Netaxen

Patient Information Leaflet

Netaxen, 3 mg/mL + 1 mg/mL, eye drops, solution in single-dose container
netilmicin + dexamethasone
Please read all of this leaflet carefully before using this medicine, because it
contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Netaxen is and what it is used for
2. What you need to know 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 Netaxen is and what it is used for

Netaxen contains two active substances: netilmicin and dexamethasone.

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

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

2. Important information before using Netaxen

Netaxen may be used in adults, including elderly patients.
Netaxen is not recommended for use in individuals under 18 years of age.
When not to use Netaxen:

• if the patient is 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 the doctor has informed the patient that intraocular pressure is too high;
• if the patient suspects a viral or fungal infection of the eye or around the eye;
• if the patient currently has or has previously had a viral eye infection caused by herpes simplex virus;
• if the doctor has informed the patient of an eye infection caused by mycobacteria.

Warnings and precautions
Before starting treatment with Netaxen, discuss it with a doctor or pharmacist.
The patient should speak with a doctor if swelling and weight gain around the trunk and face occur, as these are usually the first signs of a condition called Cushing's syndrome. After discontinuation of prolonged or intensive treatment with Netaxen, adrenal suppression may occur. The patient should consult a doctor before stopping the medication on their own. These risks are particularly significant in children and patients treated with ritonavir or cobicistat.
If blurred vision or other visual disturbances occur, the patient should contact a doctor.
If the patient uses Netaxen for a prolonged period:

• intraocular pressure may increase, leading to damage of the optic nerves and subsequent vision problems. If the patient uses Netaxen for longer than 15 days, the doctor should regularly monitor intraocular pressure;
• cataract may develop;
• wounds may heal more slowly;
• the body may become less effective at fighting other types of eye infections, such as fungal or viral infections;
• eye infections accompanied by significant pus discharge may worsen after corticosteroid use, or it may become more difficult to identify the type of bacteria causing the infection;
• the steroid contained in Netaxen may cause thinning of the eye surface, and even perforation;
• the patient may develop allergy to the antibiotic in the eye drops.

Before starting treatment with Netaxen, tell the doctor if:

• the patient has glaucoma or a family history of glaucoma;
• the patient has corneal problems;
• the patient is taking any other medications containing phosphates. The doctor will want to regularly examine the patient's 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 be applied only to the surface of the eye. This medicine must never be injected or swallowed.
Netaxen with other medicines
Netaxen may interact with other medicines. The patient should inform the doctor or pharmacist if they are taking or have recently taken any other ophthalmic products or other medicines, including those obtained without a prescription. Netaxen may be used with other ophthalmic products provided the instructions described in section 3 are followed.
The patient should inform the doctor or pharmacist if they are taking:

• other antibiotics, particularly polymyxin B, colistin, viomycin, streptomycin, vancomycin, or cephaloridine; simultaneous use of Netaxen with other 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;
• anticholinergic medicines (medicines that inhibit glandular secretions), such as atropine;
• ritonavir or cobicistat, as these may increase blood levels of dexamethasone;
• other medicines containing phosphates. The doctor will regularly examine the patient's cornea.

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 a doctor or pharmacist before using this medicine.
Use during pregnancy
Use of Netaxen is not recommended during pregnancy unless considered necessary by a doctor.
Use during breastfeeding
Netaxen should not be used during breastfeeding.
Driving and operating machinery
Blurred vision may occur transiently after using Netaxen. The patient should not drive or operate machinery until vision has returned to normal.
Netaxen contains phosphates.
This medicine contains 0.18 mg of phosphates per drop, equivalent to 3.66 mg/mL. In patients with severe damage to the transparent front layer of the eye (cornea), phosphates may, very rarely, cause corneal clouding due to calcium deposition during treatment.

3. How to use Netaxen

This medicine should always be used as directed by a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist.
The recommended dose is one drop into the affected eye four times daily, or as
directed by a physician. The duration of treatment usually lasts from 5 to 14 days.
Do not change the dose of eye drops without consulting a 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 may be used while wearing contact lenses, as it does
not contain preservatives. However, wearing contact lenses is strongly discouraged
during eye infection or inflammatory conditions. Contact lenses should not be worn
during treatment with ophthalmic steroid drops due to increased risk of infection.

Using Netaxen with other eye drops
At least 10 minutes should be waited between the application of Netaxen and other
eye drops or ointments. Ophthalmic ointments should be applied last.

Instructions for use
Check that the single-dose container is intact.

1. Wash your hands and sit comfortably or assume another comfortable position.
2. Open the aluminum sachet containing the single-dose containers.
3. Detach one single-dose container from the strip (Fig. 1) and return unused containers to the sachet.
4. Open by twisting the top part—do not pull (Fig. 2). Do not touch the tip of the container after opening.
5. Tilt your head backward.
6. Using a finger, gently pull down the lower eyelid of the affected eye.
7. Invert the single-dose container and bring the tip close to the eye, but do not touch the eye. Do not touch the eye or eyelid with the tip of the container (Fig. 3).
8. Squeeze the single-dose container gently to release only one drop, then release the lower eyelid.
9. Close the eye and press with a finger at the inner corner near the nose on the side of the affected eye. Hold for 2 minutes.
10. Repeat in the other eye as directed by the doctor.
11. After use, discard the single-dose container.

Improperly used eye drops may become contaminated with bacteria, which could lead to
eye infections. Using contaminated eye drops may result in serious eye damage and
subsequent vision loss.

Use of a higher than recommended dose of Netaxen
If more drops than recommended are instilled, occurrence of problems is unlikely.
The next dose should be administered as usual.

Missed dose of Netaxen
Do not use a double dose to make up for a missed dose.
The next dose should be administered as usual.

Stopping treatment with Netaxen
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will
experience them.
The frequency of occurrence of individual adverse effects listed below cannot be
determined from the available data.
Eye disorders
Increased intraocular pressure, development of cataract after prolonged treatment, blurred
vision, occurrence or worsening of viral eye infection caused by herpes simplex virus or
fungal infection, delayed healing of wounds.
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 have appeared on the cornea due to calcium
deposits during treatment.
Immune system disorders
Local allergic reactions: redness of the conjunctiva, burning, itching.
Endocrine disorders
Excessive body hair growth (especially in women), muscle weakness and atrophy, purple
striae on the skin, elevated blood pressure, irregular or absent menstruation, changes in
protein and calcium levels in the body, growth suppression in children and adolescents,
and swelling with weight gain and facial fullness (Cushing's syndrome) (see section 2,
"Warnings and precautions").
In all the above cases, discontinuation of treatment is recommended.
Reporting of adverse effects
If any adverse symptoms occur, including any adverse symptoms not listed in this
leaflet, inform your doctor or pharmacist. Adverse effects 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,
PL-02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website:
https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
By reporting adverse effects, additional information on the safety of the medicine can be
collected.

5. How to store Netaxen

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, sachet, and container after: EXP. The expiry date refers to the last day of the stated month.
Store below 30°C.
Store single-dose containers in the sachet to protect from light and moisture.
This medicine does not contain preservatives.
After opening the single-dose container, the medicine should be used immediately, and the container must be discarded together with any remaining content.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package 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 netilmicin and 0.3 mg dexamethasone.
• Other components: sodium citrate, monosodium dihydrogen phosphate monohydrate, disodium phosphate dodecahydrate, purified water.

What Netaxen looks like and contents of the pack
Netaxen is a clear, colourless or slightly yellow solution.
Netaxen eye drops in single-dose containers:
Five single-dose containers containing 0.3 mL of Netaxen eye drops, solution, in an aluminium sachet within a cardboard box.
Each pack contains 15 or 20 single-dose containers.
Not all pack sizes may be marketed.
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 countries under the following names:
Bulgaria, Germany, Latvia: Netildex
Greece, Spain: NETDEX
Cyprus, Czech Republic, Lithuania, Slovakia: Netaxan
Portugal: Dexamethasona + Netilmicina SIFI
France: NETAXEN
Poland: Netaxen
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.