Package Insert: Information for the User

NETDEX 3 mg/ml + 1 mg/ml Ophthalmic Gel in Single-Dose Container

netilmicina/dexametasona

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What isNETDEXand how it is used

2. What you need to know before starting to useNETDEX

3. How to use NETDEX

4. Possible adverse effects

5. Storage of NETDEX

6. Contents of the container and additional information

This medication contains two active principles: netilmicina and dexametasona.

Netilmicina is an antibiotic that eliminates the bacteria that cause infections.

Dexametasona is a corticosteroid that reduces inflammation and redness.

This medication is used in adults to reduce inflammation and eliminate bacteria in the eyes in cases of infection or when bacteria may infect the eye, even after surgery.

You should consult a doctor if your condition worsens or does not improve at the end of treatment.

No use NETDEX

•If you are allergic to netilmicina, dexametasona, aminoglucósidos antibiotics, or any of the other components of this medication (listed in section 6);

•If your doctor has warned you that your eye pressure is too high;

•If you think you may have a viral or fungal infection in or around your eye;

•If you have now, or have had in the past, a viral eye infection caused by the herpes simplex virus (HSV);

•If your doctor has warned you that you have an eye infection caused by bacteria known as mycobacteria;

•If you have an eye infection caused by tuberculosis;

•If you have conjunctivitis with inflammation and corneal ulcers (the transparent layer at the front of the eye), even in the early stages;

•In children under 3 years;

•If you are breastfeeding.

Advertencias y precauciones

Consult your doctor or pharmacist before starting to use this medication.

Consult your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. Discontinuing long-term or intensive treatment with this medication may lead to suppression of adrenal gland function. Consult your doctor before stopping treatment on your own. These risks are especially important in children and patients treated with a medication called ritonavir or cobicistat.

Use with caution in patients whose cornea (the transparent layer at the front of the eye) may be compromised and in cases where the patient uses other eye medications containing phosphates (see section 4).

Patients without pre-existing corneal damage do not appear to be at risk.

Contact your doctor if you experience blurred vision or other visual disturbances.

Niños y adolescentes

This medication is contraindicated in children under three years.

This medication is not recommended for use in children or adolescents (3 to 18 years). If in doubt, ask your doctor or pharmacist about the use of this medication.

Solo para uso externo

Use only this medication on the surface of the eye. This medication should not be injected or swallowed.

Si usa NETDEX durante un tiempo prolongado:

•The pressure in your eye may increase and cause damage to the nerves in your eye, leading to vision problems. If you use this medication for extended periods, your doctor should regularly check your eye pressure;

•You may develop cataracts;

•Wounds may take longer to heal;

•As a result of reduced immune response, your body may not fight eye infections as well as it normally would, such as fungal or viral infections;

•Eye infections that produce a lot of pus may worsen or be more difficult to identify as the type of bacteria causing the infection;

•The use of corticosteroids may cause perforation of the cornea or the white of the eye (sclera) in diseases that cause thinning of the eye surface;

•You may start to be allergic to the antibiotic contained in the eye drops.

Antes de usar NETDEX informe a su médico si:

•You have glaucoma or a family history of glaucoma;

•You have corneal problems;

•You are taking other medications that contain phosphates. Your doctor will monitor your cornea at regular intervals.

Otros medicamentos y NETDEX

Inform your doctor or pharmacist if you are using or have used recently or may need to use any eye drops or any other medication, including those obtained without a prescription.

Antes de usar NETDEX, informe a su médico o farmacéutico si está tomando:

•Any other antibiotic, particularly polymyxin B, colistin, viomicin, streptomycin, vancomycin, cefaloridin, or other aminoglycosides. The simultaneous use of netilmicina/dexametasona with other antibiotics may increase the risk of kidney or ear problems, or may affect the proper functioning of the other antibiotics;

•Cisplatin (a cancer chemotherapy medication);

•Diuretics (medications used to treat fluid retention) such as etacrynic acid and furosemide;

•Anticholinergic medications (medications that prevent gland secretion), such as atropine;

•Ritonavir or cobicistat, as they may increase the amount of dexametasona in the blood.

This medication can be used with other eye medications, but it is essential to follow the instructions in section 3.

No interactions with medications have been described with the use of NETDEX.

Usuarios de lentes de contacto

This medication can be used while wearing contact lenses because it does not contain preservatives. However, the use of contact lenses is not recommended during eye infection treatment.

Embarazo y lactancia

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Embarazo

It is preferable not to use this medication during pregnancy unless your doctor considers it necessary.

Lactancia

Do not use this medication during breastfeeding, as this medication is excreted in breast milk in small amounts.

Conducción y uso de máquinas

When using this medication, your vision may become blurry for a short period. If this happens, do not drive or use machines until your vision clears.

NETDEX contiene fosfatos

This medication contains 0.12 mg in each drop, equivalent to 2.34 mg/ml. If you have severe damage to your cornea (the transparent layer at the front of the eye), treatment with phosphates, in rare cases, may cause blurry vision due to calcium accumulation.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose isone dropin the affected eyetwice a dayor as prescribed.

Use in children and adolescents

This medication is contraindicated in children under 3 years old.

This medication is not recommended for use in children or adolescents (3 to 18 years old).

Instructions for use

1. Wash/hand disinfect your hands.
2. Open the aluminum foil package containing the single-use vials.
3. Remove a single-use vial from the strip and put the unopened vials back in the aluminum foil package.

1. Make sure the single-use vial is intact before use.
2. Hold the single-use vial upside down and shake it gently from side to side.

1. Open by turning the top and discard. Do not touch the tip after opening the vial.

1. Press gently until a drop falls into the space between your eyeball and lower eyelid. To avoid contamination, be careful not to touch your eye, eyelid, or any other surface with the tip of the vial.

1. Discard the single-use vial after use.

If you use the gel incorrectly, it may become contaminated with bacteria, which can lead to eye infections. The use of contaminated gel can cause severe eye damage and subsequent loss of vision. Since once opened, the individual single-use vial cannot be maintained sterile, the remaining content should be discarded after administration.

If you use more NETDEX than you should

No cases of overdose have been reported with the use of this medication.

If you use more eye gel than you should, it is unlikely that you will have any problems. Apply thenextdose as usual.

If you accidentally ingest or use the product for extended periods of time at excessive doses, toxic adverse effects may occur.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forgot to use NETDEX

Do not use a double dose to compensate for the missed doses. Apply the next dose as usual.

If you interrupt treatment with NETDEX

Always inform your doctor if you plan to interrupt treatment. If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

If you useNETDEXwith other eye medications

If you are using any other eye medication, you must leave 5 minutes between the use of each medication.

Eye gels should be used last.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The possible adverse effects due to the use of dexamethasone:

1) Increased intraocular pressure;

2) Formation of posterior subcapsular cataract;

3) Development or worsening of a viral eye infection caused by the herpes simplex virus (HSV) or a fungal infection;

4) Delayed wound healing;

5) Redness of the eye (conjunctival hyperemia);

6) Hormonal disorders: Excessive body hair growth (particularly in women), muscle weakness and wasting, purple striae on the body skin, increased blood pressure, irregular or absent menstrual periods, changes in body protein and calcium levels, delayed growth in children and adolescents, and facial and body swelling and weight gain (known as Cushing's syndrome) (see "Warnings and Precautions" section).

The possible adverse effects due to the use of netilmicin:

The most frequent adverse effect of topical netilmicin use is hypersensitivity, such as conjunctival redness, burning, and itching.

The frequency of each listed effect cannot be estimated from the available data.

In very rare cases (up to 1 in 10,000 people), some patients with severe damage to the transparent front layer of the eye (the cornea) have developed cloudy spots in the cornea due to calcium accumulation during treatment.

Unknown frequency (cannot be estimated from available data):

Blurred vision.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after "CAD". The expiration date is the last day of the month indicated on the product when unopened and properly stored.

Store below 25°C. Store in the original packaging.

Keep single-dose containers in the original aluminum bag to protect them from light.

This medication does not contain preservatives. NETDEX should be used immediately after opening; any remaining content should be discarded. Once the aluminum bag is opened, containers should be used within a period of 28 days; after this period, unused containers should be discarded.

Medications should not be thrown away through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medications. By doing so, you will help protect the environment.

Composition of NETDEX

• The active principles are netilmicin and dexamethasone. Each ml of gel contains 3mg of netilmicin (in the form of netilmicin sulfate) and 1mg of dexamethasone (in the form of disodium phosphate of dexamethasone).
• The other components are: sodium citrate, dihydrogen phosphate of sodium monohydrate, hydrogen phosphate of sodium dodecahydrate, xanthan gum, purified water.

Appearance of the product and contents of the packaging

NETDEX is an ophthalmic gel with a homogeneous semi-solid mass that is presented in strips of 5 single-dose containers within an aluminum foil pouch, placed inside a cardboard box.

Each cardboard box contains 10, 15 or 20 single-dose containers.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

SIFIS.p.A.

Via Ercole Patti, 36

95025 Aci Sant’Antonio (CT)

Italy

Local representative:

SIFI IBÉRICA S.L.

C/ Poeta Joan Maragall, 47

4th floor, door 402

28020 Madrid - Spain

Date of the last review of this leaflet:March 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/.