FML Eye drops, suspension Ref.[8103] Active ingredients: Fluorometholone

Eye drops containing corticosteroids should not be used for longer than a week except under an eye specialist’s careful surveillance combined with regular measurement of intraocular pressure.

Prolonged use of corticosteroids may result in elevated intraocular pressure (IOP) with possible development of glaucoma and infrequent damage to the optic nerve, defects in visual acuity and fields of vision, posterior subcapsular cataract formation, and delayed wound healing. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.

Acute untreated infection of the eye may be masked or activity enhanced by the presence of steroid medication.

Use of intraocular steroids may prolong the course and may exacerbate the severity of many viral infections on the eye (including herpes simplex). Use of a corticosteroid medication in the treatment of the patients with a history of herpes simplex keratitis requires great caution. Frequent follow-ups including slit lamp microscopy is recommended.

To prevent eye injury or contamination, care should be taken to avoid touching the applicator tip to the eye or to any other surface. The use of the bottle by more than one person may spread infection.

FML contains benzalkonium chloride which is irritant to the eye and could cause discoloration of soft contact lenses. Avoid contact with soft contact lenses. Remove contact lenses before FML is used and wait for at least 15 minutes before reinsertion.

Concomitant ocular medication should be administered 5 minutes prior to the installation of FML.

Visual disturbance

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.

No interaction studies have been performed.

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.

Pregnancy

There are no or limited amount of data from the use of fluorometholone in pregnant women.

Studies in animals have shown reproductive toxicity.

FML is not recommended during pregnancy.

Lactation

It is unknown whether fluorometholone is excreted in human milk. FML should not be used during breast-feeding.

FML has no influence on the ability to drive or use machines. However, instillation of any eye drop could result in transient blurring of vision. If this occurs, the patient should wait for the blurring to subside before driving or operating machinery or taking part in any activity where this could put themselves or others at risk.

Class effects

Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical steroids.

The following undesirable effects have been reported since FML was marketed.

Frequency:

Common: affecting >1/100 and <1/10 patients

Not known: the incidence cannot be determined from available information.

Immune system disorders

Not known: Hypersensitivity

Eye disorders

Common: Intraocular pressure increased

Not known: Eye irritation, conjunctival/ocular hyperaemia, eye pain, visual disturbance, foreign body sensation in eyes, eyelid oedema, blurred vision*, eye discharge, eye pruritis, lacrimation increased, eye oedema/eye swelling, mydriasis, cataract (including subcapsular), ulcerative keratitis, ocular infection (including bacterial, fungal, and viral* infections), visual field defect, punctate keratitis.

Gastrointestinal disorders

Not known: Dysgeusia

Skin and subcutaneous tissue disorders

Not known: Rash

* See section 4.4 for further information

Adverse reactions reported in phosphate containing 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 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 Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.

None known.