Package leaflet: Information for the patient

BENDALINA 0.5% eye drops, solution

Bendazac lysine salt
Please read all of this leaflet carefully before you start 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, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What BENDALINA is and what it is used for

BENDALINA is an eye drop containing benzadac lysine salt, an active substance belonging to a class of medicines called topical non-steroidal anti-inflammatory drugs. BENDALINA is indicated as an adjunct in the treatment of cataract (presenile and senile degenerative cataract; juvenile cataract, diabetic cataract, opacification of the lens cortex or nucleus of different origin and nature).

2. What you need to know before using BENDALINA

Do not use BENDALINA

if you are allergic to the active substance 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 BENDALINA.
Single-dose container: since the eye drops in the single-dose container do not contain preservatives, the bottle must be discarded after use, even if only partially used. The eye drops must be used within two months of opening the aluminium package.
7 ml bottle: once the bottle has been opened, the eye drops should be used within one month.
In patients wearing soft contact lenses, it is advisable to administer the eye drops during periods when lenses are not worn.

Other medicines and BENDALINA
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
There is no evidence of clinically significant interactions with other drugs used in the treatment of the condition for which this medicine is indicated.

BENDALINA with food, drinks and alcohol
No contraindications are known.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before using this medicine.

Driving and using machines
BENDALINA does not affect the ability to drive or operate machinery.

BENDALINA contains benzalkonium chloride, which may cause eye irritation.
Avoid contact with soft contact lenses.
Remove contact lenses before application and wait at least 15 minutes before reinserting them.
Decolouring effects on soft contact lenses are known to occur.

3. How to use BENDALINA

Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Single-dose containers: according to the doctor's advice, 2 drops or half the content of a single-dose
container, three times daily, for each eye.
7 ml bottle: according to the doctor's advice, 2 drops, three times daily, for each eye.
Instill into the eye.
To use the single-dose container, follow the steps below.

Detach a single-dose container from the strip (see Figure A).
Holding the single-dose container in hand, shake the nozzle to detach it.
Open the single-dose container by rotating the tab while pulling at the same time (see Figure B).
By applying moderate pressure on the walls of the single-dose container, slowly release the medicine drop by drop in the prescribed dose.

Fig. A Fig. B

Two hands holding a small medical device and rotating it clockwise as indicated by a black circular arrow

Two hands separating a single dose from a medication blister pack by pressing on the ends of the packaging

If you have any doubts 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 everybody gets them.
Bendalina has no systemic effect. In case of conjunctival irritation, it may cause a mild and transient burning sensation upon instillation.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BENDALINA

Single-dose container: after opening the aluminium package, the single-dose eye drops must be used within two months.
7 ml bottle: must be used within one month after opening the bottle. The bottle must be closed immediately after each instillation.
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.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What BENDALINA contains
The active substance is bendazac lysine salt 500 mg.
The other components are:
Single-dose container: boric acid; L-lysine; hydroxypropylmethylcellulose; potassium chloride; water for
injectable preparations.
7 ml bottle: glycerol polyethylene glycol ricinoleate; potassium chloride; hydroxypropylmethylcellulose; boric acid; L-lysine; edetate disodium; benzalkonium chloride; water for injectable preparations.
Description of the appearance of BENDALINA and contents of the package
Single-dose containers: single-dose vial made of transparent polyethylene. Box of 30 single-dose vials of 0.3 ml.
7 ml bottle: white polyethylene bottle with dropper and screw cap.
Marketing Authorization Holder and Manufacturer
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milan, Italy
Manufacturer
0.3 ml single-dose eye drops
LABORATOIRE UNITHER Z.I. de La Guérie 50211 Coutances – France
7 ml bottle
TUBILUX PHARMA S.p.A. – Via Costarica, 20/22 – 00071 Pomezia (Rome) - Italy