TOBRAMICINA 0.3% Eye drops, solution

Зміст інструкції

1. Tobramicina EG 0,3% eye drops, solution
   1. What is Tobramicina EG and what is it used for
   2. What you need to know before using Tobramicina EG
   3. How to use Tobramicina EG
   4. Possible side effects
   5. How to store Tobramicina EG
   6. Contents of the pack and other information

Tobramicina EG 0,3% eye drops, solution

Generic medicine

Read this leaflet carefully before 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 only for you. Do not give it to other people, even if their symptoms are the
same as yours, as it could be dangerous.
If any side effects occur, including those not listed in this leaflet, tell your
doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Tobramicina EG and what is it used for

Tobramicina EG 0.3% eye drops, solution contains the active ingredient tobramycin, an antibiotic of the
aminoglycoside family, which acts against various bacteria that can cause eye infections.
Tobramicina EG is used in adults and children from one year of age to treat eye infections
and related structures, caused by bacteria sensitive to tobramycin: acute, sub-acute and
chronic catarrhal inflammations of the conjunctiva (the transparent membrane that lines the white part of the eye and the inside of the
eyelids); eyelid inflammations; corneal inflammations (the transparent membrane that covers the
colored part of the eye); lacrimal sac inflammations.
Tobramicina EG is also used before and after surgical interventions on the anterior part of the eye.

2. What you need to know before using Tobramicina EG

Do not use Tobramicina EG
if you are allergic to tobramycin or any of the other ingredients of this medicine (listed in
section 6);

Warnings and precautions

• Consult your doctor before using Tobramicina EG.
• 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 itching or redness of the skin to severe general allergic reactions (anaphylactic reactions) or severe skin reactions. If you experience these symptoms during the use of Tobramicina EG, stop treatment and consult your doctor. Also, be aware that this allergic sensitivity may occur even with other antibiotics belonging to the same class of aminoglycosides, administered both to the eyes and systemically (by injection).
• Consult your doctor if you have or have ever had conditions such as myasthenia gravis or Parkinson's disease. These types of antibiotics can worsen muscle weakness.
• In patients who have taken tobramycin systemically (by injection), serious adverse effects on the nervous system, ears, and kidneys have occurred. Be careful and consult your doctor if you are using Tobramicina EG together with tobramycin taken systemically (by injection).
• As with other antibiotics, if you use Tobramicina EG for a long period of time, you may become more susceptible to eye infections, even those caused by fungi. If your symptoms worsen or suddenly reappear, consult your doctor.
• Do not wear contact lenses during the treatment of an eye infection (see also the section “Tobramicina EG contains benzalkonium chloride”).

Other medicines and Tobramicina EG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.

Incompatibilities
The tyloxapol component contained in the eye drops is incompatible with tetracycline. Do not use
Tobramicina EG together with other eye products that contain tetracycline.

Pregnancy, breastfeeding and fertility
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
Data relating to the application of tobramycin to the eyes in pregnant women are unavailable or are
limited. Studies in animals have shown reproductive toxicity. Tobramycin should
be used during pregnancy only if strictly necessary.
Breastfeeding
It is not known whether tobramycin is excreted in breast milk after application to the eyes. Tobramycin is
excreted in breast milk after systemic administration (by injection). The risk to infants cannot
be excluded. Ask your doctor, who will decide whether you should stop breastfeeding or
stop therapy with tobramycin.
Fertility
No studies have been conducted to evaluate the effect on human fertility of topical
ocular administration of Tobramicina EG eye drops.

Driving and operating machinery
Tobramicina EG does not alter or transiently alters the ability to drive vehicles and operate machinery.
For a certain period of time after instillation of Tobramicina EG, blurred vision or other visual disturbances may occur which can affect the ability to drive vehicles and
operate machinery. If you experience these effects, wait until your vision returns to normal before driving
vehicles and operating machinery.

Tobramicina EG contains benzalkonium chloride
This medicine contains 0.5 mg of benzalkonium chloride per vial. Benzalkonium chloride 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 can also cause eye irritation, especially if you have dry eyes or corneal disorders (the most superficial transparent layer of the eye). If you experience an abnormal sensation in your eye, burning or pain after using this medicine, talk to your doctor.

Tobramicina EG contains boric acid
This medicine should not be administered to children under 2 years of age without a doctor's indication,
as it contains boron and may damage fertility in the future.

3. How to use Tobramicina EG

Use Tobramicina EG only for instillation into the eyes.
Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your doctor
or pharmacist.

Recommended dose
Instill two drops into the conjunctival sac four times a day in acute forms and three times a day in
chronic forms, as directed by your doctor. Use the product for the period of time
specified by your doctor.
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 or ophthalmic ointments, allow at least 5 minutes to pass between the instillation of each
medicine. Ophthalmic ointment should be used last.

Use in children and adolescents
Do not use Tobramicina EG in children under 1 year of age as safety and efficacy have not been established in this population
and no data are available.
Tobramicina EG can be used in children from one year of age and older at the same doses as prescribed for
adults.

Due to the content of boric acid,for children between 1 and 2 years of age do not exceedthe number

maximum of drops that can be administered in a day as higher dosages may

compromise future fertility.

How to apply Tobramicina EG

1 2

• Wash your hands
• Take the Tobramicina EG bottle and unscrew the cap.
• If you are opening the bottle for the first time, remove the ring detached from the cap before using the product.
• Hold the bottle upside down between your thumb and middle finger.
• Tilt your head back. Lower your eyelid with a clean finger to form a pouch between the eyelid and the eye. The drop should be instilled into this area (figure 1).
• Bring the tip of the bottle close to the eye.
• Do not touch the eye, eyelid, surrounding areas or other surfaces with the dropper tip to avoid infecting the drops remaining in the bottle.
• Gently press the base of the bottle to release one drop of Tobramicina EG at a time.
• Do not squeeze the bottle: it is designed so that only gentle pressure on the bottom is sufficient (figure 2)
• If you are instilling drops into both eyes, repeat the same operation for the other eye.
• Immediately replace the cap after use, screwing it on tightly.
• If a drop does not enter the eye, try again.

If you use more Tobramicina EG than you should
If you use more medicine than you should, immediately wash your eye with lukewarm water. However, no adverse effects are expected.
Do not use the medicine again until the time scheduled for the next administration.

If you forget to use Tobramicina EG
If you forget to use Tobramicina EG, do not worry and instill 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 administration schedule.
Do not use a double dose to make up for the missed dose.

If you stop using Tobramicina EG
It is important to respect the duration of treatment indicated by your doctor. If you stop using this medicine
too soon, the infection may not be completely cured and the symptoms of the infection may
recur or worsen. You may also develop antibiotic resistance.
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 Tobramicina EG, the following side effects have been reported.
Common side effects (may affect up to 1 in 10 people):

• Effects on the eyes: eye discomfort, redness

Uncommon side effects (may affect up to 1 in 100 people):

• Effects on the eyes: inflammation of the surface of the eye, damage to the cornea (transparent membrane covering the colored part of the eye), impaired vision, blurred vision, redness of the eyelids, swelling of the eye and eyelid, eye pain, dry eye, eye secretion, eye itching, increased tearing.
• General side effects: allergy (hypersensitivity), headache, hives, skin inflammation (dermatitis), decreased growth or number of eyelashes, loss of skin color, itching, dry skin.

Side effects of unknown frequency (frequency cannot be estimated based on available data):

• Effects on the eyes: ocular allergy, eye irritation, eyelid itching.
• General side effects: severe allergic reactions, skin rash, severe skin rashes (Stevens-Johnson Syndrome, erythema multiforme).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. 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 Tobramicina EG

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 package and the bottle after Exp.
The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
After 28 days from first opening, the medicine must be discarded, even if not used
completely.
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 Tobramicina EG contains
The active ingredient is tobramycin. 1 vial contains 15 mg of tobramycin.
The other ingredients are tyloxapol, benzalkonium chloride, boric acid, anhydrous sodium sulfate, sodium
chloride, water for injections.

Description of the appearance of Tobramicina EG and contents of the pack
Tobramicina EG is a clear, colorless solution eye drop in a polyethylene bottle equipped with
dropper. Each bottle contains 5 ml of eye drops.
Tobramicina EG is available in packs of 1 bottle.

Marketing Authorisation Holder
EG S.p.A., Via Pavia 6 – 20136 Milan

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