FLUCON Ophthalmic suspension Ref.[115320] Active ingredients: Fluorometholone

Prolonged use may give rise to the development of iatrogenic glaucoma. Intraocular pressure should be monitored frequently.

This is especially important in paediatric patients, as the risk of corticosteroid-induced ocular hypertension may be greater in children and may occur earlier than in adults. FLUCON is not approved for use in children below 2 years old.

The risk of corticosteroid-induced raised intraocular pressure and/or cataract formation is increased in predisposed patients (e.g. diabetics).

Systemic corticosteroid side-effects may occur after intensive or long-term continuous ophthalmic corticosteroid therapy in predisposed patients, including children and patients treated with CYP3A4 inhibitors (e.g.ritonavir and cobicistat).

Corticosteroids delay wound healing, promote development and spread of infection and may mask evidence of its progression until sight is lost.

Appropriate antimicrobial therapy should be instituted in the presence of infection. FLUCON may slow corneal wound healing. Topical NSAIDs are also known to slow or delay wound healing. Concomitant use of topical NSAIDs and FLUCON may increase the potential for healing problems (see section 4.5).

Employment of FLUCON in the treatment of stromal herpes simplex requires great caution; frequent slit lamp microscopy is mandatory.

FLUCON may give rise to serious exacerbations of herpes infections of the eye. Prolonged use may result in glaucoma, damage to the optic nerve, defects in visual acuity and fields of vision, posterior subcapsular cataract formation, or may aid in the establishment of secondary ocular infection from pathogens liberated from ocular tissue.

As fungal infections of the cornea are particularly prone to develop coincidentally with long-term topical steroid applications, such as FLUCON, fungus invasion must be suspected in any persistent corneal ulceration where a steroid has been used or is in use and FLUCON should be discontinued.

Perforation has been known to occur with the use of topical steroids, such as fluorometholone in FLUCON, in those diseases of the eye which cause thinning of the cornea or sclera.

If the eye has not responded within 48 hours, the patient should be referred to an ophthalmologist because of the possibility of inducing corneal abscess, fungal keratopathy or glaucoma.

FLUCON contains benzalkonium chloride which may cause eye irritation and may possibly discolour soft contact lenses. Contact lenses must be removed before administration of eye drops and reinserted at least 15 minutes later.

After application of FLUCON, the following measures are useful to reduce systemic resorption:

• Either nasolacrimal occlusion or gently closing the eyelid(s) after administration is recommended. This may reduce the systemic absorption of medicinal products administered via ocular route and result in a decrease in systemic adverse reactions.

Concomitant use of FLUCON and topical NSAIDs may increase the potential for corneal healing problems (see section 4.4).

When pupil-dilating eye drops are used (atropine and other anticholinergic substances), which may cause elevation of intraocular pressure, an additive elevation of intraocular pressure may occur if FLUCON is used concomitantly.

If more than one eye preparation is being used, the products must be administrated at least 5 minutes apart.

Co-treatment with CYP3A4 inhibitors, including ritonavir and cobicistat, may increase systemic exposure resulting in increased 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

Safety of FLUCON in pregnant women has not been established. Studies in animals with corticosteroids have shown reproductive toxicity.

Lactation

It is unknown whether fluorometholone/metabolites are transferred to human milk following topical ocular administration of FLUCON. Systemic corticosteroids are transferred to human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. A risk to the breast-feeding child cannot be excluded. Breastfeeding during treatment with FLUCON is therefore not recommended.

Fertility

There are no data regarding the effects of FLUCON on male or female fertility.

Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machinery.

The following side effects have been derived from post-marketing experience with FLUCON ophthalmic suspension via spontaneous case reports and literature cases.

The adverse reactions are listed according to system organ classes in MedDRA the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data). Within each system organ class, adverse reactions are presented in order of decreasing seriousness.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the "6.04 Adverse Drug Reactions Reporting Form", found online under SAHPRA's publications: https://www.sahpra.org.za/Publications/Index/8.

Not applicable.