Package leaflet: Information for the user

IPOKIMA 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, consult 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What IPOKIMA is and what it is used for

IPOKIMA contains two active substances: netilmicin and dexamethasone.
Netilmicin is an antibiotic with bactericidal action.
Dexamethasone belongs to a group of medicines known as "corticosteroids" with anti-inflammatory activity (reduction of inflammation).
IPOKIMA 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 should know before using IPOKIMA

Do not use IPOKIMA

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 IPOKIMA, contact your doctor or consult your pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before using IPOKIMA.
IPOKIMA is for ocular use only; do not use it for injections or swallow it.
If you do not notice any improvement within a few days after starting treatment with IPOKIMA, consult your doctor, who may change your therapy.
Before using IPOKIMA, 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 IPOKIMA, but follow the instructions for contact lens wearers in section 3. If you use IPOKIMA for a long time:
the pressure in your eye may increase, damaging the optic nerve and causing vision problems. If you use IPOKIMA 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 a lowered immune system defense, may become unable to effectively respond to other types of infections in your eye, particularly infections caused by certain microorganisms (viruses and fungi);
eye infections with pus discharge may worsen or make it more difficult to identify the type of bacteria causing the infection when corticosteroids are used;
in diseases causing thinning of the eye surface, corticosteroid use may lead to corneal and scleral (white part of the eye) perforations;
you may develop allergic reactions. Consult 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 develop after discontinuation of prolonged or intensive treatment with IPOKIMA. Consult your doctor before stopping treatment on your own. These risks are particularly important in children and in patients treated with a medicine called ritonavir or cobicistat.

Children and adolescents
IPOKIMA is not recommended in children and adolescents under 18 years of age.
Other medicines and IPOKIMA
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
IPOKIMA may affect or be affected by other medicines you are using, including other eye drops.
Inform your doctor if you are taking:

any other antibiotic, particularly medicines containing polymyxin B, colistin, viomycin, streptomycin, vancomycin, or cephaloridine. Using these medicines together with IPOKIMA may increase the risk of kidney problems, hearing problems, or may affect the therapeutic action of these antibiotics;
an anticancer medicine 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 dexamethasone levels in the blood;
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, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
It is preferable not to use IPOKIMA during pregnancy unless your doctor considers it necessary.
Breastfeeding
If you are breastfeeding, it is preferable not to use IPOKIMA unless your doctor considers it necessary.
Driving and use of machines
While using IPOKIMA, temporary blurred vision may occur. If this happens, do not drive and do not operate machinery until your vision clears.
IPOKIMA 3 mg/ml + 1 mg/ml multidose eye drops contains benzalkonium chloride
Benzalkonium chloride is a preservative that may cause eye irritation or changes 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 between this multidose formulation and soft contact lenses.

3. How to use IPOKIMA

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 daily into the eye being treated, or as prescribed by your doctor.
Do not change the dose of this eye drop without first consulting your doctor.
Use in children and adolescents
IPOKIMA 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 multidose IPOKIMA eye drops.
After applying IPOKIMA, wait 15 minutes before reinserting your contact lenses.
If you need to use IPOKIMA with soft contact lenses, use the preservative-free single-dose vials (IPOKIMA eye drops in single-dose containers).
If you use IPOKIMA with other eye drops
Wait at least 10 minutes between administering IPOKIMA and any other eye drop.
Instructions for use
Multidose eye drop bottle
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 the eye and press with one finger on the inner 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.
Immediately recap the bottle 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 the eye and press with one finger on the inner 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.
Discard the vial and any remaining contents immediately. IPOKIMA 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 with 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 IPOKIMA than you should
Using more eye drops than prescribed by your doctor is unlikely to cause 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 IPOKIMA
Do not take a double dose to make up for a missed dose.
If you forget to use the eye drops at your usual time, wait until the next scheduled dose and apply the normal dose.
If you stop using IPOKIMA
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects related to both active substances (dexamethasone and netilmicin) contained in IPOKIMA 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 suffering from 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 healing processes.

In very rare cases (less than 1 in 10,000 people), some patients with severe damage to the clear outer layer at the front of the eye (cornea) have developed cloudy spots on the cornea due to calcium deposits 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 effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can 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 IPOKIMA

IPOKIMA 3 mg/ml + 1 mg/ml eye drops, solution (5 ml bottle)
Store the medicine below 30°C.
Keep in the original packaging to protect from light.
After first opening, store the bottle below 30°C and use 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.

IPOKIMA 3 mg/ml + 1 mg/ml eye drops, solution (Single-dose containers, 0.3 ml)
Store the medicine below 30°C.
Keep in the original packaging to protect 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 for the product kept unopened and correctly stored.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What IPOKIMA contains
IPOKIMA 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.
IPOKIMA 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 IPOKIMA and contents of the pack
IPOKIMA is presented as an eye drop solution for ophthalmic use, clear and colourless.
IPOKIMA eye drops, solution (5 ml bottle)
Pack contents: one 5 ml bottle.
IPOKIMA eye drops, solution (single-dose containers of 0.30 ml)
5 single-dose containers of 0.30 ml of eye drop solution contained in an aluminium sachet.
Packs of 20 single-dose containers.

Marketing Authorisation Holder
Doc Generici S.r.l., via Turati, 40 – 20121 Milan, Italy
Manufacturer
Genetic S.p.A., Contrada Canfora - 84084 Fisciano (SA), Italy