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  • FML Liquifilm
    / Allergan


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Suspension

    5 ml

    partial basket chart 822 6320

    Dosage

    FML Liquifilm is for topical ophthalmic use only, applied as drops into the conjunctival sac.
    Shake FML Liquifilm 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    The treatment should not be withdrawn too early.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.
    Paediatric population: The safety and efficacy in children aged 2 years or less has not been established.


    Indications

    FML Liquifilm is indicated to treat eye inflammation.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.
    FML Liquifilm is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, as well as mycobacterial and untreated bacterial infection of the eye and fungal diseases of ocular structures, and any undiagnosed ‘red eye’ as this may indicate a viral infection.


    Special Precautions

    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.
    Prolonged use of corticosteroids may result in elevated intraocular pressure (IOP) with possible development of glaucoma and infrequent damage to the optic nerve, defects in visual acuity and fields of vision, posterior subcapsular cataract formation, and delayed wound healing.
    Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.
    Acute untreated infection of the eye may be masked or activity enhanced by the presence of steroid medication.
    Use of intraocular steroids may prolong the course and may exacerbate the severity of many viral infections on the eye (including herpes simplex). Use of a corticosteroid medication in the treatment of the patients with a history of herpes simplex keratitis requires great caution. Frequent follow-ups including slit lamp microscopy is recommended.
    To prevent eye injury or contamination, care should be taken to avoid touching the applicator tip to the eye or to any other surface. The use of the bottle by more than one person may spread infection.
    FML Liquifilm 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 Liquifilm 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 Liquifilm.
    Visual disturbance: Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.


    Side Effects

    Common: Intraocular pressure increased
    See prescribing information for full details.


    Drug interactions

    No interaction studies have been performed.
    Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.


    Pregnancy and Lactation

    Pregnancy: There are no or limited amount of data from the use of fluorometholone in pregnant women. Studies in animals have shown reproductive toxicity. FML Liquifilm is not recommended during pregnancy.
    Lactation: It is unknown whether fluorometholone is excreted in human milk.
    FML Liquifilm should not be used during breast-feeding.


    Overdose

    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.


    Important notes

    Shelf life: The expiry date of the product is indicated on the packaging materials. Discard 28 days after first opening.
    Storage: Store below 25°C. Do not freeze. Keep in a dark place.


    Manufacturer
    Allergan
    Licence holder
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