Description
A medical device whose action is based on the osmotic properties of glycerol.
The main ingredient of AUDISPRAY DOLO is glycerol. Glycerol used in ear drops has two fundamental characteristics:
1) its oily consistency allows it to adhere gently to the skin in the application area and has protective properties;
2) the hygroscopicity of glycerol, administered topically, allows the removal of water retained in tissues (osmotic effect), reducing swelling and thus alleviating pain.
The glycerol contained in the AUDISPRAY DOLO medical device softens earwax, facilitates its expulsion, and, due to its water-absorbing capacity, removes excess fluids (osmotic effect) from the tissues of the ear canal, helping to eliminate discomfort that occurs in inflammatory conditions such as ear pain and swelling.
In AUDISPRAY DOLO, lidocaine is an adjuvant agent used as a local anesthetic, which intensifies the action of glycerol in addition to relieving ear pain.

Instructions for use
- Adults and children over 12 years of age: 2 drops in each ear up to three times a day. If there is no improvement after 3 days or if you feel worse, consult your doctor.
- Children over 6 months of age: 2 drops in each ear up to three times a day. Use only under the supervision of an adult or doctor. If there is no improvement after 3 days or if you feel worse, consult your doctor.
If used in children, the ear must be protected with a cotton ball.

Wash your hands and unscrew the bottle cap.
Tilt your head or lie on your side so that the treated ear is facing upwards. Gently pull the earlobe (lower part of the ear canal) away from your neck.
Unscrew and invert the AUDISPRAY DOLO bottle, pressing on both sides, then dispense 1-2 drops of the product into the ear. Keep your head tilted for a few minutes so that the drops can flow into the ear canal. Remove excess liquid with a clean tissue.
After application, it is advisable to close the external auditory canal with a cotton ball.
Replace the cap.

Components
0.5% lidocaine hydrochloride solution in glycerol (anhydrous).

Warnings
For external use only.
Not to be used in children under 6 months of age.
Avoid contact with the mucous membranes of the eyes, mouth, throat, and nose.
The course of treatment must be monitored by a doctor.
Do not use AUDISPRAY DOLO:
• if the package has been damaged;
• if the eardrum is damaged (e.g., chronic otitis media); • if an allergy to any of the product components has been previously noted;
• if the expiry date printed on the package has passed;
• if the patient has recently undergone surgery or surgical treatment on the ear;
• in children under 6 months of age;
• in case of prolonged pain or swelling caused by inflammatory conditions of bacterial or fungal origin (such disorders require medical consultation);
• in case of otorrhea or ear discharge.
Do not apply AUDISPRAY DOLO to the ear if you wear hearing aids. AUDISPRAY DOLO should be applied one hour before inserting the hearing aid into the external auditory canal.
Although there is no evidence that the use of AUDISPRAY DOLO drops has negative effects when used during pregnancy and breastfeeding, consult your doctor to assess whether the expected benefits of AUDISPRAY DOLO outweigh any potential risk.
If symptoms worsen or there is no improvement after three days of using AUDISPRAY DOLO ear drops, or in case of fever, contact your doctor. Prolonged pain or swelling may be signs of bacterial or fungal infections that may require further and more appropriate treatments.
AUDISPRAY DOLO is indicated for temporary relief of ear pain; do not use for more than 3 days or continuously.
AUDISPRAY DOLO should only be used after a thorough otoscopic examination by a doctor.
Interactions with other products have not been studied. However, it is known that antiarrhythmic drugs worsen the side effects of lidocaine; combined use can cause serious side effects. Cimetidine, beta-blockers, norepinephrine, inhalation anesthetics inhibit lidocaine metabolism by reducing hepatic flow, leading to an increase in drug serum levels. Barbiturates, rifampicin, and phenytoin accelerate lidocaine metabolism through activation of hepatic microsomal enzymes. Lidocaine increases the effect of muscle relaxants on transverse striated muscle. The manufacturer does not recommend the use of other medicines/medical devices in the form of drops or sprays while using AUDISPRAY DOLO. For the use of other medicines/medical devices in the form of drops or sprays, consult a doctor or pharmacist. Before applying AUDISPRAY DOLO drops, inform your doctor or pharmacist about any other ear products you are using and all medicines recently taken, including over-the-counter ones. After applying the drops, it is not recommended to use other medicines, medical devices, or ear drops for at least 30 minutes.
AUDISPRAY DOLO is well tolerated, and no side effects due to its use are known. In case of allergy or other undesirable effects, inform your doctor or pharmacist and discontinue the use of the drops. AUDISPRAY DOLO must be used according to the instructions for use.
Any serious incident related to the use of AUDISPRAY DOLO must be reported to the manufacturer and the competent authority of the Member State to which the user is subject.

Storage
Store in a dry place, at a temperature between 15 °C and 25 °C, and in an upright position. Store in a place protected from frost (not in the refrigerator) and protected from direct sunlight. Keep out of sight and reach of children.
Shelf life after opening: 4 weeks.

Format
7 g bottle

Code. 7DP031