Patient Information Leaflet

NETDEX 3mg/ml + 1mg/ml eye drops in single-dose solution

netilmicina/dexametasona

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is NETDEX and what it is used for

2. What you need to know before using NETDEX

3. How to use NETDEX

4. Possible side effects

5. Storage of NETDEX

6. Contents of the pack and additional information

NETDEX contains two medications: netilmicina and dexametasona.

• Netilmicina is an antibiotic that eliminates bacteria.
• Dexametasona is a corticosteroid that reduces inflammation.

NETDEX is used in adults to reduce inflammation and eliminate bacteria in swollen, irritated eyes that are at risk of being infected by bacteria.

You should consult a doctor if your condition worsens or does not improve by the end of treatment.

Netilmicina/dexametasona can be used in adults, including the elderly.

It is not recommended for people under 18 years of age.

Do not useNETDEX:

• If you are allergic to netilmicina, dexametasona, known antibiotics such as aminoglucósidos (such as: tobramicina, kanamicina, amikacina, gentamicina, etc.) or any of the other components of this medication (listed in section 6).
• If your doctor has told you that your eye pressure is too high.
• If you think you may have a viral or fungal infection in the eye or around the eye.
• If you have now, or have had in the past, a viral eye infection caused by the herpes simplex virus (VHS).
• If your doctor has warned you that you have an eye infection caused by bacteria known as mycobacteria.

Warnings and precautions

Consult your doctor or pharmacist before starting to use NETDEX.

Consult your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. Suppression of adrenal gland function may occur after interrupting intensive or long-term treatment with netilmicina/dexametasona. Consult your doctor before stopping treatment on your own. These risks are especially important in children and patients treated with a medication called ritonavir or cobicistat.

Contact your doctor if you experience blurry vision or other visual disturbances.

If you useNETDEXfor a prolonged period

• Your eye pressure may increase and cause damage to the eye nerves, leading to vision problems. If you use netilmicina/dexametasona for more than 15 days, your doctor should regularly check your eye pressure;
• You may develop cataracts;
• Wounds may take longer to heal;
• Your body may not defend against other types of eye infections as well as it normally would, such as fungal or viral infections;
• Eye infections that produce a lot of pus, with the use of corticosteroids, may worsen or it may be more difficult to identify the type of bacteria causing the infection;
• The corticosteroid in netilmicina/dexametasona may cause the surfaces of the eye to narrow and even perforate;
• You may start to be allergic to the antibiotic in the eye drops.

Inform your doctor before using NETDEX if

• You have glaucoma or a family history of glaucoma;
• You have corneal problems;
• You are taking other medications that contain phosphates. Your doctor will monitor your cornea at regular intervals.

Children and adolescents

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

For external use only

Use NETDEX only on the surface of the eye. This medication should not be injected or swallowed.

Use of NETDEX with other medications

NETDEX may interact with other medications. Inform your doctor or pharmacist if you are using, have used recently, or may need to use any eye drops or any other medication, including those obtained without a prescription. You can use netilmicina/dexametasona with other eye drops, but follow the instructions in section 3.

Especially, inform your doctor or pharmacist if you are taking:

• Any other antibiotic, particularly polimixina B, colistina, viomicina, estreptomicina, vancomicina, or cefaloridina. The simultaneous use of netilmicina/dexametasona with other antibiotics may increase the risk of kidney problems, ear problems, or may affect the proper functioning of the other antibiotics;
• Cisplatino (a chemotherapy medication);
• Diuretics (medications that reduce fluid retention) such as ácido etacrínico and furosemida;
• Anticholinergic medications (medications that stop gland secretion), such as atropina;
• Ritonavir or cobicistat, as these may increase the amount of dexametasona in the blood;
• Other medications that contain phosphates. Your doctor will monitor your cornea at regular intervals.

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Use during pregnancy

It is preferable not to use NETDEX during pregnancy unless your doctor considers it necessary.

Use during lactation

NETDEX should not be used if you are breastfeeding.

Driving and operating machinery

When using NETDEX, your vision may become blurry for a short period of time. If this happens, do not drive or operate machinery until your vision clears up.

NETDEX contains phosphates

This medication contains 0.18mg of phosphates in each drop equivalent to 3.66mg/ml. If you suffer from severe damage to the cornea (the transparent layer at the front of the eye), the treatment with phosphates, in rare cases, may cause blurry vision due to calcium accumulation.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose isone dropin the affected eyefour times a dayor as prescribed. The normal duration of treatment may vary from 5 to 14 days.

Do not change the dose of the eye drops without consulting your doctor.

Use in children and adolescents

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

Users of contact lenses

NETDEX in single-dose containers can be used while wearing contact lenses because it does not contain preservatives. Nevertheless, it is strongly recommended to avoid wearing contact lenses during an eye infection or inflammation. Contact lenses should not be used during treatment with corticosteroid eye drops, due to the increased risk of infection.

Using NETDEX with other eye drops

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

Usage instructions

Ensure that the single-dose container is intact.

1. Wash your hands and sit or position yourself comfortably.
2. Open the aluminum foil package containing the single-dose containers.
3. Remove a single-dose container from the strip (Drawing 1) and return the unopened containers to the package.
4. Open by turning the top without pulling (Drawing 2). Do not touch the tip after opening the container.
5. Incline your head backward.
6. With your finger, gently pull down the lower eyelid of the affected eye.
7. Invert the single-dose container and place the tip of the container near the eye, but do not touch it. Do not touch the eye or eyelid with the tip of the container (Drawing 3).
8. Press the single-dose container to administer only one drop, and then release the lower eyelid.
9. Close your eye and press with a finger on the corner of the affected eye, next to the nose. Hold for 2 minutes.
10. Repeat in the other eye if your doctor has instructed you to.
11. Dispose of the single-dose container after use.

If you use the eye drops incorrectly, they may become contaminated with bacteria, which can lead to eye infections. The use of contaminated eye drops can cause severe eye damage and subsequent vision loss.

Using more NETDEX than you should

If you use too much eye drop, it is unlikely that you will have problems.

Apply the next dose as usual.

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 use NETDEX

Do not use a double dose to compensate for the missed doses.

Apply the next dose as usual.

Interrupting treatment with NETDEX

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The frequency of the effect in each person cannot be estimated from the available data.

Ocular Disorders

Increased intraocular pressure, cataract formation after prolonged treatment, blurred vision, development or worsening of a viral eye infection caused by the herpes simplex virus (HSV) or a fungal infection, delayed wound healing.

In very rare cases (less than 1 in 10,000 people), some patients with severe damage to the transparent layer in front of the eye (the cornea) have developed opaque spots in the cornea due to calcium accumulation during treatment.

Immunological System Disorders

Local allergic reaction: conjunctival redness, burning, itching.

Endocrine Disorders

Excessive body hair growth (particularly in women), muscle weakness and wasting, purple skin striae, increased blood pressure, irregular or absent menstrual periods, changes in body protein and calcium levels, delayed growth in children and adolescents, and facial and body swelling and weight gain (known as Cushing's syndrome) (see section 2 "Warnings and Precautions").

In all cases mentioned above, it is recommended to discontinue treatment.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on 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 box, the overwrap, and the container after "CAD". The expiration date is the last day of the month indicated.

Store below 86°F (30°C).

Store single-dose containers in the overwrap to protect them from light and moisture.

This medication does not contain preservatives.

After the first opening of a single-dose container, use it immediately and discard the single-dose container with the remaining contents after use.

Medications should not be disposed of through drains or in the trash. Dispose of 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 containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of NETDEX

The active principles are dexamethasone 1mg/ml (in the form of disodium phosphate of dexamethasone) and netilmicin 3mg/ml (as sulfite of netilmicin). Each single-dose container contains 0.9mg of netilmicin and 0.3mg of dexamethasone.

The other components are:

sodium citrate,

sodium phosphate monobasic monohydrate,

dodecahydrate of disodium phosphate,

purified water.

Appearance of the product and contents of the packaging

NETDEX is a transparent, colorless or slightly yellowish solution.

NETDEX eye drops in single-dose containers:

Five single-dose containers, each containing 0.3ml of NETDEX eye drops in solution, wrapped in an aluminum envelope.

Each container contains 15 or 20 single-dose containers.

Only some sizes of containers may be commercially marketed.

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 prospectus:January 2020

The detailed information of this medicine is available on the website ofthe Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es.