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Section Number
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Subject
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Change
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1.0
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Name of Medicinal Product
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Text Added/Removed
FML ® Liquifilm ® - Ophthalmic 1mg/ml eye drops,sSuspension.
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2.0
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Qualitative and Quantitative Composition
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Text Added
One millilitre contains 1 mg OFluromethlone 0.10% w/v.
For a full list of excipients, see section 6.1.
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3.0
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Pharmaceutical Form
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Text Added
Eye drops, Sterile Ophthalmic sSuspension..
A white, microfine suspension.
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4.1
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Therapeutic indications
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Text Added/ Removed
For corticosteroid responsive inflammation of the palpebral and bulbar conjuvtiva, cornea and anterior segment of the globe.
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4.2
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Posology and method of administration
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Text Added/ Removed
Route of administration: topical ophthalmic administration. Topically as drops into the conjunctival sac.
1 – 2 Adults: One to two drops instilled into the conjunctival sac 2 – 4 two to four times daily. During the first initial 24 to 48 hours of treatment the dosage may be safely increased to 2 drops at one every hour intervals. Care should be taken not to discontinue therapy prematurely. The treatment should not be withdrawn too early.
Children: Not recommended for children aged two and under.
The safety and efficacy of FML has not been proven in children aged 2 years or less.
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4.3
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Contradindications
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Text Added/Moved/Removed
Hypersensitivity to any of the constituents of the medication the active substance or to any of the excipients.
Acute superficial herpes simplex (dendritic) keratitis, vaccinia, varicella and most other viral diseases of the conjunctiva and cornea. Ocular viral infections, among others keratitis dendritica and varicella-zoster infections.
Ocular bacterial infection, among others tuberculosis.
Ocular fungal infections.
Ocular tuberculosis. Fungal diseases of the eye.
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4.4
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Interaction with other medicinal products and other forms of interactions
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Text Added/ Removed:
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.
Steroid medication in the treatment of herpes simplex keratitis (involving the stroma) requires great caution: frequent slit-lamp microscopy is mandatory. Prolonged use may result in glaucoma, corneal thinning and perforation, damage to the optic nerve, defects in visual acuity and fields of vision, posterior subcapsular cataract formation, or may facilitate aid in the development establishment of secondary ocular infections especially from fungi or viruses liberated from ocular tissue.
In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with use of topical steroids.
Safety and effectiveness have not been demonstrated in children of the age group two years or below.
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 This preparation contains benzalkonium chloride which is irritant to the eye and could cause discolouration of should not be used by patients continuing to wear soft (hydrophilic) 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.
As fungal infections of the cornea are particularly prone to develop coincidentally with long term local steroid applications, fungus invasion must be suspected in any persistent corneal ulceration where a steroid has been or is in use.
Intraocular pressure should be checked frequently.
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4.6
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Pregnancy and lactation
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Text Removed
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 effects in the human foetus.
Text Added
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.
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4.7
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Effects on aAbility to dDrive and uUse mMachines
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Text Added/ Removed
None known.
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.
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4.8
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Undesirable effects
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Text Removed
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 affect facial skin.
Text Added:
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
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4.9
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Overdose
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Text Removed
Not likely to occur.
Text Added
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.
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5.
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PHARMACOLOGICAL PROPERTIES
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Text Added
Pharmacotherapeutic group: Corticosteroids, plain
ATC code: S01BA07
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5.1
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Pharmacodynamic properties
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Text Added/Removed
Fluorometholone ML is a synthetic adrenocorticosteroid (glucocorticoid), a derivative of desoxyprednisolone. It is a member of the group of universally known steroids used for the treatment of eye inflammation. It forms part of a well-known group of steroids used to treat ocular inflammation.
Glucocorticosteroids bind to complex with cytoplasmic receptors and control the subsequently stimulate synthesis of proteins with anti-inflammatory effects. infection mediators thus damping inflammatory reactions (swelling,They inhibit early phenomena of the inflammatory response (oedema, fibrin deposition, capillary dilation, phagocytic migration) and also as well as capillary proliferation, collagen deposition and scarring formation.
Although Whilst topical corticosteroid therapy treatment frequently often increases intraocular pressure both in normal eyes and in the eyes of a patient with increased intraocular pressure hypertensive subjects, fluorometholone increases intraocular pressure has a substantially lower propensity to elevate IOP 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).
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5.2
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Pharmacokinetics properties
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Text Removed
Topical application of a 0.1% tritium-labelled-fluorometholone suspension gave rise to peak radioactivity levels in the aqueous humour 30 minutes post-instillation. A high concentration of rapidly-produced metabolite was found both in aqueous humour and corneal extracts, indicating that fluorometholone undergoes metabolic change as it penetrates into the cornea and aqueous humour.
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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.
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5.3
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Preclinica l safety data
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Text Removed
No information.
Text Added
Any preclinical safety data relevant to the prescriber has been included in other sections of the Summary of Product Characteristics.
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6.1
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List of excipients
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Text Added/Removed
Polyvinyl alcohol
Benzalkonium chloride
Disodium Edetate Disodium
Sodium chloride
DisSodium phosphate, dibasic, heptahydrate
Sodium dihydrogen phosphate, monobasic, monohydrate
Polysorbate 80
Sodium hydroxide (forto adjust pH adjustment)
Purified water
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6.3
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Shelf Life
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Text Added
36 months unopened.
Discard 28 days after first opening.
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6.5
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Nature and contents of container
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Text Added/ Removed
A 5 ml and 10 ml bottles and an applicator tip dropper tips composed of low density polyethylene (LDPE). A screw cCaps of are impact polystyrene (MIPS).
The bottle contains 5 ml or 10 ml of suspension.
Not all pack sizes may be marketed.
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6.6
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Special precautions for disposalInstructions for use and handling
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Text Removed
No information.
Text Added
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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10
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DATE OF REVISION OF TEXT
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Text Removed/Added
20th December 2007 May 2011
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