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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.
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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 not suggest the existence of clinically significant
interactions.
4.6. Fertility, pregnancy and lactation

Pregnancy
No effects during pregnancy are anticipated, since systemic exposure to phenazone and
lidocain is negligible.
Therefore, in the normal conditions of use, this medicine can be used, if necessary, during
pregnancy.
Breast-feeding
In the normal conditions of use, phenazone and lidocain are not excreted in human milk.
Therefore, in the normal conditions of use, this medicine can be used, if necessary, during
breast-feeding.
4.7. Effects on ability to drive and use machines
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Otipax solution, ear drops has no influence on the ability to drive and use machines.
4.8. Undesirable effects

The side effects which have been reported are classified after by system-organ class and by
frequency defined as: very common (>1/10), common (> 1/100, < 1/10), uncommon (>
1/1,000, < 1/100), rare (> 1/10,000, < 1/1,000) and very rare (< 1/10,000), frequency not
known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing
severity.
System-Organ Rare
Ear and labyrinth Local reactions: allergy,
disorders irritation or hyperhemia of
the auditory meatus
Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions via the
national reporting system. ADR Reporting – Website:
www.medicinesauthority.gov.mt/adrportal
4.9. Overdose
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties

Pharmacotherapeutic group: local analgesic / anti-inflammatory for otological use.
S: Sensory organs. ATC code: S02 DA30.
Phenazone: pyrazolone derivative with analgesic and anti-inflammatory properties.

Lidocaine: local anaesthetic of the amide group.
5.2. Pharmacokinetic properties

Skin resorption of any of the components was not studied. It is almost absent.
There is no systemic passage of this solution unless there is an eardrum breach.
5.3. Preclinical safety data

Not available.
6. PHARMACEUTICAL PARTICULARS
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6.1. List of excipients
Sodium thiosulphate, ethanol, glycerol, purified water.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life

3 years.
6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container

Bottle (yellow glass type III) of 15 ml (containing 16 g of solution) closed by a stopper
(LDPE) with a seal (LDPE) and a dropper (PE/vinyl acetate) and a stopper (LDPE).
Box of 1 bottle.
6.6. Instructions for use/handling

No special requirements.
7. MARKETING AUTHORIZATION HOLDER

BIOCODEX
7 avenue Gallieni
94250 GENTILLY
Tel.: 33 1 41 24 30 00
Fax: 33 1 41 24 30 04
8. MARKETING AUTHORISATION NUMBER(S)

MA239/00201
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE MEDICINAL PRODUCT

28th February 2006
10. DATE OF REVISION OF THE TEXT

4th April 2017
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SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF MEDICINAL PRODUCT

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Excipient with known effect: glycerol.

4.1. Therapeutic indications

4.2. Posology and method of administration

4.4. Special warnings and precautions for use

4.6. Fertility, pregnancy and lactation

4.7. Effects on ability to drive and use machines

4.8. Undesirable effects

Reporting of suspected adverse reactions

5.1. Pharmacodynamic properties

Phenazone: pyrazolone derivative with analgesic and anti-inflammatory properties.

5.2. Pharmacokinetic properties

5.3. Preclinical safety data

6.3. Shelf life

6.4. Special precautions for storage

6.5. Nature and contents of container

6.6. Instructions for use/handling

7. MARKETING AUTHORIZATION HOLDER

8. MARKETING AUTHORISATION NUMBER(S)

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE MEDICINAL PRODUCT

10. DATE OF REVISION OF THE TEXT

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