NETDEX 3 mg/mL + 1 mg/mL OPHTHALMIC GEL, SINGLE-DOSE CONTAINER

Introduction

Package Leaflet: Information for the User

NETDEX 3 mg/ml + 1 mg/ml eye gel in single-dose container

netilmicin/dexamethasone

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is NETDEX and what is it used for
2. What you need to know before you use NETDEX
3. How to use NETDEX
4. Possible side effects
5. Storage of NETDEX
6. Contents of the pack and other information

1. What is NETDEX and what is it used for

This medicine contains two active substances: netilmicin and dexamethasone.

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

Dexamethasone is a corticosteroid that reduces inflammation and redness.

Antibiotics are used to treat bacterial infections and are not effective against viral infections.

It is important that you follow the instructions regarding dosage, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after finishing treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

This medicine is used in adults to reduce inflammation and eliminate bacteria in the eyes in case of infections or when it is possible that 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.

2. What you need to know before you use NETDEX

Do not use NETDEX

• if you are allergic to netilmicin, dexamethasone, aminoglycoside antibiotics, or any of the other components of this medicine (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 the 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 mycobacteria;
• if you have an eye infection caused by tuberculosis;
• if you have conjunctivitis with inflammation and corneal ulcers (the transparent layer of the front of the eye), even in the early stage;
• in children under 3 years of age;
• if you are breastfeeding.

Warnings and precautions

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

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

It should be used with caution in patients whose cornea (the transparent layer of the front of the eye) may be compromised and in cases where the patient uses other eye medicines that contain phosphates (see section 4).

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

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

Children and adolescents

This medicine is contraindicated in children under 3 years of age.

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

For external use only

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

If you use NETDEX for a long time:

• eye pressure may increase and cause damage to the eye nerves, leading to vision problems. If you use this medicine for prolonged periods, your doctor should check your eye pressure regularly;
• you may develop cataracts;
• wounds may take longer to heal;
• as a result of a reduced immune response, your body may not fight other types of eye infections as well as it should, such as fungal or viral infections;
• eye infections that produce a lot of pus, with the use of corticosteroids, may worsen or it may be more difficult to identify the type of bacteria that cause the infection;
• the use of corticosteroids may cause perforation of the cornea or the white of the eye (the sclera) in diseases that cause thinning of the eye surface;
• you may start to become allergic to the antibiotic contained in the eye drops.

Before using NETDEX, inform your doctor if:

• you have glaucoma or a family history of glaucoma;
• you have corneal problems;
• you are taking other medicines that contain phosphates. Your doctor will monitor your cornea at regular intervals.

Other medicines and NETDEX

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

Before using NETDEX, inform your doctor or pharmacist if you are taking:

• any other antibiotic, in particular polymyxin B, colistin, viomycin, streptomycin, vancomycin, cefaloridine, or other aminoglycosides. The simultaneous use of netilmicin/dexamethasone with other antibiotics may increase the risk of kidney or ear problems, or may affect the proper functioning of the other antibiotics;
• cisplatin (an anticancer medicine);
• diuretics (medicines used to treat fluid retention) such as ethacrynic acid and furosemide;
• anticholinergic medicines (medicines that stop gland secretion), such as atropine;
• ritonavir or cobicistat, as they may increase the amount of dexamethasone in the blood.

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

To date, no drug interactions have been described with the use of NETDEX.

Contact lens users

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

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

Driving and using machines

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

NETDEX contains phosphates

This medicine contains 0.12 mg per drop, which is equivalent to 2.34 mg/ml. If you have severe corneal damage (the transparent layer of the front of the eye), treatment with phosphates, in very rare cases, may cause blurred vision due to calcium accumulation.

3. How to use NETDEX

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

The recommended dose is one dropin the affected eye twice a dayor as prescribed by your doctor.

Use in children and adolescents

This medicine is contraindicated in children under 3 years of age.

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

Instructions for use

1. Wash/disinfect your hands.
2. Open the aluminum pouch containing the single-dose containers.
3. Remove a single-dose container from the strip and put the unopened containers back in the aluminum pouch.

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

1. Open by twisting the top and pull. Do not touch the tip after opening the container.

1. Gently press until one drop falls into the space between your eyeball and your lower eyelid. To avoid contamination, be careful not to let the tip of the container touch your eye, eyelid, or any other surface.

1. Discard the single-dose container after use.

If you use the gel incorrectly, it may become contaminated with bacteria, which can lead to eye infections. Using contaminated gel can cause serious eye damage and subsequent vision loss. Since once the single-dose container is opened, sterility cannot be maintained, the remaining contents should be discarded after administration.

If you use more NETDEX than you should

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

If you use more eye gel than you should, it is unlikely to cause any problems. Apply the next dose as usual.

If you accidentally ingest or use the product for long periods at excessive doses, toxic side effects may occur.

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

If you forget to use NETDEX

Do not use a double dose to make up for forgotten doses. Apply the next dose as usual.

If you stop treatment with NETDEX

Always inform your doctor if you plan to stop treatment. If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

If you use NETDEX with other eye medicines

If you are using another eye medicine, you should leave a 5-minute interval between the use of each medicine.

Eye ointments should be used last.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects due to the use of dexamethasone:

1. increased eye pressure;
2. formation of cataracts (subcapsular posterior);
3. development or worsening of a viral eye infection caused by the herpes simplex virus (HSV) or a fungal infection;
4. delayed healing of wounds;
5. redness of the eye (conjunctival hyperemia);
6. hormonal disorders: excessive body hair growth (particularly in women), weakness and muscle wasting, purple striae on the skin of the body, increased blood pressure, irregular or absent menstrual periods, changes in the levels of proteins and calcium in the body, delayed growth in children and adolescents, and swelling and weight gain of the body and face (called Cushing's syndrome) (see section "Warnings and precautions").

Possible side effects due to the use of netilmicin:

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

The frequency of each effect listed 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 layer of the front of the eye (the cornea) have developed cloudy spots in the cornea due to calcium accumulation during treatment.

Frequency unknown (cannot be estimated from the available data):

Blurred vision.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of NETDEX

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

Do not use this medicine after the expiry date that appears on the packaging after "EXP". The expiry date is the last day of the month indicated on the unopened and properly stored product.

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

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

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

Medicines should not be disposed of via wastewater or household waste. Place the containers and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of NETDEX

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

Appearance of the product and contents of the pack

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

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

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

SIFI S.p.A.

Via Ercole Patti, 36

95025 Aci Sant’Antonio (CT)

Italy

Local representative:

SIFI IBÉRICA S.L.

C/ Poeta Joan Maragall, 47

Planta 4, Puerta 402

28020 Madrid - Spain

Date of the last revision of this leaflet:March 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.