Floxistill
ItalyPackage leaflet: Information for the user
FLOXISTILL 5 mg/ml eye drops solution
Levofloxacin (as hemihydrate)
Generic medicine
Please read all of this leaflet carefully before 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, pharmacist, or nurse.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours.
- If you experience any side effect, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Contents of this leaflet:
- What FLOXISTILL eye drops is and what it is used for
- What you need to know before using levofloxacin eye drops
- How to use FLOXISTILL eye drops
- Possible side effects
- How to store FLOXISTILL eye drops
- Contents of the pack and other information
1. What FLOXISTILL eye drops is and what it is used for
A bottle of FLOXISTILL 5 mg/ml eye drops contains 5 ml of solution with levofloxacin as the active substance.
For a theoretical drop volume of 0.05 ml, the amount of active substance 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 as eye drops, it is used in children aged 1 year and older and in adults to treat bacterial infections affecting the front surface of the eye. One type of infection in this area is called bacterial conjunctivitis, which is an infection of the outer lining of the eye (conjunctiva).
FLOXISTILL eye drops are not suitable for the treatment of ocular infections that have spread into deeper layers of the eye tissues or into the fluid inside the eyeball.
For the treatment of these deeper and more serious infections, antibiotics taken by mouth or by injection are required.
FLOXISTILL eye drops are not recommended for children under 1 year of age.
If you do not feel better or if you feel worse after 5 days, consult your doctor.
2. What you need to know before using levofloxacine eye drops, solution
Do not use FLOXISTILL eye 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, consult 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 worsening of eye symptoms during treatment, contact your doctor as soon as possible;
- if you do not see any signs of improvement within the treatment period agreed with your doctor, contact your doctor promptly;
- generally, when an eye infection is present, no type of contact lenses should be worn;
- Levofloxacin eye drops contain the preservative benzalkonium chloride, which may cause eye irritation.
As with all products containing the preservative benzalkonium chloride, soft contact lenses must not be worn 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
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
In particular, before starting to use levofloxacin eye drops, inform 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 the application of levofloxacin eye drops and any other eye drops.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, 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 may pass into the bloodstream and breast milk, respectively, after application of the eye drops, it is very unlikely that the eye drops could cause harm to the infant.
Your doctor is aware of the potential risks and will advise you whether you can use FLOXISTILL eye drops.
Your fertility (the ability to conceive or father a child) is not impaired when levofloxacin is used according to the instructions.
Driving and using machines
Levofloxacin may slightly affect the ability to drive or operate machinery.
If use of the eye drops causes blurred vision, you must wait until this effect has passed before driving or operating machinery.
3. How to use FLOXISTILL eye drops
Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
FLOXISTILL eye drops is a product for ocular use and must be applied to the outer surface of the eye.
For patients over 1 year of age, the recommended dosage is as follows:
DAYS 1 - 2
- Apply one or two drops into the affected eye(s) every two hours.
- Apply a maximum of 8 times per day.
DAYS 3 - 5
- Apply one or two drops into the affected eye(s).
- Apply a maximum of 4 times per day.
No dose adjustment is required for elderly patients.
The usual total duration of treatment is five days. Your doctor will advise you on how long to continue using the drops.
If you are using any other eye medication, wait at least 15 minutes between each application of different eye drops.
Use in children and adolescents
No dosage adjustments are necessary for 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 help you apply the eye drops. Before application, ask the person assisting you to read these instructions together with you.
-
Wash your hands.
-
Open the bottle. Take particular care to avoid the dropper tip touching the eye, the skin around the eyes, or your fingers. If this should accidentally happen, inform your doctor or pharmacist so that you can obtain a clean bottle.
Sit down and tilt your head backwards, or lie down on your back.
- Hold the tip of the bottle close to your eye.
- Pull down the lower eyelid and look upwards.
- Gently squeeze the bottle to release one drop into the space between the lower eyelid and the eye.
- Close your eye and press with your finger on the inner corner of the eye for about one minute. This helps prevent the eye drops from draining into the tear duct.
- Remove any excess solution from the skin around the eye.
If another drop is needed, or if both eyes require treatment, repeat steps 3 to 6.
Replace the cap and close the bottle tightly.
FLOXISTILL eye drops must not be injected into the interior of the eyeball.
If you use more FLOXISTILL eye drops than you should
If you use more levofloxacin eye drops than recommended, 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 a forgotten 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 advise you on any necessary measures.
If you stop using FLOXISTILL eye drops earlier than instructed, it may delay the healing process.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not all people experience them.
An adverse reaction occurs in approximately 1 in 10 patients using levofloxacin eye drops.
Most of the adverse reactions affect only the eye and are not long-lasting. If you experience any severe or persistent side effect, you must stop using levofloxacin eye drops and consult your doctor urgently.
The frequency of possible side effects is defined as follows:
| very common | affects more than 1 in 10 users |
| common | affects 1 to 10 in 100 users |
| uncommon | affects 1 to 10 in 1,000 users |
| rare | affects 1 to 10 in 10,000 users |
| very rare | affects less than 1 in 10,000 users |
| not known | frequency cannot be estimated from the available data |
Very rarely, this medicine may cause severe allergic reactions.
The following symptoms may occur after the application of a single dose of levofloxacin eye drops:
- swelling and tightness in the throat,
- difficulty breathing.
In rare cases, other allergic reactions may develop. Symptoms of these reactions include:
- worsening of eye redness and itching,
- increase or sudden onset of swelling of the eyelids.
If any of these symptoms occur, stop using levofloxacin eye drops and consult a doctor immediately.
Common side effects (affecting 1 to 10 users in 100):
- burning sensation in the eye,
- blurred vision or mucus in the eye.
Uncommon side effects (affecting 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 front covering of the eye) or eyelid,
- unusual sensitivity to light,
- itching of the eyes,
- sticky eyelids,
- headache,
- skin rash around the eyes,
- stuffy nose or runny nose.
Rare side effects (affecting 1 to 10 users in 10,000):
- allergic reactions, e.g. skin rash.
Very rare side effects (affecting less than 1 user in 10,000):
- swelling and tightness in the throat,
- difficulty breathing.
Additional side effects in children and adolescents
The frequency, type, and severity of side effects expected in children and adolescents are the same as in adults.
If any side effect occurs, including those not listed in this leaflet, consult your doctor or pharmacist.
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 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 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 seal 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. Any remaining solution should be returned to the pharmacist for safe disposal.
To prevent infection, discard the bottle 28 days after first opening and use a new one.
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 FLOXISTILL eye drops, solution contains
- The active substance is levofloxacin (as hemihydrate) 5 mg/ml.
- The other components of FLOXISTILL are: benzalkonium chloride, sodium chloride, sodium hydroxide solution or hydrochloric acid, and water for injections.
Description of the appearance of FLOXISTILL eye drops, solution and contents of the pack
Yellowish greenish aqueous solution.
5 ml of solution in a 5 ml LDPE (low-density polyethylene) bottle with an LDPE dropper and a cap made of HDPE (high-density polyethylene) or HDPE/LDPE.
Marketing Authorization 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 authorized in the European Economic Area countries under the following
names:
ITALY: FLOXISTILL eye drops solution
PORTUGAL: Levofloxacina Bruschettini