Ear Drops Solution
Active ingredients
100 ml contain: Active ingredients: • phenazone 2.50 g • procaine hydrochloride 2.88 g. For the full list of excipients, see section 6.1.
Excipients
Excipient: glycerol.
Therapeutic indications
Pain reliever in simple inflammation of the auditory canal.
Contraindications
Myasthenia gravis, hypersensitivity and idiosyncrasy to procaine or phenazone. Perforation of the eardrum of infectious or traumatic origin.
Dosage
After thoroughly cleaning the ear canal with dry cotton, instill 3-4 drops of Otomidone into the ear canal, ensuring that the patient's auricle is in a horizontal position. Remain in this position for at least 5 minutes. Repeat the instillation of the medicine every hour until the pain stops. Thereafter, for one or two days, apply a dressing every 2-3 hours. After instillation, close the ear canal with a cotton ball or, better yet, with a strip of hemmed gauze. OTOMIDONE can also be used lukewarm by warming the bottle in a bain-marie before use. Do not exceed the recommended doses; elderly patients in particular should stick to the minimum doses indicated above.
Warnings and Precautions
Topical products may cause sensitization or irritation: in this case, discontinue treatment and consult your doctor. Do not continue administration of the drug for more than ten days: in any case, after a short period of treatment (one or two days) without appreciable results, consult your doctor. Keep out of reach of children. In the presence of local lesions, the possibility of systemic effects from increased absorption of procaine and phenazone should be considered. As a precaution, ensure the integrity of the eardrum before administering the product. The container of this medicine is made of latex rubber. May contain traces of procaine and phenazone. cause serious allergic reactions.
Interactions
None known.
Side effects
The use of phenazone, even systemically, has been associated with a high risk of agranulocytosis. This drug, like procaine, can cause allergic reactions in sensitized individuals and, following absorption, even anaphylactic reactions. In case of perforation of the eardrum, the product, in contact with the structure of the middle ear, can cause side effects at that level. If any other type of side effects occur, contact your doctor or pharmacist.
Pregnancy and breastfeeding
In pregnant women, the product must be administered under the direct supervision of a doctor and only in cases of real need.
Product Code:FRCM046871
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This product has been on sale since 25/09/2017
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