Otipax ear solution Dropper bottle 16 g

1. NAME OF THE MEDICATION Otipax ear solution Dropper bottle 16 g

OTIPAX, solution for auricular instillation

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Phenazone............................................................................................................................. 4.00 g

Lidocaine hydrochloride....................................................................................................... 1.00 g

For 100 g of solution for auricular instillation.

Notable excipients: Glycerol, ethanol.

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for auricular instillation.

4. Clinical data Otipax ear solution Dropper bottle 16 g

4.1. therapeutic indications :

Local symptomatic treatment of certain painful conditions of the middle ear with closed eardrum:

- Acute congestive otitis media,

- Influenza-like otitis called phlyctenular,

- Barotraumatic otitis.

4.2. Posology and mode of administration

Dosage:

4 drops 2 to 3 times a day in the painful ear.

Mode of administration:

Auricular route.

Dropper bottle: pour 4 drops into the ear canal by exerting a slight pressure on the flexible part of the dropper.

To avoid the unpleasant contact of the cold solution in the ear, warm the bottle between the hands before use.

4.3. Contraindications

This medicine should NEVER BE USED in case of :

- Tympanic perforation of infectious or traumatic origin (see section 4.4),

- Hypersensitivity to the active substances, in particular to lidocaine, or to any of the excipients mentioned in section 6.1.

4.4 Special warnings and precautions for use

Special warnings

As a precautionary measure, ENSURE TYMPANIC INTEGRITY BEFORE ANY ADMINISTRATION.

In the event of tympanic destruction, intra-auricular administration may bring the product into contact with middle ear structures and cause adverse effects in the middle ear.

The attention of the sportsmen is drawn to the fact that this speciality contains an active principle being able to induce a positive reaction of the tests practised at the time of the anti-doping controls.

Precautions for use :

Limit the duration of treatment to 10 days. Beyond this period, the therapeutic behaviour should be re-evaluated.

4.5. Interactions with other drugs and other forms of interaction

The data available to date do not suggest the existence of clinically significant interactions.

4.6. Fertility, pregnancy and lactation

Systemic passage in the absence of a tympanic seal is unlikely.

Therefore, under normal conditions of use, this drug may, if necessary, be administered during pregnancy or when breast-feeding.

4.7. Effects on ability to drive and use machines

OTIPAX Ear Instillation Solution has no effect on the ability to drive and use machines.

4.8. Undesirable effects

Risk of local reactions such as allergy, irritation or hyperemia of the ear canal.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after drug approval is important. It allows continuous monitoring of the benefit/risk ratio of the drug. Health professionals report any suspected adverse reaction via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centres - Website: www.ansm.sante.fr.

4.9. Overdose

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic class: LOCAL ANTALGIC /ANTI-INFLAMMATORY FOR OTOLOGICAL USE (S: Sense organ), ATC code: S02DA30.

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

Lidocaine : local anesthetic of the amide group.

5.2. Pharmacokinetic properties

There is no systemic passage except in the case of tympanic breach.

5.3. Preclinical safety data

No information available.

6. PHARMACEUTICAL DATA

6.1. List of excipients

Sodium thiosulfate, ethanol, glycerol, purified water.

6.2 Incompatibilities

Not applicable.

6.3. Shelf life

Glass bottle and tube: 3 years.

Glass bottle after first opening: 30 days.

Tube after first opening: 10 days.

6.4. Special storage precautions

Store at a temperature below 30°C.

6.5. Nature and content of the outer packaging

Bottle (yellow glass type III) of 15 ml (containing 16 g of solution) closed by a cap (LDPE) with a seal (LDPE) fitted with a dropper tip (PE/vinyl acetate) and a stopper (LDPE), box of 1.

Tube (painted aluminum) containing 5 g of solution, closed with an HDPE dropper, itself closed with an HDPE screw cap, box of 1.

6.6. Special precautions for disposal and handling

No special requirements.

7. MARKETING AUTHORIZATION HOLDER

BIOCODEX

7, AVENUE GALLIENI

94250 GENTILLY

8. MARKETING AUTHORIZATION NUMBER(S)

- 327 906-6 or 34009 327 906 6 1 : 16 g in bottle (yellow glass) + dropper tip (PE/vinyl acetate).

- 34009 301 000 5 9 : 5 g in tube (aluminum varnished) + dropper tip (HDPE)

9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION

[to be completed later by the holder]

10. DATE OF UPDATE OF THE TEXT

[to be completed later by the holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

CONDITIONS OF PRESCRIPTION AND DELIVERY

Not subject to medical prescription.