FML

Section Number

Subject

Change

1

Name

FML Liquifilm Sterile Ophthalmic Suspension

FML^TM Liquifilm 0.1% w/v Sterile Eye Drops Suspension

2

Qualitative and quantitative composition

Revised text: Each millilitre contains 1 mg Fluorometholone (0.1% w/v).

Excipients: also includes Benzalkonium chloride, 0.0046% w/v.

For a full list of excipients, see section 6.1.

3

Pharmaceutical form

Eye Drops, Suspension. (Eye Drops).

A white, sterile homogeneous suspension microfine suspension

4.2

Posology and method of administration

General rewording of section and some more significant changes:

Adults and children over the age of 2 years only:

Topically as drops into the conjunctival sac.

The safety and efficacy of FML has not been proven in children aged 2 years or less.

4.3

Contraindications

General rewording of section

4.4

Special warnings and precautions for use

General rewording of section and some more significant changes:

Steroid medication in the treatment of herpes simplex keratitis (involving the stroma) requires great caution, frequent slit-lamp microscopy is mandatory, in severe cases once a day.

A red eye, where the diagnosis is unconfirmed, may be due to herpes simplex virus, and a corticosteroid may aggravate the condition, leading to corneal ulceration, with possible damage to vision and even loss of the eye. 

Adverse topical effects of steroid treatment, such as skin atrophy, striae and teleangiectasia, may occur especially in the facial skin.

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 instillation of FML.

4.6

Pregnancy and lactation

There is inadequate evidence of safety in human pregnancy.  Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation.  There may therefore be a very small risk of such defects in the human foetus.

Pregnancy

Fluorometholone should only be used during pregnancy if it is clearly necessary.  Fluorometholone is, as are other corticosteroids, teratogenic in animal studies.

Lactation

Fluorometholone may pass into breast milk so it is recommended that FML is not used in nursing mothers unless clearly necessary.

4.7

Effects on ability to drive and use machines

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.

4.8

Undesirable effects

Glaucoma with optic nerve damage, visual acuity or field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens liberated from ocular tissues, perforation of the globe.

Local side-effects of steroid therapy, i.e. skin atrophy, striae and telangiectasia, are especially likely to effect facial skin.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

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.

Eye disorders

Not known: Eye irritation, conjunctival hyperaemia, eye pain, visual disturbance, foreign body sensation in eyes, eyelid oedema, blurred vision, eye discharge, eye pruritis, lacrimation increased, ocular hyperaemia, eye oedema, mydriasis, eye inflammation, corneal disorder, cataract (including subcapsular)

Immune system disorders

Not known: Hypersensitivity

Investigations

Common: Intraocular pressure increased

Nervous system disorders

Not known: Dysgeusia, headache, dizziness

Skin and subcutaneous tissue disorders

Not known: Rash

Vascular disorders

Not known: Hypertension

4.9

Overdose

No case of overdose has been reported.  Overdosage 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

Pharmacotherapeutic group: Corticosteroids, plain

ATC code: S01BA07

5.1

Pharmacodynamic properties

General rewording of section

5.2

Pharmacokinetic properties

General rewording of section

5.3

Preclinical safety data

Any preclinical safety data relevant to the prescriber has been included in other sections of the Summary of Product Characteristics.

6.3

Shelf Life

Slight rewording of section

6.5

Nature and contents of container

Bottles and dropper tips composed of low density polyethylene containing either 5 or 10 ml of FML.  Screw caps are medium impact polystyrene.

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

The bottle contains 5 ml or 10 ml of suspension.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

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 bottle tightly closed when not in use.

No special requirements.