NAME PAIN CERULISIN, 1% + 5% EAR DROPS, 6 G BOTTLE SOLUTION
PHARMACOTHERAPEUTIC CATEGORY Otological, analgesics and anesthetics, associations.
ACTIVE PRINCIPLES Procaine hydrochloride; phenazone.
EXCIPIENTS Glycerol.
INDICATIONS Otalgia.
CONTRAINDICATIONS / SECONDARY EFFECT Hypersensitivity to the components of the product and to other strictly correlated substances from a chemical point of view; in case of perforation of the eardrum, refrain from use. The product, in contact with the middle ear structure, can cause undesirable effects at this level.
DOSAGE Instill into the external ear canal 2-4 times a day: adults: 5-8 drops each time; children: 4-5 drops each time. It is advisable to warm the bottle before use.
STORAGE No special storage precautions.
WARNINGS As a precautionary measure, before administering the product, ensure the integrity of the eardrum membrane. The products for topical application can give rise to sensitization or irritation phenomena: in this case, stop the treatment and consult the doctor in order to establish suitable therapy. Do not use for prolonged treatments, in any case, after a short period of treatment (1-2 days) without appreciable results, consult your doctor.
INTERACTIONS None known.
SIDE EFFECTS In case of perforation of the eardrum, the product, in contact with the structure of the middle ear, can cause undesirable effects at this level. The use of phenazone, albeit systemically, has been associated with a high risk of agranulocytosis; this drug, as well as procaine, can cause allergic reactions in sensitized subjects and, following systemic absorption, also anaphylactic manifestations. The reporting of suspected adverse reactions that occur after the authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine.
PREGNANCY AND BREASTFEEDING In pregnancy, during breastfeeding and in very early childhood, the drug should be used only in case of real need and not for prolonged periods.
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