Patient leaflet - Netilmicin/dexamethasone 3 mg/ml + 1 mg/ml eye drops, solution
1. What Netildex is and what it is used for
Netildex contains two medicines: netilmicin and dexamethasone.
Netilmicin is an antibiotic which kills
bacteria.
- Dexamethasone is a steroid 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.
You must 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 anyone
under 18 years of age.
Do not use Netildex:
if you are allergic to netilmicin,
dexamethasone, antibiotics that are
known as aminoglycoside antibiotics
(such as: tobramycin, kanamicyn, amikacin, gentamicin, etc) 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 bacterium known as mycobacteria.
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 a long-term or intensive treatment with Netildex. Talk to your doctor before stopping the treatment by yourself. These risks are especially important in children and 1G156372P1
NetilDEX 3 mg/ml + 1 mg/ml eye drops, solution
Netilmicin / Dexamethasone
Package leaflet: Information for the patient
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patients treated with a drug called ritonavir or cobicistat.
Contact your doctor if you experience blurred vision or other visual disturbances.
If you use Netildex for a long time
- you may develop cataract;
- wounds may take longer to heal;
- 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 steroid in Netildex may cause thinning of the surfaces of the eye and even perforations;
- you may start to become allergic to the antibiotic in 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;
- wear contact lenses. You can still use Netildex, but follow the instructions for contact lens wearers in section 3.
Children and adolescents
Netildex is not recommended for use in children or adolescents (aged from birth to 18 years of age).
For external use only
Only use Netildex on the surface of your eye. This medicine should never be injected or swallowed.
Other medicines and Netildex
Netildex may interact with other medicines. Tell your doctor or pharmacist if you are taking or have recently taken any ophthalmic product or any other medicines, including medicines obtained without a prescription. You can still use Netilmicin + Dexamethasone 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.
Using other
antibiotics at
the same time
as Netildex may
increase the risk of
kidney problems,
hearing problems
or it may affect how well the other antibiotics work;
- cisplatin, an anti-cancer drug;
- diuretics (medicines to reduce water retention) such as ethacrynic acid and furosemide;
- anticholinergic medicines (medicines that stop glands secreting), 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 taking this medicine.
Use in pregnancy
It is preferable not to use Netildex during pregnancy unless your doctor considers it is necessary.
Use in breast-feeding
Netildex should not be used if you are breast-feeding.
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 benzalkonium chloride and phosphates
This medicine contains 0.05 mg
benzalkonium chloride in each ml. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or
disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging 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 (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 four times a day or as prescribed. The usual treatment duration 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 (aged from birth to 18 years of age).
Contact lens wearers
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 you need to use Netildex while you wear contact lenses you should use Netildex in single-dose containers without preservative.
However, contact lenses should not be worn during treatment with steroid eye drops due to increased risk of infection. It is also strongly advised to avoid wearing contact lenses during an eye infection or inflammation.
If you use Netildex with other eye drops
Wait at least 10 minutes between using Netildex and using the other eye drops or ointments.
Eye ointments should be placed last.
Instructions for use
Make sure the bottle is intact.
- 1. Wash your hands and sit comfortably.
- 2. Screw the cap down tightly in order to pierce the tip of the bottle. Unscrew the cap.
- 3. Tilt the head back.
- 4. Use your finger to gently pull down the lower eyelid of your affected eye.
- 5. Invert the bottle and place the tip of the bottle close to, but not touching your eye. Do not touch your eye or eyelid with the dropper tip.
- 6. Squeeze the bottle gently in order to administrate only one drop, then release the lower eyelid.
- 7. Close your eye and press a finger against the corner by the nose of the affected eye. Hold for 2 minutes.
- 8. Repeat in the other eye if your doctor has told you to do this.
- 9. Put the cap back on the bottle.
If you use the eye drops 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 eye drops.
If you use more Netildex than you should
If you use too many drops it is unlikely to have problems.
Apply the next dose as usual.
If you ingest the entire content of a Netildex, you should consult your doctor immediately, as side effects might 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.
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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. The frequency of the individual effect listed cannot be estimated from the available data.
Eye disorders
Increased eye pressure, cataract formation after prolonged treatments, blurred vision, developing or worsening of a viral infection of the eye caused by the herpes simplex virus (HSV) or a fungal infection, delayed wound healing.
In very rare cases (less than 1 in every 10,000), some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.
Immune system disorders
Local allergic reaction: redness of the conjunctiva, burning, pruritus.
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 2, “Warnings and precautions”).
In all the above cases, it is recommended to discontinue treatment.
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 the 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 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 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 solution contains netilmicin sulphate 4.55 mg (equivalent to netilmicin 3 mg) and dexamethasone disodium phosphate 1.32 mg (equivalent to dexamethasone 1 mg).
The other ingredients are:
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 or slightly yellow solution. One bottle containing 5 ml of Netildex eye drops, solution.
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
95025 Aci Sant’Antonio (CT) Italy