Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Allergan Limited, Marlow International, The Parkway, Marlow, Bucks, SL7 1YL, UK
For corticosteroid responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.
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The treatment should not be withdrawn too early.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.
The safety and efficacy in children aged 2 years or less has not been established.
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.
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.
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