Description
AUDIO SPRAY
MISLEAD
DROPS
EARPHONES
Description
Medical device, whose action is based on the osmotic properties of glycerol.
The main ingredient of AUDISPRAY DOLO 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 the tissues (osmotic effect), reducing swelling and therefore alleviating pain.
The glycerol contained in the AUDISPRAY DOLO medical device softens earwax, facilitates its expulsion and, due to its ability to absorb water, removes excess fluids (osmotic effect) from the tissues of the ear canal, promoting the elimination of disorders that occur in conditions of inflammation such as pain and swelling of the ear.
In AUDISPRAY DOLO, lidocaine is an adjuvant agent used as a local anesthetic, which intensifies the action of glycerol as well as relieving ear pain.
How to use
- Adults and children over 12 years: 2 drops in each ear up to three times a day. If after 3 days there is no improvement or if you feel worse, consult your 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 doctor. If after 3 days there is no improvement or if you feel worse, consult your doctor.
If used in children, it is necessary to protect the ear 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 up. Gently pull the earlobe (bottom of the ear canal) away from your neck.
Unscrew and turn the AUDISPRAY DOLO bottle upside down by pressing on both sides, then dose 1-2 drops of 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 cotton ball.
Replace the cap.
Components
Lidocaine hydrochloride 0.5% solution in glycerol (anhydrous).
Warnings
For external use only.
It 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 DOLO:
• 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 detected;
• if the expiry date printed on the package has passed;
• 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 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 must 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 if used 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 develop a fever, contact your doctor. Prolonged pain or swelling may be signs of bacterial or fungal infections that may require additional and more appropriate treatment.
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, antiarrhythmic drugs are known to aggravate the side effects of lidocaine; combined 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 drug levels. Barbiturates, rifampicin and phenytoin accelerate the metabolism of lidocaine by activating 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 of any other ear products used and all recently taken medications, including over-the-counter ones. After applying the drops, it is not recommended to use other medications, medical devices, ear drops for at least 30 minutes.
AUDISPRAY DOLO is well tolerated and there are no known side effects due to its use. In case of allergy or other side effects, inform your doctor or pharmacist and stop using 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 notified to the manufacturer and to the competent authority of the Member State to which the user is subject.
Conservation
Store in a dry place, at a temperature between 15 °C and 25 °C and in an upright position. Store in a frost-free place (not in the refrigerator) and protected from direct sunlight. Keep out of the sight and reach of children.
Shelf life after opening: 4 weeks.
Format
7g bottle
Cod. 7DP031
Medical device, whose action is based on the osmotic properties of glycerol.
The main ingredient of AUDISPRAY DOLO 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 the tissues (osmotic effect), reducing swelling and therefore alleviating pain.
The glycerol contained in the AUDISPRAY DOLO medical device softens earwax, facilitates its expulsion and, due to its ability to absorb water, removes excess fluids (osmotic effect) from the tissues of the ear canal, promoting the elimination of disorders that occur in conditions of inflammation such as pain and swelling of the ear.
In AUDISPRAY DOLO, lidocaine is an adjuvant agent used as a local anesthetic, which intensifies the action of glycerol as well as relieving ear pain.
How to use
- Adults and children over 12 years: 2 drops in each ear up to three times a day. If after 3 days there is no improvement or if you feel worse, consult your 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 doctor. If after 3 days there is no improvement or if you feel worse, consult your doctor.
If used in children, it is necessary to protect the ear 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 up. Gently pull the earlobe (bottom of the ear canal) away from your neck.
Unscrew and turn the AUDISPRAY DOLO bottle upside down by pressing on both sides, then dose 1-2 drops of 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 cotton ball.
Replace the cap.
Components
Lidocaine hydrochloride 0.5% solution in glycerol (anhydrous).
Warnings
For external use only.
It 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 DOLO:
• 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 detected;
• if the expiry date printed on the package has passed;
• 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 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 must 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 if used 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 develop a fever, contact your doctor. Prolonged pain or swelling may be signs of bacterial or fungal infections that may require additional and more appropriate treatment.
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, antiarrhythmic drugs are known to aggravate the side effects of lidocaine; combined 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 drug levels. Barbiturates, rifampicin and phenytoin accelerate the metabolism of lidocaine by activating 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 of any other ear products used and all recently taken medications, including over-the-counter ones. After applying the drops, it is not recommended to use other medications, medical devices, ear drops for at least 30 minutes.
AUDISPRAY DOLO is well tolerated and there are no known side effects due to its use. In case of allergy or other side effects, inform your doctor or pharmacist and stop using 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 notified to the manufacturer and to the competent authority of the Member State to which the user is subject.
Conservation
Store in a dry place, at a temperature between 15 °C and 25 °C and in an upright position. Store in a frost-free place (not in the refrigerator) and protected from direct sunlight. Keep out of the sight and reach of children.
Shelf life after opening: 4 weeks.
Format
7g bottle
Cod. 7DP031
