Description
OCTO-LEN
EAR DROPS
Description
Medical device 0.5% solution of lidocaine hydrochloride in glycerol (anhydrous).
It relieves itching and pain of the external auditory canal and helps in case of ear inflammation.
Octolen can be a valid support in all the following cases:
- inflammatory conditions characterized by swelling, pain and itching of the external auditory canal;
- painful disorders caused by frequent exposure to water and humidity (e.g. swimming pool);
- disorders accompanied by pain caused by prolonged use of headphones or by earwax obstructing the external auditory canal;
- painful disorders caused by frequent use of detergents that damage the natural protective layer that lines the external auditory canal (e.g. shampoos, soaps, gels).
Octolen can be used in adults and children aged 6 months and above.
How to use
1. Wash your hands thoroughly and unscrew the cap from the bottle.
2. Tilt your head to one side (or lie on your side) so that the ear to be treated is facing upwards.
3. Gently pull the earlobe forward and out.
4. Insert the dispenser into the ear and press the bottle on both sides, dispensing 2 drops of product into the ear.
5. Remain with your head tilted for a few minutes so that the drops can flow into the ear canal.
6. Remove excess liquid with a clean tissue.
7. At the end of the application, it is advisable to close the external auditory canal with a cotton ball. 8. Close the bottle.
Adults and children over 6 months of age: 2 drops up to 3 times a day.
In children, always use under the supervision of a doctor; after use, it is necessary to protect the child's ear with a cotton ball.
If there is no improvement after 3 days or the situation worsens, consult your doctor. Only your doctor can verify the success of the treatment.
Components
0.5% solution of lidocaine hydrochloride in glycerol (anhydrous).
Warnings
1. Warnings and contraindications:
- if the packaging is damaged;
- if the eardrum is damaged (e.g. chronic otitis media);
- if a careful otoscopic examination by the doctor has not been performed before use;
- if you have previously had an allergy to any of the components of the product;
- if the expiry date indicated on the packaging has been exceeded;
- if you have just had surgery or surgical treatment of the ear;
- in children under 6 months of age;
- in case of prolonged pain or swelling due to inflammatory conditions of bacterial or fungal origin: these disorders require a doctor's consultation;
- in case of ear discharge;
- if you wear a hearing aid, apply Octolen at least one hour before putting on the hearing aid;
- although there is no evidence that Octolen drops can cause problems during pregnancy and breastfeeding, in these cases, before using the product, consult a doctor so that he can assess whether the expected benefits outweigh the potential risks;
- if after three days of using Octolen the symptoms do not improve or worsen or if you have a fever, stop treatment and consult a doctor. Prolonged pain or swelling may be signs of a bacterial or fungal infection that requires specific and more appropriate treatment.
- For external use only.
- Avoid using the product directly on the mucous membranes of the eyes, mouth, throat and nose.
- Octolen is indicated for temporary relief from ear pain, and should be used for a maximum of 3 consecutive days; for prolonged use of the product, it is necessary to consult a doctor.
2. Concomitant use and interaction with other medicinal products/medical devices
Interactions with other products have not been studied. However, antiarrhythmic drugs are known to exacerbate the side effects of lidocaine: concomitant use may cause serious side effects. Cimetidine, beta-blockers, norepinephrine, inhalation anesthetics inhibit the metabolism of lidocaine by reducing hepatic blood flow, leading to increased serum levels of the drug. Barbiturates, rifampicin and phenytoin accelerate the metabolism of lidocaine by activating hepatic microsomal enzymes.
Lidocaine increases the effect of transverse striated muscle relaxants. The manufacturer does not recommend the concomitant use of other medicinal products/medical devices in drops or sprays in the ear while using Octolen; if you intend to use other medicinal products/medical devices in drops together with Octolen, always ask your doctor or pharmacist for advice first. Before starting treatment with Octolen, inform your doctor or pharmacist if you are taking other ear products or even other medicines, including over-the-counter ones.
After using Octolen, wait at least 30 minutes before using another medicine or medical device in ear drops.
Conservation
Octolen should be stored:
- in a cool, dry place, at a temperature between 15°C and 25°C and in an upright position (avoid storing the product in the refrigerator or freezing it);
- protected from direct sunlight;
Validity after opening: 1 month.
Format
Multidose bottle containing 7 g of solution.
Medical device 0.5% solution of lidocaine hydrochloride in glycerol (anhydrous).
It relieves itching and pain of the external auditory canal and helps in case of ear inflammation.
Octolen can be a valid support in all the following cases:
- inflammatory conditions characterized by swelling, pain and itching of the external auditory canal;
- painful disorders caused by frequent exposure to water and humidity (e.g. swimming pool);
- disorders accompanied by pain caused by prolonged use of headphones or by earwax obstructing the external auditory canal;
- painful disorders caused by frequent use of detergents that damage the natural protective layer that lines the external auditory canal (e.g. shampoos, soaps, gels).
Octolen can be used in adults and children aged 6 months and above.
How to use
1. Wash your hands thoroughly and unscrew the cap from the bottle.
2. Tilt your head to one side (or lie on your side) so that the ear to be treated is facing upwards.
3. Gently pull the earlobe forward and out.
4. Insert the dispenser into the ear and press the bottle on both sides, dispensing 2 drops of product into the ear.
5. Remain with your head tilted for a few minutes so that the drops can flow into the ear canal.
6. Remove excess liquid with a clean tissue.
7. At the end of the application, it is advisable to close the external auditory canal with a cotton ball. 8. Close the bottle.
Adults and children over 6 months of age: 2 drops up to 3 times a day.
In children, always use under the supervision of a doctor; after use, it is necessary to protect the child's ear with a cotton ball.
If there is no improvement after 3 days or the situation worsens, consult your doctor. Only your doctor can verify the success of the treatment.
Components
0.5% solution of lidocaine hydrochloride in glycerol (anhydrous).
Warnings
1. Warnings and contraindications:
- if the packaging is damaged;
- if the eardrum is damaged (e.g. chronic otitis media);
- if a careful otoscopic examination by the doctor has not been performed before use;
- if you have previously had an allergy to any of the components of the product;
- if the expiry date indicated on the packaging has been exceeded;
- if you have just had surgery or surgical treatment of the ear;
- in children under 6 months of age;
- in case of prolonged pain or swelling due to inflammatory conditions of bacterial or fungal origin: these disorders require a doctor's consultation;
- in case of ear discharge;
- if you wear a hearing aid, apply Octolen at least one hour before putting on the hearing aid;
- although there is no evidence that Octolen drops can cause problems during pregnancy and breastfeeding, in these cases, before using the product, consult a doctor so that he can assess whether the expected benefits outweigh the potential risks;
- if after three days of using Octolen the symptoms do not improve or worsen or if you have a fever, stop treatment and consult a doctor. Prolonged pain or swelling may be signs of a bacterial or fungal infection that requires specific and more appropriate treatment.
- For external use only.
- Avoid using the product directly on the mucous membranes of the eyes, mouth, throat and nose.
- Octolen is indicated for temporary relief from ear pain, and should be used for a maximum of 3 consecutive days; for prolonged use of the product, it is necessary to consult a doctor.
2. Concomitant use and interaction with other medicinal products/medical devices
Interactions with other products have not been studied. However, antiarrhythmic drugs are known to exacerbate the side effects of lidocaine: concomitant use may cause serious side effects. Cimetidine, beta-blockers, norepinephrine, inhalation anesthetics inhibit the metabolism of lidocaine by reducing hepatic blood flow, leading to increased serum levels of the drug. Barbiturates, rifampicin and phenytoin accelerate the metabolism of lidocaine by activating hepatic microsomal enzymes.
Lidocaine increases the effect of transverse striated muscle relaxants. The manufacturer does not recommend the concomitant use of other medicinal products/medical devices in drops or sprays in the ear while using Octolen; if you intend to use other medicinal products/medical devices in drops together with Octolen, always ask your doctor or pharmacist for advice first. Before starting treatment with Octolen, inform your doctor or pharmacist if you are taking other ear products or even other medicines, including over-the-counter ones.
After using Octolen, wait at least 30 minutes before using another medicine or medical device in ear drops.
Conservation
Octolen should be stored:
- in a cool, dry place, at a temperature between 15°C and 25°C and in an upright position (avoid storing the product in the refrigerator or freezing it);
- protected from direct sunlight;
Validity after opening: 1 month.
Format
Multidose bottle containing 7 g of solution.
