Otifaes Calmadol Ear Drops , 7 gr

Solution of lidocaine hydrochloride 0.5% in glycerol (anhydrous).

Oti FAES CALMADOL can be used in children from 6 months of age and adults. 1- Wash your hands and unscrew the cap of the bottle. 2- Tilt your head, or lie on your side so that the ear where the product is to be applied is facing upwards. 3- Slightly pull the earlobe away from the neck. 4- Place the uncapped bottle of otiFAES CALMADOL upside down and press both sides so that 2 drops of product fall into the ear. 5- Keep your head tilted to one side for a few minutes to allow the drops to penetrate the ear canal. 6- Remove excess liquid with a clean tissue. 7- It is recommended to cover the ear canal with cotton wool after application. This is especially recommended for children. 8- Replace the cap on the bottle.

Lidocaine hydrochloride solution 0.5% in glycerol (anhydrous).

Contraindications: Do not use oti FAES CalmaDOL: - If you notice damage to the container; - In case of damage to the eardrum (e.g. chronic otitis media); - In chronic otitis media: Chronic otitis media); - In case of known allergy to any of the ingredients of the product; - If the expiry date indicated on the pack has been exceeded; - If the patient has just undergone an operation or surgical treatment on the ear; - In infants under the age of five years; - If the patient is allergic to any of the ingredients of the product.In infants under 6 months of age; - In case of swelling or prolonged pain, as this could indicate bacterial otitis externa or otitis externa of fungal origin, in which case a doctor should be consulted; - In case of ear discharge. Warnings: Oti FAES CalmaDOL should only be used after an otological examination by a doctor, especially in children under 3 years of age, it is important to have a medical evaluation before using the product to avoid pain masking other pathologies and delaying their treatment. - If you use hearing aids: oti FAES CalmaDOL should not be applied with the hearing aid in place, oti FAES CalmaDOL should be applied one hour before placing the hearing aid in the ear canal; - There is no evidence that oti FAES CalmaDOL drops are harmful during pregnancy and breast-feeding, but you should still consult your doctor before applying oti FAES CalmaDOL drops to the ear canal; - There is no evidence that oti FAES CalmaDOL drops are harmful during pregnancy and breast-feeding, but you should still consult your doctor before applying oti FAES CalmaDOL drops to the ear canal.If you are pregnant or breast-feeding, you should consult your doctor before using oti FAES CalmaDOL drops to assess whether the expected benefits of oti FAES CalmaDOL outweigh the potential risk; - If your symptoms do not improve after three days of treatment with oti FAES CalmaDOL ear drops, you should consult your doctor before using oti FAES CalmaDOL drops.If symptoms do not improve after three days of treatment with oti FAES CalmaDOL ear drops, including worsening or fever, you should consult your doctor; as prolonged pain or swelling may indicate a bacterial or fungal infection, which may require a different, more appropriate treatment; - External use only; - Avoid contact with eyes, nose and throat; - Avoid contact with skin, eyes and mucous membranes; - Avoid contact with eyes, mucous membranes, mucous membranes and skin. Avoid contact with the eyes, mouth, throat and mucous membranes of the nose; - Oti FAES CalmaDOL is indicated for the temporary relief of ear pain and itching and should not be used for more than 3 days at a time, or chronically; Concomitant use with other medical devices, medicines or other treatments. Interactions with other products have not been studied. However, anti-arrhythmic drugs are known to intensify the side effects of lidocaine; concomitant use could have serious side effects. Cimetidine, beta-blockers, norepinephrine and inhalation anaesthetics inhibit lidocaine metabolism because they reduce hepatic blood flow, leading to increased blood levels of the drug. Barbiturates, rifampicin and phenytoin accelerate the metabolism of lidocaine by activating microsomal enzymes in the liver. Lidocaine enhances the effect of muscle relaxants on striated muscle tissue. The manufacturer advises against the concomitant use of oti FAES CalmaDOL with other treatments in the form of drops or sprays or even with medicines. Consult your doctor or pharmacist before using in combination with other treatments in the form of drops or sprays or with medicines. If you have recently used other ear products or taken any other medicines, even over-the-counter medicines, tell your doctor or pharmacist before using FAES CalmaDOL oti drops. After using oti FAES CalmaDOL drops, it is not recommended to use any other medicines, medical devices or ear drops for at least 30 minutes after the application of oti FAES CalmaDOL. How to use Oti FAES CalmaDOL 1. Wash your hands and unscrew the cap from the bottle. 2. Tilt your head, or lie on your side so that the ear where the product is to be applied is facing upwards. Gently pull the earlobe (lower part of the ear canal) away from the neck. 4. Place the uncapped bottle of oti FAES CalmaDOL upside down and squeeze both sides so that 2 drops of the product fall into the ear. 5. Keep your head tilted to one side for a few minutes to allow the drops to penetrate into the ear canal. 6. Remove excess liquid with a clean tissue. 7. It is recommended to plug the ear canal with cotton wool after application. This is especially recommended for children. 8. Replace the cap on the bottle. Dosage: Adults and children over 6 months: 2 drops in each ear, a maximum of 3 times a day. Children between 6 months and 12 years: Apply only under the supervision of an adult or doctor. In children, the ear should be covered with cotton wool to protect the ear. If there is no improvement after 3 days of application or if the discomfort worsens: you should consult your doctor. Oti FAES CalmaDOL is contraindicated in infants under 6 months of age. External use only. Consult your doctor to monitor the effect of the treatment. Oti FAES CalmaDOL contains 7 g of solution. Possible side effects Oti FAES CalmaDOL is well tolerated and there are no known side effects after use. In case of allergy or other side effects, inform your doctor or pharmacist and stop using the drops. Follow the instructions for use of oti FAES CalmaDOL. 5. How to store oti FAES CalmaDOL Oti FAES CalmaDOL should be stored: - In an upright position in a cool, dry place, at a temperature between 15°C and 25°C; - Do not store in the refrigerator and avoid freezing; - Do not expose to direct sunlight; - Out of the reach and sight of children; - After opening: oti FAES CalmaDOL can be used for up to 4 weeks; Note the date of first opening of the bottle in the place reserved for this purpose on the bottle itself. Once used: dispose of the container in accordance with local legislation. Additional information Oti FAES CalmaDOL is a class III medical device. Packaging: The dosage bottle contains 7 g of solution. Date of last revision of the instructions for use: 04.2023A_EN_IFU Legend of the two symbols used Permitted shelf life Refer to instructions for use Do not use if container is damaged Manufacturer CE marking Protect from sunlight Lot number Warning Expiration date 00A23P EmergoPharm Sp. z o.o. Sp.K. ul. Pilsudskiego 11, 05-510 Konstancin-Jeziorna (Poland) Faes Farma, S.A. Av. Autonomía, 10 48940 Leioa - Bizkaia - Spain www.faesfarma.com Contents: 1.What is oti FAES CalmaDOL and what is it used for 2. Important information before use 3. How to use oti FAES CalmaDOL 4. Possible side effects 5. How to store oti FAES CalmaDOL 6. Additional information Ingredients: 0.5% solution of lidocaine hydrochloride in glycerol (anhydrous). What is oti FAES CalmaDOL and what is it used for Oti FAES CalmaDOL ear drops is a medical device containing glycerol and lidocaine 0.5% and is indicated for the relief of pain and itching in the ear canal. Its action is based on the osmotic properties of its main component, glycerol. Glycerol is used in ear drops mainly because of two of its characteristics: (i) its oily texture, which allows it to adhere delicately to the skin of the ear canal at the point of application and provide a protective effect, and (ii) its hygroscopicity, which means that glycerol, applied topically, helps to remove water from inflamed tissues (osmotic effect), which helps to reduce inflammation and, consequently, favours the relief of pain and itching. Lidocaine, a local anaesthetic, is used for pain relief and complements the action of glycerol. Oti FAES CalmaDOL is recommended in: - Swelling, pain and itching of the external auditory canal related to an inflammatory process; - Discomfort accompanied by pain caused by regular exposure to water and moisture, e.g. in swimming pools; - Pain in the external auditory canal related to an inflammatory process; - Pain in the external auditory canal related to an inflammatory process; - Pain in the external auditory canal related to an inflammatory process. Pain in the ear canal caused by prolonged use of earphones, earplugs and hearing aids; - Pain caused by frequent use of hygiene products, which destroy the natural membrane that protects the ear canal, e.g. shampoos, soaps, gels, shampoos, gels, gels, gels, gels, gels, gels, gels, gels, gels, gels, gels, gels, gels, gels, gels, gels and gels: shampoos, soaps, gels... Oti FAES CalmaDOL can be used in children from 6 months of age, and in adults. 2. Important information before use Contraindications: Do not use oti FAES CalmaDOL: - If the packaging is damaged; - In case of damage to the eardrum (e.g. chronic otitis media); - In chronic otitis media: Chronic otitis media); - In case of known allergy to any of the ingredients of the product; - If the expiry date indicated on the pack has been exceeded; - If the patient has just undergone an operation or surgical treatment on the ear; - In infants under the age of five years; - If the patient is allergic to any of the ingredients of the product.In infants under 6 months of age; - In case of swelling or prolonged pain, as this could indicate bacterial otitis externa or otitis externa of fungal origin, in which case a doctor should be consulted; - In case of ear discharge. Warnings: Oti FAES CalmaDOL should only be used after an otological examination by a doctor, especially in children under 3 years of age, it is important to have a medical evaluation before using the product to avoid pain masking other pathologies and delaying their treatment. - If you use hearing aids: oti FAES CalmaDOL should not be applied with the hearing aid in place, oti FAES CalmaDOL should be applied one hour before placing the hearing aid in the ear canal; - There is no evidence that oti FAES CalmaDOL drops are harmful during pregnancy and breast-feeding, but you should still consult your doctor before applying oti FAES CalmaDOL drops to the ear canal; - There is no evidence that oti FAES CalmaDOL drops are harmful during pregnancy and breast-feeding, but you should still consult your doctor before applying oti FAES CalmaDOL drops to the ear canal.If you are pregnant or breast-feeding, you should consult your doctor before using oti FAES CalmaDOL drops to assess whether the expected benefits of oti FAES CalmaDOL outweigh the potential risk; - If your symptoms do not improve after three days of treatment with oti FAES CalmaDOL ear drops, you should consult your doctor before using oti FAES CalmaDOL drops.If symptoms do not improve after three days of treatment with oti FAES CalmaDOL ear drops, including worsening or fever, you should consult your doctor; as prolonged pain or swelling may indicate a bacterial or fungal infection, which may require a different, more appropriate treatment; - External use only; - Avoid contact with eyes, nose and throat; - Avoid contact with skin, eyes and mucous membranes; - Avoid contact with eyes, mucous membranes, mucous membranes and skin. Avoid contact with the eyes, mouth, throat and mucous membranes of the nose; - Oti FAES CalmaDOL is indicated for the temporary relief of ear pain and itching and should not be used for more than 3 days at a time, or chronically; Concomitant use with other medical devices, medicines or other treatments. Interactions with other products have not been studied. However, anti-arrhythmic drugs are known to intensify the side effects of lidocaine; concomitant use could have serious side effects. Cimetidine, beta-blockers, norepinephrine and inhalation anaesthetics inhibit lidocaine metabolism because they reduce hepatic blood flow, leading to increased blood levels of the drug. Barbiturates, rifampicin and phenytoin accelerate the metabolism of lidocaine by activating microsomal enzymes in the liver. Lidocaine enhances the effect of muscle relaxants on striated muscle tissue. The manufacturer advises against the concomitant use of oti FAES CalmaDOL with other treatments in the form of drops or sprays or even with medicines. Consult your doctor or pharmacist before using in combination with other treatments in the form of drops or sprays or with medicines. If you have recently used other ear products or taken any other medicines, even if they are over-the-counter, tell your doctor or pharmacist before using FAES CalmaDOL oti drops. After using oti FAES CalmaDOL drops, it is not recommended to use any other medicine, medical device or ear drops for at least 30 minutes after application of oti FAES CalmaDOL