SCHEDULING STATUS:
Schedule 4

PROPRIETARY NAME
(and dosage form):

FML-NEO Liquifilm Eye Suspension

COMPOSITION
FML-NEO Liquifilm Eye Suspension contains per mL:

Fluorometholone 1,0 mg
Neomycin sulfate (equivalent to 3,5 mg neomycin base) 5,0 mg
Liquifilm (polyvinyl alcohol) 14,0 mg
Preservative:
Benzalkonium chloride 0,004% m/v

PHARMACOLOGICAL CLASSIFICATION
A. 15.2 Ophthalmic preparation with corticosteroids.

PHARMACOLOGICAL ACTION
Fluorometholone is an anti-inflammatory steroid. Glucocorticoids inhibit the oedema, fibrin deposition, capillary dilation, and phagocytic migration of the acute inflammatory response as well as capillary proliferation, deposition of collagen and scar formation. Adrenocorticoids and their derivatives are capable of producing a rise in intraocular pressure. In clinical studies on patients’ eyes treated with both dexamethasone and fluorometholone, those eyes treated with dexamethasone showed both a clinically and statistically significant increase in mean intraocular pressure. The eyes of patients treated only with fluorometholone did not show a clinically or statistically significant increase in mean intraocular pressure.
Neomycin is a broad spectrum bactericidal antibiotic effective against a variety of gram-positive and gram-negative organisms, such a Klebsiella, Proteus, Haemophilus, Corynebacteruim, Staphylococcus, and Streptococcus. Pus, exudates, and bacteria growth products do not inactivate the antibiotic.

INDICATIONS
FML-NEO is effective in the treatment of infectious conjunctivitis due to organisms sensitive to neomycin.
FML-NEO may be used for the treatment of anterior segment inflammatory disorders complicated by bacteria sensitive to neomycin.
FML-NEO is effective following removal of foreign bodies as well as before and after surgery.

CONTRA-INDICATIONS
Acute untreated purulent ocular infections caused by micro-organisms not sensitive to neomycin.
Superficial herpes simplex (dendritic keratitis), vaccinia, varicella, and most other viral diseases of the conjunctiva and cornea. Ocular tuberculosis. Fungal diseases of the eye. Hypersensitivity to any of the components of the drug.

WARNINGS
As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmologic preparations cannot be excluded, regular ophthalmologic examination is required.
Caution should be exercised in the use of benzalkonium chloride preserved topical medication over and extended period in patients with extensive ocular surface disease.

DOSAGE AND DIRECTIONS FOR USE
1 to 2 drops in the conjunctival sac two to four times daily. During the initial 24-48 hours, the dosage may be safely increased to 1 drop every hour. Care should be taken not to discontinue treatment prematurely. Shake well before using. Do not freeze

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
In diseases due to micro-organisms resistant to neomycin, infection may be masked, enhanced or activated by the steroid. Prolonged use may result in overgrowth of non-susceptible organisms.
Articles in current medical literature indicate an increase in the prevalence of persons sensitive to neomycin. The possibility of such a reaction should be borne in mind. If sensitivity or other untoward reactions occur, discontinue the medication.
As fungal infections of the cornea have been reported coincidentally with long-term local steroid applications, fungal invasion may be suspected in any persistent corneal ulceration where a steroid has been used, or is in use, over a prolonged period of time.
In those diseases causing thinning of the cornea, perforation has been known to have occurred with the use of topical steroids.
Acute purulent untreated infections of the eye may be masked, enhanced or activated by the presence of steroid medication. Secondary ocular infection may occur form pathogens liberated form ocular tissues.
Use of steroid medication in the presence of stromal herpes simplex requires great caution; frequent slit-lamp microscopy is required.
Reports in the literature indicate that posterior subcapsular lenticular opacities have occurred after heavy or protracted use of topical ophthalmic corticosteroids.
Prolonged use of topical steroids may increase intraocular pressure. Although currently available data indicate that intraocular pressure rise is generally not a problem with patients being treated fluorometholone, their intraocular pressure should be checked periodically.
Because of the possibility of inducing corneal abscess, fungal keratopathy or glaucoma, the patient should be referred to an ophthalmologist if the eye has not responded within 48 hours.
Safety of intensive or protracted use of topical steroids during pregnancy has not been substantiated.
Patients with histories of herpes simplex keratitis should be treated with caution. Use of topical steroids may increase intraocular pressure. With prolonged use of FML-NEO the intraocular pressure and lens should be examined periodically.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Refer to ‘Side Effects and Special Precautions’listed above.

IDENTIFICATION
A milky white slightly viscous, sterile microfine suspension.

PRESENTATION
FML-NEO Liquifilm Eye Suspension is supplied in sterile dropper bottles containing 5 mL suspension.

STORAGE INSTRUCTIONS
Store below 25°C. Do not freeze. Do not use for more than 30 days after first opening. Store in an upright position. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
J/15.4/335

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Allergan Pharmaceuticals (Pty) Ltd.
30 New Road (entrance off Bavaria Road)
Randjespark Ext 11, Midrand, 1682
Johannesburg, Gauteng
South Africa

DATE OF PUBLICATION OF THIS PACKAGE INSERT
19 December 1977