Please refer to Summary of Product Characteristics before prescribing. Further information about this product can be requested from the Marketing Authorisation Holder or may be found in the Summary of Product Characteristics.
Contains: Prednisolone Sodium Phosphate 0.5% w/v.
Main Indications, Dosage and Administration: Non-infected inflammatory conditions of the eye. Adults and the elderly: One or two drops as required. Paediatric population: At the discretion of the physician.
Contraindications, Precautions and Warnings: Use is contraindicated in viral, fungal, tuberculous and other bacterial infections. Prolonged application to the eye of preparations containing corticosteroids has caused increased intraocular pressure and therefore the drops should not be used in patients with glaucoma. In children, long-term, continuous topical corticosteroid therapy should be avoided due to possible adrenal suppression. Hypersensitivity to the active substance or to any of the excipients. Care should be taken to ensure that the eye is not infected before prednisolone is used. Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the passage of drops via the naso-lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.). Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. Avoid long-term use in children due to possible adrenal suppression. Instillation of eyedrop may cause temporarily blurred vision and photophobia. Patients should be advised not to drive or operate machinery until vision is clear.
Interactions: Corticosteroids are known to increase the effects of barbiturates, sedative hypnotics and tricyclic antidepressants and decrease the effects of anticholinesterases, antiviral eye preparations and salicylates. Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.
Use in Pregnancy and Lactation: Should be avoided during pregnancy.
Undesirable Effects: Prolonged treatment with corticosteroids in high dosage is occasionally associated with cataract. The systemic effects of steroids are possible following the use of Minims Prednisolone, but are, however, unlikely due to the reduced absorption of topical eye drops. 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. Instillation of eye drops may cause temporarily blurred vision.
Legal Category: POM.
UK PL No: 03468/ 0079 Basic NHS Price: £ 13.50
Marketing Authorisation Holder: Bausch & Lomb UK Limited, Bausch & Lomb House, 106 London Road, Kingston-Upon-Thames, Surrey, UK, KT2 6TN
Date of Revision: March 2023
Exemption Level: Not Available For Optometry Use
Evocative Code: PRED 0.5
PIP Code: 015-5671
United Kingdom (UK)
