IPOKIMA 0.3% + 0.1% Krople do oczu, roztwór

Treść ulotki

1. IPOKIMA 3 mg/ml + 1 mg/ml eye drops, solution
   1. What is IPOKIMA and what is it used for
   2. What you need to know before using IPOKIMA
   3. How to use IPOKIMA
   4. Possible side effects
   5. How to store IPOKIMA
   6. Contents of the pack and other information

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

Netilmicin and Desamethasone
Generic Medicine

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What IPOKIMA is and what it is used for
• 2. What you need to know before you use IPOKIMA
• 3. How to use IPOKIMA
• 4. Possible side effects
• 5. How to store IPOKIMA
• 6. Contents of the pack and other information

1. What is IPOKIMA and what is it used for

IPOKIMA contains two active ingredients: netilmicin and desamethasone.
Netilmicin is an antibiotic with bactericidal action.
Desamethasone belongs to the category 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 and with a probability of being infected by bacteria, in adults over 18 years of age and in the elderly.

2. What you need to know before using IPOKIMA

Do not use IPOKIMA

• If you are allergic to the active ingredients (netilmicin and desamethasone) 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) that has affected the inside or outside of the eye (intra or extraocular).
• If you have, or have had in the past, a viral eye infection caused by the Herpes Simplex (HSV) virus.
• If your doctor has told you that you have an eye infection caused by bacteria known as mycobacteria.
• If you are not sure whether you should use IPOKIMA, contact your doctor or ask your pharmacist.

Warnings and precautions
Consult your doctor or pharmacist before using IPOKIMA.
IPOKIMA is only for ocular use, do not use it for injections or ingest it.
If you do not notice an improvement after a few days of starting treatment with IPOKIMA, consult your
doctor who may modify the therapy.
Before using IPOKIMA, tell your doctor if:

• you or a family member suffers from a disease known as glaucoma (damage to the optic nerve caused by a high increase in pressure inside the eye);
• you have problems with the cornea (the transparent membrane that covers the front 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 can 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 and damage the optic nerve and cause vision problems. If you use IPOKIMA for more than 15 days, your eye pressure should be checked regularly by your doctor;
• you may develop a disease called cataract;
• the healing processes may be slowed down;
• your body, due to a lowering of the defenses of your immune system, may not be able to react effectively to other types of infection in your eye, in particular infections caused by some microorganisms (viruses and fungi);
• eye infections with pus secretions, with the use of corticosteroids, may worsen or make it more difficult to identify the type of bacteria causing the infection;
• in diseases that cause thinning of the surface of the eye, the use of corticosteroids may cause perforation of the cornea and the white of the eye (sclera);
• you may develop allergic reactions. Consult your doctor if you feel swelling and weight gain around the trunk and face as these are usually the first manifestations of a syndrome called Cushing's syndrome. Suppression of the function of the adrenal glands can 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 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
IPOKIMA can affect or be affected by other medicines you are taking including other eye drops.
Tell your doctor if you are taking:

• any other antibiotic, especially medicines containing polymyxin B, colistin, viomycin, streptomycin, vancomycin and cefaloridine. The use of such medicines simultaneously with IPOKIMA may increase the risk of kidney problems, hearing problems or may affect the therapeutic action of these antibiotics;
• an anticancer drug containing cisplatin;
• medicines used for the reduction of water retention known as “diuretics” such as ethacrinic acid and furosemide;
• medicines used to block the secretion of the glands known as “anticholinergics”, such as atropine;
• medicines containing ritonavir or cobicistat, because they may increase the level of desamethasone in the blood;
• other medicines containing phosphates. Your doctor will check your cornea at regular intervals.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
It is preferable that you do not use IPOKIMA during pregnancy unless your doctor considers it necessary.

Breastfeeding
If you are breastfeeding, it is preferable that you do not use IPOKIMA, unless your doctor considers it necessary.

Driving and operating machinery
During the use of IPOKIMA, temporary blurring of your vision may occur. If this
should happen, do not drive or operate machinery until your vision is clear again.

IPOKIMA 3 mg/ml + 1 mg/ml eye drops, multidose contains benzalkonium chloride
Benzalkonium chlorideis a preservative that may cause eye irritation or alteration of the
surface of the eye. Benzalkonium chloridecan be absorbed by contact lenses, and is known to cause
a change in the color of soft contact lenses. Therefore, avoid contact of this medicine in the
multidose form with soft contact lenses.

3. How to use IPOKIMA

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.

The recommended dose is:
One drop four times a day in the eye to be treated 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
IPOKIMA is not recommended in children and adolescents under 18 years of age.

Contact lens wearers
If you wear contact lenses, you must remove them before applying IPOKIMA multidose eye drops.
After applying IPOKIMA, you should wait 15 minutes before putting your contact lenses back in.
If you need to use IPOKIMA with soft contact lenses, use IPOKIMA eye drops in single-dose containers
because it is preservative-free.

If you are using IPOKIMA with other eye drops
Wait at least 10 minutes between administering IPOKIMA and administering another eye drop.

Instructions for use

Multidose eye drops
Make sure the bottle is intact.

• 1. Wash your hands and sit comfortably.
• 2. Remove the cap with a slight twist.
• 3. Tilt your head back.
• 4. With your fingers, gently pull down the lower eyelid of the affected eye.
• 5. Turn the bottle upside down and position the tip of the bottle close to the eye but without touching it. Do not touch the eye or eyelid with the tip of the dropper.
• 6. Apply slight pressure to the bottle so that only one drop goes inside the eye, then release the lower eyelid.
• 7. Close your eye and press with a finger on the corner of the affected eye, near the nose for 2 minutes.
• 8. Repeat the operation on the other eye as well, if your doctor has told you to do so.
• 9. Close the bottle immediately after use. Single-dose eye dropsMake sure the single-dose container is intact.
• 1. Wash your hands and sit comfortably.
• 2. Remove a vial from the strip and unscrew the cap with a slight twist.
• 3. Tilt your head back.
• 4. With your fingers, gently pull down the lower eyelid of the affected eye.

• 5. Turn the single-dose container upside down and position the tip of the vial close to the eye but without touching it. Do not touch the eye or eyelid with the tip of the vial.
• 6. Apply slight pressure to the vial so that only one drop goes inside the eye, then release the lower eyelid.
• 7. Close your eye and press with a finger on the corner of the affected eye, near the nose for 2 minutes.
• 8. Repeat the operation on the other eye as well, if your doctor has told you to do so.
• 9. Throw away the vial and any remaining contents. IPOKIMA single-dose eye drops should 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 that can cause
eye infections. Using contaminated eye drops can cause serious eye damage and
even resulting loss of vision.

If you use more IPOKIMA than you should
If you use more eye drops than prescribed by your doctor, it is unlikely to cause you any problems.
Apply the next dose normally but, if you feel it is necessary, talk to your doctor.
If you ingest the product, consult your doctor immediately, as side 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 the usual time, wait until the time of the next dose and apply the dose
normally.

If you stop treatment with IPOKIMA
If you have any doubts 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 ingredients (dexamethasone and netilmicin)
contained in IPOKIMA may occur.
Sufficient data are not available to establish the frequency of the individual effects listed.

Eye disorders

• increased eye pressure after 15-20 days of application in subjects suffering from glaucoma or predisposed to it;
• cataract formation following prolonged use of the medicine;
• development or worsening of viral infections caused by the Herpes Simplex (HSV) virus or by microorganisms (fungi);
• delayed healing processes.

In very rare cases (less than 1 in 10,000), some patients with severe damage to the clear layer in the front
part of the eye (cornea) have developed cloud-like spots on the cornea due to
calcium accumulation during treatment.

Immune system disorders

• Local allergic reaction: redness of the conjunctiva, burning and itching.

Hormonal problems

• Increased hair growth on the body (especially in women), weakness and muscle atrophy, purple stretch marks on the skin of the body, 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 and weight gain of the body and face (called “Cushing’s syndrome”)
  (see section 2 “Warnings and precautions”).
  In all these cases it is appropriate to discontinue treatment and consult a doctor for appropriate therapy.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist.
You can also report side effects directly through the national reporting system
at 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 at a temperature below 30°C.
Store in the original package to protect the medicine from light.
After first opening, the bottle must be stored at a temperature 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 designated space on the box.

IPOKIMA 3 mg/ml+1 mg/ml eye drops, solution (Single-dose containers of 0.3 ml)
Store the medicine at a temperature below 30°C.
Store in the original package to protect the medicine from light.
After first opening the aluminum pouch: store at a temperature 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 which is stated on the pack after “EXP”.
The expiry date refers to the last day of that month and the product that is intact and correctly
stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. 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 ingredients are: netilmicin sulfate equivalent to 3.00 mg of netilmicin and desamethasone sodium phosphate
equivalent to 1.00 mg of desamethasone.
The other ingredients are: sodium citrate, disodium 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 ingredients are: netilmicin sulfate equivalent to 3.00 mg of netilmicin and desamethasone sodium phosphate
equivalent to 1.00 mg of desamethasone.
The other ingredients are: sodium citrate, disodium phosphate dihydrate, disodium phosphate dodecahydrate,
water for injections.

Description of the appearance of IPOKIMA and contents of the pack
IPOKIMA is presented as eye drops, a clear and colorless solution for ophthalmic use.

IPOKIMA eye drops, solution (5 ml bottle)
The contents of the pack are a 5 ml bottle.

IPOKIMA eye drops, solution (single-dose containers of 0.30 ml)
5 single-dose containers of 0.30 ml of eye drops, solution contained in an aluminum sachet.
Packs of 20 single-dose containers.

Marketing Authorisation Holder
Doc Generici S.r.l. via Turati, 40 – 20121 Milano

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