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Summary of Changes to FMLTM Irish Summary of Product Characteristics (SPC)
The current FMLTM SPC is dated (December/2008)
This supersedes SPC dated (December/2004)
Section Number
Subject
Change
1
Name
FML Liquifilm Sterile Ophthalmic Suspension
FMLTM 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
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
5.2
Pharmacokinetic properties
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.
Key:
Words added within the text are in red and underlined eg (Eye Drops).
Words deleted from the text are in black and are struck through eg sterile homogeneous suspension