Netildex 3 mg/ml + 1 mg/ml eye gel in single-dose Container – patient leaflet, side effects, dosage

1. What Netildex is and what it is used for

Netildex contains two active substances:

netilmicin and dexamethasone. Netilmicin

is an antibiotic which kills bacteria that are

responsible for infections.

Dexamethasone is a corticosteroid that

reduces inflammation and redness.

Netildex is used in adults to reduce

inflammation and to kill bacteria in the eyes in the presence of infections or in cases

when the eye is likely to be infected by

bacteria, even after surgery.

You must talk to a doctor if you do not feel

better or if you feel worse at the end of the

therapy.

2. What you need to know before you use 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 advised you that the

  pressure in your eye is too high;

  • if you think you may have a viral or fungal infection in or around your eye;
  • if you have now, or have had in the past, a viral infection of the eye caused by the herpes simplex virus (HSV);
  • if your doctor has advised you that you have an infection of the eye caused by the bacteria known as mycobacteria;
  • if you have an eye infection caused by tuberculosis;
  • if you are affected by conjunctivitis with inflammation and ulceration of the cornea (the clear front layer of the eye) even in the early stages;
  • in children less than 3 years of age;
  • if you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before using Netildex

Talk to your doctor if you experience swelling and weight gain around the trunk and in the face as these are usually the first manifestations of a syndrome called “Cushing’s syndrome”. Suppression of the adrenal gland function may develop after stopping long-term or intensive treatment with Netildex. Talk to your doctor before stopping the treatment by yourself. These 1G156380P1

Package leaflet: information for the patient

NetilDEX 3 mg/ml + 1 mg/ml eye gel in single-dose container netilmicin/dexamethasone

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risks are especially important in children and patients treated with a drug called ritonavir or cobicistat.

The product should be used with caution in patients with compromised cornea (clear front layer of the eye) and in cases where the patient uses other ophthalmic products containing phosphates (see section 4). Patients without pre-existing corneal damage do not seem to be at risk.

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

Children and adolescents

Netildex is contraindicated in children less than three years of age. Netildex is not recommended for use in children and adolescents (from 3 to 18 years of age). Ask to your doctor or pharmacist if you are not sure how to use Netildex

For external use only

Only use Netildex on the surface of your eye. This medicine should never be injected or swallowed.

If you use Netildex for a long time:

• you may develop cataract;
• wounds may take longer to heal;
• as a result of a reduction of the/your immune response, your body may not fight other types of infections in your eye as well as normal, such as fungal or viral infections;
• eye infections that produce a lot of pus, with the use of corticosteroids, may become worse or it may be more difficult to identify the type of bacteria causing the infection;
• the use of corticosteroids may cause perforations of the cornea or of the “white part of the eye” (sclera) in diseases that cause thinning of the ocular surface;
• you may start to become allergic to the antibiotic of the eye drops.

Before you use Netildex tell your doctor if you:

• have glaucoma or a family history of glaucoma;
• have problems with your cornea;

• are taking any other medicines containing phosphates. Your doctor will want to check your cornea at regular intervals.

  Other medicines and Netildex

  Tell your doctor or pharmacist if you are taking or have recently taken or might take any ophthalmic product or any other medicines, including medicines obtained without a prescription.

  Before using Netildex, tell your doctor or pharmacist if you are taking:

  • any other antibiotics, in particular polymyxin B, colistin, viomycin, streptomycin, vancomycin, cephaloridine or other aminoglycosides. Using other antibiotics at the same time as Netildex may increase the risk of kidney or hearing problems or it may affect how well the other antibiotics work;
  • cisplatin (an anti-cancer drug);
  • diuretics (medications to treat fluid retention) such as ethacrynic acid and furosemide;
  • anticholinergic medicines (medicines that stop glands secreting), such as atropine;
  • ritonavir or cobicistat, as they may increase the amount of dexamethasone in the blood.

Netildex can be used with other medicines for ophthalmic use, but it is important to follow the instructions in section 3. No drug interactions have been reported so far with the use of Netildex.

Contact lens wearers

Netildex can be used while you wear contact lenses because it doesn´t contain preservatives. However contact lens wear is not recommended during the treatment of an ocular infection.

Pregnancy and breast-feeding

If you are pregnant, or breast-feeding, think you may be pregnant or planning to have a baby ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breast-feeding

Do not use Netildex during breast-feeding as this medicine is excreted into breast milk in small amounts.

Driving and using machines

When you use Netildex your vision may become blurred for a short time. If this happens, do not drive or use any tools or machines until your vision becomes clear again.

Netildex contains phosphates

This medicine contains 0.12 mg in each drop, which is equivalent to 2.34 mg/ml. If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.

3. How to use Netildex

Always use this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The recommended dose is one drop in the affected eye two times a day or as prescribed.

Use in children and adolescents

Netildex is contraindicated in children less than 3 years of age. Netildex is not recommended for use in children and adolescents (from 3 to 18 years of age).

Instructions for use

1. 1) Wash/sanitize your hands.
2. 2) Open the aluminium sachet containing the single-dose containers.
3. 3) Separate one single-dose container from the strip and put the unopened containers back into the aluminium sachet.
4. 4) Make sure the single-dose container is intact before use.
5. 5) Hold the single-dose container upside down and shake it lightly back and forth.
6. 6) Open by twisting the upper part and pull. Do not touch the tip after opening the container.
7. 7)

   Gently squeeze until one drop falls into the gap between your eyeball and lower eyelid. To avoid contamination, take care

   not to touch the tip of the container with your eye, eyelid, or any other surface.

   1. 8) Discard the single dose container after use.

If you use the gel incorrectly, it can become contaminated by bacteria which may lead to eye infections. Serious ocular damage and subsequent loss of vision may result from using contaminated gel. Since sterility cannot be maintained after the individual single dose container is opened, any remaining content must be discarded after administration.

If you use more Netildex than you should

Cases of overdose have never been reported using Netildex.

If you use more eye gel than you should it is unlikely to cause problems. Apply the next dose as usual. If the product is accidentally swallowed or used for long periods of time in excessive doses, this may cause toxic side effects.

If you forget to use Netildex

Do not use a double dose to make up for a forgotten dose. Apply the next dose as usual.

If you stop using Netildex

Always tell your doctor if you are thinking about stopping the treatment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If you use Netildex with other eye medicines

If you are using any other eye medicine, you should wait 5 minutes between using each medicine. Eye ointments should be used last.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Possible undesirable effects due to dexamethasone:

1. 1) increased eye pressure;
2. 2) cataract formation (posterior subcapsular);
3. 3) development or worsening of a viral infection of the eye caused by the herpes simplex virus (HSV) or a fungal infection;

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1. 4) delayed wound healing;
2. 5) eye redness (conjunctival hyperemia);
3. 6) hormonal disorders: growth of extra body hair (particularly in women), muscle weakness and wasting, purple stretch marks on body skin, increased blood pressure, irregular or missing periods, changes in the levels of protein and calcium in your body, stunted growth in children and teenagers and swelling and weight gain of the body and face (called ‘Cushing’s syndrome’) (see section “Warnings and precautions”).

Possible side effects caused by netilmicin: The most common side effect of the topical use of netilmicin is hypersensitivity, such as redness of the conjunctiva, burning and itching.

Frequency of each listed effect cannot be estimated from the available data.

In very rare case (up to 1 in 10,000 people), some patients with severe damage to the clear layer in the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at: www.mhra.gov.uk/ yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 after EXP. The expiry date refers to the last day of that month of the unopened and properly stored product.

Store below 25 °C. Store in the original package.

Keep the single-dose containers in the original aluminum sachet in order to protect from light.

The product does not contain preservatives. Netildex must be used immediately after opening; any remaining content should be discarded. After opening of the aluminium sachet, the containers should be used within 28 days: after this period, the remaining containers should be discarded.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Netildex contains

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

What Netildex looks like and contents of the pack

Netildex is an eye gel with an homogeneous semisolid mass contained in 5 single-dose containers which in turn are wrapped in an aluminum sachet inside a carton box. Each carton box contains 10, 15 or 20 single-dose containers. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

SIFI Pharmaceuticals Limited

29/30 Fitzroy Square

London W1T 6LQ

United Kingdom

Manufacturer

SIFI, S.P.A.

Via Ercole Patti, 36

I-95020 Aci S. Antonio (Catania) Italy

This leaflet was last revised in November 2022