Netildex

Package leaflet: Information for the patient

Netildex 3 mg/ml / 1 mg/ml Ophthalmic Gel

netilmicin/dexamethasone
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet; 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. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Netildex is and what it is used for

Netildex contains the active substances netilmicin and dexamethasone.
Netilmicin is an antibiotic that works by killing the bacteria responsible for infections.
Dexamethasone is a corticosteroid that helps reduce inflammation and redness.
Netildex is used in adults to reduce inflammation and kill bacteria in the eyes in the presence of infections or when there is a risk of bacterial infection, including after eye surgery.
Consult your doctor if you do not notice any improvement by the end of the prescribed treatment, or if your condition worsens.

2. What you need to know before using Netildex

Do not use Netildex:

• if you are allergic to netilmicin, dexamethasone, aminoglycoside antibiotics, or 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 have a viral or fungal infection inside the eye or in the area around the eye;
• if you have, or have previously had, an eye infection caused by the herpes simplex virus (HSV);
• if you have conjunctivitis with ulcerative keratitis, even in the early stage (positive fluorescein test);
• if your doctor has told you that you have an eye infection caused by bacteria known as mycobacteria;
• in children under three years of age;
• if you have an eye infection resulting from tuberculosis;
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before using Netildex.
Contact your doctor if you notice 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 develop after stopping prolonged or intensive treatment with Netildex. Consult your doctor before stopping treatment on your own. These risks are particularly important in children and in patients treated with a medicine called ritonavir or cobicistat.
This product should be used with caution in patients with compromised cornea and in cases where the patient is using other ophthalmic products containing phosphates (see section 4).
Patients without pre-existing corneal damage do not appear to be at risk.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
Netildex is contraindicated in children under 3 years of age.
No data are available in children over 3 years of age and in adolescents.

For external use only
Use Netildex only on the surface of the eye. This medicine must not be injected or swallowed.

If you use Netildex for a long time:

• the pressure in your eye may increase and damage the optic nerve, leading to vision problems. If you use Netildex for a long period, your eye pressure should be monitored regularly by your doctor;
• you may develop cataracts;
• wound healing processes may be slowed;
• your body, due to a weakened immune system, may be less able to fight other types of eye infections, especially viral or fungal infections;
• eye infections with pus may worsen with corticosteroid use, or it may become more difficult to identify the type of bacteria causing the infection;
• in diseases causing thinning of the eye surface, corticosteroid use may lead to corneal or scleral perforation ("white part of the eye");
• you may develop allergies to the antibiotic contained in the product.

Before using Netildex, tell 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 check your cornea at regular intervals.

Other medicines and Netildex
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other ophthalmic medicines or other medicines, including those not requiring a prescription.
Talk to your doctor or pharmacist before taking Netildex if you are taking any of the following medicines:

• any other antibiotic, especially polymyxin B, colistin, viomycin, streptomycin, vancomycin, or cephaloridine. Using other antibiotics together with Netildex may increase the risk of kidney problems, hearing problems, or interactions affecting the activity of antibiotics administered in combination with Netildex;
• cisplatin, an anticancer medicine;
• diuretics (medicines that reduce fluid retention) such as ethacrynic acid and furosemide;
• anticholinergic medicines (medicines that block glandular secretion), such as atropine;
• ritonavir or cobicistat, because they may increase the level of dexamethasone in the blood.

Other ophthalmic medicines and Netildex
If you are using other ophthalmic products, wait at least 5 minutes between using one product and the next. Ointments should be used last.

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

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

Breastfeeding
You should not use Netildex while breastfeeding.

Driving and using machines
When using Netildex, you may experience temporary blurred vision. If this occurs, do not drive or operate machinery until your vision is clear again.

Netildex ophthalmic gel contains monobasic monohydrate sodium phosphate and dodecahydrate disodium phosphate
This medicine contains 0.12 mg of phosphate buffer per drop, equivalent to 2.34 mg/ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause calcium deposits in the cornea leading to opaque corneal spots during treatment (see section 4).

3. How to use Netildex

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Dosage
Adults
The recommended dose is 1 drop twice daily, or as prescribed by the doctor.
Children
Netildex is contraindicated in children under 3 years of age.
Instructions for use

1. Wash/disinfect your hands thoroughly.
2. Detach the single-dose container from the strip.
3. Make sure the single-dose container is intact.
4. Hold the single-dose container by the base and shake downwards.

5. Open the single-dose container by twisting the top part and pulling it off.
6. Apply the gel, taking care not to touch the eye, eyelid, or any other surface with the tip of the single-dose container; this helps prevent contamination.
   If the gel is handled incorrectly, it may become contaminated with bacteria, which could lead to eye infections. The use of contaminated gel may cause serious eye damage and subsequent vision loss.
   If you use more Netildex than you should
   Overdose with Netildex has never been reported.
   If you use more gel than you should, it is unlikely to cause you problems; apply the next dose as usual.
   If the gel is accidentally swallowed or used for a prolonged period at excessive doses, toxic effects may occur.
   If you forget to use Netildex
   Do not use a double dose to make up for the missed dose. If you forget to use the eye gel at the usual time, wait until the next scheduled dose and then apply it as normal.
   If you stop using Netildex
   If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects due to dexamethasone are:

1. increased pressure inside the eyes;
2. development of cataract (posterior subcapsular);
3. development or worsening of viral infections caused by Herpes simplex virus (HSV) or fungal infections;
4. delayed healing;
5. eye redness (conjunctival hyperemia);
6. hormonal problems: increased body hair growth (especially in women), muscle weakness and atrophy, purple stretch marks on the skin, increased blood pressure, irregular or absent menstrual cycle, changes in protein and calcium levels in the body, delayed growth in children and adolescents, and swelling with weight gain in the body and face ("Cushing's syndrome") (see section "Warnings and precautions").

Possible side effects due to netilmicin:
The most common side effect with topical use of netilmicin is hypersensitivity. This may present as redness of the conjunctiva, burning, and itching.
There are insufficient data available to determine the frequency of individual listed side effects.
In very rare cases (fewer than 1 in 10,000 people), some patients with severe damage to the clear layer at the front of the eye (cornea) have developed cloudy spots on the cornea due to calcium accumulation during treatment.
Unknown side effects (frequency cannot be estimated from the available data): Blurred vision.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the website
adverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Netildex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP.
The expiry date refers to the last day of that month and applies to the product in its original, undamaged
condition and properly stored.
Store below 25°C in the original packaging.
Netildex does not contain preservatives and must be used immediately after opening; any remaining medicine
should be discarded. After opening the aluminium pouch, the containers must be used within 28
days: any remaining containers must be discarded after this period.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Netildex contains

• The active substances are netilmicin and dexamethasone. 1 ml of gel contains 3 mg of netilmicin (as netilmicin sulfate) and 1 mg of dexamethasone (as dexamethasone sodium phosphate).
• The other components are: sodium citrate, monobasic monohydrate sodium phosphate, dodecahydrate disodium phosphate, xanthan gum, purified water.

What Netildex looks like and contents of the pack
Netildex is an ophthalmic gel and is presented as a homogeneous semisolid mass in 5 single-dose containers
containing 0.4 ml of gel, each wrapped in an aluminum pouch.
Pack sizes of 10, 15 or 20 single-dose containers.
Not all pack sizes may be marketed.
Marketing Authorization Holder
SIFI S.p.A. - Via Ercole Patti, 36 – 95025 Aci S. Antonio (CT)
Detailed and updated information on this product is available by scanning the QR code
shown on the package leaflet and product packaging, using a smartphone.
The same information is also available at the following URL:
http://qr.sifigroup.com/netildex-3-mgml-1-mgml-gel-oftalmico
Package leaflet: information for the patient

NETILDEX 3 mg/ml / 1 mg/ml eye drops, solution

netilmicin and dexamethasone
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

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

1. What Netildex is and what it is used for

Netildex contains two active substances: netilmicin and dexamethasone.

• Netilmicin is an antibiotic with bactericidal activity.
• Dexamethasone is a corticosteroid that reduces inflammation.

Netildex is used in adults to reduce inflammation and to kill bacteria in eyes that are swollen,
irritated, and likely to be infected by bacteria.
Contact your doctor if you do not notice improvement by the end of the prescribed treatment,
or if you notice worsening symptoms.

2. What you need to know before using Netildex

Netildex can be used in adults, including the elderly.
It is not recommended for people under 18 years of age.
Do not use Netildex:

• if you are allergic to netilmicin, dexamethasone, antibiotics known as aminoglycosides, or 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 suspect you have a viral or fungal intra- or extraocular infection;
• if you have or have previously had a viral eye infection caused by herpes simplex virus (HSV);
• if your doctor has told you that you have an eye infection caused by bacteria known as mycobacteria. The product should be used with caution in patients with compromised cornea and in cases where the patient is using other ophthalmic products containing phosphates (see section 4). Patients without pre-existing corneal damage do not appear to be at risk.

Warnings and precautions
Talk to your doctor or pharmacist before using Netildex.
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 develop after discontinuation of prolonged or intensive treatment with Netildex. Consult your doctor before stopping treatment on your own. These risks are particularly important in children and in patients treated with a medicine called ritonavir or cobicistat.
Contact your doctor if blurred vision or other visual disturbances occur.
Use in children and adolescents
Netildex is not recommended for use in children and adolescents (from birth to 18 years of age).
For external use only
Use Netildex only on the surface of the eye. This medicine must not be injected or swallowed.
If you use Netildex for a long time:

• the pressure inside your eye may increase, damaging the optic nerve and causing vision problems. If you use Netildex for more than 15 days, your doctor should regularly monitor your eye pressure;
• you may develop cataracts;
• wound healing processes may be slowed;
• due to reduced immune defenses, your body may be less able to fight other types of eye infections, particularly fungal and viral infections;
• purulent eye infections may worsen with corticosteroid use, or it may become more difficult to identify the type of bacteria causing the infection;
• in conditions causing thinning of the ocular surface, corticosteroid use may lead to corneal or scleral (the white part of the eye) perforation;
• you may develop an allergy to the antibiotic contained in the eye drops.

Before using Netildex, tell your doctor if:

• you have glaucoma or a family history of glaucoma;
• you have corneal problems;
• you are taking other medications containing phosphates. Your doctor will check your cornea at regular intervals;
• you wear contact lenses. You may use Netildex, but follow the instructions for contact lens wearers in section 3.

Other medicines and Netildex
Netildex may interact with other medicines. Inform your doctor or pharmacist if you are taking or have recently taken any other eye drops or other medicines, including medicines without a prescription. You may use Netildex with other eye drops, but follow the instructions provided in section 3.
In particular, tell your doctor or pharmacist if you are taking:

• any other antibiotic, especially polymyxin B, colistin, viomycin, streptomycin, vancomycin, or cephaloridine. The use of other antibiotics together with Netildex may increase the risk of kidney problems, hearing problems, or interference with the activity of antibiotics administered in combination with Netildex;
• cisplatin, an anticancer medicine;
• diuretics (medicines that reduce fluid retention) such as ethacrynic acid and furosemide;
• anticholinergic medicines (medicines that block glandular secretion), such as atropine;
• ritonavir or cobicistat, because they may increase the level of dexamethasone in the blood;
• other medicines containing phosphates. Your doctor will check your cornea at regular intervals.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Use during pregnancy
It is preferable not to use Netildex during pregnancy unless your doctor considers it necessary.
Use during breastfeeding
You should not use Netildex while breastfeeding.
Driving and using machines
While using Netildex, your vision may become blurred for a short time. If this happens, do not drive or operate machinery until your vision is clear again.
Netildex multidose eye drops contain a preservative called benzalkonium chloride.
This preservative may cause eye irritation or changes to the surface of the eye. It may be absorbed by contact lenses and is known to discolor soft contact lenses.
Therefore, avoid contact between this medicine and soft contact lenses.

3. How to use Netildex

Use this medicine exactly as prescribed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose is one drop into the affected eye four times a day, or as
prescribed by your doctor.
Do not change the dose of the eye drops without consulting your doctor.
Use in children and adolescents
Netildex is not recommended for use in children and adolescents (from birth to 18 years of
age).
Contact lens wearers
If you wear contact lenses, you must remove them before using Netildex multidose eye drops.
After administering Netildex, wait 15 minutes before reinserting your contact lenses.
If you need to use Netildex while wearing soft contact lenses, use Netildex preservative-free
single-dose eye drops.
If you use Netildex with other eye drops
Wait at least 10 minutes between administering Netildex and any other eye drops.
Instructions for use
Multidose eye drops
Ensure the bottle is intact.

1. Wash your hands and sit comfortably.
2. Screw the cap down firmly until the bottle is punctured. Unscrew the cap (Figure 1).
3. Tilt your head backward.
4. Use your fingers to gently pull down the lower eyelid of the affected eye.
5. Invert the bottle and place the tip near the eye, but without touching it. Do not touch the eye or eyelid with the dropper tip.
6. Gently press the bottle to release only one drop, then release the lower eyelid (Figure 2).
7. Close the eye and press a finger against the corner of the affected eye near the nose. Hold pressure for 2 minutes.
8. Repeat in the other eye if your doctor has instructed you to do so.
9. Replace the cap on the bottle (Figure 3).

Single-dose eye drops
Ensure the single-dose container is intact.

1. Wash your hands and sit or position yourself comfortably.
2. Separate the single-dose container from the strip (Figure 4).
3. Open by twisting the top part without pulling (Figure 5).
4. Tilt your head backward.
5. Gently pull down the lower eyelid of the affected eye with your fingers.
6. Invert the single-dose container and place its tip near the eye, but without touching it. Do not touch the eye or eyelid with the tip of the single-dose container (Figure 6).
7. Squeeze the single-dose container to release only one drop, then release the lower eyelid.
8. Close the eye and press a finger against the corner of the affected eye near the nose. Hold pressure for 2 minutes.
9. Repeat in the other eye if your doctor has instructed you to do so.
10. Dispose of after use.

Netildex single-dose eye drops should be used immediately after opening.
After administration, the single-dose container and any unused contents must be discarded.
If the eye drops are handled incorrectly, they may become contaminated with bacteria, which
could lead to eye infections. Using contaminated eye drops may cause serious eye damage and
result in loss of vision.
If you use more Netildex than you should
It is unlikely that using more eye drops than prescribed will cause problems.
Apply the next dose as usual.
If you accidentally swallow the entire contents of a multidose container of Netildex, you must
consult your doctor immediately, as adverse effects may occur.
If you forget to use Netildex
Do not use a double dose to make up for a missed dose. Apply the next dose as usual.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
There are insufficient data available to determine the frequency of the individual side effects listed.

Eye disorders
Increased intraocular pressure, cataract formation following prolonged treatment, development or worsening of viral infections caused by herpes simplex virus (HSV) or fungal infections, delayed healing.
In very rare cases (less than 1 person in 10,000), some patients with severe damage to the clear layer at the front of the eye (cornea) developed cloudy, cloud-like spots on the cornea due to calcium accumulation during treatment.

Immune system disorders
Local allergic reaction: conjunctival redness, burning, itching.

Endocrine problems
Increased body hair growth (especially in women), muscle weakness and atrophy, purple stretch marks on the skin, increased blood pressure, irregular or absent menstrual cycle, changes in levels of proteins and calcium in the body, growth retardation in children and adolescents, and swelling with weight gain in the body and face (called “Cushing's syndrome”) (see section 2 “Warnings and precautions”).

Side effects not known (frequency cannot be estimated from the available data):
Blurred vision.

In all these cases, treatment should be discontinued.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Netildex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the label of the bottle after Exp.
The expiry date refers to the last day of that month and to the product kept intact and stored correctly.
Store below 30 °C.

Netildex multidose eye drops:
After first opening, do not use this bottle for more than 28 days. When not using Netildex multidose eye drops, keep the bottle inside the outer packaging to protect it from light.

Netildex single-dose eye drops:
This product does not contain preservatives.
Single-dose containers must be used immediately after opening; any remaining medicine must be discarded.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Netildex contains:
The active substances are dexamethasone 1 mg/ml (as dexamethasone sodium phosphate) and netilmicin 3 mg/ml (as netilmicin sulfate).
The other components are:
Netildex multidose eye drops:
sodium citrate,
monobasic monohydrate sodium phosphate,
dibasic dodecahydrate disodium phosphate,
benzalkonium chloride,
purified water.
Netildex single-dose eye drops:
sodium citrate,
monobasic monohydrate sodium phosphate,
dibasic dodecahydrate disodium phosphate,
purified water.

Description of the appearance of Netildex and contents of the pack
Netildex is a clear, colourless, slightly viscous solution.
Netildex multidose eye drops:
One bottle containing 5 ml of Netildex eye drops, solution.
Netildex single-dose eye drops:
Five single-dose units of 0.3 ml of Netildex eye drops, solution, wrapped in an aluminium sachet.
Packs of 15 or 20 single-dose units.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
SIFI S.p.A.
Via Ercole Patti, 36
95025 Lavinaio
Aci S. Antonio (Catania), Italy.
Tel.: +39 0957922111
Fax: +39 0957922254
e-mail: [email protected]