NETILMICIN/ DEXAMETHASONE

Posology For ophthalmic use only. Adults (including the elderly) Instill 1 drop into the conjunctival sac four times a day in each affected eye or according to medical prescription. When using nasolacrimal occlusion or closing the eyelids for 2 minutes, systemic absorption is reduced.

This may result in a decrease of systemic side effects and an increase in local activity. Paediatric population The safety and efficacy of Netildex in children and adolescents less than 18 years of age has not yet been established. No data is available.

The product should be administered in paediatric patients only after a careful benefit- risk assessment and strict medical control. Method of administration Make sure the single-dose container is intact before use. 1. Wash your hands and sit comfortably.

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 sachet. 4. Open by twisting the upper part without pulling. Do not touch the tip after opening the container.

5. Tilt the head back. 6. Use your finger to gently pull down the lower eyelid of your affected eye. 7. Invert the single-dose container and place the tip of the container close to, but not touching your eye. Do you not touch your eye or eyelid with the container tip.

8. Squeeze the single-dose container in order to administrate only a drop, then release the lower eyelid. 9. Close your eye and press a finger against the corner by the nose of the affected eye. Hold for 2 minutes. 10. Repeat in the other eye according to medical prescription.

11. Discard the single dose container after use. Netildex single-dose eye drops must be used immediately after opening. After administration, the single-dose container and any unused content should be discarded. Precautions to be taken before handling or administering the medicinal product During a superficial eye infection or an inflammation, the usage of contact lenses is strongly discouraged.

Patients should be advised that eye drops, if handled incorrectly, can become contaminated by bacteria, which may lead to eye infections. Serious ocular damage and subsequent loss of vision may result from using contaminated eye drops.

If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart. Eye ointments should be placed last. Duration of treatment The usual treatment duration can vary from 5 to 14 days.

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 - intraocular pressure increased (after 15-20 days of topical administration in susceptible or glaucomatous patients) - posterior subcapsular cataract formation - blurred vision - occurrence or worsening of Herpes simplex or fungal infections - impaired healing.

Immune system disorders - ocular hypersensitivity: conjunctival hypereamia, burning, itching. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Netildex is for ophthalmic use only and should not be orally administered nor should it be introduced into the anterior chamber of the eye. Intraocular pressure should be routinely monitored in case of treatment lasting longer than 15 days.

Prolonged use may result in ocular hypertension/glaucoma with resultant damage to the optic nerve and defects in visual acuity and visual fields. Prolonged use of corticosteroids may result in: 1) posterior subcapsular cataract formation, 2) delayed wound healing, 3) decrease of the host response and thus increased hazard of secondary ocular infections, in particular of fungal or viral nature.

In acute purulent infections of the eye, corticosteroids administration may mask or exacerbate infection. In those diseases causing thinning of the cornea or sclera, perforation has been reported with the use of topical steroids. Sensitivity to topically applied aminoglycosides may occur in some patients.

If sensitivity does occur, discontinue use. This product contains dexamethasone and should be used cautiously in patients with glaucoma and should be considered carefully in patients with a family history of this disease. Co-treatment with CYP3A inhibitors, including ritonavir and 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. This product contains phosphates which may lead to corneal deposits or corneal opacity when topically administered.

5). If significant clinical improvement is not reported within a few days, or should any irritation or sensitization phenomena occur, discontinue treatment and start an adequate therapy. Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use.

2).

1. The product contains corticosteroids therefore its use is contraindicated in patients affected by: 1) intraocular hypertension, 2) herpetic keratitis or other ocular infections caused by herpes simplex, 3) viral diseases of the cornea and of the conjunctiva, 4) ocular fungal diseases, 5) mycobacterial ocular infections.