Auricular pain dolo +6 months - auricular drops 7 g

Product Description

Medical device in the form of eye drops useful for relieving pain and itching in the external auditory canal.

Indications

Dolo +6Mesi by Audispray are ear drops indicated for relieving pain and itching in the external auditory canal, promoting the healing of ear inflammation. The main ingredient is glycerol and has two fundamental characteristics:

• The oily consistency allows it to adhere delicately to the skin in the application area and has protective properties;
• The hygroscopicity of glycerol, administered topically, allows the removal of water retained in the tissues (osmotic effect), reducing swelling and therefore relieving pain.

Glycerol softens earwax, facilitates its removal expulsion and, due to its ability to absorb water, removes excess fluid (osmotic effect) from the tissues of the ear canal, promoting the elimination of discomfort that occurs in conditions of inflammation such as pain and swelling in the ear. Lidocaine is an adjuvant agent used as a local anesthetic, which intensifies the action of glycerol and also relieves ear pain.

Composition

0.5% lidocaine hydrochloride solution in glycerol (anhydrous).

Directions for use and Dosage

Wash your hands and unscrew the bottle cap. Tilt your head or lie on your side so that the treated ear is facing upward. Gently pull the earlobe (lower part of the ear canal) away from your neck. Unscrew and invert the bottle by pressing on both sides, then dispense 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.

• Adults and children over 12 years of age: 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 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. When used in children, protect the ear with a cotton ball.

Warnings

For external use only. Cannot be used in children under 6 months. Avoid contact with mucous membranes of the eyes, mouth, throat, and nose. The progress 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 product's components has previously been detected;
• If the expiry date printed on the packaging has passed;
• If the patient has just undergone surgery or surgical treatment on the ear;
• If children under 6 months of age;
• In case of prolonged pain or swelling caused by inflammatory conditions of bacterial or fungal origin (such conditions require medical consultation);
• In case of otorrhea or discharge from the ear.

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 Audispray Dolo drops have any negative effects when used during pregnancy and breastfeeding, consult your doctor to determine whether the expected benefits of Audispray Dolo outweigh the potential risks. If symptoms worsen or there is no improvement 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 further, more appropriate treatment. Audispray Dolo is indicated for temporary relief of ear pain; do not use for more than three 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, and inhalation anesthetics inhibit lidocaine metabolism by reducing hepatic blood flow, leading to increased serum drug levels. Barbiturates, rifampicin, and phenytoin accelerate lidocaine metabolism 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 of any other ear products you are using and 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 no side effects are known. If you experience an allergy or other side effects, inform your doctor or pharmacist and discontinue use. 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, 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

7 g