Package leaflet: Information for the user

Slaner 3 mg/ml + 1 mg/ml eye drops, solution

Netilmicin and Dexamethasone
Generic Medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Slaner is and what it is used for
What you need to know before using Slaner
How to use Slaner
Possible side effects
How to store Slaner
Contents of the pack and other information

1. What Slaner is and what it is used for

Slaner contains two active substances: netilmicin and dexamethasone.
Netilmicin is an antibiotic with bactericidal action.
Dexamethasone belongs to a class of medicines known as "Corticosteroids" with anti-inflammatory activity (reduction of inflammation).
Slaner is indicated to reduce inflammation and to kill bacteria in swollen, irritated eyes that are likely to be infected by bacteria, in adults over 18 years of age and in the elderly.

2. What you need to know before using Slaner

Do not use Slaner

If you are allergic to the active substances (netilmicin and dexamethasone) or to any of the other ingredients of this medicine (listed in section 6).
If you are allergic to a class of antibiotics known as "aminoglycosides".
If your doctor has told you that your eye pressure is too high.
If you think you have an infection caused by microorganisms (viruses or fungi) affecting the internal or external part of the eye (intra- or extraocular).
If you have, or have previously had, a viral eye infection caused by Herpes Simplex virus (HSV).
If your doctor has told you that you have an eye infection caused by bacteria known as mycobacteria.
If you are unsure whether you should use Slaner, contact your doctor or ask your pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before using Slaner.
Slaner is for ocular use only; do not inject or ingest it.
If you do not notice improvement within a few days after starting treatment with Slaner, consult your doctor, who may change your therapy.
Before using Slaner, inform your doctor if:

you or a family member suffers from a disease known as glaucoma (damage to the optic nerve caused by increased pressure inside the eye);
you have problems with the cornea (the transparent membrane covering the front part of the eye);
you are taking other medicines containing phosphates; in this case, your doctor will check your cornea at regular intervals;
you wear contact lenses. You may use Slaner, but follow the instructions for contact lens wearers in section 3.

If you use Slaner for a long time:

the pressure in your eye may increase, potentially damaging the optic nerve and causing vision problems. If you use Slaner for more than 15 days, your eye pressure must be monitored regularly by your doctor;
you may develop a condition called cataract;
wound healing processes may be slowed;
your body, due to reduced defenses of the immune system, may be unable to effectively respond to other types of eye infections, particularly those caused by certain microorganisms (viruses and fungi);
eye infections with pus discharge may worsen or become more difficult to diagnose when using corticosteroids, making it harder to identify the type of bacteria causing the infection;
in diseases causing thinning of the eye surface, corticosteroid use may lead to corneal or scleral (white part of the eye) perforation;
you may develop allergic reactions.

Contact your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. Suppression of adrenal gland function may occur after discontinuation of prolonged or intensive treatment with Slaner. Consult your doctor before stopping treatment on your own. These risks are particularly important in children and in patients taking a medicine called ritonavir or cobicistat.
Children and adolescents
Slaner is not recommended in children and adolescents under 18 years of age.
Other medicines and Slaner
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Slaner may affect or be affected by other medicines you are taking, including other eye drops.
Inform your doctor if you are taking:

any other antibiotic, especially medicines containing polymyxin B, colistin, viomycin, streptomycin, vancomycin, or cephaloridine. Using these medicines together with Slaner may increase the risk of kidney problems, hearing problems, or may interfere with the therapeutic effect of these antibiotics;
an anticancer drug containing cisplatin;
medicines used to reduce fluid retention known as "diuretics," such as ethacrynic acid and furosemide;
medicines used to block gland secretion known as "anticholinergics," such as atropine;
medicines containing ritonavir or cobicistat, as they may increase blood levels of dexamethasone;
other medicines containing phosphates. Your doctor will check your cornea at regular intervals.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
It is preferable not to use Slaner during pregnancy unless your doctor considers it necessary.
Breastfeeding
If you are breastfeeding, it is preferable not to use Slaner unless your doctor considers it necessary.
Driving and using machines
During use of Slaner, temporary blurred vision may occur. If this happens, do not drive or operate machinery until your vision clears.
Slaner 3 mg/ml + 1 mg/ml multidose eye drops contain benzalkonium chloride
Benzalkonium chloride is a preservative that may cause eye irritation or damage to the surface of the eye. Benzalkonium chloride can be absorbed by contact lenses and is known to cause discoloration of soft contact lenses. Therefore, avoid contact of this multidose formulation with soft contact lenses.

3. How to use Slaner

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Recommended dose:
One drop four times a day into the affected eye, or as prescribed by your doctor.
Do not change the dose of the eye drops without first consulting your doctor.
Use in children and adolescents
Slaner is not recommended for children and adolescents under 18 years of age.
Contact lens wearers
If you wear contact lenses, you must remove them before applying Slaner multidose eye drops.
After applying Slaner, wait 15 minutes before reinserting your contact lenses.
If you need to use Slaner while wearing soft contact lenses, use Slaner preservative-free eye drops in single-dose containers.
If you use Slaner with other eye drops
Wait at least 10 minutes between administering Slaner and any other eye drops.
Instructions for use
Multidose eye drops
Ensure the bottle is intact.

Wash your hands and sit comfortably.
Remove the cap with a gentle twist.
Tilt your head backwards.
Gently pull down the lower eyelid of the affected eye with your fingers.
Invert the bottle and position the tip close to the eye, without touching it. Do not touch the eye or eyelid with the dropper tip.
Gently squeeze the bottle so that a single drop enters the eye, then release the lower eyelid.
Close your eye and press with one finger on the corner of the affected eye near the nose for 2 minutes.
Repeat the procedure in the other eye, if your doctor has instructed you to do so.
Close the bottle immediately after use.
Single-dose eye drops
Ensure the single-dose container is intact.
Wash your hands and sit comfortably.
Remove one vial from the strip and unscrew the cap with a gentle twist.
Tilt your head backwards.
Gently pull down the lower eyelid of the affected eye with your fingers.
Invert the single-dose container and position the tip of the vial close to the eye, without touching it. Do not touch the eye or eyelid with the tip of the vial.
Gently squeeze the vial so that a single drop enters the eye, then release the lower eyelid.
Close your eye and press with one finger on the corner of the affected eye near the nose for 2 minutes.
Repeat the procedure in the other eye, if your doctor has instructed you to do so.
Dispose of the vial and any remaining contents. Slaner single-dose eye drops must be used immediately after opening. After administration, the single-dose container and any residual medicine must be discarded.

If you use the eye drops incorrectly, they may become contaminated by bacteria, which could lead to
eye infections. Using contaminated eye drops may cause serious eye damage and even result in loss of vision.
If you use more Slaner than you should
Using more eye drops than prescribed by your doctor is unlikely to cause you problems.
Apply the next dose as usual, but if you are concerned, speak to your doctor.
If you accidentally swallow the product, contact your doctor immediately, as adverse effects may occur.
If you forget to use Slaner
Do not take a double dose to make up for a forgotten dose.
If you forget to use the eye drops at your usual time, wait until the next scheduled dose and apply it as normal.
If you stop using Slaner
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Side effects related to both active substances (dexamethasone and netilmicin) contained in Slaner may occur.
There are insufficient data available to determine the frequency of the individual side effects listed below.

Eye disorders

Increased intraocular pressure after 15–20 days of application in patients with glaucoma or predisposed to it;
Development of cataract following prolonged use of the medicine;
Development or worsening of viral infections caused by Herpes Simplex virus (HSV) or by microorganisms (fungi);
Delayed wound healing processes. In very rare cases (fewer than 1 in 10,000 people), some patients with severe damage to the clear layer at the front of the eye (cornea) have developed cloudy spots on the cornea due to calcium accumulation during treatment.

Immune system disorders

Local allergic reaction: conjunctival redness, burning, and itching.

Endocrine disorders

Increased body hair growth (especially in women), muscle weakness and atrophy, purple stretch marks on the skin, increased blood pressure, irregular or absent menstrual cycle, changes in protein and calcium levels in the body, delayed growth in children and adolescents, and swelling with weight gain in the body and face (called “Cushing's syndrome”) (see section 2 “Warnings and precautions”).

In all these cases, you should stop treatment and consult your doctor for appropriate therapy.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You may also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Slaner

Slaner eye drops, solution (5 ml bottle)
Store the medicine below 30°C.
Keep in the original packaging to protect the medicine from light.
After first opening, the bottle must be stored below 30°C and used within 28 days; after this period, any remaining medicine must be discarded.
Record the date of first opening in the space provided on the carton.

Slaner eye drops, solution (Single-dose containers 0.3 ml)
Store the medicine below 30°C.
Keep in the original packaging to protect the medicine from light.
After first opening of the aluminium pouch: store below 30°C and use within 28 days; after this period, any remaining containers must be discarded.
The single-dose container must be used immediately after opening; any remaining medicine must be discarded.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “EXP”.
The expiry date refers to the last day of that month and to the product in its intact, properly stored condition.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Slaner contains
Slaner eye drops, solution (5 ml bottle)
In 1 ml of solution:
The active substances are: netilmicin sulfate equivalent to 3.00 mg of netilmicin and dexamethasone sodium phosphate
equivalent to 1.00 mg of dexamethasone.
The other components are: sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate,
benzalkonium chloride, water for injections.

Slaner eye drops, solution (single-dose containers of 0.30 ml)
In 1 ml of solution:
The active substances are: netilmicin sulfate equivalent to 3.00 mg of netilmicin and dexamethasone sodium phosphate
equivalent to 1.00 mg of dexamethasone.
The other components are: sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate,
water for injections.

Description of the appearance of Slaner and contents of the pack
Slaner is presented as a clear, colourless eye drop solution for ophthalmic use.

Slaner eye drops, solution (5 ml bottle)
Pack contains one 5 ml bottle.

Slaner eye drops, solution (single-dose containers of 0.30 ml)
5 single-dose containers of 0.30 ml eye drops solution contained in an aluminium pouch.
Pack sizes of 20 single-dose containers.

Marketing Authorization Holder
Genetic S.p.A. Via G. Della Monica, 26 - 84083 Castel San Giorgio (SA)

Manufacturer
Genetic S.p.A. Contrada Canfora - 84084 Fisciano (SA)