Neladex 3500 IU/6000IU/1 mg/ml. eye droops 5ml.

1. What Neladex is and what it is used for
Neladex eye drops are a corticosteroid-anti-inflammatory combination.
The corticosteroids (dexamethasone in this case) help prevent or reduce inflammation in the eye. The anti-inflammatory agents (neomycin sulfate and polymyxin B sulfate in this case) are effective against a wide range of microorganisms that can infect the eye(s).

Neladex is used to treat inflammation and possible infection in the eye(s). This inflammation may be caused by an infection or by a foreign body or an injury to the eye.

2. What you need to know before you use Neladex
Do not use Neladex:
if you are allergic to neomycin sulfate, polymyxin B sulfate and/or dexamethasone or any of the other ingredients of this medicine (listed in section 6);
if you have or suspect that you have:
herpes simplex keratitis (eye herpes caused by a virus and affecting the cornea of ​​the eye), smallpox (variola), chickenpox/shingles or other viral infection of the eye;
fungal eye disease or untreated parasitic eye infection;
tuberculosis of the eye.
Warnings and precautions
Talk to your doctor before using Neladex.

If you experience allergic reactions when using Neladex, stop using it and consult your doctor. Allergic reactions can range from localized itching or redness of the skin to severe allergic reactions (anaphylactic reaction) or serious skin reactions. Such allergic reactions can also occur with the use of other antibiotics for topical or systemic use of the same group (aminoglycosides).
The use of this medicine may cause skin redness, irritation and discomfort.
Talk to your doctor if you are using other antibiotic treatment together with Neladex.
If you use Neladex for a long time, you may:
have increased pressure in your eye(s). Your intraocular pressure should be checked regularly while using Neladex. Neladex is not recommended for use in paediatric patients. The risk of increased intraocular pressure and/or cataract formation caused by the use of corticosteroids is higher in predisposed patients (e.g. diabetics);
develop cataracts;
become more susceptible to eye infections;
it is possible that you may develop Cushing's syndrome from the passage of the medicine into your blood. Talk to your doctor if you experience rounding and obesity, mainly in the face and torso, as these are usually the first signs of a syndrome called Cushing's syndrome. After stopping long-term or intensive treatment with Neladex, suppression of the function of the adrenal glands may develop. Consult your doctor before stopping treatment on your own. These risks are particularly important in children and patients treated with a medicine containing ritonavir or cobicistat.
If your symptoms worsen or suddenly return, please consult your doctor. You may become more susceptible to eye infections with the use of this product.
Steroids applied to the eye may delay the healing of eye wounds. Topical NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) are also known to delay healing. The simultaneous use of topical steroids and topical NSAIDs may increase the possibility of healing problems.
Contact your doctor if you have blurred vision or other visual disturbances;
Consult your doctor or pharmacist before using this medicine if you have a condition that causes thinning of the eye tissues.
If you wear contact lenses:
Wearing contact lenses (soft or hard) is not recommended during treatment for eye inflammation or infection.
If you have increased pressure in the eye (glaucoma), consult your doctor for advice.
Your doctor may need to check the pressure in your eye(s) during treatment with this medicine. You should follow their advice.

Other medicines and Neladex
You should tell your doctor or pharmacist if you are taking or have recently taken
any other medicines.

Be sure to tell your doctor if you are using topical NSAIDs. The simultaneous use of topical steroids and topical NSAIDs may increase the possibility of problems with corneal healing.

Tell your doctor if you are taking ritonavir or cobicistat, as this may increase the amount of dexamethasone in your blood.

Neladex with food, drink and alcohol
It is recommended that Neladex be taken with food (see section 3 “How to take Neladex”).

Pregnancy, breast-feeding and fertility
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. Neladex should not be used during pregnancy or breast-feeding.

Driving and using machines
It may be possible to immediately
You may experience temporary blurred vision after using Neladex. Do not drive or operate machinery until your vision clears.

Important information about some of the ingredients of Neladex
The preservative in Neladex (benzalkonium chloride) may cause eye irritation and is also known to discolour soft contact lenses. If your doctor decides that you can wear contact lenses, remove them immediately before using Neladex and wait 15 minutes before putting them back in.

This medicine contains less than 1 mmol sodium (23 mg) per millilitre, i.e. essentially sodium-free.

3. How to use Neladex
Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

If the protective ring is loose after removing the cap, remove it before use. Use Neladex for instillation into your eye(s) only.

After applying the drops, hold your eyelid closed and at the same time gently press the tear duct with your finger to reduce the amount of medicine that will pass into the blood.

For mild conditions, the dose is one to two drops in the conjunctival sac of the affected eye(s) 4 to 6 times a day.

For severe conditions, the dose is one to two drops every hour, gradually decreasing until the inflammatory process subsides.

Your doctor will tell you how long your treatment will last.

The safety and effectiveness of Neladex in pediatric patients have not been established, therefore use in children is not recommended.

How to use

1. Take Neladex and a mirror.
2. Wash your hands.
3. Shake the bottle well.
4. Twist the cap.
5. Hold the bottle pointing downwards, between your thumb and middle finger (figure 1).
6. Tilt your head back. Open your eyelid with your clean fingers so that a “pocket” forms between it and your eye. The drop should fall into this place (figure 2).
7. Bring the dropper tip of the bottle close to your eye. Use a mirror if this makes it easier.
8. Do not touch your eye, eyelid, surrounding area or other surfaces with the tip of the dropper tip. This may contaminate the drops.
9. Gently press the base of the upside-down bottle with your index finger to release one drop of Neladex (figure 3).
10. After inserting Neladex, release your lower eyelid, close your eye and gently press your finger on the eye, in the corner of your nose (figure 4). This will prevent Neladex from spreading to the rest of your body.
11. If you need to use the drops for both eyes, repeat the steps for the other eye.
12. Replace the cap and close the bottle tightly immediately after use.
13. Use only one bottle.

If the drop does not get into the eye, try again.

If you have used more Neladex than you should
Rinse with warm water. Do not use any more until it is time for your next regular dose.

If you forget to use Neladex
Continue with the next dose as scheduled. However, if it is already time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

If you stop using Neladex
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If you are using other eye drops or eye ointment, wait at least 5 minutes between each medicine. The eye ointment should be applied last.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been observed with Neladex.

Uncommon side effects (may affect up to 1 in 100 people):
effects related to the eye: inflammation of the eye surface, increased eye pressure, itching in the eye, eye discomfort, eye irritation.
Additional side effects identified during post-marketing experience, the frequencies of which are not known:

effects related to the eye: corneal ulceration, blurred vision, sensitivity to light, increased pupil size, drooping eyelid, eye pain, eye swelling, abnormal sensation in the eye, eye redness, increased tearing;
hormonal problems: increased body hair (especially in women), muscle weakness and loss of muscle mass, purple stretch marks on the skin, high blood pressure, irregular or absent menstruation, changes in protein and calcium levels in the body, growth retardation in children and adolescents and rounding and obesity in the face and torso (Cushing's syndrome) (see section 2, subsection "Warnings and precautions");
effects related to the whole body: allergy, headache, serious skin reactions (Stevens-Johnson syndrome).
Reporting side effects
If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Neladex
Keep out of the reach and sight of children.

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

Store below 25°C.

The bottle should be discarded 4 weeks after first opening to avoid
possible infections.

Medicines should not be thrown away via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help protect the environment.

6. Contents of the pack and other information
What Neladex contains
The active substances: neomycin sulphate 3500 IU/ml and polymyxin B sulphate 6000 IU/ml, dexamethasone 1 mg/ml.
The other ingredients are: benzalkonium chloride, disodium edetate, sodium chloride, polysorbate 80, sodium hydroxide, hydrochloric acid, hypromellose (hydroxypropylmethylcellulose E464), purified water.
What Neladex looks like and contents of the pack
Neladex is a white, odourless suspension supplied in a white, opaque LDPE bottle with a dropper applicator and a volume of 5 ml, closed with a white HDPE-LDPE cap. Each bottle is placed in a cardboard box with a patient information leaflet.

 

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