For corticosteroid responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

Method of administration

FML is for topical ophthalmic use only, applied as drops into the conjuctival sac. Shake FML well before use.

Posology

Instil 1 – 2 drops into the conjunctival sac 2 – 4 times daily. During the first 24 to 48 hours of treatment, the dose may be safely increased to 2 drops at one hour intervals.

The treatment should not be withdrawn too early.

In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.

Paediatric population

The safety and efficacy in children aged 2 years or less has not been established.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

FML is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, as well as mycobacterial and untreated bacterial infection of the eye and fungal diseases of ocular structures, and any undiagnosed 'red eye' as this may indicate a viral infection.

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.

Breast-feeding

It is unknown whether fluorometholone/metabolites are 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.

Adverse reactions are categorized by frequency as follows: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1000 to <1/100), rare (≥ 1/10,000 to <1/1000) and very rare (<1/10,000), not known (frequency cannot be estimated from the available data).

Table 1: Adverse reactions

*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.

Overdosage by the topical ophthalmic route will not ordinarily cause acute problems.

If accidental overdosage occurs in the eye, the eye should be flushed with water or normal saline. If accidentally ingested, the patient should drink fluids to dilute.

Pharmacotherapeutic group: Corticosteroids, plain

ATC code: S01BA07

Fluorometholone is a synthetic corticosteroid (glucocorticoid), a derivative of desoxyprednisolone. It is a member of the group of universally known steroids used for the treatment of eye inflammation.

Glucocorticosteroids bind to cytoplasmic receptors and control the synthesis of infection mediators thus damping inflammatory reactions (swelling, fibrin deposition, capillary dilatation, phagocyte migration) and also capillary proliferation, collagen deposition and scarring.

Although topical corticosteroid treatment often increases intraocular pressure both in normal eyes and in the eyes of a patient with increased intraocular pressure, fluorometholone increases intraocular pressure less than, for example, dexamethasone. A study showed that fluorometholone after six weeks' treatment increased intraocular pressure statistically significantly less than dexamethasone (mean change dexamethasone: 9 mmHg, mean change fluorometholone: 3 mmHg).

When tritium-labelled 0.1 % fluorometholone suspension was administered locally, the peak concentration of the radioactive substance in aqueous humour was achieved 30 minutes after administration. A rapidly forming metabolite occurred at high concentrations both in aqueous humour and corneal extracts, which shows that fluorometholone is metabolised to a certain extent while penetrating the cornea and aqueous humour.

Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose ocular toxicity and repeated dose systemic toxicity.

Polyvinyl alcohol

Benzalkonium chloride

Edetate disodium

Sodium chloride

Disodium phosphate, heptahydrate

Sodium dihydrogen phosphate, monohydrate

Polysorbate 80

Sodium hydroxide (for pH adjustment)

Purified water

None known.

36 months unopened.

Discard 28 days after first opening.

Do not store above 25° C. Do not freeze.

A bottle and an applicator tip of low density polyethylene (LDPE). A screw cap of polystyrene (MIPS).

The bottle contains 5 ml or 10 ml of suspension.

Not all pack sizes may be marketed.

This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the applicator tip to the eye or to any other surface.

The use of the product by more than one person may spread infection.

Keep the bottle tightly closed when not in use.

There are no special precautions for disposal.