SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Betnesol Eye, Ear and Nose Drops Solution 0.1% w/v

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Betamethasone sodium phosphate PhEur 0.1% w/v.

For excipients, see 6.1

3 PHARMACEUTICAL FORM

Ear/Eye/Nose Drops, Solution A clear and colourless aqueous solution.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Short-term treatment of steroid responsive inflammatory conditions of the eye after clinical exclusion of bacterial, viral and fungal infections.

Non-infected inflammatory conditions of the ear or nose.

4.2 Posology and method of administration

The frequency of dosing depends on the clinical response. If there is no clinical response within 7 days of treatment, the drops should be discontinued.

Treatment should be the lowest effective dose for the shortest possible time. After more prolonged treatment (over 6 to 8 weeks), the drops should be withdrawn slowly to avoid relapse.

Eyes

1    or 2 drops instilled into the eye every one or two hours until control is achieved, when the frequency may be reduced.

Ears

2    or 3 drops instilled into the ear every two or three hours until control is achieved, when the frequency may be reduced.

Nose 2 or 3 drops instilled into each nostril two or three times daily.

4.3 Contraindications

Bacterial, viral, fungal, tuberculous or purulent conditions of the eye. Use is contra-indicated 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 an extension of the ulcer and marked visual deterioration.

Corticosteroids should not be used in patients with a perforated tympanic membrane.

Hypersensitivity to any component of the preparation.

4.4    Special warnings and precautions for use

A patient information leaflet should be supplied with this product.

Topical corticosteroids should never be given for an undiagnosed red eye as inappropriate use is potentially blinding. Ophthalmological treatment with corticosteroid preparations should not be repeated or prolonged without regular review to exclude raised intraocular pressure, cataract formation or unsuspected infections.

Nasal administration of corticosteroids is not advised if an untreated nasal infection is present, or if the patient has pulmonary tuberculosis or following nasal surgery (until healing has occurred).

Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations. Potential systemic effects may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

4.5    Interaction with other medicinal products and other forms of interaction

Betnesol Drops contain benzalkonium chloride as a preservative and therefore, should not be used to treat patients who wear soft contact lenses.

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.

4.7 Effects on ability to drive and use machines

May cause transient blurring of vision on instillation. Patients should be warned 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 corneal ulceration, 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 formation of posterior subcapsular cataracts.

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

Mydriasis, ptosis, epithelial punctate keratitis and glaucoma have also been reported following ophthalmic use of corticosteroids.

Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.

Following nasal administration, the most common effects are nasal irritation and dryness, although sneezing, headache, lightheadedness, urticaria, nausea, epistaxis, rebound congestion, bronchial asthma, perforation of the nasal septum, ulceration of the nasal septum, anosmia, parosmia and disturbance to sense of taste have also been reported.

Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. Growth retardation has been reported in children receiving nasal corticosteroids at licensed doses.

It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid, if possible, to the lowest dose at which effective control of symptoms is maintained. In addition, consideration should also be given to referring the patient to a paediatric specialist.

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 on the MHRA website (www.mhra.gov.uk/yellowcard).

4.9 Overdose

Oral ingestion of the contents of one bottle (up to 10ml) of drops, or one tube (3g) of ointment is unlikely to lead to any serious adverse effects. Long-term intensive topical use may lead to systemic effects.

Treatment with higher than recommended doses may result in clinically significant adrenal suppression. If there is evidence of higher than

recommended doses being used then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC Code: S03B A

Not applicable.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

None stated.

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Benzalkonium chloride solution

Disodium hydrogen phosphate anhydrous

Sodium chloride

Disodium edentate

Sodium hydroxide

Phosphoric acid

Water for Injection

6.2    Incompatibilities

None known.

6.3    Shelf life

Unopened: 24 months

Opened:    4 weeks

6.4    Special precautions for storage

Store at a temperature not exceeding 25 DC. Avoid freezing. Always replace the bottle back in the carton after use to protect its contents from light. The sterility of the drops is assured until the cap seal is broken.

6.5 Nature and contents of container