Flumetasone/Clioquinol 0.02% w/v / 1% w/v Ear Drops solution

Inflammatory conditions of the external ear where a secondary infection is suspected. Otorrhoea.

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

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

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

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.

None known via this topical route.

Pregnancy

There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development, including cleft palate and intra-uterine growth retardation. There may, therefore, be a very small risk of such effects in the human foetus.

Breast-feeding

It is not known whether the active substances of this medicine and/or their metabolite(s) pass into breast milk after topical administration. Use in lactating mothers should only be at the doctor's discretion.

Fertility

No data available

Not relevant.

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)

*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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

This medicine is for topical (external) use only. If accidental ingestion of large quantities occurs, there is no specific antidote and general measures to eliminate the drug and reduce its absorption should be undertaken. Symptomatic treatment should be administered as appropriate.

Pharmacotherapeutic group: Otologicals corticosteroids and anti-infectives in combination, ATC code: SO2CA02

This medicine combine the anti-fungal and anti-bacterial properties of clioquinol with the anti-inflammatory activity of Flumetasone pivalate.

No pharmacokinetic data on this medicine is available.

Not applicable.

Polyethylene Glycol

Not applicable

18 months

Do not store above 25° C.

Plastic dropper bottle containing 7.5ml or 10ml.

Not all pack sizes may be marketed.

Keep out of the sight and reach of children.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.