Locorten Vioform Ear Drops

Active ingredients:

Flumetasone pivalate 0.02% w/v

Clioquinol BP 1.0% w/v

Ear drops, solution.

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

Instil 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 Locorten Vioform, appropriate microbiological investigations should be carried out and local or systemic antibiotic treatment given.

Use in the elderly

There is no evidence to suggest that dosage should be different in the elderly.

Use in children

Locorten Vioform Ear Drops are contra-indicated in children below the age of two years.

Route of administration: Auricular use

Hypersensitivity to any component of the formulation or iodine. 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.

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. Locorten Vioform should not be allowed to come into contact with the conjunctiva.

None known via this topical route.

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.

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

None known.

Locorten Vioform 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. Hypersensitivity reactions may also occasionally occur. Treatment should be discontinued if patients experience severe irritation or sensitisation.

Locorten Vioform may cause hair discoloration.

Locorten Vioform 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.

Locorten Vioform Ear Drops combine the anti-fungal and anti-bacterial properties of clioquinol with the anti-inflammatory activity of flumetasone pivalate.

No pharmacokinetic data on Locorten Vioform Ear Drops are available.

Not applicable.

Polyethylene glycol.

None known.

36 months.

Do not store above 25°C.

Plastic dropper bottle containing 7.5 ml or 10ml.

Medicines should be kept out of the reach of children.

Amdipharm plc

Regency House

Miles Gray Road

Basildon

Essex

SS14 3AF

UK

PL 20072/0012

11^th October 2004

23/06/2006