VISUCOMBIDEX 0.3% + 0.1% Krople do oczu, roztwór

Treść ulotki

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

Visucombidex 3 mg/ml + 1 mg/ml eye drops, solution, 3 mg/ml + 1 mg/ml eye drops, solution in single-dose container

tobramycin and dexamethasone
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 their symptoms are the same as yours, as it could 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 Visucombidex is and what it is used for
• 2. What you need to know before you use Visucombidex
• 3. How to use Visucombidex
• 4. Possible side effects
• 5. How to store Visucombidex
• 6. Contents of the pack and other information

1. What is Visucombidex and what is it used for

Visucombidex eye drops contain a combination of two medicines: desamethasone, which belongs to the class of corticosteroids and has an anti-inflammatory effect, and tobramycin, which belongs to the class of aminoglycoside antibiotics and acts against various bacteria that can cause eye infections.
Visucombidex eye drops are indicated in adults and children from two years of age for the treatment of eye inflammation when a corticosteroid is necessary and when an eye infection exists or there is a risk of eye infections.

2. What you need to know before using Visucombidex

Do not use Visucombidex:

• if you are allergic (hypersensitive) to tobramycin, dexamethasone, or any of the other ingredients of this medicine (listed in section 6); If you suffer from:
• inflammation of the cornea (the transparent membrane covering the colored part of the eye) caused by the Herpes simplex virus (Herpes simplex keratitis) if you suffer from eye infections caused by viruses (acute Herpes simplexinfections and most other viral diseases of the cornea), except in cases where specific medicines (chemotherapeutic agents) are used in association for the treatment of the Herpesvirus or if you have inflammation of the membrane of the eye called “conjunctiva” (conjunctivitis) and the cornea with lesions (ulcerative keratitis) even in the early stages. If you suffer from inflammation of a part of the eye called “cornea” caused by the Herpesvirus (viral herpetic keratitis), Visucombidex will only be prescribed under strict control of the ophthalmologist;
• smallpox vaccination, chickenpox or other viral infections of the cornea and conjunctiva (the transparent membrane covering the white part of the eye and the inside of the eyelids)
• eye infections from fungi (eye mycosis) or untreated parasitic eye infections.
• eye infections from mycobacteria (eye tuberculosis)
• high pressure in the eyes
• eye inflammations with pus production (acute purulent ophthalmias, purulent conjunctivitis and purulent and herpetic blepharitis) which may be masked or aggravated by corticosteroids
• if you suffer from an infection of the eyelid characterized by a swelling similar to a pimple or abscess (hordeolum).

Warnings and precautions
Talk to your doctor or pharmacist before using Visucombidex.

• In some patients, sensitization (allergic reaction) to aminoglycoside antibiotics such as tobramycin, administered to the eyes, may occur. This allergic reaction can range from localized skin itching or redness to severe general allergic reactions (anaphylactic reactions) or severe skin reactions. If these symptoms occur during the use of Visucombidex eye drops, stop treatment and see your doctor. Also, be aware that this allergic sensitivity may also occur with other antibiotics belonging to the same class of aminoglycosides, administered both to the eyes and systemically (by injection).
• Talk to your doctor if you have or have ever had conditions such as myasthenia gravis or Parkinson's disease. These types of antibiotics may worsen muscle weakness.
• In patients who have taken aminoglycoside antibiotics, such as tobramycin, systemically (by injection), serious toxic effects have occurred at the level of the nervous system, ears and kidneys. Be careful and see your doctor if you are using Visucombidex together with aminoglycoside antibiotics taken systemically (by injection).
• Application to the eyes for a long period of corticosteroids can cause increased pressure in the eyes (including a disease called glaucoma, with damage to the optic nerve), vision problems and cataract formation (clouding of the lens inside the eye, called the crystalline lens). If you use Visucombidex eye drops for a long time, you should check your eye pressure regularly and frequently. This is particularly important in children, as the risk of increased eye pressure caused by corticosteroids may be greater in children under six years of age and may appear sooner than it appears in adults. Ask your doctor for advice, especially if you need to use Visucombidex eye drops in children. The risk of increased eye pressure induced by corticosteroids and/or cataract formation is increased in predisposed patients (e.g. patients with diabetes). If Visucombidex is used for a child, the doctor will carefully assess the frequency and duration of treatment and monitor eye pressure at the beginning of therapy with Visucombidex (See also “Warnings and precautions”).
• Talk to your doctor if you feel swelling and weight gain around the trunk and face as these are usually the first signs 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 Visucombidex. Talk to 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.
• With the use of Visucombidex eye drops, you may become more susceptible to eye infections caused by bacteria, viruses, fungi or parasites: if your symptoms worsen or recur suddenly, see your doctor.

suddenly, see your doctor.

• If you have a corneal ulcer that does not heal, stop therapy and see your doctor.
• Talk to your doctor before using this medicine if you have diseases that cause thinning of the tissues of the eye, as perforation may occur with the administration of corticosteroids to the eyes.
• Corticosteroids applied to the eyes can slow down the healing of corneal wounds. NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) applied to the eyes are also known to slow down or delay healing. The concomitant application of NSAIDs and corticosteroids to the eyes may potentially increase problems with eye wound healing (see section “Other medicines and Visucombidex”).
• Do not wear contact lenses during the treatment of an eye inflammation or infection.

Read also the section “Visucombidex eye drops contains benzalkonium chloride”.

• Use Visucombidex eye drops under the direct supervision of your doctor.
• Use Visucombidex eye drops only for application to the eyes.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Visucombidex 3 mg/ml + 1 mg/ml eye drops, solution in a multidose container must not be injected

For athletes:the use of the drug without therapeutic necessity constitutes doping and
may still result in positive doping tests.
If you use Visucombidex for prolonged treatments for more than 10 days, your doctor will subject you to frequent
checks of eye pressure.
Prolonged use of corticosteroids, such as dexamethasone, may cause:

• a disease due to increased pressure in the eye (glaucoma);
• damage to the nerves of the eye;
• visual defects (of acuity and visual field);
• clouding of the lens of the eye (cataract).

Prolonged use of corticosteroids may promote the establishment of eye infections.
It is recommended not to apply Visucombidex for more than one consecutive month.
Prolonged use of antibiotics, such as tobramycin, may promote the development of resistant bacteria.
If you do not notice improvements within a reasonable period of time, your doctor will tell you to stop using
Visucombidex and will prescribe you appropriate therapy.

Other medicines and Visucombidex
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Tell your doctor especially if you are taking other medicines for the eyes that contain
drugs belonging to the class of NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). The concomitant application
of NSAIDs and corticosteroids to the eyes may potentially increase problems with
healing of corneal wounds.
Talk to your doctor if you are using ritonavir or cobicistat, as they may increase the level of
dexamethasone in the blood.
Some medicines may increase the effects of Visucombidex and your doctor may want to
keep you under close observation if you are taking these medicines (including some medicines for
the treatment of HIV: ritonavir, cobicistat).
Incompatibilities
The tyloxapol component contained in Visucombidex eye drops is incompatible with tetracycline.
Do not use Visucombidex eye drops together with other products for the eyes that contain
tetracycline.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Data relating to the use of tobramycin and dexamethasone in the eyes in pregnant women do not exist
or are limited. Studies in animals have shown reproductive toxicity
following systemic administration (by mouth or by injection) of dexamethasone and tobramycin.
Visucombidex should be used during pregnancy only if strictly necessary. Talk to
your doctor, who will decide whether you should use Visucombidex during pregnancy.
Breastfeeding
It is not known whether tobramycin or dexamethasone are excreted in breast milk after
administration to the eyes. Tobramycin is excreted in breast milk after systemic administration
(by injection).
There are no data on the passage of dexamethasone into human breast milk. The risk to
infants cannot be excluded. Talk to your doctor, who will decide whether you should stop
breastfeeding or stop therapy with Visucombidex.
If you are breastfeeding, your doctor will prescribe Visucombidex with caution and under his direct
supervision, because the safety and efficacy in children under two years of age has not been demonstrated
(See also “Use in children”).
Fertility
No studies have been conducted to evaluate the effect on human fertility of topical ocular administration of tobramycin.
Clinical data to evaluate the effect of ocular administration of dexamethasone on male or female fertility
are limited.

Driving and operating machinery
For a certain period of time after instillation of Visucombidex eye drops, it is possible that
blurred vision or other visual disturbances may occur that may impair your ability
to drive vehicles and operate machinery. If you experience these effects, wait until they return
to normal before driving vehicles or operating machinery.

Visucombidex 3 mg/ml + 1 mg/ml eye drops, solution in a multidose container contains benzalkonium
chloride.
The medicine contains benzalkonium chloride 0.1 mg per 1 ml equivalent to 0.50 mg/ml which may
be absorbed by soft contact lenses and may lead to a change in their color.
Remove contact lenses before using this medicine and wait 15 minutes before re-applying them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or
corneal disorders (the most superficial layer of the eye). If you experience an abnormal sensation in the eye, burning or pain after using this medicine, talk to your doctor.

3. How to use Visucombidex

Apply Visucombidex eye drops only to the eyes.
Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is:
1 or 2 drops 4-5 times a day as prescribed by your doctor.
Use the medicine for the period of time that your doctor has prescribed.
The following operation is useful to limit the amount of medicine that passes into the blood after
application to the eyes: keep the eyelid closed and at the same time apply gentle
pressure with a finger on the inner corner of the eye near the nose for at least 2 minutes.
If you are using other eye drops, allow at least 5 minutes to pass between the instillation of each medicine.

Use in children
Do not use Visucombidex eye drops, solution in children under two years of age given that in
this population safety and efficacy have not been established and no data are available.
Visucombidex eye drops can be used in children from two years of age onwards at the same doses
as provided for adults.

How to apply Visucombidex eye drops

• Wash your hands.
• Hold the bottle/container upside down between your thumb and middle finger.
• Tilt your head backwards. Lower the eyelid with a clean finger to form a pouch between the
• Bring the tip of the bottle/container close to the eye.
• Do not touch the eye, eyelid, surrounding areas or other surfaces with the tip of the bottle/container to avoid infecting the remaining drops.
• Gently press the base of the bottle/container releasing one drop of Visucombidex at a time.
• If you instill drops in both eyes, repeat the same operation for the other eye.
• Eye drops, solution in a multi-dose bottle: Immediately replace the cap after use, screwing it on tightly.
• Eye drops, solution in single-dose containers: Throw away the container and any remaining contents.
• If a drop does not enter the eye, try again.

If you use more Visucombidex than you should
Considering that the medicine is applied to the eyes, it is difficult for cases of
overdose to occur. However, if this should happen, wash the eye thoroughly with running water.
Do not use the medicine again until the time scheduled for the next administration.

If you forget to use Visucombidex
If you forget to use Visucombidex, do not worry and apply it as soon as you remember. However, if it is
almost time to administer the next dose, skip the missed dose and return to the regular
schedule of administration.
Do not use a double dose to compensate for forgetting the dose.
If you have any doubts about 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.
With the use of Visucombidex eye drops, the following side effects have been reported.
Uncommon (may affect up to 1 in 100 people)

• increased pressure in the eye(s), eye pain, eye itching, eye discomfort, eye irritation.

Rare ( may affect up to 1 in 1,000)

• inflammation of the surface of the eye (keratitis), eye allergy, blurred vision, dry eye, eye redness, unpleasant taste.

Not known (frequency cannot be estimated from available data)
swelling of the eyelids, redness of the eyelids, increased pupil size,
increased tear production, blurred vision, increased hair growth on the body
(especially in women), muscle weakness and 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”) severe allergic reactions (hypersensitivity), dizziness, headache, nausea, abdominal discomfort, rash, severe skin reactions (erythema multiforme), swelling of the
face, itching.
If you are taking tobramycin at the same time both locally and systemically (by mouth or
by injection), your doctor will monitor you.

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 through the
national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Visucombidex

Keep this medicine out of the sight and reach of children.
Eye drops: store at a temperature below 25°C. Do not freeze.
Do not use this medicine after the expiry date which is stated on the pack after “Expiry”.
The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.

Single-dose containers
The medicine must be used immediately after opening the single-dose container. Discard any
residue. Use the medicine within 28 days of opening the aluminium sachet.

5 ml bottle
The medicine must be used within 28 days of first opening the bottle.
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 Visucombidex contains

Visucombidex 3 mg/ml + 1 mg/ml eye drops, solution in single-dose container

• The active ingredients are: tobramycin and dexamethasone sodium phosphate. One single-dose container contains 0.75 mg of tobramycin and 0.329 mg of dexamethasone sodium phosphate, equivalent to dexamethasone 0.25 mg.
• The other ingredients are: tyloxapol, disodium edetate, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH adjuster), water for injections.

Visucombidex 3 mg/ml + 1 mg/ml eye drops, solution in multi-dose bottle

• The active ingredients are: tobramycin and dexamethasone sodium phosphate. One 5 ml bottle contains 15 mg of tobramycin and 6.58 mg of dexamethasone sodium phosphate, equivalent to dexamethasone 5 mg.
• The other ingredients are: tyloxapol, benzalkonium chloride, disodium edetate, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH adjuster), water for injections.

1 ml of eye drops contains 3 mg of tobramycin and 1 mg of dexamethasone.

Description of the appearance of Visucombidex and contents of the pack
Visucombidex is presented as eye drops, solution.
The contents of the pack are:

• Pack of 20 single-dose containers of 0.25 ml.
• Pack of 1 dropper bottle of 5 ml.

Marketing Authorisation Holder
Visufarma S.p.A.
Via Alberto Cadlolo, 21
00136 Rome

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