Package leaflet: Information for the patient

Tobramycin OmniVision 0.3% eye drops, solution

tobramycin
Generic medicine
Please read all of this leaflet carefully before taking 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 others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Tobramycin OmniVision is and what it is used for

Tobramycin OmniVision contains the active substance tobramycin, an antibiotic belonging to the aminoglycoside family, which acts against various bacteria that can cause eye infections.
This medicine is used in adults and children from two years of age onwards to treat infections of the eye and associated structures caused by bacteria sensitive to tobramycin:
acute, subacute, and chronic catarrhal inflammations of the conjunctiva (the transparent membrane covering the white part of the eye and the inner surface of the eyelids); eyelid inflammations; corneal inflammations (the transparent membrane covering the colored part of the eye); lacrimal sac inflammations.
Tobramycin OmniVision is also used before and after surgical procedures on the front part of the eye.

2. What you need to know before using Tobramycin OmniVision

Do not use Tobramycin OmniVision
if you are allergic to tobramycin or to any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Tobramycin OmniVision.
In some patients, sensitization (allergic reaction) to aminoglycoside antibiotics such as tobramycin administered in the eyes may occur. This allergic reaction may range from localized itching or redness of the skin to severe generalized allergic reactions (anaphylactic reactions) or serious skin reactions. If you experience these symptoms while using Tobramycin OmniVision, stop treatment and consult your doctor. Also note that this allergic sensitivity may occur with other antibiotics belonging to the same aminoglycoside class, whether administered in the eyes or systemically (by injection).
Consult your doctor if you have or have ever had conditions such as myasthenia gravis or Parkinson’s disease. Antibiotics of this type may worsen muscle weakness.
In patients who have received tobramycin systemically (by injection), serious adverse effects affecting the nervous system, ears, and kidneys have occurred. Be cautious and consult your doctor if you are using Tobramycin OmniVision together with systemic tobramycin (by injection).
As with other antibiotics, if you use Tobramycin OmniVision for a prolonged period, you may become more susceptible to eye infections, including those caused by fungi. If your symptoms worsen or suddenly reappear, consult your doctor.
Do not wear contact lenses during treatment for an eye infection (also read section “Tobramycin OmniVision 0.3% eye drops, solution contains benzalkonium chloride”).
Other medicines and Tobramycin OmniVision
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Incompatibilities
The ingredient tyloxapol is incompatible with tetracycline. Do not use Tobramycin OmniVision together with other eye products containing tetracycline.
Tobramycin OmniVision with food and alcohol
Not applicable.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Data on the use of tobramycin in the eyes during pregnancy are lacking or limited in number. Animal studies 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 ocular administration. Tobramycin is excreted in breast milk following systemic administration (by injection). The risk to infants cannot be ruled out. Consult your doctor, who will decide whether you should discontinue breastfeeding or discontinue tobramycin therapy.
Fertility
No studies have been conducted to evaluate the effect of topical ocular administration of Tobramycin OmniVision on human fertility.
Driving and using machines
Tobramycin OmniVision does not affect or only transiently affects the ability to drive and use machines.
For a certain period after instillation of Tobramycin OmniVision, blurred vision or other visual disturbances may occur, which could affect your ability to drive or use machines. If you experience these effects, wait until your vision clears before driving or using machines.
Tobramycin OmniVision contains benzalkonium chloride
This medicine contains 2.95 micrograms of benzalkonium chloride per drop, equivalent to 0.1 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their color. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outermost layer of the eye). If you experience an unusual sensation in the eye, burning, or pain after using this medicine, speak with your doctor.
Tobramycin OmniVision contains boric acid
This medicine must not be administered to children under 2 years of age, as it contains boron and may impair future fertility.

3. How to use Tobramycin OmniVision

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is: two drops, four times a day in acute conditions, and three times a day in chronic conditions, as prescribed by your doctor. Use the product for the length of time specified by your doctor.
Instill into the eye.

The following procedure is useful to limit the amount of medicine that passes into the bloodstream after application to the eye:

keep the eyelid closed and, at the same time, apply gentle pressure with a finger to the inner corner of the eye near the nose for at least 2 minutes.
If you are using other eye drops or ophthalmic ointments, wait at least 5 minutes between instilling each medicine. The ophthalmic ointment should be used last.

Use in children and adolescents
Do not use Tobramycin OmniVision in children under two years of age, as safety and efficacy have not been established in this population and no data are available.
Tobramycin OmniVision may be used in children from two years of age onwards at the same doses as recommended for adults.

If you use more Tobramycin OmniVision than you should
If you use more medicine than you should, immediately rinse the eye with lukewarm water. However, no adverse effects are expected.
Do not use the medicine again until the time for your next scheduled dose.

If you forget to use Tobramycin OmniVision
If you forget to use Tobramycin OmniVision, do not worry; instill it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and return to your regular dosing schedule.
Do not use a double dose to make up for the forgotten dose.

If you have any questions about how to use 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.
The following side effects have been reported with the use of Tobramycin OmniVision.

Common side effects (may affect up to 1 in 10 people)

Eye-related effects: eye discomfort, eye redness.

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

Eye-related effects: inflammation of the surface of the eye, corneal damage (the transparent membrane covering the coloured part of the eye), visual disturbance, blurred vision, eyelid redness, eye and eyelid swelling, eye pain, dry eye, eye discharge, eye itching, increased tearing.
General side effects: allergy (hypersensitivity), headache, urticaria, skin inflammation (dermatitis), reduced growth or number of eyelashes, loss of skin pigmentation, itching, dry skin.

Side effects of unknown frequency (frequency cannot be estimated from the available data)

Eye-related effects: eye allergy, eye irritation, eyelid itching.
General side effects: severe allergic reactions, skin rash, severe skin reactions (Stevens-Johnson syndrome, erythema multiforme).

Reporting of side effects
If you experience any side effect, 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 website [insert address].
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tobramycin OmniVision

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 25°C.
The product must not be used more than 30 days after first opening the container.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tobramycin OmniVision contains

The active substance is tobramycin. 1 ml of eye drops contains 3 mg of tobramycin.
The other components are: tyloxapol, boric acid, anhydrous sodium sulfate, sodium chloride, benzalkonium chloride, purified water.

Description of the appearance of Tobramycin OmniVision and contents of the pack
5 ml bottle made of neutral low-density polyethylene, with dropper, sealed with a cap made of
polypropylene.
Marketing Authorization Holder
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milan, Italy
Manufacturer
Bruschettini S.r.l.
Via Isonzo, 6
16147 Genoa, Italy