NETILDEX 3 mg /Ml/1 Mg/Ml Eye Drops, Solution

Зміст інструкції

1. Netildex 3 mg/ml / 1 mg/ml Ophthalmic Gel
   1. What is Netildex and what is it 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
2. NETILDEX 3 mg/ml / 1 mg/ml eye drops, solution
   1. What is Netildex and what is it 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

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

netilmicin/desamethasone
Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is Netildex and what is it 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 to relieve inflammation and redness.
Netildex is used in adults to reduce inflammation and to kill bacteria in the eyes in the presence of
infections or with a probability of being infected by bacteria, even after undergoing
surgery.
Contact your doctor if you do not notice an improvement or if you notice
worsening at the end of the prescribed therapy.

2. What you need to know before using Netildex

Do not use Netildex:

• if you are allergic to netilmicin, desamethasone, aminoglycoside antibiotics or any of the other ingredients of this medicine (listed in section 6);
• if your doctor has told you that the pressure in your eyes is too high;
• if you think you have a viral or fungal infection inside your eye or in the area around your eye;
• if you have, or have had in the past, a viral eye infection caused by Herpes simplex virus (HSV);
• if you have conjunctivitis with ulcerative keratitis even in the early stages (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.
Talk to your doctor if you notice swelling and weight gain around your trunk and face as these
are usually the first signs of a syndrome called “Cushing’s syndrome”. Suppression
of the function of the adrenal glands may develop after discontinuation of prolonged or
intensive treatment with Netildex. Talk to your doctor before stopping treatment on your own. These risks are
particularly important in children and patients treated with a medicine called ritonavir or cobicistat.
The product must be used with caution in patients with compromised cornea and in cases where the patient
uses 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 adolescents.

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

If you use Netildex for a long time:

• the pressure in your eye may increase and damage the optic nerve causing vision problems. If you use Netildex for a long period, your eye pressure should be checked regularly by your doctor;
• you may develop cataracts;
• the healing processes may be slowed down;
• your body, due to a lowering of immune defenses, may not effectively counteract other types of infection in your eye, particularly viral or fungal infections;
• eye infections with pus, with the use of corticosteroids, may worsen or it may be more difficult to identify the type of bacteria causing the infection;
• in diseases that cause thinning of the ocular surface, the use of corticosteroids may cause perforation of the cornea or the “white of the eye” (sclera);
• you may develop allergies to the antibiotic present in the product.

Before using Netildex tell your doctor if:

• you have glaucoma or a history of glaucoma in your family;
• you have problems with your cornea;
• you are taking other medicines containing phosphates. Your doctor will check your cornea at regular intervals.

Other medicines and Netildex
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other ophthalmic medicines or other medicines, including over-the-counter medicines.
Talk to your doctor or pharmacist before taking Netildex if you are taking any of the following
medicines:

• any other antibiotic, in particular polymyxin B, colistin, viomycin, streptomycin, vancomycin and cefaloridine. The use of other antibiotics simultaneously with Netildex may increase the risk of kidney problems, hearing problems or repercussions on the activity of antibiotics administered in association with Netildex;
• cisplatin, an anti-cancer drug;
• diuretics (medicines that reduce fluid retention) such as ethacrylic acid and furosemide;
• anticholinergic drugs (medicines that block glandular secretion), such as atropine;
• ritonavir or cobicistat, because they can increase the level of desamethasone in the blood.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice 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 if you are breastfeeding.

Driving and operating machinery
If you are using Netildex you may experience transient blurred vision. If this happens, do not
drive or operate machinery until your vision is clear again.

Netildex ophthalmic gel contains sodium phosphate monobasic monohydrate and disodium phosphate dodecahydrate
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 cause
in very rare cases opaque spots on the cornea due to calcium accumulation during treatment (see
section 4.

3. How to use Netildex

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.

Dosage
Adults
The recommended dose is 1 drop2 times a dayor as prescribed by your 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 from the strip.

• 3) Make sure the single dose is intact.
• 4) Hold the single-dose container by the base and shake it downwards.

• 5) Open the single-dose container by rotating the top and pulling.

• 6) Apply the gel, taking care not to touch the eye, eyelid, or any other surface with the tip of the single dose; this can avoid contamination.

If you handle the gel incorrectly, it may become contaminated with bacteria that can cause
eye infections. Use of contaminated gel can cause serious eye damage and subsequent
loss of vision.

If you use more Netildex than you should
No cases of overdose have ever been reported with the use of Netildex.
If you use more gel than you should, it is unlikely to cause you problems and apply the next dose
normally.

If the gel is accidentally ingested or used for a long 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 ophthalmic gel at the
usual time, wait for the time of the next dose and apply the dose normally.

If you stop treatment with Netildex
If you have any doubts about the use of 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 desamethasone are:

• 1) increased pressure inside the eyes;
• 2) formation of cataract (posterior subcapsular);
• 3) development or worsening of infections caused by Herpes simplex virus (HSV) or fungal infections;
• 4) delayed wound healing;
• 5) redness of the eyes (conjunctival hyperemia);
• 6) hormonal problems: increased hair growth on the body (especially in women), weakness and muscle atrophy, purple stretch marks on the skin of the body, 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 and weight gain of the body and face (“Cushing’s syndrome”) (see paragraph “Warnings and precautions”). Possible side effects due to netilmicin: The most common side effect with topical use of netilmicin is hypersensitivity. This manifests with redness of the conjunctiva, burning and itching. Insufficient data are available to establish the frequency of individual effects listed. In very rare cases (less than 1 in 10,000), some patients with severe damage to the clear layer in the front of the eye (cornea) have developed cloud-like spots on the cornea due to calcium accumulation during treatment. Unknown side effects (frequency cannot be estimated based on available data): Blurred vision.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 which is reported on the packaging after SCAD.
The expiry date refers to the last day of that month and the product is intact, correctly
stored.
Store at a temperature below 25°C in the original packaging.
Netildex does not contain preservatives and must be used immediately after opening; any remaining medicine must
be discarded. After opening the aluminum sachet, the containers must be used within 28
days: after this period, any remaining containers must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Netildex contains

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

How Netildex looks and contents of the pack
Netildex is an ophthalmic gel and is presented as a homogeneous semi-solid mass in 5 single-dose containers
of 0.4 ml of gel wrapped in an aluminum sachet.
Packs of 10, 15 or 20 single-dose containers.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
SIFI S.p.A. - Via Ercole Patti, 36 – 95025 Aci S. Antonio (CT)

Detailed and up-to-date information for this product is available by scanning the QR
The same information is also available at the following URL:
http://qr.sifigroup.com/netildex-3-mgml-1-mgml-gel-oftalmico

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

netilmicin and dexamethasone
Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is Netildex and what is it used for

Netildex contains two active ingredients: netilmicin and desamethasone.

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

Netildex is used in adults to reduce inflammation and to kill bacteria in swollen eyes,
irritated eyes and with a probability of being infected by bacteria.
Contact your doctor if you do not notice an improvement at the end of the prescribed therapy
or if you notice a worsening.

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, desamethasone, antibiotics known as aminoglycosides 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 have a viral or fungal intra- or extraocular infection;
• if you have, or have had in the past, 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 uses 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.
Talk to your doctor if you feel swelling and weight gain around your trunk and face as
these are usually the first signs of a syndrome called Cushing's syndrome.
Suppression of adrenal gland function may develop after discontinuation of a
prolonged or intensive treatment with Netildex. Talk to your doctor before stopping the
treatment on your own. These risks are particularly important in children and patients treated
with a medicine called ritonavir or cobicistat.

Contact your doctor if you experience blurred vision or other visual disturbances.
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 should not be injected or
ingested.

If you use Netildex for a long time:

• the pressure in your eye may increase and damage the optic nerve and cause vision problems. If you use Netildex for more than 15 days, your eye pressure should be checked regularly by your doctor;
• you may develop cataracts;
• the healing processes may be slowed down;
• your body, as a result of a lowering of the immune defenses, may not effectively counteract other types of infection in your eye, in particular fungal and viral infections;
• purulent eye infections, with the use of corticosteroids, may worsen or it may be more difficult to identify the type of bacteria that cause the infection;
• in conditions that cause thinning of the ocular surface, the use of corticosteroids may cause perforation of the cornea and the “white” of the eye (sclera);
• you may develop allergies to the antibiotic present in the eye drops.

Before using Netildex tell your doctor if:

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

Other medicines and Netildex
Netildex may interact with other medicines. Tell your doctor or pharmacist if you are
taking or have recently taken any other eye drops or other medicines, including over-the-counter medicines. You can use Netildex with other eye drops, but follow the instructions in
section 3.
In particular, tell your doctor or pharmacist if you are taking:

• any other antibiotic, especially polymyxin B, colistin, viomycin, streptomycin, vancomycin and cefaloridine. The use of other antibiotics at the same time as Netildex may increase the risk of kidney problems, hearing problems or effects on the activity of antibiotics administered in association with Netildex;
• cisplatin, an anticancer drug;
• diuretics (medicines that reduce fluid retention) such as ethacrinic acid and furosemide;
• anticholinergic drugs (drugs that block glandular secretion), such as atropine;
• ritonavir or cobicistat, because they can increase the level of desamethasone in the blood;
• other medicines containing phosphates. Your doctor will check your cornea at regular intervals.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding with
breast milk, 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 if you are breastfeeding.

Driving and operating machinery
During the use of Netildex your vision may become blurred for a short period. If
this happens, do not drive and do not use 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 can
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 following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Dose
The recommended dose is one dropin the affected eye four times a dayor 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 putting your contact lenses back in.
If you need to use Netildex with soft contact lenses, you should use Netildex eye drops in single-dose containers without a preservative.

If you are using Netildex with other eye drops
Wait at least 10 minutes between administering Netildex and other eye drops.

Instructions for use

Multidose eye drops
Make sure the bottle is intact.

• 1. Wash your hands and sit comfortably.
• 2. Screw the cap on tightly until it pierces the bottle. Unscrew the cap (Figure 1).
• 3. Tilt your head back.
• 4. Use your fingers to gently pull down the lower eyelid of the affected eye.
• 5. Turn the bottle upside down and position the tip of the bottle close to the eye, but without touching it. Do not touch the eye or eyelid with the tip of the dropper.
• 6. Gently press the bottle to administer only one drop, then release the lower eyelid (Figure 2).
• 7. Close your eye and press a finger against the corner of the affected eye near the nose. Hold for 2 minutes.
• 8. Repeat in the other eye if your doctor has told you to do so.
• 9. Put the cap back on the bottle (Figure 3).

Single-dose eye drops
Make sure the single-dose container is intact.

• 1. Wash your hands and sit or get into a comfortable position.
• 2. Separate the single-dose container from the strip (Figure 4).
• 3. Open by twisting the top without pulling (Figure 5).
• 4. Tilt your head back.
• 5. Gently pull down the lower eyelid of the affected eye with your fingers.
• 6. Turn the single-dose container upside down and position the tip of the container close to the eye, but without touching it. Do not touch the eye or eyelid with the tip of the container (Figure 6).
• 7. Press the single-dose container to administer only one drop, then release the lower eyelid.
• 8. Close your eye and press a finger against the corner of the affected eye near the nose. Hold for 2 minutes.
• 9. Repeat in the other eye if your doctor has told you to do so.
• 10. Discard after use.

Netildex single-dose eye drops should be used immediately after opening.
After administration, the single-dose container and unused contents must be discarded.
If you handle the eye drops incorrectly, they may become contaminated with bacteria that can cause eye infections. Use of contaminated eye drops can cause serious eye injury and subsequent loss of vision.

If you use more Netildex than you should
If you use more eye drops than you should, it is unlikely to cause you problems.
Apply the next dose normally.
If you swallow the entire contents of a multidose container of Netildex, you should consult your doctor immediately, as side effects may occur.

If you forget to use Netildex
Do not use a double dose to make up for the missed dose. Apply the next dose normally.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Sufficient data are not available to establish the frequency of the individual effects listed.

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

Immune system disorders
Local allergic reaction: redness of the conjunctiva, burning, itching.

Hormonal problems
Increased hair growth on the body (especially in women), weakness and muscle atrophy,
purple stretch marks on the skin of the body, 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 and weight gain of the body and face (called “Cushing’s syndrome”)
(see section 2 “Warnings and precautions”).

Side effects with unknown frequency (frequency cannot be estimated based on available data):
Blurred vision.
In all these cases it is advisable to stop treatment.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
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 which is stated on the packaging and
on the bottle label after Exp.
The expiry date refers to the last day of that month and to the product that is intact and correctly
stored.
Store at a temperature 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:
The product does not contain preservatives.
The single-dose containers must be used immediately after opening; any
remaining medicine must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Netildex contains:
The active ingredients are dexamethasone 1 mg/ml (as dexamethasone sodium phosphate) and netilmicin 3
mg/ml (as netilmicin sulfate).
The other ingredients are:

Netildex multidose eye drops:
sodium citrate,
monobasic sodium phosphate monohydrate,
disodium phosphate dodecahydrate,
benzalkonium chloride,
purified water.

Netildex single-dose eye drops:
sodium citrate,
monobasic sodium phosphate monohydrate,
disodium phosphate dodecahydrate,
purified water.

Description of the appearance of Netildex and contents of the pack
Netildex is a clear, colorless and 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 containers of 0.3 ml of Netildex eye drops, solution wrapped in an aluminum
sachet.
Packs of 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 Lavinaio
Aci S. Antonio (Catania), Italy.
Tel.: +39 0957922111
Fax: +39 0957922254
e-mail: [email protected]