NETENAX 3 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the Patient

Netenax 3mg/ml Eye Drops Solution

netilmicin

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Netenax and what is it used for
2. What you need to know before using Netenax
3. How to use Netenax
4. Possible side effects
5. Storage of Netenax
6. Package Contents and Additional Information

1. What is Netenax and what is it used for

This medication contains the active ingredient netilmicin, an antibiotic belonging to a group called aminoglycosides, which kills bacteria.

It is indicated in adults for the topical treatment of external eye infections and surrounding areas caused by bacteria sensitive to netilmicin.

You should consult a doctor if your condition worsens or does not improve.

2. What you need to know before using Netenax

Do not use Netenax:

• if you are allergic to netilmicin, any other aminoglycoside antibiotic (gentamicin, tobramycin, kanamycin, etc.) or to any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Netenax.

If you use antibiotics for an extended period, you may become more susceptible to eye infections.

Aminoglycoside antibiotics can cause severe ear and kidney problems. If you are using another antibiotic treatment, even orally, along with this medication, consult your doctor.

This medication is not injectable. Therefore, it should not be injected into the eye or introduced into the front part (anterior chamber) of the eye.

In all the above cases, or if you experience allergic reactions with this medication, discontinue use and consult your doctor.

Children and Adolescents

The safety and efficacy of this medication have not been established in children or adolescents.

Other Medications and Netenax

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

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

Inform your doctor or pharmacist if you are taking:

• any other antibiotic, particularly polymyxin B, colistin, viomycin, streptomycin, vancomycin, or cefaloridine. The simultaneous use of this medication with other aminoglycoside antibiotics may increase the risk of kidney problems, ear problems, or affect the proper functioning of the other antibiotics;
• cisplatin (used in anticancer treatments);
• diuretics (medicines that reduce fluid retention) such as etacrynic acid and furosemide.

Pregnancy and Breastfeeding

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

Pregnancy

You should use this medication only if your doctor considers it appropriate.

Breastfeeding

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

Driving and Using Machines

You may experience temporary blurred vision after using this medication. Do not drive or use machinery until your vision is clear.

Netenax 3mg/ml Eye Drops Solution in Multidose Container Containsbenzalkonium chloride

This medication contains 0.05 mg of benzalkonium chloride per ml.

Benzalkonium chloride can be absorbed by soft contact lenses, altering their color. Remove contact lenses before using this medication and wait 15 minutes before putting them back on.

Benzalkonium chloride can cause eye irritation, especially if you have dry eye or other corneal diseases (transparent layer in the front of the eye). Consult your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medication.

3. How to Use Netenax

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 1 or 2 drops in the affected eye 3 times a day or as directed by your doctor.

If you wear contact lenses

The use of contact lenses is not recommended during the treatment of a superficial eye infection.

If you wear contact lenses, you should remove them before using Netenax eye drops. After using this medication, wait 15 minutes before putting your contact lenses back on.

Instructions for Use

1. Wash your hands thoroughly.
2. Tighten the cap by turning it downward to puncture the tip of the bottle.

1. Remove the cap, turn the bottle upside down, and press it gently to release one drop into the affected eye(s). Do not touch the eye, eyelids, or any other surface with the tip of the bottle to avoid contamination.

1. Replace the cap on the dropper and tighten it well.

Keep the affected eye closed and press the tip of your finger against the tear duct of the closed eye, and hold for 1 minute. This is important because it reduces the amount of medication that passes into the rest of your body.

If you use more Netenax than you should

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

If you accidentally instill more drops than you should, it is unlikely to cause any problems. Apply the next dose as scheduled.

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

If you forget to useNetenax

Do not apply a double dose to make up for forgotten doses.

If you interrupt treatment with Netenax

If you have any further questions about the use of this medication, ask your doctor, pharmacist, or nurse.

If you useNetenax with other eye medications

If you are using any other eye medication, you should wait 5 minutes between using one medication and the other.

Eye ointments should be used last.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them. Most people treated with this eye drop do not suffer any side effects.

The following side effects have occurred with netilmicin. The frequency is unknown (cannot be estimated from the available data):

• eye irritation
• redness in the eyes
• rash on the eyelid
• swelling of the eyelid
• itching in the eyes
• allergic reaction
• hives

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Netenax

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

Do not use this medication after the expiration date stated on the label and carton after CAD. The expiration date is the last day of the month indicated on the unopened and properly stored product.

You can use this medication for up to 28 days after first opening.

Do not store above 25°C.

Keep the bottle in the outer packaging to protect it from light.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Netenax

• The active ingredient is netilmicin. Each ml of solution contains 3 mg of netilmicin (as netilmicin sulfate).
• The other ingredients are sodium chloride, benzalkonium chloride, sodium hydroxide (for pH adjustment), and purified water.

Appearance of the Product and Package Contents

Netenax is a clear, colorless, or pale yellow solution contained in a 5 ml bottle, which comes in a cardboard box.

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 Package Leaflet:November 2019

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