Axotonil Max

Package Leaflet: Information for the Patient

Axotonil Max, 440 mg/mL, Ear Spray, Solution

Choline Salicylate

Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

This medication should always be used exactly as described in this patient leaflet or as advised by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet

• 1. What is Axotonil Max and what is it used for
• 2. Important information before using Axotonil Max
• 3. How to use Axotonil Max
• 4. Possible side effects
• 5. How to store Axotonil Max
• 6. Contents of the pack and other information

1. What is Axotonil Max and what is it used for

Axotonil Max contains the active substance choline salicylate, which is a derivative of salicylic acid and belongs to the group of nonsteroidal anti-inflammatory drugs. Topically applied, choline salicylate has analgesic, anti-inflammatory, and weak antibacterial effects against certain microorganisms. It reduces pain and inflammation in the course of external ear canal inflammation (so-called ear inflammation). The glycerol contained in the medication moisturizes the external ear canal and dissolves and softens the earwax, making it easier to remove. Axotonil Max does not contain preservatives. After local application to the ear, the medication does not have a systemic effect. Axotonil Max is indicated for use in adults:

• in inflammatory conditions of the external ear canal characterized by pain, itching, redness,
• for the softening of hardened earwax (earwax plug) before rinsing the external ear canal.

2. Important information before using Axotonil Max

When not to use Axotonil Max

• if you are allergic to the active substance - choline salicylate, other salicylates (e.g., acetylsalicylic acid/aspirin), or any of the other ingredients of this medication (listed in section 6);
• if you have bleeding or discharge from the ear;
• if you experience severe ear pain along with hearing impairment;
• if you have previously been diagnosed with eardrum damage (perforation or rupture);
• in individuals under 18 years of age.

Eardrum damage (perforation) may be indicated by: severe ear pain (gradually decreasing), ringing in the ears (which may indicate damage to deeper ear structures), hearing loss, dizziness, and/or discharge from the ear. The cause of perforation may be infections, injuries (including improper ear cleaning with earbuds), and medical procedure-related causes (e.g., improper ear flushing due to earwax).

Warnings and precautions

Before starting to use Axotonil Max, discuss it with your doctor or pharmacist. Any ear pain is a reason to consult a doctor. The medication used to treat external ear canal inflammation can be used without consulting a doctor for a short period, no longer than 3 days. In the event of no improvement or worsening of symptoms within 3 days of using the medication and the occurrence of additional symptoms such as fever, malaise, weakness, dizziness, discharge from the ear, or suspicion of a foreign body in the ear canal, you should consult a doctor. In the event of recurrence of the disease, the use of the medication should be decided by a doctor. The use of the medication may mask (hide) symptoms of other external ear diseases and hinder or delay their proper diagnosis. You should inform your doctor about the use of this medication. You should avoid contact of the medication with the mucous membranes of the eyes, mouth, and nose. Do not use orally or on open wounds.

Children and adolescents

Do not use in children and adolescents under 18 years of age.

Axotonil Max and other medications

Tell your doctor or pharmacist about all medications you are currently taking, have recently taken, or plan to take.

• The medication should not be used simultaneously with other medications applied locally to the external ear canal.
• Concomitant use with nonsteroidal anti-inflammatory drugs (e.g., aspirin, ibuprofen) may enhance the local effect of the medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medication.

Driving and using machines

Axotonil Max does not affect the ability to drive and use machines.

Axotonil Max contains ethanol

This medication contains 6.59 mg of alcohol (ethanol) in each 0.05 mL of solution (1 dose). It may cause burning of damaged skin. The medication is flammable. Do not use near open flames, lit cigarettes, or certain devices (e.g., hair dryers).

3. How to use Axotonil Max

This medication should always be used exactly as described in this patient leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. Axotonil Max is applied locally to the external ear canal.

Recommended dose:

Adults:

• For short-term, local, symptomatic treatment of external ear canal inflammation: usually 1 dose into the external ear canal every 6 to 8 hours for a period not exceeding 3 days.
• For softening hardened earwax before rinsing the external ear canal: usually 1 dose into the external ear canal every 12 hours for 4 days.

Use in children and adolescents

Do not use in children and adolescents under 18 years of age.

Elderly

No dose adjustment is necessary.

Patients with liver or kidney impairment

No dose adjustment is necessary.

Instructions for using Axotonil Max

Instructions for the glass bottle with a spray pump

Before the first use of the medication, the dispenser must be filled to achieve proper spraying. To do this, press the dispenser pump 20 times, with the nozzle pointing away from you and the bottle held vertically. If the medication has not been used for two days or longer, you need to prepare the pump again - by spraying the aerosol 2 times, with the nozzle pointing away from you and the bottle held vertically.

The medication requires the attachment of the dispenser nozzle before the first use – fig. 1.

• Turn the dispenser nozzle to the horizontal position as shown in fig. 2.
• Attach the turned dispenser nozzle as shown in fig. 3.
• Gently pull the earlobe (lower part of the auricle) away from the neck.
• Direct the dispenser nozzle to the treated ear.
• Press the dispenser firmly with your index finger as shown in fig. 4.

Wipe off any excess liquid with a clean cloth.

Instructions for the polyethylene bottle with a spray pump and applicator

Before the first use of the medication, the dispenser must be filled to achieve proper spraying. To do this, press the dispenser pump 9 times, with the nozzle pointing away from you and the bottle held vertically. If the medication has not been used for two days or longer, you need to prepare the pump again - by spraying the aerosol 1 time, with the nozzle pointing away from you and the bottle held vertically.

The medication does not require the attachment of the dispenser nozzle before the first use – fig. 1.

• Gently pull the earlobe (lower part of the auricle) away from the neck.
• Direct the dispenser nozzle to the treated ear - fig. 2.
• Press the dispenser firmly with your index finger.
• Wipe off any excess liquid with a clean cloth.

Be careful not to let water enter the ear after applying the medication. If after 3 days there is no improvement or you feel worse within 3 days of starting the medication, consult your doctor.

Overdose of Axotonil Max

There is no possibility of overdosing with the medication when applied to the ear. Symptoms of overdose that may occur after accidental oral ingestion of the medication include: disorientation, dizziness, excessive sweating, vomiting, ringing in the ears, and excessive breathing (hyperventilation). In the case of very large doses of the medication, there may be central nervous system disorders, including breathing and circulation disorders. In the event of oral ingestion of Axotonil Max, contact your doctor immediately.

Missing a dose of Axotonil Max

If you miss a dose, use it as soon as possible. If it is almost time for the next dose, skip the missed dose. Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medications, Axotonil Max can cause side effects, although not everybody gets them.

Possible side effects

Frequency not known(cannot be estimated from the available data):

• local hypersensitivity reactions (redness, skin itching).

In individuals with eardrum perforation during the use of the medication, hearing loss may occur.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301/Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medication.

5. How to store Axotonil Max

Keep the medication out of the sight and reach of children. Do not use this medication after the expiry date stated on the carton and label after EXP. The expiry date refers to the last day of the month. Store the medication below 25°C. Do not store in the refrigerator or freeze. The shelf life after first opening is 3 months. Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Axotonil Max contains

• The active substance is choline salicylate. 1 mL of solution contains 440 mg of choline salicylate. The other ingredients are glycerol, ethanol 96%, purified water.

A single dose of the aerosol contains 0.05 mL of solution.

What Axotonil Max looks like and contents of the pack

Axotonil Max is a colorless to light yellow solution. The medication packaging is a brown glass bottle with a spray pump made of HDPE/LDPE/POM/stainless steel/EVA/PP/mixture of LDPE and HDPE with an applicator made of PP/HDPE in a carton, or a polyethylene HDPE bottle with a spray pump and applicator (polypropylene, polyethylene LDPE, stainless steel) in a carton. The pack contains 10 mL of the medication.

Marketing authorization holder and manufacturer

Aflofarm Farmacja Polska Sp. z o.o., ul. Partyzancka 133/151, 95-200 Pabianice, Tel. (42) 22-53-100

Date of last revision of the leaflet: