Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Bausch & Lomb UK Limited, Bausch & Lomb House, 106 London Road, Kingston-Upon-Thames, Surrey, UK, KT2 6TN
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 listed in section 6.1.
Care should be taken to ensure that the eye is not infected before Minims 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.
Corticosteroids are known to increase the effects of barbiturates, sedative hypnotics and tricyclic antidepressants.
They will, however, 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.
Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development and although the relevance of this finding to human beings has not been established, the use of Minims Prednisolone during pregnancy should be avoided.
Not relevant.
Not known: vision, blurred (see also section 4.4)
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.
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: United Kingdom, Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.
Not applicable.
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