SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

FML® Liquifilm® Ophthalmic 1 mg/ml eye drops, suspension

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

One millilitre contains 1 mg Fluorometholone For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Eye drops, suspension.

A white, microfine suspension.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

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

4.2    Posology and method of administration

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

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The treatment should not be withdrawn too early.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.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

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.

4.4 Special warnings and precautions for use

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.

4.5. Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed

4.6.    Fertility, pregnancy and lactation

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.

4.7.    Effects on ability to drive and use machines

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.

4.8 Undesirable effects

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.

4.9    Overdose

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.

5.    PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

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).

5.2 Pharmacokinetic properties

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.

5.3. Preclinical safety data

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

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Polyvinyl alcohol Benzalkonium chloride Edetate disodium Sodium chloride

Disodium phosphate, heptahydrate Sodium dihydrogen phosphate, monohydrate Polysorbate 80

Sodium hydroxide (for pH adjustment) Purified water

6.2. Incompatibilities

None known.

6.3 Shelf life

36 months unopened.

Discard 28 days after first opening.

6.4. Special Precautions for Storage

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

6.5    Nature and contents of container

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.

6.6    Special precautions for disposal

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.

7    MARKETING AUTHORISATION HOLDER

Allergan Ltd Marlow International The Parkway Marlow

Bucks SL7 1YL UK

8. MARKETING AUTHORISATION NUMBER(S)

PL 00426/0028

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

23/09/2009

10 DATE OF REVISION OF THE TEXT

15/01/2015