FLUMETASONE/CLIOQUINOL

Posology Instill 2 or 3 drops twice daily directly into the auditory canal of the affected ear. Treatment should be limited to 7-10 days. If there is little improvement after 7 days treatment with this medicine, appropriate microbiological investigations should be carried out and local or systemic antibiotic treatment given.

Elderly There is no evidence to suggest that dosage should be different in the elderly. Paediatric population This medicine is contra-indicated in children below the age of two years. Method of administration Auricular use

The adverse drug reactions are listed according to system organ classes in MedDRA. Within each system organ class, ADRs are presented in order of decreasing seriousness. The names used to describe each of the frequency groupings should follow standard terms established in each official language using the following convention: Not known (cannot be estimated from the available data) System Organ Class Undesirable effect Immune system disorders Hypersensitivity reactions.

4) Skin and subcutaneous tissue disorders Hair discoloration General disorders and administration site conditions *Irritation, burning, pruritus and rash in the application site. *This medicine is generally well tolerated, but occasionally at the site of application, there may be signs of irritation such as a burning sensation, itching or skin rash.

Treatment should be discontinued if patients experience severe irritation or sensitization. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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Long-term continuous topical therapy should be avoided since this can lead to adrenal suppression. Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects.

The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects. Topical application of clioquinol-containing preparations may lead to a marked increase in protein-bound iodine (PBI).

The results of thyroid function tests, such as PBI, radioactive iodine and butanol extractable iodine, may be affected. However, other thyroid function tests, such as the T3 resin sponge test or T4 determination, are unaffected. The ferric chloride test of phenylketonuria may yield a false-positive result when clioquinol is present in the urine.

This medicine should not be allowed to come into contact with the conjunctiva. Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

1. Primary bacterial, viral or fungal infections of the outer ear. Perforation of the tympanic membrane. Use in children below the age of two years.