Patient leaflet - Netilmicin/ Dexamethasone 3 mg/ml + 1 mg/ml eye drops, solution, in single-dose Container
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 1G155360P2
Package leaflet: Information for the patient
NetilDEX® 3 mg/ml + 1 mg/ml eye drops, solution 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.
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
- 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;
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 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. 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 phosphates
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
Netildex in single-dose containers can be used while you wear contact lenses because it does not contain preservatives. However, it is strongly advised to avoid wearing contact lenses during an eye infection or inflammation. Contact lenses should not be worn during treatment with steroid eye drops due to increased risk of infection. 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 single dose container is intact.
- 1.
Wash your hands and sit or position your
self comfortably.
- 2.
Open the aluminium sachet containing
the single-dose containers.
- 3.
Separate the single-dose container
from the strip (Picture 1) and put the unopened containers back into the sachet
- 4.
Open by twisting the upper part without
pulling (Picture 2)
Do not touch the tip after opening the container.
- 5. Tilt the head back.
- 6.
Use your finger to gently pull down the
lower eyelid of your affected eye.
- 7.
Invert the single-dose container and
place the tip of the container close to, but not touching your eye.
Do not allow the container tip to touch your eye or eyelid (Picture 3).
- 8.
Squeeze the single-dose container in
order to administrate only one drop, then release the lower eyelid.
- 9.
Close your eye and press a finger against
the corner by the nose of the affected eye. Hold for 2 minutes.
- 10.
Repeat in the other eye if your doctor has
told you to do this.
- 11.
Discard the single dose container after use.
(Picture 1) (Picture 2) (Picture 3)
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 cause problems.
Apply the next dose as usual.
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.
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.
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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, sachet and container after EXP. The expiry date refers to the last day of that month.
Store below 30 °C.
Store the single-dose containers in the sachet in order to protect from light and moisture.
This medicine does not contain
preservatives.
After first opening of a single-dose container, use immediately and throw away the single-dose container with any remaining contents after use.
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 dexamethasone 1 mg/ml (as dexamethasone disodium phosphate) and netilmicin 3 mg/ml (as netilmicin sulphate). Each single dose container contains 0.9 mg of netilmicin and 0.3 mg of dexamethasone.
The other ingredients are:
sodium citrate,
monobasic sodium phosphate
monohydrate,
disodium phosphate dodecahydrate, purified water.
What Netildex looks like and contents of the pack
Netildex is a clear, colourless or slightly yellow solution.
Netildex single dose eye drops:
Five single-dose containers, each containing 0.3 ml of Netildex eye drops, solution wrapped in an aluminium sachet. Each pack contains 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
95025 Aci S. Antonio (Catania) Italy
Distributed by:
ParaPharm Development Limited, Building 1410
Arlington Business Park
Theale – Reading, RG7 4SA, United Kingdom
This leaflet was last revised in August 2022
Detailed information on this medicine is available on the website of
www.mhra.gov.uk.
Detailed and updated information on this product is available by scanning the QR code included below or on the outer packaging with a smartphone.
The same information is also available at the following URL:
http://qr.sifigroup.com/1g155360/