Axotonil max
Poland
Table of Contents
Package leaflet: Information for the patient
Axotonil Max, 440 mg/mL, ear spray, solution
Choline salicylate
Read the entire leaflet before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a physician or pharmacist.
- Keep this leaflet for future reference.
- If advice or additional information is needed, consult a pharmacist.
- If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.
- If there is no improvement after 3 days or if the patient feels worse, consult a doctor.
Table of contents
- What Axotonil Max is and what it is used for
- Important information before using Axotonil Max
- How to use Axotonil Max
- Possible side effects
- How to store Axotonil Max
- Contents of the pack and other information
1. What Axotonil Max is and what it is used for
Axotonil Max contains the active substance choline salicylate, a derivative of salicylic acid, belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
When applied locally, choline salicylate exerts analgesic and anti-inflammatory effects and shows weak bactericidal activity against certain microorganisms. It reduces pain and inflammation associated with external otitis (so-called ear infection).
The glycerol contained in the product moisturizes the external auditory canal and dissolves and softens accumulated earwax, facilitating its removal. Axotonil Max does not contain preservatives.
When administered locally into the ear, the drug does not produce systemic effects.
Axotonil Max is indicated for use in adults:
- in inflammatory conditions of the external auditory canal associated with pain, itching, and redness;
- to soften hardened earwax (impacted cerumen) prior to irrigation of the external auditory canal.
2. Important information before using Axotonil Max
When not to use Axotonil Max
- if the patient is allergic to the active substance – choline salicylate, other salicylates (e.g. acetylsalicylic acid/aspirin), or any of the other ingredients of this medicine (listed in section 6);
- if the patient has bleeding or discharge from the ear;
- if the patient experiences severe ear pain accompanied by hearing loss;
- if the patient has previously been diagnosed with tympanic membrane damage (perforation or disruption of continuity);
- in individuals under 18 years of age.
Signs suggesting damage (perforation) of the tympanic membrane include: acute ear pain (gradually decreasing), tinnitus (which may indicate damage to deeper ear structures), hearing loss, dizziness, and/or ear discharge. Causes of perforation may include: infections, injuries (e.g. due to improper ear cleaning with cotton swabs), or medical procedures (e.g. improper ear irrigation due to cerumen impaction).
Warnings and precautions
Before starting to use Axotonil Max, consult a doctor or pharmacist.
Any ear pain should prompt consultation with a doctor.
This medicine, used to treat inflammation of the external auditory canal, may be used without prior medical consultation only on a temporary basis, for no longer than 3 days.
If there is no improvement or if symptoms worsen within 3 days of using the medicine, or if additional symptoms occur such as fever, malaise, weakness, dizziness, ear discharge, or suspicion of a foreign body in the ear canal, medical advice must be sought.
In case of recurrent disease, the decision to use the medicine should be made by a doctor.
Use of this medicine may mask (hide) symptoms of other external ear diseases and may hinder or delay their proper diagnosis. Inform the doctor about using this medicine.
Avoid contact of the medicine with mucous membranes of the eyes, mouth, and nose. Do not take orally or apply to open wounds.
Children and adolescents
Do not use in children and adolescents under 18 years of age.
Axotonil Max and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.
- This medicine should not be used simultaneously with other medicines applied locally to the external auditory canal.
- Concomitant use with non-steroidal anti-inflammatory drugs (e.g. aspirin, ibuprofen) may enhance the local effect of the medicine.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Axotonil Max does not affect the ability to drive or operate machinery.
Axotonil Max contains ethanol
This medicine contains 6.59 mg of alcohol (ethanol) in each 0.05 mL of solution (one dose).
It may cause a burning sensation on damaged skin.
The medicine is flammable. Do not use near open flames, lit cigarettes, or certain devices (e.g. hair dryers).
3. How to use Axotonil Max
This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Axotonil Max is for topical use in the external auditory canal.
Recommended dose:
Adults:
- For short-term, local symptomatic treatment of inflammation of the external auditory canal: usually 1 dose into the external auditory canal every 6 to 8 hours for no longer than 3 days.
- To soften impacted earwax prior to irrigation of the external auditory canal: usually 1 dose into the external auditory canal every 12 hours for 4 days.
Use in children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.
Elderly patients
No dosage adjustment is necessary.
Patients with hepatic and/or renal impairment
No dosage adjustment is necessary.
Instructions for use of Axotonil Max
Instructions for use of the glass bottle with spray pump
Before first use, prime the spray pump to ensure proper spray function.
To do this, press the pump nozzle firmly 20 times with the nozzle directed away from you and the bottle held vertically.
If the medicine has not been used for two days or longer, re-prime the pump by spraying the aerosol twice, with the nozzle directed away from you and the bottle held vertically.
The medicine requires attachment of the spray nozzle before first use – Fig. 1.
- Rotate the spray nozzle to the horizontal position as shown in Fig. 2.
- Attach the rotated spray nozzle as shown in Fig. 3.
- Gently pull the earlobe (lower part of the auricle) in the direction away from the neck.
- Direct the spray nozzle into the affected ear.
- Firmly press the spray pump with the index finger as shown in Fig. 4.
Wipe off any excess liquid with a clean tissue.
Instructions for use of the polyethylene bottle with spray pump and applicator
Before first use, prime the spray pump to ensure proper spray function.
To do this, press the pump nozzle firmly 9 times with the nozzle directed away from you and the bottle held vertically.
If the medicine has not been used for two days or longer, re-prime the pump by spraying the aerosol once, with the nozzle directed away from you and the bottle held vertically.
The medicine does not require attachment of the spray nozzle before first use – Fig. 1.
- Gently pull the earlobe (lower part of the auricle) in the direction away from the neck.
- Direct the spray nozzle into the affected ear – Fig. 2.
- Firmly press the spray pump with the index finger.
- Wipe off any excess liquid with a clean tissue.
Care should be taken to prevent water from entering the ear that has been treated with the medicine.
If there is no improvement after 3 days, or if symptoms worsen during the first 3 days of treatment, medical advice should be sought.
Use of more than the recommended dose of Axotonil Max
Overdose is not possible when the medicine is used as directed in the ear.
Symptoms of overdose that may occur after accidental oral ingestion include: disorientation, dizziness, excessive sweating, vomiting, tinnitus, and abnormally rapid breathing (hyperventilation). Ingestion of very large doses may lead to disturbances of the central nervous system, resulting in respiratory and circulatory disorders.
In case of accidental oral ingestion of Axotonil Max, seek immediate medical attention.
Missed dose of Axotonil Max
If a dose is missed, administer it as soon as possible. If it is almost time for the next dose, skip the missed dose.
Do not administer a double dose to make up for a missed dose.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Possible adverse reactions
Frequency unknown (cannot be estimated from available data):
- local hypersensitivity reactions (redness, skin itching).
In patients with perforation of the eardrum, use of this medicine may lead to hearing damage.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department for Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 01 / Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables continued monitoring of the medicine's safety and helps provide more information on the safe use of the medicine.
5. How to store Axotonil Max
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and on the label after EXP. The expiry date refers to the last day of the stated month.
Store the medicine below 25°C. Do not store in the refrigerator or freeze.
The shelf life after first opening is 3 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Contents of the packaging and other information
What the medicine Axotonil Max contains
- The active substance is choline salicylate. 1 mL of solution contains 440 mg of choline salicylate. The other ingredients are: glycerol, 96% ethanol, 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 colourless to pale yellow solution.
The medicine is packaged in a brown glass bottle with a spray pump made of HDPE/LDPE/POM/Stainless steel/EVA/PP/mixture of LDPE and HDPE, with a PP/HDPE applicator, in a cardboard box, or
in a high-density polyethylene (HDPE) bottle with a spray pump and applicator (polypropylene, low-density polyethylene (LDPE), stainless steel) in a cardboard box.
The pack contains 10 mL of medicine.
Marketing Authorisation Holder and Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. (42) 22-53-100