Netenax 3 mg/ml eye drops solution in single-dose container
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Netenax 3 mg/ml eye drops solution in single-dose container
netilmicin
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, ask your doctor or pharmacist.
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This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Netenax is and what it is used for
- What you need to know before using Netenax
- How to use Netenax
- Possible side effects
- How to store Netenax
- Contents of the pack and other information
1. What Netenax is and what it is used for
This medicine contains the active substance netilmicin, an antibiotic belonging to a group called aminoglycosides, which kills bacteria.
Antibiotics are used to treat bacterial infections and are not effective against viral infections. It is important to follow your doctor's instructions regarding dosage, administration interval, and treatment duration. Do not store or reuse this medication. If you have leftover antibiotics after completing treatment, return them to the pharmacy for proper disposal. Medicines must not be disposed of via the sink, toilet, or regular trash. |
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 the 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 aminoglycoside antibiotic (gentamicin, tobramycin, kanamycin, etc.) or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Netenax.
If you use antibiotics for a prolonged period, you may become more susceptible to ocular infections.
Aminoglycoside antibiotics may cause serious ear and kidney problems. If you are taking another antibiotic treatment, even orally, in combination with this medicine, consult your doctor.
This medicine is not for injection. Therefore, it must 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 medicine, stop using it and consult your doctor.
Children and adolescents
The safety and efficacy of this medicine in children or adolescents has not been established.
Other medicines and Netenax
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
This medicine may be used with other ophthalmic medicines, but it is important 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 cephaloridine. The simultaneous use of this medicine with other aminoglycoside antibiotics could increase the risk of kidney problems, ear problems, or could affect the effectiveness of the other antibiotics;
- cisplatin (used in anticancer treatments);
- diuretics (medicines that reduce fluid retention) such as ethacrynic 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 medicine.
Pregnancy
You should use this medicine only if your doctor considers it appropriate.
Breastfeeding
The use of this medicine during breastfeeding is not recommended, as this medicine is excreted in breast milk in small amounts.
Driving and using machines
You may experience temporary blurred vision after using this medicine. Do not drive or operate machinery until your vision is clear again.
3. How to use Netenax
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, please 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 physician.
If you wear contact lenses
Wearing contact lenses is not recommended during treatment of a superficial eye infection.
If you wear contact lenses, use Netenax in single-dose containers, as they contain no preservatives.
Instructions for use
- Wash/clean your hands thoroughly before applying the eye drops.
- Open the aluminum foil pouch containing the single-dose containers.
- Check that the single-dose container is intact.
- Separate the single-dose container from the strip and return the unopened containers to the pouch.
- Open by twisting the tab without pulling it off.
- Do not touch the tip after opening the container.
- Gently squeeze the single-dose container so that a single drop falls into the affected eye(s). Do not touch the eye, eyelids, or any other surface with the dropper tip to avoid contamination.
Keep the affected eye closed and press the tip of your finger against the tear duct of the closed eye, holding it 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 medicine.
If more drops are accidentally instilled than recommended, it is unlikely that you will experience any problems. Take the next dose as appropriate.
In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount taken.
If you forget to use Netenax
Do not use a double dose to make up for forgotten doses.
If you stop using Netenax
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
If you use Netenax with other eye medicines
If you are using any other eye medication, you should wait 5 minutes between using one medicine and another.
Eye ointments should be used last.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Most people treated with this eye drop do not experience any side effects.
The following side effects have been reported with netilmicin. Frequency is unknown (cannot be estimated from the available data):
- eye irritation
- redness of the eyes
- eyelid rash
- eyelid swelling
- eye itching
- allergic reaction
- hives
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Netenax
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottom of each unit, on the aluminum pouch, and on the carton, following the label "CAD". The expiry date refers to the last day of the month indicated for the product, provided it has not been opened and has been properly stored.
Do not store above 25°C.
Keep the single-dose units in their original aluminum pouch to protect them from light.
The eye drops in single-dose units are for single use only. Once the single-dose unit is opened, it must be used immediately, and the container should be discarded after use.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, please consult your pharmacist on how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. Package contents and additional information
Composition of Netenax
- The active substance is netilmicin. Each ml of solution contains 3 mg of netilmicin (as netilmicin sulfate).
- The other components are sodium chloride, sodium hydroxide (for pH adjustment), purified water.
Appearance of the product and contents of the container
Netenax is a clear, colourless or pale yellow solution contained in a single-dose container, which is in turn enclosed in an aluminium pouch inside a cardboard box.
Each box contains 15 or 20 single-dose containers.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
SIFI S.p.A.
Via Ercole Patti 36
95025 Aci Sant'Antonio (CT)
Italy
Local representative:
Faes Farma, S.A.
Autonomia Etorbidea, 10
48940 Leioa (Bizkaia)
Spain
Date of the most recent review of this leaflet: November 2019.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es