FML LIQUIFILM OPHTHALMIC

Method of administration FML is for topical ophthalmic use only, applied as drops into the conjuctival sac. Shake FML well before use. Posology 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The treatment should not be withdrawn too early.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.

Class effects:

Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical steroids. The following undesirable effects have been reported since FML was marketed. Adverse reactions are categorized by frequency as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000), not known (frequency cannot be estimated from the available data).

Table 1:

Adverse reactions System Organ Class Very common (≥1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Not Known (cannot be estimated from the available data) Immune system disorders Hypersensitivity Eye disorders Intraocular pressure increased Eye irritation, conjunctival/ocular hyperaemia, eye pain, visual disturbance, foreign body sensation in eyes, eyelid oedema, eyelid ptosis, blurred vision*, eye discharge, eye pruritis, lacrimation increased, eye oedema/eye swelling, mydriasis, cataract (including subcapsular)*, ulcerative keratitis, ocular infection (including bacterial, fungal*, and viral* infections), visual field defect, punctate keratitis.

4 for further information Adverse reactions reported in phosphate containing eye drops Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

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 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 installation of FML. 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.

1. FML 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.