AUDISPRAY
FRAUD

DROPS
HEADPHONES

Description
Medical device, whose action is based on the osmotic properties of glycerol.
The main ingredient in AUDISPRAY DOLO is glycerol. The glycerol used in ear drops has two fundamental characteristics:
1) the oily consistency allows it to easily adhere to the skin in the application area and has protective properties;
2) the hygroscopicity of glycerol, administered topically, allows the elimination of water retained in the tissues (osmotic effect), reducing swelling and therefore relieving pain.
The glycerol contained in the AUDISPRAY DOLO medical device softens earwax, facilitates its expulsion and, due to its ability to absorb water, eliminates excess fluids (osmotic effect) from the tissues of the ear canal, favoring the elimination of conditions that occur in inflammatory conditions, such as pain and swelling of the ear.
In AUDISPRAY DOLO, lidocaine is an adjuvant agent used as a local anesthetic, which enhances the action of glycerol and relieves ear pain.

How to use
- Adults and children over 12 years: 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 a doctor.
- Children over 6 months: 2 drops in each ear up to three times a day. Use only under the supervision of an adult or a doctor. If no improvement is observed after 3 days or if you feel worse, consult a doctor.
If used on children, it is necessary to protect the ear with a cleansing pad.

Wash your hands and unscrew the bottle cap.
Tilt your head or lie on your side so that the treated ear is facing up. Gently pull the earlobe (the bottom of the ear canal) away from your neck.
Unscrew and invert the bottle of AUDISPRAY DOLO by pressing on both sides, then apply 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 recommended to close the external auditory canal with a cleansing pad.
Put the lid back on.

components
Lidocaine hydrochloride solution 0.5% in glycerol (anhydrous).

warnings
For external use only.
It cannot be used in children under 6 months.
Avoid contact with 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 packaging has been damaged;
• if the eardrum is affected (e.g. chronic otitis media); • if an allergy to one of the components of the product has been previously detected;
• if the expiration date written on the packaging has been exceeded;
• if the patient has just 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 (these conditions 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 during pregnancy and breastfeeding, consult your doctor to assess whether the expected benefits of AUDISPRAY DOLO outweigh the possible risk.
If symptoms worsen or do not improve after three days of using AUDISPRAY DOLO ear drops, or if you have a fever, contact your doctor. Prolonged pain or swelling may be a sign of bacterial or fungal infections that may require additional, more appropriate treatment.
AUDISPRAY DOLO is indicated for temporary relief of earaches, do not use for more than 3 days or continuously.
AUDISPRAY DOLO should only be used after a thorough otoscopic examination performed by a physician.
Interactions with other products have not been studied. However, antiarrhythmic drugs are known to increase the side effects of lidocaine; combined use may cause serious side effects. Cimetidine, beta-blockers, norepinephrine, and inhaled 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 enhances the effect of muscle relaxants on transverse striated muscle. The manufacturer does not recommend the use of other medications/medical devices in the form of drops or sprays while using AUDISPRAY DOLO. Consult a doctor or pharmacist before using other medications/medical devices in the form of drops or sprays. Before applying AUDISPRAY DOLO drops, inform your doctor or pharmacist about any other ear products you are using and about all recent medications, including over-the-counter medications. After applying the drops, it is not recommended to use other medications, medical devices, or ear drops for at least 30 minutes.
AUDISPRAY DOLO is well tolerated and has no known side effects. If you experience an allergy or other adverse reaction, inform your doctor or pharmacist and discontinue use. AUDISPRAY DOLO should be used according to the instructions for use.
Any serious incident related to the use of AUDISPRAY DOLO must be notified to the manufacturer and the competent authority in the Member State to which the user is subject.

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

Format
7g bottle

Code 7DP031