Patient Information Leaflet

NETDEX 3mg/ml + 1 mg/ml eye drops in solution

netilmicina/dexametasona

Read this leaflet carefully before you start 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 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 yourdoctor 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 starting to use NETDEX

3.How to use NETDEX

4.Possible side effects

5.Storage of NETDEX

6.Contents of the pack and additional information

NETDEXcontains two medications: netilmicina and dexametasona.

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

NETDEXis used in adults to reduce inflammation and eliminate bacteria in swollen, irritated eyes that are at risk of bacterial infection.

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 use NETDEX:

-If you are allergic to netilmicina, dexametasona, known antibiotics such as aminoglucósidos (such as: tobramicina, kanamicina, amikacina, gentamicina, etc.) or to any of the other components of this medication (including 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 your eye or around your 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 blurred vision or other visual disturbances.

If you use NETDEX for a prolonged period

-Your eye pressure may increase and cause damage to the nerves of the eye, 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;

-You may be less able to defend yourself against other types of eye infections, such as fungal or viral infections;

-Eye infections that produce a lot of pus may worsen or be more difficult to identify the type of bacteria that causes 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.

Before usingNETDEX inform your doctor 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;
• You use contact lenses. You may continue to use netilmicina/dexametasona, but you must follow the instructions for use with contact lenses in section 3.

Children and adolescents

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

Only for external use

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 medications obtained without a prescription. You can use netilmicina/dexametasona with other eye drops, but you must follow the instructions in section 3.

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

• Certain other antibiotics, 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 cancer medication);
• Diuretics (medications that reduce fluid retention) such as ácido etacrínico and furosemida;
• Anticholinergic medications (medications that stop the secretion of glands) 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 breastfeeding

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

Use during pregnancy

It is preferable not to useNETDEXduring pregnancy unless your doctor considers it necessary.

Use during breastfeeding

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.

NETDEX containsbenzalkonium chloride and phosphates

This medication contains 0.05mg of benzalkonium chloride in each ml.

Benzalkonium chloride can be absorbed by soft contact lenses, altering their color. Remove your contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer on the front of the eye). Consult your doctor if you experience a strange sensation, burning, or pain in the eye after using this medication.

This medication contains 0.18 mg of phosphates in each drop equivalent to 3.66 mg/ml.

If you have severe damage to the cornea (the transparent layer on the front of the eye), treatment with phosphates, in rare cases, may cause blurred vision due to calcium accumulation.

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

The recommended dose isone dropin theaffected eyefour timesa 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 usein children or adolescents (from birth to 18 years of age).

Users of contact lenses

If you wear contact lenses, you must remove them before using the NETDEX eye drops. After using this medication, wait 15 minutes before putting your contact lenses back on.

If you need to use NETDEX while wearing contact lenses, you must use NETDEX in a single-use container without preservative.

However, do not wear contact lenses during treatment with eye drops containing steroids, due to a higher risk of infection. It is also strongly recommended that you avoid wearing contact lenses during an eye infection or inflammation.

If you useNETDEX with other eye drops

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

Instructions for use

Make sure the bottle is intact.

1. Wash your hands and sit or recline comfortably.
2. Twist the cap downwards with force to pierce the tip of the bottle. Unscrew the cap.

1. Incline your head backwards.
2. With your finger, gently pull down the lower eyelid of the affected eye.
3. Invert the bottle and bring the tip of the bottle close to the eye without touching it.

Do not touch the eye or eyelid with the tip of the bottle.

1. Press lightly on the bottle to administer only one drop, and then release the lower eyelid.

1. Closure of the eye and pressing with a finger on the corner of the affected eye, next to the nose. Hold for 2 minutes.

1. Repeat in the other eye if your doctor has instructed you to.
2. Replace the cap on the bottle.

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 loss of vision.

If you use 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.

If you ingest the contents of NETDEX, you should consult a doctor immediately, as adverse effects may occur.

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 useNETDEX

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

Apply the next dose as usual.

If you interrupt treatment with NETDEX

If you have any other questions 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 striae on the skin of the body, increased blood pressure, irregular or absent menstrual periods, changes in the body's 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 that does not appear 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 label and on the box after “CAD”. The expiration date is the last day of the month indicated.

Store below 30°C.

Do not use the eye drops after 28 days after opening the bottle for the first time.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of NETDEX

• The active principles are netilmicin and dexamethasone.

Each milliliter of solution contains 4.55 mg of netilmicin sulfate (equivalent to 3 mg of netilmicin) and 1.32 mg of dexamethasone sodium phosphate (equivalent to 1 mg of dexamethasone).

• The other components are:

sodium citrate,

sodium monobasic phosphate monohydrate,

dodecahydrate disodium phosphate,

benzalkonium chloride,

purified water.

Appearance of the product and contents of the packaging

NETDEX is a transparent, colorless, or slightly yellowish solution.

One bottle contains 5 ml of NETDEX eye drops in solution.

Holder of the marketing authorization and manufacturer responsible

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 medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es.