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Ototalgin

Ototalgin

About the medicine

How to use Ototalgin

Leaflet attached to the packaging: information for the patient

OTOTALGIN,200 mg/g, ear drops
Choline salicylate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions.

  • You should keep this leaflet, so that you can read it again if you need to.
  • If you need advice or additional information, you should consult a pharmacist.
  • If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
  • If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Ototalgin and what is it used for

Ototalgin is a medicine indicated for short-term use in inflammatory conditions of the external auditory canal, characterized by pain, itching, and redness.
The medicine is recommended for softening and removing earwax before rinsing the external auditory canal.
The medicine contains a derivative of salicylic acid - choline salicylate.
Choline salicylate, when applied locally, has analgesic and anti-inflammatory properties. The glycerol contained in the medicine softens the earwax in the ear, making it easier to remove.

2. Important information before using Ototalgin

When not to use Ototalgin:

  • if the patient is hypersensitive (allergic) to choline salicylate or salicylates (e.g. acetylsalicylic acid/aspirin), or to any of the other ingredients of this medicine (listed in section 6);
  • in case of previous diagnosis of eardrum damage;
  • in case of bleeding or discharge from the ear;
  • in case of severe ear pain with hearing impairment.

Warnings and precautions

Any ear pain is an indication for consultation with a doctor.
The medicine is intended for short-term use, not longer than 3 days due to the content of chlorobutanol hemihydrate. If additional symptoms appear, indicating a developing disease process (fever, ear discharge) or after 3 days of using the medicine the symptoms do not disappear,
you should contact your doctor.
Ototalgin may mask the symptoms of other ear canal diseases and make their proper diagnosis difficult. You should inform your doctor about using the medicine.
The medicine contains the preservative chlorobutanol hemihydrate. Additional information - see above.

Ototalgin and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as about medicines you plan to use, including those that are available without a prescription.
The medicine is used locally and does not have a general effect. Concurrent use with non-steroidal anti-inflammatory drugs (e.g. aspirin, ibuprofen) may enhance the local effect.

Pregnancy and breastfeeding

Before using the medicine, you should consult your doctor or pharmacist.

Driving and operating machines

The medicine does not affect the ability to drive and operate machines.

3. How to use Ototalgin

This medicine should always be used exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions. In case of doubts, you should consult your doctor or pharmacist.
The medicine is intended for adult patients. The medicine is for local use in the ear.
Recommended dose: 3-4 drops of the medicine should be instilled into the affected ear 2-4 times a day.

Use in children and adolescents

Before using the medicine, you should consult your doctor.

Missing a dose of Ototalgin

If you forget to use a dose of the medicine, you should use the next scheduled dose at the right time. You should not use a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Symptoms of hypersensitivity (e.g. skin irritation) may occur.
If you experience any side effects, you should stop using the medicine.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
Thanks to the reporting of side effects, more information can be collected on the safety of the medicine.

5. How to store Ototalgin

Do not use after the expiry date stated on the packaging.
Store in a temperature below 25°C, in a place out of sight and reach of children.

6. Contents of the packaging and other information

What Ototalgin contains

The active substance of the medicine is choline salicylate.
The excipients are: glycerol, ethanol (96%), chlorobutanol hemihydrate, purified water.

What Ototalgin looks like and what the packaging contains

The packaging of the medicine is a polyethylene bottle with a dropper and a screw cap, in a cardboard box with a leaflet. The packaging contains 10 g of the medicine.

Marketing authorization holder and manufacturer

Farmina sp. z o.o.
ul. Lipska 44
30-721 Kraków
centrala@farmina.pl
[Logo]

Date of last revision of the leaflet:

  • Country of registration
  • Active substance
  • Prescription required
    No
  • Manufacturer
  • Importer
    Farmina Sp. z o.o.

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