FLOXISTILL 5 mg /Ml Eye Drops, Solution

Зміст інструкції

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

FLOXISTILL 5 mg/ml eye drops solution

Levofloxacin (as hemihydrate)
Generic medicine

Read this leaflet carefully before you start to use 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse.

Contents of this leaflet:

• 1. What FLOXISTILLeye drops are and what they are used for
• 2. What you need to know before you use levofloxacin eye drops
• 3. How to use FLOXISTILLeye drops
• 4. Possible side effects
• 5. How to store FLOXISTILLeye drops
• 6. Contents of the pack and other information

1. What is FLOXISTILL eye drops and what are they used for

A bottle of FLOXISTILL5 mg/ml eye drops contains 5 ml of solution with levofloxacin as the active
ingredient.
For the theoretical volume of one drop of 0.05 ml, the amount of active ingredient is 0.256 mg of
levofloxacin hemihydrate, equivalent to 0.250 mg of levofloxacin.
Levofloxacin is an antibiotic of the fluoroquinolone type (sometimes referred to briefly as quinolones). It
works by killing certain types of bacteria that can cause infections.
When levofloxacin is administered in the form of eye drops, it is used in children aged 1 year or older and in
adults to treat bacterial infections affecting the anterior surface of the eye. One type of infection in this area
is called bacterial conjunctivitis, which is an infection of the anterior lining of the eye (conjunctiva).

FLOXISTILLeye drops are not suitable for the treatment of eye infections that have spread to the deeper
layers of the eye linings or to the fluid inside the eyeball.
To treat these deeper and more serious infections, antibiotics must be used orally or by injection.

FLOXISTILLeye drops are not recommended for children under 1 year of age.
Contact your doctor if you do not feel better or if you feel worse after 5 days.

2. What you need to know before using levofloxacin eye drops, solution

Do not use FLOXISTILLeye drops, solution:

• if you are allergic to levofloxacin, to other quinolones, or to any of the other ingredients of this medicine (listed in section 6).
• if you have any doubts, ask your doctor or pharmacist before using this medicine.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using FLOXISTILL

• if you experience an allergic reaction, even after a single dose, stop using this medicine;
• if you notice a worsening of your eye symptoms during treatment, contact your doctor as soon as possible;
• if you do not see any signs of improvement within a certain treatment period agreed with your doctor, contact your doctor as soon as possible;
• generally, when an eye infection is present, no type of contact lenses should be used;
• Levofloxacin eye drops contains the preservative benzalkonium chloride, which can cause eye irritation.

As with all products containing the preservative benzalkonium chloride, you should not wear soft contact lenses during the use of this medicine, as it may cause irritation of the eye surfaces.

Children and adolescents
The special warnings and precautions for use of this medicine are the same for adults, adolescents and
children aged  1 year.

Other medicines and Levofloxacin eye drops, solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
In particular, before starting to use levofloxacin eye drops, tell your doctor or pharmacist if you are using
any other type of eye drops or ophthalmic ointment.
If you are using other eye drops, wait at least 15 minutes between applying levofloxacin eye drops and any
other eye drops.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Levofloxacin eye drops should be used during pregnancy only if the potential benefit justifies the risks
to the fetus.
Although very small amounts of levofloxacin pass into the blood and breast milk, respectively,
after application of the eye drops, it is very unlikely that the eye drops can harm the baby.
The doctor is aware of the potential risks and will decide if you can take FLOXISTILLeye drops .
Your fertility (the ability to start a pregnancy or have a child) is not impaired
when you apply levofloxacin following the instructions for use.

Driving and using machines.
Levofloxacin slightly alters the ability to drive vehicles or use machines.
If the use of the eye drops causes blurred vision, you should wait for this effect to pass before
driving vehicles or using machines.

3. How to use FLOXISTILL eye drops

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
FLOXISTILL eye drops are a product for ocular use and must be applied to the external surface
of the eye.
For patients over 1 year of age, the recommended dose is as follows:
DAYS 1 - 2

• Apply one or two drops to the affected eye(s) every two hours.
• Apply a maximum of 8 times a day. DAYS 3 - 5
• Apply one or two drops to the affected eye(s).
• Apply a maximum of 4 times a day.

No dose adjustment is necessary in elderly patients.
The usual total duration of the treatment cycle is five days. Your doctor will advise you for how long
to apply the drops.
If you are using any other medicine for your eyes, wait at least 15 minutes between applications of the various
eye drops.

Use in children and adolescents
No dosage adjustments are necessary in children aged ≥ 1 year and adolescents. The use of
levofloxacin is not recommended in children under 1 year of age.

Before applying the eye drops:
If possible, ask someone to apply the eye drops for you. Before applying the eye drops, ask the person who is
helping you to read these instructions together with you.

• 1) Wash your hands
• 2) Open the bottle. Pay particular attention to avoid touching the tip of the dropper bottle to the eye, the skin around the eyes, or your fingers. If this should accidentally happen, you should inform your doctor or pharmacist, so that you can obtain a clean bottle. Sit up and tilt your head back, or lie on your back.

• 3) Position the tip of the bottle near your eye.

• 4) Pull down your lower eyelid and look upwards.

• 5) Gently press on the bottle and let one drop fall into the space between your lower eyelid and your eye.

• 6) Close your eye and press with your finger on the inner corner of your eye for about one minute. This may help prevent the eye drops from draining into the tear duct.

• 7) Remove any residual solution from the skin around your eye.

If another drop is needed and if you need to treat both eyes, repeat steps 3 to 6.
Reapply the cap and close the bottle tightly.
FLOXISTILL eye drops should not be injected into the inner part of the eyeball.

If you use more FLOXISTILL eye drops than you should
If you use more levofloxacin eye drops than you should, rinse your eye(s) with water and inform your doctor or
pharmacist.

If you forget to use FLOXISTILL eye drops
If you forget to use the eye drops, apply the next dose as soon as you remember. Do not use a double
dose to make up for the missed dose.

If you accidentally swallow FLOXISTILL eye drops
The amount of levofloxacin contained in the supplied bottle is too small to cause adverse effects.
However, if you are concerned, consult your doctor or pharmacist, who will inform you about any measures
that may be necessary.

If you stop using FLOXISTILL eye drops before completing the course,it may delay the healing process.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In about one in ten people who use levofloxacina eye drops, a side effect occurs. Most side effects only affect the eye and do not last long. If you experience any serious or persistent side effect, you should stop using the levofloxacina eye drops and consult your doctor urgently.
The frequency of possible side effects is defined as follows:

Very rarely, this medicine can cause serious allergic reactions.
The following symptoms may occur even after application of a single dose of levofloxacina eye drops:

• swelling and a feeling of tightness in the throat,
• difficulty breathing. In rare cases, other allergic reactions may develop. The symptoms of these reactions are:
• worsening of redness and itching of the eyes
• sudden increase or appearance of swelling of the eyelids. If any of these symptoms occur, stop using levofloxacina eye drops and consult a doctor immediately.

Common side effects (affect 1 to 10 users in 100):

• burning sensation in the eye,
• reduced vision or mucus in the eye.

Uncommon side effects (affect 1 to 10 users in 1,000):

• stinging or irritation of the eyes,
• eye pain,
• dry or inflamed eyes,
• swelling or redness (bloodshot eyes) of the conjunctiva (the clear membrane covering the front of the eye) or eyelid,
• unusual light sensitivity,
• itchy eyes,
• crusty eyelids,
• headache,
• skin rash around the eyes,
• nasal congestion or runny nose.

Rare side effects (affect 1 to 10 users in 10,000):

• allergic reactions, e.g. skin rash

Very rare side effects (affect less than 1 in 10,000 users):

• swelling and a feeling of tightness in the throat
• difficulty breathing

Additional side effects in children and adolescents
It is expected that the frequency, type and severity of side effects in children and adolescents will be
the same as in adults.
If any side effect occurs, including those not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 FLOXISTILL eye drops solution

Keep this medicine out of the sight and reach of children.
Keep the bottle tightly closed.
Do not use this medicine after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month. Do not use this medicine if you notice that the plastic coating
around the cap and neck of the bottle is missing or damaged before starting a new
bottle.
LEvofloxacin eye drops must be used within 28 days of first opening the bottle. The remaining solution
must be returned to the pharmacist for safe disposal.

To prevent infections, you must discard the bottle 28 days after first opening and use a new one.
Do not dispose of any medicine in the drain or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FLOXISTILL eye drops, solution contains

• The active ingredient is levofloxacin (as hemihydrate) 5 mg/ml.
• The other components of FLOXISTILL are: benzalkonium chloride, sodium chloride, sodium hydroxide or hydrochloric acid solution and water for injections.

Description of the appearance of FLOXISTILL eye drops, solution and contents of the pack
Light yellowish-green aqueous solution.
5 ml of solution in a 5 ml LDPE (low density polyethylene) bottle with LDPE droppers and a
HDPE (low density polyethylene) or HDPE/ LDPE cap.

Marketing Authorisation Holder
Bruschettini s.r.l.
Via Isonzo, 6
16147 GENOVA
ITALY

Manufacturer
RAFARM S.A.,
Thesi Pousi-Xatzi Agiou Louka, Paiania Attiki 19002
Greece

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
ITALY:FLOXISTILL eye drops solution
PORTUGAL:Levofloxacina Bruschettini