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Otipax Ear Drops, 15 ml
Over-the-counter medication

Otipax Ear Drops, 15 ml

Brand : Biocodex Biocodex

Otipax Ear Dropsis indicated for the local treatment of pain caused by certain cases of closed-tympanic-membrane otitis media.

€2.84 EXCL. VAT €2.90 INCL. VAT
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Otipax Ear Drops to relieve pain caused by certain types of closed-eardrum ear infections.

For warnings, precautions, and contraindications, please refer to the package insert.

Otipax, available without a prescription, is an ear drop solution; it is a medication belonging to the pharmacotherapeutic class ofanalgesics and anti-inflammatoriesfor otological use.

What are the indications for Otipax 15 mL Ear Instillation Solution?

This medical device is used for the local treatment of pain caused by certain types of closed-eardrum otitis media:
  • Acute congestive otitis media.
  • Flu-associated otitis media, also known as phlyctenular otitis media.
  • Barotraumatic otitis media.

Two types of chronic otitis media may occur: with a closed eardrum and with an open eardrum.

In both cases, a gargle can be used to soothe the throat if there is associated pharyngeal pain.

In the first case, the eardrum is intact. The space behind it (the tympanic cavity) is therefore filled with a secretion that prevents eardrum vibration and the free movement of the ossicular chain (malleus, incus, stapes). Conductive hearing loss sets in. The most common example is serous otitis in children following recurrent middle ear infections.

How should this Otipax Ear Drops solution be used without a prescription?

  • Warm the bottle between your hands to avoid the uncomfortable sensation caused by the cold solution in the ear.
  • Apply 4 drops into the ear canal by gently squeezing the soft part of the dropper, 2 to 3 times a day in the affected ear.

Method and Route of Administration

Intr auricular.
How to use the dropper bottle:
  • Unscrew the cap from the bottle,
  • Screw the dropper onto the bottle,
  • Remove the cap from the dropper,
  • Hold the bottle upside down and gently squeeze the tip to dispense 1 drop,
  • Squeeze again until 4 drops are dispensed,
  • Replace the cap on the tip after use.

Duration of Treatment

Do not exceed 10 days of treatment. If symptoms persist, consult your doctor.

What are the ingredients in the Otipax dropper bottle?

  • Active ingredients

Phenazone: 4 g
Lidocaine hydrochloride: 1 g
Per 100 g of ear drops solution.
  • Inactive ingredients

Sodium thiosulfate, ethanol, glycerol, purified water.

What are the precautions for using this over-the-counter medication?

  • Special Warnings

If the eardrum is perforated, this medication may cause adverse effects in the middle ear.
As a precaution, before use, have a doctor check that your eardrum is intact.
  • Precautions

The duration of treatment with over-the-counter Otipax should not exceed 10 days. If symptoms persist, consult your doctor.
If in doubt, consult a healthcare professional.

Product Information - Packaging

Otipax ear drops are available for purchase from our online pharmacy in 15-ml dropper bottles.

Warnings Regarding Medications Purchased Online

Please note: Medications are not like other products. Read the medication guide carefully before ordering. Keep medications out of the reach of children. If symptoms persist, consult your doctor or pharmacist. Be aware of potential interactions with your current medications.

  • Please inform your online pharmacist of any current treatments to identify potential interactions. The order confirmation form includes a custom message field for this purpose.
  • Find the package insert for this medication on the website of the French National Agency for Medicines and Health Products Safety (ANSM).

Advice from your expert pharmacist

  • Although Otipax is available without a prescription, have a doctor check to ensure youreardrumis not perforated.
  • If symptoms persist after 10 days of treatment, consult your doctor again.

Otipax Ear Drops - Ear Relief

Discover Otipax Ear Drops

Otipax Ear Drops is a valuable solution for relieving ear pain. Specifically designed to treat pain associated with certain types of closed-eardrum ear infections, this medication provides essential hearing comfort. Discover how Otipax can help you restore your ears’ well-being.

Why Choose Otipax Ear Drops?

Formulation Based on Medical Expertise

The formulation of Otipax Ear Drops is the result of medical expertise. It offers a targeted and effective solution for soothing ear pain, particularly that caused by certain types of otitis media with a sealed eardrum.

Otipax Ear Drops—Your Partner in Hearing Health

Dosage and Usage

For best results, carefully follow the dosage and usage recommendations provided in the product insert. This will ensure optimal relief from your ear pain.

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

NOTICE

ANSM - Last updated: 17/08/2017

Name of the medicinal product

OTIPAX, solution for atrial instillation

Phenazone / Lidocaine Hydrochloride

framed

Please read this leaflet carefully before you start using this medicine because it contains important information for you.

You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.

· Keep this leaflet. You might need to read it again.

· Ask your pharmacist for advice or information.

· If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.

· You should talk to your doctor if you do not feel better or feel less well.

What is in this leaflet?

1. What is OTIPAX, solution for ear instillation and in which cases it is used?

2. What information should be known before using OTIPAX, solution for ear instillation ?

3. How to use OTIPAX, solution for ear instillation ?

4. What are the possible side effects?

5. How to store OTIPAX, solution for atrial instillation ?

6. Package contents and other information.

1. WHAT IS OTIPAX, solution for atrial instillation AND WHAT IT IS USED FOR?

Pharmacotherapeutic group : ANTALGIC LOCAL / ANTI-INFLAMMATORY FOR OTOLOGICAL USE (S: Body of the senses), ATC code: S02DC

 

Therapeutic indications

 

Local treatment of pain due to certain otitis with closed eardrum:

· Otitis media acute congestive,

· Influenza-like sore called phlyctenular,

· Barotraumatic otitis.

2. BEFORE YOU USE OTIPAX, solution for ear instillation?

Never use OTIPAX, solution for ear instillation in the following cases:

· If you are allergic to any of the active ingredients or to any of the other ingredients of this medication mentioned in section 6.

· If you have a perforation of the eardrum,

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

 

Warnings and Precautions

 

Special warnings

If the eardrum is opened, this drug may cause undesirable effects in the middle ear.

BY PRECAUTION, before any administration, the integrity of your eardrum should be checked by a DOCTOR.

 

Precautions for use

The treatment time should not exceed 10 days. If the symptoms persist, consult your doctor.

IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST

 

children

Not applicable.

Other medicines and OTIPAX, solution for atrial instillation

Inform your doctor or pharmacist if you are taking, have recently taken, or may be taking any other medication.

OTIPAX, solution for ear instillation with food, drinks and alcohol

Not applicable.

 

Pregnancy and breast feeding

Under normal conditions of use, this medication may be used during pregnancy or in case of breast-feeding.

Generally, during pregnancy and breast-feeding, always seek the advice of your doctor or pharmacist before using any medication

 

Sport

The attention of athletes is drawn to the fact that this specialty contains an active principle that can induce a positive reaction of the tests carried out during anti-doping controls.

Driving and using machines

Not applicable.

OTIPAX, solution for ear instillation contains glycerol and ethanol.

3. HOW TO USE OTIPAX, solution for atrial instillation?

Instructions for proper use

Not applicable.
 

Dosage

· Dropper bottle or tube: pour 4 drops into the ear canal by exerting a slight pressure on the soft part of the dropper, 2 to 3 times a day in the painful ear.

Method and route of administration

 

Ear canal.

 

How to use the dropper bottle:

· Unscrew the cap from the bottle,

· Screw the dropper onto the bottle,

· Remove the cap from the dropper,

· Turn the bottle upside down and gently squeeze the tip to get 1 drop,

· Press again until 4 drops are obtained,

· Replace cap on cap after use.

Warm the bottle to avoid the unpleasant sensation of the cold solution in the ear.

 

 

Duration of treatment

Do not exceed 10 days of treatment. If the symptoms persist, consult your doctor.

 

If you have used more OTIPAX, solution for atrial instillation than you should have

Not applicable.

If you forget to use OTIPAX, solution for atrial instillation

Not applicable.

If you stop using OTIPAX, solution for auricular instillation

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine may cause side effects, although not everybody gets them.

· R isk of local reactions of allergy type, irritation or redness of the ear canal. Declaration of side effects

Declaration of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr .

 

By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE OTIPAX, solution for atrial instillation?

Keep this medicine out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the outer packaging. The expiry date refers to the last day of that month.

Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

 

Duration of use of the bottle after first opening: 30 days.

Duration of use of the tube after opening: 10 days.

 

 

Storage conditions


Store at a temperature not exceeding 30 ° C.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What OTIPAX contains, solution for atrial instillation

The active substances are:

Phenazone ................................................. .................................................. ............................. 4 g

Lidocaine Hydrochloride ............................................... .................................................. .......... 1 g

For 100 g of solution for atrial instillation.

The other components are:

Sodium thiosulfate, ethanol, glycerol, purified water.

What is OTIPAX, solution for ear instillation and contents of the outer packaging

This medication is in the form of a solution for atrial instillation in 16 g vial or 5 g tube.

Marketing Authorization Holder

BIOCODEX

7, AVENUE GALLIENI

94250 GENTILLY

LA FRANCE

Marketing Authorization Operator

BIOCODEX

7, AVENUE GALLIENI

94250 GENTILLY

LA FRANCE

Maker

BIOCODEX

1, AVENUE BLAISE PASCAL

60000 BEAUVAIS

LA FRANCE

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

The last date on which this leaflet was revised is:

[to be completed later by the holder]

Other

Not applicable.

VIDAL OF THE FAMILY

Otipax

Local treatment of ear infections

lidocaine, phenazone

. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

OTIPAX: solution for atrial instillation; 15 ml dropper bottle.
Refunded at 15%. - price: 1,74 euro (s).

Biocodex Laboratory

COMPOSITION (summary)
p 100 g
Lidocaine hydrochloride 1 g
phenazone 4 g

INDICATIONS (summary)
This analgesic ear solution contains a local anesthetic and an anti-inflammatory .
It is used in the treatment of pain in certain ear infections .
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
WARNING (Contents)
Although this medication may be sold without a prescription, have a physician check the absence of perforation of your eardrum.
Sportive: local anesthetics were removed from the list of doping substances published in the decrees of 20 April and 16 August 2004 by the Ministry of Youth and Sports.
PREGNANCY AND BREAST-FEEDING (summary)
The substances contained in this medication do not pass into the blood under the conditions of use (the doctor checks before prescription that the eardrum does not have perforation). It can be used during pregnancy or lactation.
DIRECTIONS FOR USE AND DOSAGE (summary)
Reheat the bottle between the hands before use to limit the unpleasant sensation associated with the introduction of cold liquid into the ear.
Tilt the head to the side and insert the solution into the ear. Keep your head in this position for 10 minutes (ear bath).

Usual dosage:

4 drops in the ear to treat, 2 or 3 times a day.
Treatment should not exceed 10 days.
TIPS (summary)
If the condition persists despite proper treatment, consult your doctor.
POSSIBLE ADVERSE EFFECTS (summary)
Irritation, local allergic reaction .


GLOSSARY (summary)


allergy
Skin reaction (itching, pimples, swelling) or general discomfort occurring after contact with a particular substance, use of a medication or ingestion of food. The main forms of allergy are eczema, urticaria, asthma, angioedema and allergic shock (anaphylactic shock). Food allergy can also result in digestive disorders.


anesthetic
Medication that results in anesthesia. In addition to the general anesthetics that allow the patients to fall asleep before surgery, there are local anesthetics that can be injected in contact with a nerve to insensitize a region of the body. Local anesthetics are also called contact anesthetics.


analgesic
Medication that works against pain. Analgesics act either directly on the centers of pain in the brain or by blocking the transmission of pain to the brain.
Synonym: analgesic.


anti-inflammatory
Medicine that fights against inflammation. It can be either derived from cortisone (steroidal anti-inflammatory), or not derived from cortisone (nonsteroidal anti-inflammatory or NSAID).


ear infections
Inflammation or infection of the ear. Otitis externa affects only the ear canal. Acute otitis media and chronic otitis media affect the part of the ear behind the eardrum (middle ear).


allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.

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