Netildex 3 mg/ml eye droop 5 ml.

1. What Netildex is and what it is used for
Netildex contains two medicines: netilmicin and dexamethasone:

netilmicin is an antibiotic that kills bacteria;

dexamethasone is a steroid that reduces inflammation.

Netildex is used in adults to reduce inflammation and kill bacteria in the eyes when they are swollen, irritated and possibly infected with bacteria.

You should talk to a doctor if you do not feel better, or if you feel worse at the end of the treatment.

2. What you need to know before you use 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 aminoglycoside antibiotics (such as tobramycin, kanamycin, amikacin, gentamicin and others), 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 may have a viral or fungal infection in or around the eye;
if you currently have or have ever had a viral eye infection caused by the herpes simplex virus;
if your doctor has told you that you have an eye infection caused by bacteria known as mycobacteria.
Warnings and precautions
Talk to your doctor or pharmacist before using Netildex.
Talk to your doctor if you experience swelling and puffiness of the torso and face, as these are usually the first signs of a syndrome called Cushing's syndrome. Adrenal gland suppression may develop after stopping long-term or intensive treatment with Netildex. Talk to your doctor before stopping treatment yourself. These risks are particularly significant in children and patients treated with a medicine called ritonavir or cobicistat.

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

If you use Netildex for a long time:
the pressure in your eye may increase, leading to damage to the nerves in your eye and causing problems with your vision. If you use Netildex for more than 15 days, your eye pressure should be checked regularly by your doctor;

you may develop cataracts;
wounds may heal more slowly;
your body may not cope as well as usual with other types of eye infections, such as fungal or viral infections;

eye infections that produce a lot of pus may get worse or it may become more difficult to identify the type of bacteria causing the infection when using corticosteroids;
the steroid in Netildex can cause thinning of the eye surfaces and even perforations;
you may develop an allergy to the antibiotic in the eye drops.
Before using Netildex, tell your doctor if:
you have glaucoma or a family history of glaucoma;
you have problems with your cornea;
you are taking other medicines containing phosphates. Your doctor will want to check your cornea at regular intervals;
you wear contact lenses. You can still use Netildex, but follow the instructions for wearing contact lenses in section 3.
Children and adolescents
Netildex is not recommended for use in children or 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 swallowed.

Other medicines and Netildex
Netildex may interact with other medicines. You should tell your doctor or pharmacist if you are taking or have recently taken any ophthalmic products or any other medicines, including medicines obtained without a prescription. You can still use Netildex with other ophthalmic products, but follow the instructions in section 3.

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

any other antibiotics, in particular polymyxin B, colistin, viomycin,
streptomycin, vancomycin and cephaloridine. Taking other antibiotics at the same time as Netildex may increase the risk of kidney problems, hearing problems or may affect the way other antibiotics work;
cisplatin, an anticancer medicine;
diuretics (medicines to reduce water retention) such as ethacrynic acid and furosemide;
anticholinergic medicines (medicines that stop the secretion of glands) such as atropine;
ritonavir or cobicistat, as this may increase the amount of dexamethasone in the blood;
other medicines containing phosphates. Your doctor will monitor your cornea at regular intervals.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, 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 breast-feeding
Netildex should not be used if you are breast-feeding.

Driving
and using machines
When using Netildex, your vision may become blurred for a short time. In this case, do not drive or use tools or machines until your vision clears.

Netildex contains phosphates
This medicine contains 0.05 mg benzalkonium chloride in each ml.
Benzalkonium chloride can be absorbed by soft contact lenses and may discolour the lenses. You should remove your contact lenses before using this medicine and wait at least 15 minutes before putting them back in. Benzalkonium chloride may also cause eye irritation, especially if you have “dry eye” or disorders of the cornea (the clear layer at the front of the eye). If you experience any unusual eye sensations, such as burning or pain in the eye after using this medicine, talk to your doctor.

This medicine contains 0.18 mg phosphates in each drop, which is equivalent to 3.66 mg/ml. If you suffer from severe damage to the clear layer at the front of the eye (cornea), in very rare cases phosphates may cause cloudy spots 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. If you are not sure, ask your doctor or pharmacist.

The recommended dose is one drop in the affected eye four times a day or as prescribed. The usual duration of treatment can vary from 5 to 14 days.

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 or adolescents (from birth to 18 years of age).

People with contact lenses
If you wear contact lenses, you should remove them before using Netildex eye drops. After using Netildex, you should wait 15 minutes before putting your contact lenses back in.
If it is necessary to use Netildex when you wear contact lenses, you should use Netildex in single-dose containers without a preservative.
However, contact lenses should not be worn during treatment with steroid eye drops due to the increased risk of infection. It is also strongly recommended that contact lenses not be worn if the eye is infected or inflamed.

If you use Netildex with other eye drops
Wait at least 10 minutes between applying Netildex and other eye drops or ointments. Eye ointments should be applied last.

Directions for use
Make sure the bottle is intact.

1. Wash your hands and sit comfortably.

2. Press down on the cap with a twist to pierce the top of the bottle. Unscrew the cap.

3. Tilt your head back.
4. Gently pull down the lower eyelid of the affected eye with your finger.
5. Turn the bottle upside down and bring the tip of the dropper close to the eye, but without touching it.
Do not touch the eye or eyelid with the tip of the dropper.
6. Squeeze the bottle gently to dispense just one drop, then release the lower eyelid.

7. Close your eye and press your finger against the corner of the affected eye by the nose. Hold for 2 minutes.

8. Repeat with the other eye, if your doctor has told you to do so.
9. Replace the cap on the bottle.

If you use eye drops incorrectly, they can become contaminated with bacteria, which can lead to eye infections. Serious eye damage and subsequent vision loss can be caused by contaminated eye drops.
If you use more than the required dose of Netildex
If you use more than the required number of drops, it is unlikely that you will have problems.
Apply the next dose as usual.

If you swallow the entire contents 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 a forgotten dose.
Apply the next dose as usual.

If you stop using Netildex
If you have any further questions on the use of 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.

It is not possible to estimate the frequency of individual listed reactions from the available data.

Eye disorders
Increased eye pressure, cataract formation after prolonged treatment, blurred vision, development or worsening of a viral infection of the eye caused by the herpes simplex virus or a fungal infection, delayed wound healing.

In very rare cases (less than 1 in 10,000), some patients with severe damage to the clear layer at the front of the eye (cornea) develop cloudy spots on the cornea due to calcium build-up during treatment.

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

Hormonal disorders
Increased body hair (especially in women), muscle weakness and loss of muscle mass, purple stretch marks on the skin of the body, high blood pressure, irregular or absent menstrual cycles, changes in protein and calcium levels in the body, growth retardation in children and teenagers and swelling and fatness of the
body and face (called “Cushing’s syndrome”) (see section 2 “Warnings and precautions”).

In the above cases, stopping treatment is recommended.

5. How to store Netildex
Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and bottle after “EXP”. The expiry date refers to the last day of that month.

Store below 30°C.

After first opening the bottle, use within 28 days.

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

6. Contents of the pack and other information
What Netildex contains
Active substances: netilmicin and dexamethasone.
Each ml of solution contains: netilmicin sulphate 4.55 mg (equivalent to netilmicin 3 mg) and dexamethasone disodium phosphate 1.32 mg (equivalent to dexamethasone 1 mg).

Other ingredients:
sodium citrate,
monobasic sodium phosphate monohydrate,
disodium phosphate dodecahydrate,
benzalkonium chloride,
purified water.

What Netildex looks like and contents of the pack
Netildex is a clear, colourless to pale yellow solution.

One bottle containing 5 ml of Netildex eye drops, solution.

 

 

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