Netaxen

Package Leaflet: Information for the Patient

Netaxen, 3 mg/mL + 1 mg/mL, Eye Drops, Solution in Single-Dose Container

netilmicin + dexamethasone

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

• Keep this package 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, please tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

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

1. What is Netaxen and what is it used for

Netaxen contains two active substances: netilmicin and dexamethasone.

• Netilmicin is an antibiotic that kills bacteria.
• Dexamethasone is a corticosteroid that reduces inflammation.

Netaxen is used in adults to reduce inflammation and kill bacteria in the eye, where there is swelling and irritation, and where a bacterial infection is likely to occur.
If there is no improvement after finishing the treatment or if you feel worse, you should contact your doctor.

2. Important information before using Netaxen

Netaxen can be used in adults, including the elderly.
The medicine is not recommended for use in children under 18 years of age.

When not to use Netaxen:

• if you are allergic to netilmicin, dexamethasone, aminoglycoside antibiotics (such as tobramycin, kanamycin, amikacin, gentamicin, etc.) or any of the other ingredients of this medicine (listed in section 6).
• if your doctor has told you that the pressure in your eye is too high.
• if you think you may have a viral or fungal infection in or around your eye.
• if you have had a viral infection of the eye caused by the herpes simplex virus.
• if your doctor has told you that you have an eye infection caused by tuberculosis.

Warnings and precautions

Before starting treatment with Netaxen, discuss it with your doctor or pharmacist.
You should talk to your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first symptoms of a condition called Cushing's syndrome. After stopping long-term or intensive treatment with Netaxen, there may be a decrease in adrenal function. Before stopping treatment, you should discuss it with your doctor. These risks are particularly important in children and patients treated with ritonavir or cobicistat.
If you experience blurred vision or other vision disturbances, you should contact your doctor.

If you use Netaxen for a long time:

• the pressure in your eye may increase and cause damage to the nerves in your eye, leading to vision problems. If you use Netaxen for more than 15 days, your doctor should regularly check the pressure in your eye;
• you may develop cataracts;
• wounds may heal more slowly;
• your body may not fight other types of eye infections (e.g. fungal or viral) as effectively as usual;
• eye infections with significant discharge may worsen or be more difficult to identify after using corticosteroids;
• the steroid in Netaxen may cause thinning of the surface of your eye, even perforation;
• you may become allergic to the antibiotic in the eye drops.

Before using Netaxen, tell your doctor if:

• you have glaucoma or a family history of glaucoma;
• you have problems with your cornea;
• you are taking any other medicines that contain phosphates. Your doctor will regularly check your cornea.

Children and adolescents

Netaxen is not recommended for use in children and adolescents (from birth to 18 years of age).
For external use only.
Netaxen should only be used on the surface of the eye. This medicine should never be injected or swallowed.

Netaxen and other medicines

Netaxen may interact with other medicines. You should tell your doctor or pharmacist if you are taking or have recently taken any other eye products or other medicines, including those obtained without a prescription. Netaxen can be used with other eye products provided the instructions described in section 3 are followed.
You should tell your doctor or pharmacist if you are taking:

• other antibiotics, especially polymyxin B, colistin, viomycin, streptomycin, vancomycin, or cefaloridine; Using Netaxen with other antibiotics may increase the risk of kidney, hearing, or other problems;

cisplatin (a medicine used to treat cancer);

• diuretics (medicines that help remove excess water from the body) such as ethacrynic acid and furosemide;
• anticholinergic medicines (medicines that reduce secretions) such as atropine;
• ritonavir or cobicistat, as this may increase the amount of dexamethasone in your blood;
• other medicines that contain phosphates. Your doctor will regularly check your cornea.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Use during pregnancy
Use of Netaxen is not recommended during pregnancy unless your doctor considers it necessary.
Use during breastfeeding
Netaxen should not be used during breastfeeding.

Driving and using machines

After using Netaxen, you may experience temporary blurred vision. Do not drive or use machines until your vision is clear.

Netaxen contains phosphates.

This medicine contains 0.18 mg of phosphates in each drop, which corresponds to 3.66 mg/mL. If you have severe damage to the clear front layer of your eye (cornea), phosphates may, in very rare cases, cause clouding of the cornea due to calcium deposits during treatment.

3. How to use Netaxen

This medicine should always be used exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
The recommended dose is one dropinto the affected eye four times a dayor as directed by your doctor. The duration of treatment is usually between 5 and 14 days.
Do not change the dose of the eye drops without consulting your doctor.

Use in children and adolescents

Netaxen is not recommended for use in children and adolescents (from birth to 18 years of age).

Contact lenses

Netaxen in single-dose containers can be used while wearing contact lenses, as it does not contain preservatives. However, during eye infections or inflammatory conditions, it is strongly advised not to wear contact lenses. Contact lenses should not be worn during treatment with corticosteroid eye drops due to the increased risk of infection.

Using Netaxen with other eye drops

Wait at least 10 minutes between using Netaxen and other eye drops or ointments. Eye ointments should be used last.

Instructions for use

Check that the single-dose container is not damaged.

• 1. Wash your hands and sit comfortably or take another comfortable position.
• 2. Open the aluminum sachet containing the single-dose containers.
• 3. Tear off one single-dose container from the strip (fig. 1) and put the unopened containers back into the sachet.
• 4. Open by twisting the top, without pulling (fig. 2). Do not touch the tip of the container after opening.
• 5. Tilt your head back.
• 6. Using your finger, gently pull down the lower eyelid of the affected eye.
• 7. Invert the single-dose container and place the tip close to the eye, without touching the eye. Do not touch the eye or eyelid with the tip of the container (fig. 3).
• 8. Squeeze the single-dose container, releasing only one drop, then release the lower eyelid.
• 9. Close your eye and press the corner of your eye near your nose for 2 minutes.
• 10. Repeat in the other eye as directed by your doctor.
• 11. After use, discard the single-dose container.

Improperly used eye drops can become contaminated with bacteria, which can lead to eye infections. Using contaminated eye drops can cause serious eye damage and vision loss.

Using more Netaxen than recommended

If you accidentally put more drops in your eye than recommended, it is unlikely to cause problems.
Use the next dose at the usual time.

Missing a dose of Netaxen

Do not use a double dose to make up for a forgotten dose.
Use the next dose at the usual time.

Stopping treatment with Netaxen

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Netaxen can cause side effects, although not everybody gets them.
The frequency of the following side effects cannot be estimated from the available data.
Eye disorders
Increased pressure in the eye, cataract formation after long-term treatment, blurred vision, occurrence or worsening of viral eye infections caused by the herpes simplex virus or fungal infections, delayed wound healing.
In very rare cases (less than 1 in 10,000) in some patients with severe damage to the clear front layer of the eye (cornea), cloudy spots appeared on the cornea due to calcium deposits during treatment.
Immune system disorders
Local allergic reactions: conjunctival redness, burning, itching.
Endocrine disorders
Excessive hair growth on the body (especially in women), weakness and muscle wasting, purple streaks on the skin, high blood pressure, irregular menstrual periods or absence of menstruation, changes in protein and calcium levels in the body, growth retardation in children and adolescents, and swelling and weight gain around the trunk and face (Cushing's syndrome) (see section 2, "Warnings and precautions").
In all the above cases, treatment should be discontinued.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-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, you can help provide more information on the safety of this medicine.

5. How to store Netaxen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, sachet, and container after: EXP. The expiry date refers to the last day of that month.
Store below 30°C.
Single-dose containers should be stored in the sachet to protect from light and moisture.
This medicine does not contain preservatives.
After opening the single-dose container, use the medicine immediately and discard the container with any remaining contents.
Medicines should 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 pack and other information

What Netaxen contains

• The active substances are dexamethasone 1 mg/mL (as dexamethasone sodium phosphate) and netilmicin 3 mg/mL (as netilmicin sulfate). Each single-dose container contains 0.9 mg of netilmicin and 0.3 mg of dexamethasone.
• The other ingredients are: sodium citrate, sodium dihydrogen phosphate monohydrate, disodium phosphate dodecahydrate, purified water.

What Netaxen looks like and contents of the pack

Netaxen is a clear, colorless or slightly yellow solution.
Netaxen eye drops in single-dose container:
Five single-dose containers containing 0.3 mL of Netaxen eye drops, solution in an aluminum sachet in a cardboard box.
Each pack contains 15 or 20 single-dose containers.
Not all pack sizes may be marketed.

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: Netildex
Greece, Spain: NETDEX
Cyprus, Czech Republic, Lithuania, Slovakia: Netaxan
Portugal: Dexametasona + Netilmicina SIFI
France: NETAXEN
Poland: Netaxen

Date of last revision of the package leaflet:

Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products - www.urpl.gov.pl.