Predsol Drops for Eye and Ear

Prednisolone Sodium Phosphate EP 0.5% w/v

Sterilised clear and colourless aqueous solution

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.

Eyes

1 or 2 drops instilled into the eyes 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 can be reduced.

Frequency of dosing depends on clinical response. If there is no clinical response within 7 days treatment, the drops should be discontinued. Treatment should be the lowest effective dose for the shortest possible time. After more prolonged treatment (over 6-8 weeks), the drops should be withdrawn slowly to avoid relapse.

Bacterial, viral, fungal tuberculous or purulent conditions of the eye. Use is contraindicated if glaucoma is present or where herpetic keratitis (e.g. dendritic ulcer) is considered a possibility. Inadvertent use of topical steroids in the latter condition can lead to the extension of the ulcer and marked visual deterioration. Hypersensitivity to the preparation.

In the ear, topical corticosteroids are contraindicated in patients with fungal diseases of the auricular structure, and in those with a perforated tympanic membrane.

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

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.

The use of corticosteroids may reduce resistance to or mask the signs of infection. Appropriate anti-infective agents should be used if infection is present.

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

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 be a very small risk of such effects in the human foetus.

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

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. Other side effects include mydriasis, ptosis, epithelial punctate keratitis and possible corneal or scleral malacia. Within a few days after discontinuing topical ophthalmic corticosteroid therapy and occasionally during therapy, acute anterior uveitis has occurred in patients (mainly blacks) without pre-existing ocular inflammation or infection.

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.

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.

Not available.

Not applicable.

Not available.

Benzalkonium chloride solution EP

Sodium chloride EP

Sodium acid phosphate EP

Disodium edetate EP

Sodium hydroxide EP

Phosphoric acid EP

Purified water EP

Not known.

18 months unopened.

4 weeks after first opening.

Store at a temperature not exceeding 25°C. Avoid freezing. Always replace bottle in carton to protect contents from light. Sterility of the drops is assured until cap seal is broken.

Single 5ml or 10ml bottle with nozzle insert moulded in natural low density polyethylene closed with a tamper evident high density polyethylene cap.

Store below 25°C. Protect from light.

UCB Pharma Limited

208 Bath Road

Slough

Berkshire

SL1 3WE

UK

PL 00039/0393

4 December 1992

June 2005