Netenax

Package Leaflet: Information for the Patient

Netenax, 3 mg/ml, Eye Drops, Solution

Netilmicin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Netenax and what is it used for
• 2. Important information before using Netenax
• 3. How to use Netenax
• 4. Possible side effects
• 5. How to store Netenax
• 6. Contents of the pack and other information

1. What is Netenax and what is it used for

Netenax contains the active substance netilmicin, an antibiotic that kills bacteria.
This medicine is indicated in adults for the local treatment of external eye and adnexa infections caused by bacteria susceptible to netilmicin.
If there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before using Netenax

When not to use Netenax:

• if the patient is allergic to netilmicin, any other aminoglycoside antibiotic (gentamicin, tobramycin, kanamycin, etc.) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Netenax, the patient should discuss it with their doctor or pharmacist.
Prolonged use of antibiotics may make the patient more prone to eye infections.
Aminoglycoside antibiotics can cause serious hearing and kidney problems. If the patient is using other antibiotics, including oral antibiotics, at the same time as Netenax, they should consult their doctor.
Netenax is not intended for injection and should not be injected into the eye or introduced into the anterior chamber of the eye.
In all of the above cases or in the event of an allergic reaction during use of this medicine, the patient should stop using it and consult a doctor.

Children and adolescents

The safety and efficacy of Netenax in children and adolescents have not been established.

Netenax and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Netenax can be used at the same time as other eye medicines, but the patient should follow the instructions in section 3.
The patient should tell their doctor or pharmacist if they are taking:

• another antibiotic, in particular polymyxin B, colistin, viomycin, streptomycin, vancomycin, or cephaloridine. Using Netenax with other aminoglycoside antibiotics may increase the risk of kidney or hearing problems or may affect the efficacy of other antibiotics;
• cisplatin (a medicine used to treat cancer);
• diuretics (medicines that help remove excess water from the body) such as ethacrynic acid and furosemide.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should ask their doctor for advice before using this medicine.
Pregnancy
The medicine should only be used if the doctor considers it necessary.
Breastfeeding
Using Netenax is not recommended during breastfeeding, as the medicine passes into human milk in small amounts.

Driving and using machines

After using Netenax, temporary blurred vision may occur. The patient should not drive or use machines until their vision is clear again.

Netenax 3 mg/ml eye drops, solution contains benzalkonium chloride

This medicine contains 0.05 mg of benzalkonium chloride per ml.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. The patient should remove their contact lenses before using the drops and wait at least 15 minutes before putting them back in.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If the patient experiences any abnormal sensations in the eye, stinging, or eye pain after using the medicine, they should contact their doctor.

3. How to use Netenax

This medicine should always be used exactly as the doctor or pharmacist has told the patient. If the patient is not sure, they should ask their doctor or pharmacist.
The recommended dose is one or two drops into the affected eye, three times a day, or as directed by the doctor.

Contact lenses

During superficial treatment of eye infections, it is not recommended to wear contact lenses.
If the patient wears contact lenses, they should remove them before using Netenax eye drops. After using the drops, they should wait 15 minutes before putting their lenses back in.

Instructions for use

• 1) Wash your hands thoroughly.
• 2) Tighten the cap to break the seal on the bottle tip.

• 3) Remove the cap, turn the bottle upside down, and gently squeeze to release one drop into the affected eye. Do not touch the bottle tip to the eye, eyelid, or any other surface to avoid contamination.

• 4) Put the cap back on the bottle.

Without opening the affected eye, press the inner corner of the eye with your finger and hold for one minute. This is important, as it reduces the amount of medicine that gets into the body.

Using more Netenax than recommended

No cases of overdose with Netenax have been reported.
If more medicine than recommended is accidentally used, problems are unlikely to occur. The next dose should be used as usual.

Missing a dose of Netenax

The patient should not use a double dose to make up for a missed dose.

Stopping treatment with Netenax

If the patient has any further questions on the use of this product, they should ask their doctor, pharmacist, or nurse.

Using Netenax with other eye medicines

If more than one eye medicine is being used, the patient should wait at least 5 minutes before using the next one.
Eye ointments should be used last.

4. Possible side effects

Like all medicines, Netenax can cause side effects, although not everybody gets them. Most people using these eye drops do not experience any side effects.
The following side effects have been observed during treatment with Netenax. Frequency not known (cannot be estimated from the available data):

• eye irritation
• eye redness
• eyelid rash
• eyelid swelling
• eye itching
• allergic reaction
• hives

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, the patient can help provide more information on the safety of this medicine.

5. How to store Netenax

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of the month.
Shelf life after first opening the bottle: 28 days
Do not store above 25°C.
Keep the bottle in the outer carton to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Netenax contains

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

What Netenax looks like and contents of the pack

Netenax is a clear, colorless or pale yellow solution in a LDPE bottle with a screw cap, containing 5 ml of eye drops, in a cardboard box.

Marketing authorization holder and manufacturer

SIFI S.p.A.
Via Ercole Patti 36
95025 Aci S. Antonio (CT)
Italy
[email protected]

This medicine is authorized in the Member States of the European Economic Area under the following names:

Bulgaria, Germany, Latvia, Lithuania: Nettacin
Cyprus, Greece, Poland, Portugal, Slovakia, Spain: Netenax
Czech Republic, France: Anetena

Date of last revision of the leaflet: