Package Insert: Information for the Patient

Netenax 3mg/ml Eye Drop Solution in Single-Dose Container

netilmicina

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 is Netenax and how is it used

2.What you need to know before starting to use Netenax

3.How to use Netenax

4.Possible adverse effects

5.Storage of Netenax

6.Contents of the container and additional information

This medication contains the active ingredient netilmicina, an antibiotic that belongs to a group called aminoglucosides and kills bacteria.

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

You should consult a doctor if you worsen or do not improve.

Do not use Netenax:

-if you are allergic to netilmicin, any 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 a prolonged period, you may become more susceptible to eye infections.

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

This medication is not injectable. Therefore, do not inject it into the eye or introduce it into the anterior (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 taken recently or may have to take any other medication.

This medication may 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 may 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, or if you think you may be pregnant or plan to become pregnant, consult your doctor before using this medication.

Pregnancy

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

Breastfeeding

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

Driving and operating machines

You may experience temporary blurred vision after using this medication. Do not drive or operate machinery until your vision returns to normal.

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

The recommended dose is 1 or 2 drops in the affected eye 3 times a day or according to your doctor's instructions.

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, useNetenaxin single-dose packaging since it does not contain preservatives.

Instructions for use

1. Wash your hands thoroughly before applying the eye drops.
2. Open the aluminum foil package that contains the single-dose packaging.
3. Make sure the single-dose packaging is intact.

1. Separate the single-dose packaging from the strip and put the unopened packaging back in the package.

1. Open it by turning the tab without tearing it.
2. Do not touch the tip after opening the packaging.

1. Press the single-dose packaging lightly so that a single drop falls into the affected eye(s). Do not touch the eye, eyelids, or any other surface with the tip of the bottle to avoid contamination.

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 to the rest of your body.

If you use more Netenax than you should

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

If you accidentally instill more drops than you should, it is unlikely that you will have any problems. Apply the next dose as needed.

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 useNetenax

Do not apply a double dose to compensate for the missed doses.

If you interrupt treatment with Netenax

If you have any other 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 the use of one medication and the other.

Eye creams should be used last.

Like all medications, this medication may produce adverse effects, although not all people experience them. Most people treated with this eye drop do not suffer any side effects.

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

• Eye irritation
• Redness in the eyes
• Blistering on the eyelid
• Swelling on the eyelid
• Itching in the eyes
• Allergic reaction
• Urticaria

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about 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 bottom of each unit, on the aluminum pouch, and on the box after CAD. The expiration date is the last day of the month indicated on the product when unopened and properly stored.

Do not store at a temperature above 25°C.

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

The eye drops in single-dose containers are for single use only. Once the single-dose container is opened, it must be used immediately and discarded after use.

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

Composition of Netenax

• The active ingredient is netilmicin. Each milliliter of solution contains 3mg of netilmicin (in the form of netilmicin sulfate).
• The other components are sodium chloride, sodium hydroxide (for pH adjustment), purified water.

Appearance of the product and contents of the packaging

Netenax is a transparent, colorless, or pale yellow solution contained in a single-dose vial that is in turn contained in an aluminum bag, which is inside a cardboard box.

Each box contains 15 or 20 single-dose vials.

Only some sizes of vials may be commercially available.

Holder of the marketing authorization and responsible 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

4th Floor, Door 402

28020 Madrid - Spain

Last review date of this prospectus:November 2019.

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