SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Vistamethasone N Drops for Eye, Ear and Nose (Betamethasone N Drops)

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Betamethasone Sodium Phosphate    0.1% w/v

Neomycin Sulphate BP    0.5% w/v

3.    PHARMACEUTICAL FORM

Drops for eye, ear or nose.

4.    CLINICAL PARTICULARS

4.1    Therapeutic indications

By topical application for inflammatory conditions of the eye, ear or nose where secondary infection is likely.

4.2    Posology and method of administration

For Adults, Elderly and Children:

Eye:    Initially one or two drops to be instilled every two hours. Frequency of

administration should be reduced once the condition is under control.

Ear:    Initially two or three drops instilled every three to four hours. Frequency of

administration should be reduced once the condition is under control.

Nose: Two or three drops into each nostril twice daily or as required.

Contra-indications

Viral, fungal, tuberculous or purulent conditions of the eye. Use is contraindicated if glaucoma is present or herpetic keratitis (e.g. dendritic ulcer) is considered a possibility. Use of topical steroids in the latter condition can lead to extension of the ulcer and marked visual deterioration. Otitis extema should not be treated when the eardrum is perforated due to the risk of ototoxicity.

Hypersensitivity to any component of the medicinal product.

4.4 Special warnings and special precautions for use

Topical corticosteroids should never be given for an undiagnosed red eye as inappropriate use is potentially blinding.

Treatment with corticosteroid / antibiotic combinations should not be used for more than 7 days in the absence of any clinical improvement, since prolonged use may lead to occult extension of infection due to the masking effect of the steroid. Prolonged use may also lead to skin sensitisation and the emergence of resistant organisms.

Prolonged use may lead to the risk of adrenal suppression in infants.

Ophthalmological treatment with corticosteroid preparations should not be repeated or prolonged without regular review to exclude raised intraocular pressure, cataract formation or unsuspected infections.

Aminoglycoside antibiotics may cause irreversible, partial or total deafness when given systemically or when applied topically to open wounds or damaged skin. This effect is dose related and is enhanced by renal or hepatic impairment. Although this effect has not been reported following topical ocular use, the possibility should be considered when high dose topical treatment is given to small children or infants.

4.5 Interactions with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

Safety for use in pregnancy and lactation has not been established. 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 intrauterine growth retardation. There may therefore be a very small risk of such effects in the human foetus. There

is a risk of foetal ototoxicity if aminoglycoside antibiotic preparations are administered during pregnancy.

4.7 Effects on ability to drive and use machines

May cause transient blurring of vision on instillation. Warn patients not to drive or operate hazardous machinery unless vision is clear.

4.8 Undesirable effects

Hypersensitivity reactions, usually of the delayed type, may occur leading to irritation, burning, stinging, itching and dermatitis.

Topical corticosteroid use may result in increased intraocular pressure leading to optic nerve damage, reduced visual acuity and visual field defects.

Intensive or prolonged use of topical corticosteroids may lead to the formation of posterior subeapsular cataracts.

In those diseases causing thinning of the cornea or selera, corticosteroid therapy may result in thinning of the globe leading to perforation.

This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reaction may occur.

4.9 Overdose

Long term intensive topical use may lead to systemic effects.

Oral ingestion of the contents of one bottle (up to 10ml) is unlikely to lead to any serious adverse effects.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Neomycin sulphate is a broad-spectrum antibiotic effective against bacterial infection. Corticosteroids are used to treat inflammatory conditions and are readily absorbed from sites of local application.

5.2    Pharmacokinetic properties

No data available.

5.3    Preclinical safety data

None available.

6. PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Disodium hydrogen orthophosphate BP Thiomersal BP Purified Water BP

6.2    Incompatibilities

None known.

6.3    Shelf life

36 months unopened 28 days from first opening.

6.4    Special precautions for storage

Store below 25°C.

Protect from light.

6.5    Nature and contents of container

6.6 Instructions for use/handling

No special instructions

7    MARKETING AUTHORISATION HOLDER

Martindale Pharmaceuticals Ltd

Bampton Road

Harold Hill

Romford

RM3 8UG

8. MARKETING AUTHORISATION NUMBER

PL 00156/0084

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

14/04/2005

10 DATE OF REVISION OF THE TEXT

14/04/2005