Octolen Ear Drops 7 G

Description
Medical device 0.5% lidocaine hydrochloride solution in glycerol (anhydrous).
Relieves itching and pain in the external auditory canal, aiding in cases of ear inflammation.
Octolen can be a valid support in all of the following cases:
- inflammatory conditions characterized by swelling, pain, and itching of the external auditory canal;
- disorders accompanied by pain caused by frequent exposure to water and humidity (e.g. swimming pool);
- disorders accompanied by pain caused by prolonged use of headphones or cerumen obstructing the external auditory canal;
- disorders accompanied by pain caused by the frequent use of cleansers that damage the natural protective layer covering the external auditory canal (e.g. shampoo, soaps, gels).
Octolen can be used in adults and children from 6 months of age.

Method of use
1. Wash your hands well 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 upward.
3. Gently pull the earlobe forward and outward.
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 auditory canal.
6. Remove excess liquid with a clean tissue.
7. At the end of the application, it is recommended to close the external auditory canal with a cotton ball. 8. Re-cap the bottle.
Adults and children over 6 months: 2 drops up to 3 times a day.
In children, always use under medical supervision; after use, it is necessary to protect the child’s ear with a cotton ball.
If there is no improvement after 3 days or if the situation worsens, consult a doctor. Only a doctor can verify the successful outcome of the treatment.

Components
0.5% lidocaine hydrochloride solution 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 thorough otoscopic examination by a doctor has not been performed before use;
- if an allergy to any of the product's components has been previously identified;
- if the expiration date indicated on the package has been exceeded;
- if you have recently undergone surgery or surgical treatment of the ear;
- in children under 6 months;
- in case of prolonged pain or swelling due to inflammatory conditions of bacterial or fungal origin: these disorders require medical consultation;
- in case of ear discharges;
- if wearing a hearing aid, apply Octolen at least one hour before wearing the hearing aid;
- although there is no evidence that Octolen drops can cause problems during pregnancy and breastfeeding, in these cases, consult a doctor before using the product so that they can evaluate whether the expected benefits outweigh the potential risks;
- if after three days of using Octolen symptoms do not improve or intensify, or if there is a fever, stop treatment and consult a doctor. Prolonged pain or swelling can 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 of ear pain and should be used for no more than 3 consecutive days; for prolonged use of the product, it is necessary to consult a doctor.
2. Concurrent use and interaction with other medicines/medical devices
Interactions with other products have not been studied. However, it is known that antiarrhythmic drugs exacerbate the side effects of lidocaine: concurrent use may cause severe side effects. Cimetidine, beta-blockers, norepinephrine, inhalational anesthetics inhibit the metabolism of lidocaine through reduced hepatic flow, leading to increased serum levels of the drug. Barbiturates, rifampicin, and phenytoin accelerate the metabolism of lidocaine through the activation of hepatic microsomal enzymes.
Lidocaine increases the effect of neuromuscular blockers. The manufacturer does not recommend concurrent use in the ear of other medicines/medical devices in drops or sprays during the use of Octolen; if there is an intention to use other medicines/medical devices in drops along with Octolen, always consult a doctor or pharmacist beforehand. Before starting treatment with Octolen, inform the doctor or pharmacist if you are taking other otological products or other medicines, including over-the-counter ones.
After using Octolen, wait at least 30 minutes before using another medicinal product or medical device in drops for the ears.

Storage
Octolen must 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 a refrigerator or freezing it);
- protected from direct sunlight;
Validity after opening: 1 month.

Format
Multidose bottle containing 7 g of solution.