1    NAME OF THE MEDICINAL PRODUCT

Locorten Vioform Ear Drops

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

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredients:

Flumetasone Pivalate 0.02% w/v Clioquinol BP 1.0% w/v

3.    PHARMACEUTICAL FORM

Ear drops, solution

4.    CLINICAL PARTICULARS

4.1.    Therapeutic Indications

4.2. Posology and Method of Administration

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 this medicine, 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

This medicine is contra-indicated in children below the age of two years.

Route of administration: Auricular use

4.3. Contra-indications

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.

Special Warnings and Precautions for Use

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. This medicine should not be allowed to come into contact with the conjunctiva.

4.5. Interactions with other Medicaments and other forms of Interaction

None known via this topical route.

4.6. Pregnancy and Lactation

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 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.

4.7. Effects on Ability to Drive and Use Machines

None known.

4.8. Undesirable Effects

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

This medicine may cause hair discoloration.

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 at: www.mhra.gov.uk/yellowcard.

Overdose

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.

5.1. Pharmacodynamic Properties

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

5.2. Pharmacokinetic Properties

No pharmacokinetic data on this medicine is available.

5.3. Preclinical Safety Data

Not applicable.

6. PHARMACEUTICAL PARTICULARS

6.1. List of Excipients

Polyethylene Glycol

Incompatibilities

None known.

6.3. Shelf Life

36 months.

6.4. Special Precautions for Storage

Do not store above 25°C.

6.5. Nature and Contents of Container

Plastic dropper bottle containing 7.5ml or 10ml.

6.6. Instruction for Use/Handling

Medicines should be kept out of the reach of children.

7 MARKETING AUTHORISATION HOLDER

Amdipharm UK Limited

Capital House, 85 King William Street,

London EC4N 7BL, UK

8. MARKETING AUTHORIZATION NUMBER(S)

PL 20072/0012

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

12/07/2006

10 DATE OF REVISION OF THE TEXT

10/02/2015