NETILDEX

Posology Adults (including the elderly) Instil 1 drop into the conjunctival sac 2 (two) times a day or according to medical prescription. Paediatric population Netildex is not recommended for use in children and adolescents (from birth to 18 years of age).

Method of administration Ocular use. Patients should be informed of the correct handling of the single-dose container: 1) Wash/sanitize your hands. 2) Open the aluminium sachet containing the single-dose containers. 3) Separate one single-dose container from the strip and put the unopened containers back into the aluminium sachet.

4) Make sure the single-dose container is intact before use. 5) Hold the single-dose container upside down and shake it lightly back and forth. 6) Open by twisting the upper part and pull. Do not touch the tip after opening the container.

7) Gently squeeze until one drop falls into the gap between your eyeball and lower eyelid. To avoid contamination take care not to touch the tip of the container with your eye, eyelid, or any other surface. 8) The container should be immediately discarded after use.

Systemic absorption of the medicinal product may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the gel (this blocks the passage of the gel via the naso-lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa).

During a superficial eye infection, the usage of contact lenses is strongly discouraged.

The reported undesirable effects are listed below according to MedDRA system organ classification. There is not enough data available to determine the frequency of the individual effects listed.

Frequency not known:

Eye disorders Increased intraocular pressure, posterior subcapsular cataract formation, development or worsening of Herpes simplex or fungal infections, delayed healing, conjunctival hyperemia, burning, pruritus. 4). Immune system disorders Allergic reaction.

4). 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 side effects 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. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Prolonged use of topical products may cause irritation or sensitization phenomena. In these events, discontinue use and start an appropriate treatment. Netildex is for ophthalmic use only and should not be administered subconjunctivally nor should it be introduced into the anterior chamber of the eye.

The patient should be informed not to touch the tip of the container with the eye, hands or any other surface. Prolonged use of corticosteroids may result in: 1) onset of subcapsular cataract (therefore it is not advisable to use corticosteroids for long periods of time); 2) in injured tissue, wound healing of damaged tissue is delayed, therefore increasing the incidence and spread of infections; 3) decrease of the host response and thus increased hazard of secondary ocular infections, in particular of fungal or viral nature; 4) ocular hypertension with possible damage to the optic nerve (glaucoma) and defects in visual acuity; it is recommended to monitor the intraocular pressure if corticosteroids are used for longer than two weeks.

Particular attention should be given to disorders associated to corneal thinning. Some eye diseases and the long-term use of corticosteroids can cause corneal or scleral thinning; in these cases, the use of topical steroids could give rise to corneal or scleral perforations.

3). In acute purulent conditions of the eye and bacterial, viral or fungal conjunctivitis, topical corticosteroids may mask infection. Cushing's syndrome and/or adrenal suppression with systemic absorption of ocular dexamethasone may occur after intensive or long-term continuous therapy in predisposed patients, including children and patients treated with CYP3A4 inhibitors (including ritonavir and cobicistat).

In these cases, treatment should be progressively discontinued. The use of Netildex in children has not been studied. Therefore, in children aged 3 to 12 years the medicinal product should be administered only after a careful benefit-risk assessment and under strict medical control.

1. Children less than 3 years of age. 6). The medicinal product contains dexamethasone therefore its use is contraindicated in patients with: • Intraocular hypertension. • Herpetic keratitis or other ocular infections caused by Herpes simplex.

• Viral diseases of the conjunctiva and of the cornea at acute ulcerative stage. • Conjunctivitis with ulcerative keratitis even at the initial stage (positive fluorescein test). • Tuberculosis and mycosis of the eye. • Mycobacterial ocular infections.