Netdex 3 mg/ml + 1 mg/ml eye drops solution

Package Leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

netilmicin/dexamethasone

Read the entire 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, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, 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.

Leaflet contents

1. What NETDEX is 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. How to store NETDEX
6. Contents of the pack and other information

1. What NETDEX is and what it is used for

NETDEX contains two medicines: netilmicin and dexamethasone.

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

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

You should consult a doctor if symptoms worsen or do not improve by the end of treatment.

2. What you need to know before using NETDEX

Netilmicin/dexamethasone can be used in adults, including elderly people.

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

Do not use NETDEX:

• If you are allergic to netilmicin, dexamethasone, or to antibiotics known as aminoglycoside antibiotics (such as: tobramycin, kanamycin, amikacin, gentamicin, etc.), or to any of the other ingredients of this medicine (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 or around the eye.
• If you currently have, or have previously had, a viral eye infection caused by the herpes simplex virus (HSV).
• If your doctor has warned you that you have an eye infection caused by bacteria known as mycobacteria.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use NETDEX.

Contact 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 stopping intensive or long-term treatment with netilmicin/dexamethasone. Consult your doctor before stopping treatment on your own. These risks are particularly important in children and patients taking a medicine called ritonavir or cobicistat.

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

If you use NETDEX for a prolonged period

• Eye pressure may increase and cause damage to the eye nerves, leading to vision problems. If you use netilmicin/dexamethasone 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 become less able to defend against other types of eye infections than normal, such as fungal or viral infections;
• Eye infections producing a lot of pus may worsen with corticosteroid use, or it may become more difficult to identify the type of bacteria causing the infection;
• The corticosteroid contained in netilmicin/dexamethasone may cause thinning of the eye surfaces and even perforations;
• You may become allergic to the antibiotic contained in the eye drops.

Before using NETDEX, inform your doctor if:

• You have glaucoma or a family history of glaucoma;
• You have corneal problems;
• You are taking other medicines containing phosphates. Your doctor will monitor your cornea at regular intervals;
• You wear contact lenses. You may continue using netilmicin/dexamethasone, 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 up to 18 years of age).

For external use only

Use NETDEX only on the surface of the eye. This medicine must not be injected or swallowed.

Using NETDEX with other medicines

NETDEX may interact with other medicines. Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other ophthalmic products or any other medicines, including those obtained without a prescription. You may still use netilmicin/dexamethasone with other ophthalmic products, but you must follow the instructions in section 3.

In particular, inform your doctor or pharmacist if you are taking:

• Any other antibiotic, especially polymyxin B, colistin, viomycin, streptomycin, vancomycin, or cephaloridine. Concurrent use of netilmicin/dexamethasone with other antibiotics may increase the risk of kidney problems, ear problems, or may affect the effectiveness of the other antibiotics;
• Cisplatin (an anticancer medicine);
• Diuretics (medicines that reduce fluid retention) such as ethacrynic acid and furosemide;
• Anticholinergic medicines (medicines that stop gland secretions) such as atropine;
• Ritonavir or cobicistat, as these may increase the amount of dexamethasone in the blood;
• Other medicines containing phosphates. Your doctor will monitor your cornea at regular intervals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Use during pregnancy

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

Use during breastfeeding

NETDEX must not be used if you are breastfeeding.

Driving and using machines

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

NETDEX contains benzalkonium chloride and phosphates

This medicine contains 0.05 mg of benzalkonium chloride per ml.

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

Benzalkonium chloride may cause ocular irritation, especially if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain after using this medicine.

This medicine contains 0.18 mg of phosphates per drop, equivalent to 3.66 mg/ml.

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

3. How to use NETDEX

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one drop in the affected eye four times a day, or as prescribed by your doctor. The normal duration of treatment may vary from 5 to 14 days.

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

Use in children and adolescents

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

Contact lens wearers

If you wear contact lenses, you must remove them before using NETDEX eye drops. After using this medicine, wait 15 minutes before reinserting your contact lenses.

If you need to use NETDEX while wearing contact lenses, you should use NETDEX in single-dose containers without preservatives.

However, contact lenses should not be worn during treatment with eye drops containing steroids, due to an increased risk of infection. It is also strongly recommended that you avoid wearing contact lenses during an eye infection or inflammation.

If you use NETDEX with other eye drops

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

Instructions for use

Make sure the bottle is intact.

1. Wash your hands and sit or position yourself comfortably.
2. Screw the cap down firmly to pierce the tip of the bottle. Unscrew the cap.

1. Tilt your head backwards.
2. Gently pull down the lower eyelid of the affected eye with your finger.
3. Invert the bottle and bring the tip close to the eye without touching it.

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

1. Gently press the bottle to release only one drop, then release the lower eyelid.

1. Close the eye and press with one finger on the inner corner of the affected eye, next to the nose. Hold for 2 minutes.

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

If you use the eye drops incorrectly, contamination by bacteria may occur, which could lead to eye infections. Use of contaminated eye drops may cause serious eye damage and subsequent vision loss.

If you use more NETDEX than you should

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

Apply the next dose as usual.

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

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to use NETDEX

Do not use a double dose to make up for forgotten doses.

Apply the next dose as usual.

If you stop using NETDEX

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. The frequency of occurrence in each individual cannot be estimated from the available data.

Eye disorders

Increased intraocular pressure, cataract formation following prolonged treatment, blurred vision, development or worsening of a viral eye infection caused by 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 front layer of the eye (the cornea) have developed opaque corneal spots due to calcium accumulation during treatment.

Immune system disorders

Local allergic reaction: conjunctival redness, burning, itching.

Endocrine disorders

Excessive body hair growth (particularly in women), muscle weakness and wasting, purple stretch marks on the skin, increased blood pressure, irregular or absent menstruation, changes in body protein and calcium levels, growth retardation in children and adolescents, and swelling with weight gain in the body and face (known as ‘Cushing’s syndrome’) (see section 2 “Warnings and precautions”).

In all the above cases, treatment discontinuation is recommended.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of NETDEX

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the label and on the carton after "EXP". The expiry date refers to the last day of the month indicated.

Store below 30°C.

Do not use the eye drops more than 28 days after first opening the bottle.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of NETDEX

• The active substances are netilmicin and dexamethasone.

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

• The other components are:

sodium citrate,

monobasic sodium phosphate monohydrate,

dibasic sodium phosphate dodecahydrate,

benzalkonium chloride,

purified water.

Appearance of the product and contents of the container

NETDEX is a transparent, colourless or slightly yellowish solution.

One bottle contains 5 ml of NETDEX ophthalmic solution.

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 revision of this leaflet: January 2020

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es.