Netenax

Package leaflet: Information for the patient

Netenax, 3 mg/ml, eye drops, solution
netylmycine
Please read the entire leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm someone else, even if their symptoms are the same.
• If any side effects occur, including side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Netenax is and what it is 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 Netenax is and what it is used for

Netenax contains the active substance called netylmycine, which is an antibiotic that kills bacteria.
This medicine is indicated in adults for the local treatment of external eye and surrounding area infections caused by bacteria sensitive to netylmycine.
If there is no improvement or if the patient feels worse, consult a doctor.

2. Information before using Netenax

When not to use Netenax:

• if the patient is allergic to netilmicin, any other aminoglycoside antibiotic (such as 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, consult your doctor or pharmacist.
With prolonged use of antibiotics, the patient may become more susceptible to eye infections.
Aminoglycoside antibiotics may cause serious hearing and kidney problems. If the patient is using other antibiotics, including oral antibiotics, concurrently with Netenax, medical advice should be sought.
Netenax is not intended for injections and must not be injected into the eye or introduced into the anterior chamber of the eye.
In all the above cases, or if an allergic reaction occurs during treatment with this medicine, treatment must be discontinued and medical advice sought.
Children and adolescents
The safety and efficacy of Netenax in children and adolescents have not been established.
Netenax and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use.
Netenax may be used concurrently with other ophthalmic medicines, but instructions in section 3 must be followed.
Inform your doctor or pharmacist if the patient is taking:

• another antibiotic, particularly polymyxin B, colistin, viomycin, streptomycin, vancomycin, or cefaloridine. Concurrent use of 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 in cancer treatment);
• diuretics (medicines that counteract fluid retention in the body), such as ethacrynic acid and furosemide.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Pregnancy
This medicine should be used only if considered appropriate by the doctor.
Breastfeeding
Use of Netenax is not recommended during breastfeeding, as the medicine passes into human milk in small amounts.
Driving and operating machinery
Blurred vision may occur transiently after using Netenax. Do not drive or operate machinery until vision clears.
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 may alter their color. Contact lenses must be removed before instilling the drops and at least 15 minutes should be waited before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially in individuals with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations in the eye, stinging, or eye pain occur after using the medicine, contact a doctor.

3. How to use Netenax

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose is one or two drops administered into the affected eye three times daily, or as
directed by a doctor.
Contact lenses
Wearing contact lenses is not recommended during topical treatment of eye infection.
If the patient wears contact lenses, they should be removed before using Netenax eye drops. After applying this medicine, wait 15 minutes before reinserting the lenses.
Instructions for use

1. Wash/clean hands thoroughly.
2. Firmly screw on the cap to pierce the tip of the bottle.

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

4. Replace and tighten the cap on the dropper bottle.

Without opening the affected eye, press with a finger on the inner corner of the eye and hold for one
minute. This is important because it reduces the amount of medicine that enters the body.

Use of more than the recommended dose of Netenax
Cases of overdose with Netenax have not been reported.
If an excessive amount of the medicine is accidentally administered, problems are unlikely to occur. The next dose should be used as usual.
Missed dose of Netenax
Do not use a double dose to make up for a missed dose.
Stopping treatment with Netenax
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.
Using Netenax with other ophthalmic medicines
If more than one ophthalmic medicinal product is being used, wait at least 5 minutes before administering the next medicine.
Eye ointments should be used last.

4. Possible adverse reactions

Like any medicine, this product may cause adverse reactions, although not everyone experiences them.
Most people using these eye drops do not experience any adverse reactions.
The following adverse reactions have been observed during the use of Netenax:

Frequency unknown (frequency cannot be determined from available data):

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

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide further information on the safety of this medicine.

5. How to store the medicine 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 on the carton following:
EXP. The expiry date refers to the last day of the stated month for an unopened product stored
under the recommended conditions.
Shelf-life after first opening the bottle: 28 days
Do not store above 25°C.
Store the bottle in the outer packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package 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 (solution), sodium hydroxide (for pH adjustment), purified water.

What Netenax looks like and contents of the pack
Netenax is a clear, colourless or slightly yellow solution in an LDPE bottle with a screw cap, containing 5 ml of eye drops, packed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
SIFI S.p.A.
Via Ercole Patti 36
95025 Aci S. Antonio (CT)
Italy
[email protected]
This medicinal product is authorised in the European Economic Area member states under the following names:
Bulgaria, Germany, Latvia, Lithuania: Nettacin
Cyprus, Greece, Poland, Portugal, Slovakia, Spain: Netenax
Czech Republic, France: Anetena