Audispray Dolo +6Months 7G

Description
Medical device, whose action is based on the osmotoxic properties of glycerol.
The main ingredient of AUDISPRAY DOLOR is glycerol. The glycerol used in ear drops has two fundamental characteristics:
1) the oily consistency allows it to gently adhere 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 medical device AUDISPRAY DOLOR softens earwax, facilitates its expulsion and, due to its ability to absorb water, removes excess liquids (osmotic effect) from the tissues of the ear canal, promoting the elimination of discomfort caused by inflammation such as pain and swelling.
In AUDISPRAY DOLOR, lidocaine is an adjuvant agent used as a local anesthetic, which intensifies the action of glycerol in addition to relieving ear pain.

Directions for use
- Adults and children over 12 years: 2 drops in each ear up to three times a day. If no improvement occurs after 3 days or if symptoms worsen, consult a doctor.
- Children over 6 months of age: 2 drops in each ear up to three times a day. Use only under adult or medical supervision. If no improvement occurs after 3 days or if symptoms worsen, consult a doctor.
When used in children, it is necessary to protect the ear with a cotton ball.

Wash hands and unscrew the bottle cap.
Tilt your head or lie on your side so that the treated ear faces upwards. Gently pull on the earlobe (bottom part of the ear canal) from the neck.
Unscrew and turn the AUDISPRAY DOLOR bottle upside down by pressing on both sides, then dose 1-2 drops of product into the ear. Keep the 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 cotton ball.
Replace the cap.

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

Precautions
For external use only.
Cannot be used in children under 6 months of age.
Avoid contact with mucous membranes of eyes, mouth, throat, and nose.
The course of treatment should be monitored by a doctor.
Do not use AUDISPRAY DOLOR:
• if the packaging has been damaged;
• if the eardrum is damaged (e.g., chronic otitis media); • if an allergy to one of the components of the product has been previously identified;
• if the expiration date printed on the package has passed;
• if the patient has undergone recent ear surgery or surgical treatment;
• 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 other discharges from the ear.
Do not apply AUDISPRAY DOLOR in the ear if wearing hearing aids, AUDISPRAY DOLOR must be applied one hour before inserting the hearing aid into the external ear canal.
Although there is no evidence that the use of AUDISPRAY DOLOR drops has adverse effects if used during pregnancy and breastfeeding, consult a doctor to evaluate whether the expected benefits from AUDISPRAY DOLOR outweigh any potential risks.
If symptoms intensify or do not improve after three days of using AUDISPRAY DOLOR ear drops, or if fever occurs, contact your doctor. Prolonged pain or swelling may be signs of bacterial or fungal infections that may require further and more appropriate treatments.
AUDISPRAY DOLOR is indicated for temporary relief of ear pain, do not use for more than 3 days or continuously.
AUDISPRAY DOLOR 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 exacerbate the side effects of lidocaine; combined use can cause serious side effects. Cimetidine, beta-blockers, norepinephrine, inhalation anesthetics inhibit mitochondria lidocaine metabolism through reduced liver flow, leading to increased serum levels of drugs. Barbiturates, rifampin, and phenytoin accelerate lidocaine metabolism via activation of hepatic microsomal enzymes. Lidocaine enhances the effect of muscle relaxants on cross-striated muscle. The manufacturer does not recommend the use of other medicinal products/medical devices in the form of drops or spray during AUDISPRAY DOLOR use. For the use of other medicinal products/medical devices in the form of drops or spray, consult a doctor or pharmacist. Before applying AUDISPRAY DOLOR drops, inform the doctor or pharmacist of any other ear products used and all recently taken medications, including over-the-counter drugs. After applying the drops, the use of other medications, medical devices, or ear drops is not recommended for at least 30 minutes.
AUDISPRAY DOLOR is well tolerated and no side effects due to use are known. In case of allergy or other adverse effects, inform your doctor or pharmacist and discontinue use of the drops. AUDISPRAY DOLOR must be used according to the instructions for use.
Any serious incidents related to the use of AUDISPRAY DOLOR 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, in an upright position. Store protected from freezing (not in the refrigerator) and from direct sunlight. Keep out of the sight and reach of children.
Opened shelf life: 4 weeks.

Format
7 g bottle

Code 7DP031