Ototalgin

Package leaflet: Information for the patient

OTOTALGIN, 200 mg/g, ear drops
Choline salicylate
Please read carefully all the information in this 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
your doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days of treatment, or if you feel worse, you should contact your doctor.

Table of contents

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

1. What Ototalgin is and what it is used for

Ototalgin is a medicine indicated for immediate use in inflammatory conditions of the external
auditory canal associated with pain, itching, and redness.
It is also recommended for softening and removing earwax prior to irrigation of the external auditory canal.
The product contains a derivative of salicylic acid – choline salicylate.
When applied locally, choline salicylate has analgesic and anti-inflammatory properties.
The glycerol contained in the medicine softens earwax, facilitating its removal.

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 previously diagnosed tympanic membrane damage;
• in case of bleeding or discharge from the ear;
• in case of severe ear pain accompanied by hearing loss.

Warnings and precautions
Any ear pain requires consultation with a doctor.
This medicine is intended for short-term use only, not longer than 3 days, due to the presence of chlorobutanol hemihydrate. If additional symptoms appear indicating a developing disease process (fever, ear discharge), or if symptoms do not subside after 3 days of treatment, consult a doctor.
Ototalgin may mask symptoms of other ear canal disorders and make correct diagnosis more difficult. Inform the doctor about using this medicine.
Ototalgin contains the preservative chlorobutanol hemihydrate. Additional information – see above.

Ototalgin and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use, including those available without a prescription.
This medicine is applied locally and does not exhibit systemic effects. Concurrent use with non-steroidal anti-inflammatory drugs (e.g. aspirin, ibuprofen) may enhance local effects.

Pregnancy and breastfeeding
Consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Ototalgin does not affect the ability to drive or operate machinery.

3. How to use Ototalgin

This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is intended for adult patients. The medicine is for topical use in the ear.
Recommended dose: 3–4 drops of the medicine should be instilled into the affected ear 2–4 times daily.
Use in children and adolescents
Consult a doctor before use.
Missed dose of Ototalgin
If a dose is missed, the next dose should be taken at the usual time. Do not use 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 everybody will experience them.
Hypersensitivity symptoms (e.g. skin irritation) may occur.
If any adverse reactions occur, use of the medicine should be discontinued.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ototalgin

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

6. Package contents and other information

What Ototalgin medicinal product contains
The active substance is choline salicylate.
The other components are: glycerol, ethanol (96%), chlorobutanol hemihydrate, purified water.
What Ototalgin medicinal product looks like and contents of the pack
The medicine is packaged in a polyethylene bottle with a dropper and a screw cap, placed in a
cardboard box with a leaflet. The pack contains 10 g of medicine.
Marketing Authorisation Holder and Manufacturer
Farmina sp. z o.o.
ul. Lipska 44
30-721 Kraków
[email protected]
[Logo]

Package leaflet: information for the patient

OTOTALGIN, 200 mg/g, ear drops
Cholini salicylas
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as advised by your
doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days of treatment, or if you feel worse, you should contact your doctor.

Leaflet contents

1. What Ototalgin medicinal product is and what it is 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 pack and other information

1. What Ototalgin medicinal product is and what it is used for

Ototalgin is a medicine indicated for short-term use in inflammatory conditions of the external
auditory canal associated with pain, itching, and redness.
It is recommended for softening and removing earwax prior to irrigation of 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. Glycerol contained in the medicine softens earwax, facilitating its removal.

2. Important information before using Ototalgin

Do not use Ototalgin:

• if you are allergic (hypersensitive) to choline salicylate or to salicylates (e.g. acetylsalicylic acid/aspirin), or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously been diagnosed with a perforated eardrum;
• if there is bleeding or discharge from the ear;
• if you have severe ear pain accompanied by hearing loss.

Warnings and precautions
Any ear pain should prompt consultation with a doctor.
This medicine is intended for short-term use, not longer than 3 days, due to the presence of chlorobutanol hemihydrate. If additional symptoms appear, indicating a developing illness (e.g. fever, ear discharge), or if symptoms do not resolve after 3 days of treatment, contact your doctor.
Ototalgin may mask symptoms of other ear canal disorders and make correct diagnosis more difficult. Inform your doctor that you are using this medicine.
Ototalgin contains the preservative chlorobutanol hemihydrate. Additional information – see above.
Ototalgin with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those not requiring a prescription.
This medicine is for topical use and does not produce systemic effects. Concurrent use with non-steroidal anti-inflammatory drugs (e.g. aspirin, ibuprofen) may enhance local effects.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before using this medicine.
Driving and using machines
Ototalgin has no influence on the ability to drive or operate machinery.

3. How to use Ototalgin

Always use this medicine exactly as described in this patient leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is intended for adult patients. It is for topical ear use.
Recommended dose: 3–4 drops of the medicine should be instilled into the affected ear 2–4 times daily.
Use in children and adolescents
Consult a doctor before use.
If you forget to use Ototalgin
If you miss a dose, apply the next dose at the scheduled time. Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Hypersensitivity reactions (e.g. skin irritation) may occur.
If any side effects occur, stop using the medicine.
Reporting of side effects
If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 directly to the Marketing Authorisation Holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Ototalgin

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

6. Contents of the pack and other information

What Ototalgin medicinal product contains
The active substance is choline salicylate.
The other components are: glycerol, ethanol (96%), chlorobutanol hemihydrate, purified water.
What Ototalgin medicinal product looks like and contents of the pack
The medicine is packaged in a polyethylene bottle with a dropper and a screw cap, placed in a
cardboard box with a leaflet. The pack contains 10 g of medicine.
Marketing Authorisation Holder and Manufacturer
Farmina sp. z o.o.
ul. Lipska 44
30-721 Kraków
[email protected]
[Logo]

1. What is Ototalgin and what is it used for

Ototalgin is a medicine indicated for immediate use in inflammatory conditions of the external auditory canal accompanied by pain, itching, and redness.
The medicine is recommended for softening and removing earwax before irrigation of the external auditory canal.
Ototalgin 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 earwax, facilitating its removal.

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 previously diagnosed tympanic membrane damage;
• in case of bleeding or discharge from the ear;
• in case of severe ear pain accompanied by hearing loss.

Warnings and precautions
Any ear pain should prompt consultation with a doctor.
This medicine is intended for short-term use only, not longer than 3 days due to the content of
chlorobutanol hemihydrate. If additional symptoms appear indicating a developing medical condition (fever, ear discharge), or if symptoms persist after 3 days of treatment,
consult a doctor.
Ototalgin may mask symptoms of other ear canal disorders and make their correct diagnosis more difficult. Inform the doctor about using this medicine.
This medicine contains the preservative chlorobutanol hemihydrate. Additional information – see above.

Ototalgin and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use, including those available without a prescription.
This medicine is for topical use and does not produce systemic effects. Concurrent use
with non-steroidal anti-inflammatory drugs (e.g. aspirin, ibuprofen) may enhance local effects.

Pregnancy and breastfeeding
Consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Ototalgin has no influence on the ability to drive or operate machinery.

3. How to use Ototalgin

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is intended for adult patients. The medicine is for topical use in the ear.
Recommended dose: 3–4 drops of the medicine should be instilled into the affected ear 2–4 times daily.
Use in children and adolescents
Consult a doctor before use.
If you forget to use Ototalgin
If the patient forgets to take a dose, they should apply the next prescribed dose at the correct time. Do not use 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.
Hypersensitivity symptoms (e.g. skin irritation) may occur.
If any adverse reactions occur, use of the medicine should be discontinued.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
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 helps to provide more information on the safety of the medicine.

5. How to store Ototalgin

Do not use after the expiry date stated on the packaging.
Store below 25°C, in a place invisible and inaccessible to children.

6. Contents of the packaging and other information

What Ototalgin contains
The active substance is choline salicylate.
The excipients are: glycerol, ethanol (96%), chlorobutanol hemihydrate, purified water.
What Ototalgin looks like and contents of the pack
The medicine is packed in a polyethylene bottle with a dropper and cap, placed in a cardboard box with a leaflet. The pack contains 10 g of the medicine.
Marketing Authorisation Holder and Manufacturer
Farmina sp. z o.o.
ul. Lipska 44
30-721 Kraków
[email protected]
[Logo]

Package leaflet: information for the patient

OTOTALGIN, 200 mg/g, ear drops
Choline salicylate
Please read carefully all the information in this 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 doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days of treatment, or if you feel worse, consult your doctor.

Leaflet contents

1. What Ototalgin is and what it is 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 Ototalgin is and what it is used for

Ototalgin is a medicine indicated for short-term use in inflammatory conditions of the external auditory canal associated with pain, itching, and redness.
It is recommended for softening and removal of earwax prior to irrigation of the external auditory canal. The medicine contains a derivative of salicylic acid – choline salicylate.
Choline salicylate, when applied topically, has analgesic and anti-inflammatory properties. Glycerol contained in the medicine softens earwax, facilitating its removal.

2. Important information before using Ototalgin

When not to use Ototalgin:

• if you are allergic (hypersensitive) to choline salicylate or salicylates (e.g. acetylsalicylic acid/aspirin), or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously been diagnosed with a perforated eardrum;
• if there is bleeding or discharge from the ear;
• if you have severe ear pain accompanied by hearing loss.

Warnings and precautions
Any ear pain should prompt consultation with a doctor.
Ototalgin is intended for short-term use only, not exceeding 3 days, due to the presence of chlorobutanol hemihydrate. If additional symptoms appear, indicating a developing illness (e.g. fever, ear discharge), or if symptoms do not resolve after 3 days of treatment, consult your doctor.
Ototalgin may mask symptoms of other ear canal disorders and may complicate their correct diagnosis. Inform your doctor about using this medicine.
Ototalgin contains the preservative chlorobutanol hemihydrate. See above for further information.
Ototalgin with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription, as well as any medicines you plan to use.
This medicine is for topical use and does not produce systemic effects. Concurrent use with non-steroidal anti-inflammatory drugs (e.g. aspirin, ibuprofen) may enhance local effects.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before using this medicine.
Driving and operating machinery
Ototalgin has no effect on the ability to drive or operate machinery.

3. How to use Ototalgin

Always use this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is intended for adult patients. It is for topical use in the ear.
Recommended dose: 3–4 drops of the medicine should be instilled into the affected ear 2–4 times daily.
Use in children and adolescents
Consult a doctor before use.
If you forget to use Ototalgin
If you miss a dose, apply the next dose at the scheduled time. Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Hypersensitivity reactions (e.g. skin irritation) may occur.
If any adverse reactions occur, discontinue use of the medicine.
Reporting of adverse reactions
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported directly to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ototalgin

Do not use after the expiry date stated on the packaging.
Store 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 is choline salicylate.
The excipients are: glycerol, ethanol (96%), chlorobutanol hemihydrate, purified water.
What Ototalgin looks like and contents of the pack
The medicine is packed in a polyethylene bottle with a dropper and cap, placed in a cardboard box with a leaflet. The pack contains 10 g of the medicine.
Marketing Authorisation Holder and Manufacturer
Farmina sp. z o.o.
ul. Lipska 44
30-721 Kraków
[email protected]
[Logo]