Prospect: information for the patient

Netenax 3mg/ml eye drop solution

netilmicina

Read this prospect carefully before starting to use this medication, because it contains important information for you.

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

-This medication has been prescribed only to you, and you should not give it to other people, 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 prospect. See section 4.

1.What isNetenaxand what is it used for

2.What you need to know before starting to useNetenax

3.How to useNetenax

4.Possible adverse effects

5.Storage ofNetenax

6.Contents of the package and additional information

This medication contains the active ingredient netilmicina,a type of 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 any of the other components of this medication (listed in section 6).(gentamicin, tobramycin, kanamycin, etc.)

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 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 (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 need 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 (medications that reduce fluid retention) such as etacrynic acid and furosemide.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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 machinery

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

Netenax 3 mg/ml eye drops in multidose container containsbenzalkonium chloride

This medication contains 0.05 mg of benzalkonium chloride in each ml.

Benzalkonium chloride may be absorbed by soft contact lenses, altering their color. Remove contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may 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 experience a strange sensation, burning, or pain in the eye after using this medication.

Follow exactly the administration instructions for this medication as 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 theaffected eye3 times a day or asindicated 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 must remove them before using the Netenax eye drops. After using this medication, wait 15 minutes before putting your contact lenses back in.

Instructions for use

1. Wash your hands thoroughly.
2. Twist the cap downwards with force to pierce the tip of the bottle.

1. Twist the cap back, invert the bottle, and gently press it to allow a single drop to fall into the (the) affected eye(s). Do not touch the eye, eyelids, or any other surface with the tip of the bottle, in order to avoid contamination.

1. Replace the cap on the dropper and screw it tightly.

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

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 everyone experiences 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 the 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 label 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.

You may use this medication up to 28 days after its first opening.

Do not store at a temperature above 25°C.

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

Medications should not be disposed of through drains or in the trash.Deposit 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. In this way, 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, benzalkonium 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 5ml glass bottle that comes in a cardboard box.

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

Date of the last review of this leaflet:November 2019

The 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