of administration
_Posology: _
4 drops in the auditory meatus, 2 or 3 times a day in the painful ear.
_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 the drops in the auditory meatus by applying
gentle pressure to the soft
part of the dropper in the painful ear.
Page 2 of 4
4.3.
Contraindications
-
Tympanic perforation of infectious or traumatic origin (see section
4.4),
-
Hypersensitivity to the active substances or to any of the excipients
listed in the section 6.1.
4.4.
Special warnings and precautions for use
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.
This medicine contains an active ingredient which may give a positive
result in the anti-
doping tests.
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
The
data
currently
available
do